Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious...

26
Reporting Noncompliant Events to OLAW Axel Wolff, M.S., D.V.M Director, Division of Compliance Oversight, OLAW OLAW Online Seminar March 5, 2009

Transcript of Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious...

Page 1: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Reporting Noncompliant Events to OLAW

Axel Wolff MS DVM

Director Division of Compliance Oversight OLAW

OLAW Online Seminar

March 5 2009

The Law and How Itrsquos Implemented

Health Research Extension Act of 1985 Public Law 99-158 ldquoAnimals In Researchrdquo November 20 1985

Public Health Service Policy on Humane Care and Use of Laboratory Animals Revised August 2002

Reporting Requirements PHS Policy IVF3

The IACUC through the Institutional Official shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to

this Policy

Any serious deviation from the provisions of the Guide or

Any suspension of an activity by the IACUC

Any serious or continuing noncompliance with

Guide for the Care and Use of Laboratory Animals

Institute for Laboratory Animal Research

Performance Standards

Published data

Expert opinion and experience

Scientific principles

Currently under review for new edition

National Academy of Sciencesrsquo

Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals

NOT-OD-05-034 (NIH Guide for Grants amp Contracts)

Issued 22405

Provides specific examples of reportable items

Provides examples of situations not normally required to be reported

Serious or Continuing Noncompliance with PHS Policy

Conducting animal related activities without appropriate IACUC review and approval

Failure of animal care and use personnel to adhere to IACUC-reviewed and -approved protocols institutional policies or procedures

Failure to correct deficiencies identified during the semiannual evaluation in a timely manner

Serious Deviation from the Provisions of the Guide

Conditions that jeopardize the health or well-being of animals including accidents natural disasters and mechanical failures resulting in actual animal harm or death

Shortcomings in programs of veterinary care occupational health or training identified during semiannual program review and not corrected within the institutionally determined time frame

Suspension of an Activity by the IACUC

An IACUC intervention that results in the temporary or permanent interruption of an activity involving animals

IACUC suspends after review by a convened quorum with majority voting for suspension

IO in consultation with IACUC takes corrective action and reports to OLAW

Serious Noncompliance Must Be Reported

Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the Assured institution even if identified initially by other agencies site visitors or consultants such as

Other NIH site visitors funding component Office of Extramural Research grants officials

AAALAC (Association for the Assessment and Accreditation of Laboratory Animal Care Int

USDA

CDC

FDA

Semiannual Program Review and Facility Inspection

If the IACUC identifies a serious problem during the semiannual review a prompt report to OLAW is required

Semiannual reports are not routinely submitted to OLAW other than when non accredited institutions submit Assurances for review

Prompt Reporting

Self-reporting is a component of self-regulation

Report as soon as possible

Make initial report by telephone fax emailhellipdonrsquot wait until problem is solved

Donrsquot wait until Annual Report is due

Final report must contain specific and reasonable corrective plans and schedules

Funding Component Contact

Suspension of an animal activity by the IACUC must be reported to the PHS funding component

Provide clear statement of problem planned or completed corrective action

Include the length of suspension

Funding component may withhold funds for animal related work during suspension period

Common Compliance Issues - 1

Conduct of activities not approved by the IACUC

Failure to obtain initial approval

Conduct of activities after protocol expired

Conduct of activities during suspension

Implementation of an unapproved significant change

Common Corrective Actions - 1

Conduct of activities not approved by the IACUC

Stop unapproved activity

Place animals on holding protocol

Do not charge the PHSNIH grant

Counsel and retrain staff

Implement better laboratory oversight communication tracking understanding of protocol content

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 2: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

The Law and How Itrsquos Implemented

Health Research Extension Act of 1985 Public Law 99-158 ldquoAnimals In Researchrdquo November 20 1985

Public Health Service Policy on Humane Care and Use of Laboratory Animals Revised August 2002

Reporting Requirements PHS Policy IVF3

The IACUC through the Institutional Official shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to

this Policy

Any serious deviation from the provisions of the Guide or

Any suspension of an activity by the IACUC

Any serious or continuing noncompliance with

Guide for the Care and Use of Laboratory Animals

Institute for Laboratory Animal Research

Performance Standards

Published data

Expert opinion and experience

Scientific principles

Currently under review for new edition

National Academy of Sciencesrsquo

Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals

NOT-OD-05-034 (NIH Guide for Grants amp Contracts)

Issued 22405

Provides specific examples of reportable items

Provides examples of situations not normally required to be reported

Serious or Continuing Noncompliance with PHS Policy

Conducting animal related activities without appropriate IACUC review and approval

Failure of animal care and use personnel to adhere to IACUC-reviewed and -approved protocols institutional policies or procedures

Failure to correct deficiencies identified during the semiannual evaluation in a timely manner

Serious Deviation from the Provisions of the Guide

Conditions that jeopardize the health or well-being of animals including accidents natural disasters and mechanical failures resulting in actual animal harm or death

Shortcomings in programs of veterinary care occupational health or training identified during semiannual program review and not corrected within the institutionally determined time frame

Suspension of an Activity by the IACUC

An IACUC intervention that results in the temporary or permanent interruption of an activity involving animals

IACUC suspends after review by a convened quorum with majority voting for suspension

IO in consultation with IACUC takes corrective action and reports to OLAW

Serious Noncompliance Must Be Reported

Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the Assured institution even if identified initially by other agencies site visitors or consultants such as

Other NIH site visitors funding component Office of Extramural Research grants officials

AAALAC (Association for the Assessment and Accreditation of Laboratory Animal Care Int

USDA

CDC

FDA

Semiannual Program Review and Facility Inspection

If the IACUC identifies a serious problem during the semiannual review a prompt report to OLAW is required

Semiannual reports are not routinely submitted to OLAW other than when non accredited institutions submit Assurances for review

Prompt Reporting

Self-reporting is a component of self-regulation

Report as soon as possible

Make initial report by telephone fax emailhellipdonrsquot wait until problem is solved

Donrsquot wait until Annual Report is due

Final report must contain specific and reasonable corrective plans and schedules

Funding Component Contact

Suspension of an animal activity by the IACUC must be reported to the PHS funding component

Provide clear statement of problem planned or completed corrective action

Include the length of suspension

Funding component may withhold funds for animal related work during suspension period

Common Compliance Issues - 1

Conduct of activities not approved by the IACUC

Failure to obtain initial approval

Conduct of activities after protocol expired

Conduct of activities during suspension

Implementation of an unapproved significant change

Common Corrective Actions - 1

Conduct of activities not approved by the IACUC

Stop unapproved activity

Place animals on holding protocol

Do not charge the PHSNIH grant

Counsel and retrain staff

Implement better laboratory oversight communication tracking understanding of protocol content

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 3: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Reporting Requirements PHS Policy IVF3

The IACUC through the Institutional Official shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to

this Policy

Any serious deviation from the provisions of the Guide or

Any suspension of an activity by the IACUC

Any serious or continuing noncompliance with

Guide for the Care and Use of Laboratory Animals

Institute for Laboratory Animal Research

Performance Standards

Published data

Expert opinion and experience

Scientific principles

Currently under review for new edition

National Academy of Sciencesrsquo

Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals

NOT-OD-05-034 (NIH Guide for Grants amp Contracts)

Issued 22405

Provides specific examples of reportable items

Provides examples of situations not normally required to be reported

Serious or Continuing Noncompliance with PHS Policy

Conducting animal related activities without appropriate IACUC review and approval

Failure of animal care and use personnel to adhere to IACUC-reviewed and -approved protocols institutional policies or procedures

Failure to correct deficiencies identified during the semiannual evaluation in a timely manner

Serious Deviation from the Provisions of the Guide

Conditions that jeopardize the health or well-being of animals including accidents natural disasters and mechanical failures resulting in actual animal harm or death

Shortcomings in programs of veterinary care occupational health or training identified during semiannual program review and not corrected within the institutionally determined time frame

Suspension of an Activity by the IACUC

An IACUC intervention that results in the temporary or permanent interruption of an activity involving animals

IACUC suspends after review by a convened quorum with majority voting for suspension

IO in consultation with IACUC takes corrective action and reports to OLAW

Serious Noncompliance Must Be Reported

Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the Assured institution even if identified initially by other agencies site visitors or consultants such as

Other NIH site visitors funding component Office of Extramural Research grants officials

AAALAC (Association for the Assessment and Accreditation of Laboratory Animal Care Int

USDA

CDC

FDA

Semiannual Program Review and Facility Inspection

If the IACUC identifies a serious problem during the semiannual review a prompt report to OLAW is required

Semiannual reports are not routinely submitted to OLAW other than when non accredited institutions submit Assurances for review

Prompt Reporting

Self-reporting is a component of self-regulation

Report as soon as possible

Make initial report by telephone fax emailhellipdonrsquot wait until problem is solved

Donrsquot wait until Annual Report is due

Final report must contain specific and reasonable corrective plans and schedules

Funding Component Contact

Suspension of an animal activity by the IACUC must be reported to the PHS funding component

Provide clear statement of problem planned or completed corrective action

Include the length of suspension

Funding component may withhold funds for animal related work during suspension period

Common Compliance Issues - 1

Conduct of activities not approved by the IACUC

Failure to obtain initial approval

Conduct of activities after protocol expired

Conduct of activities during suspension

Implementation of an unapproved significant change

Common Corrective Actions - 1

Conduct of activities not approved by the IACUC

Stop unapproved activity

Place animals on holding protocol

Do not charge the PHSNIH grant

Counsel and retrain staff

Implement better laboratory oversight communication tracking understanding of protocol content

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 4: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Guide for the Care and Use of Laboratory Animals

Institute for Laboratory Animal Research

Performance Standards

Published data

Expert opinion and experience

Scientific principles

Currently under review for new edition

National Academy of Sciencesrsquo

Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals

NOT-OD-05-034 (NIH Guide for Grants amp Contracts)

Issued 22405

Provides specific examples of reportable items

Provides examples of situations not normally required to be reported

Serious or Continuing Noncompliance with PHS Policy

Conducting animal related activities without appropriate IACUC review and approval

Failure of animal care and use personnel to adhere to IACUC-reviewed and -approved protocols institutional policies or procedures

Failure to correct deficiencies identified during the semiannual evaluation in a timely manner

Serious Deviation from the Provisions of the Guide

Conditions that jeopardize the health or well-being of animals including accidents natural disasters and mechanical failures resulting in actual animal harm or death

Shortcomings in programs of veterinary care occupational health or training identified during semiannual program review and not corrected within the institutionally determined time frame

Suspension of an Activity by the IACUC

An IACUC intervention that results in the temporary or permanent interruption of an activity involving animals

IACUC suspends after review by a convened quorum with majority voting for suspension

IO in consultation with IACUC takes corrective action and reports to OLAW

Serious Noncompliance Must Be Reported

Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the Assured institution even if identified initially by other agencies site visitors or consultants such as

Other NIH site visitors funding component Office of Extramural Research grants officials

AAALAC (Association for the Assessment and Accreditation of Laboratory Animal Care Int

USDA

CDC

FDA

Semiannual Program Review and Facility Inspection

If the IACUC identifies a serious problem during the semiannual review a prompt report to OLAW is required

Semiannual reports are not routinely submitted to OLAW other than when non accredited institutions submit Assurances for review

Prompt Reporting

Self-reporting is a component of self-regulation

Report as soon as possible

Make initial report by telephone fax emailhellipdonrsquot wait until problem is solved

Donrsquot wait until Annual Report is due

Final report must contain specific and reasonable corrective plans and schedules

Funding Component Contact

Suspension of an animal activity by the IACUC must be reported to the PHS funding component

Provide clear statement of problem planned or completed corrective action

Include the length of suspension

Funding component may withhold funds for animal related work during suspension period

Common Compliance Issues - 1

Conduct of activities not approved by the IACUC

Failure to obtain initial approval

Conduct of activities after protocol expired

Conduct of activities during suspension

Implementation of an unapproved significant change

Common Corrective Actions - 1

Conduct of activities not approved by the IACUC

Stop unapproved activity

Place animals on holding protocol

Do not charge the PHSNIH grant

Counsel and retrain staff

Implement better laboratory oversight communication tracking understanding of protocol content

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 5: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals

NOT-OD-05-034 (NIH Guide for Grants amp Contracts)

Issued 22405

Provides specific examples of reportable items

Provides examples of situations not normally required to be reported

Serious or Continuing Noncompliance with PHS Policy

Conducting animal related activities without appropriate IACUC review and approval

Failure of animal care and use personnel to adhere to IACUC-reviewed and -approved protocols institutional policies or procedures

Failure to correct deficiencies identified during the semiannual evaluation in a timely manner

Serious Deviation from the Provisions of the Guide

Conditions that jeopardize the health or well-being of animals including accidents natural disasters and mechanical failures resulting in actual animal harm or death

Shortcomings in programs of veterinary care occupational health or training identified during semiannual program review and not corrected within the institutionally determined time frame

Suspension of an Activity by the IACUC

An IACUC intervention that results in the temporary or permanent interruption of an activity involving animals

IACUC suspends after review by a convened quorum with majority voting for suspension

IO in consultation with IACUC takes corrective action and reports to OLAW

Serious Noncompliance Must Be Reported

Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the Assured institution even if identified initially by other agencies site visitors or consultants such as

Other NIH site visitors funding component Office of Extramural Research grants officials

AAALAC (Association for the Assessment and Accreditation of Laboratory Animal Care Int

USDA

CDC

FDA

Semiannual Program Review and Facility Inspection

If the IACUC identifies a serious problem during the semiannual review a prompt report to OLAW is required

Semiannual reports are not routinely submitted to OLAW other than when non accredited institutions submit Assurances for review

Prompt Reporting

Self-reporting is a component of self-regulation

Report as soon as possible

Make initial report by telephone fax emailhellipdonrsquot wait until problem is solved

Donrsquot wait until Annual Report is due

Final report must contain specific and reasonable corrective plans and schedules

Funding Component Contact

Suspension of an animal activity by the IACUC must be reported to the PHS funding component

Provide clear statement of problem planned or completed corrective action

Include the length of suspension

Funding component may withhold funds for animal related work during suspension period

Common Compliance Issues - 1

Conduct of activities not approved by the IACUC

Failure to obtain initial approval

Conduct of activities after protocol expired

Conduct of activities during suspension

Implementation of an unapproved significant change

Common Corrective Actions - 1

Conduct of activities not approved by the IACUC

Stop unapproved activity

Place animals on holding protocol

Do not charge the PHSNIH grant

Counsel and retrain staff

Implement better laboratory oversight communication tracking understanding of protocol content

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 6: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Serious or Continuing Noncompliance with PHS Policy

Conducting animal related activities without appropriate IACUC review and approval

Failure of animal care and use personnel to adhere to IACUC-reviewed and -approved protocols institutional policies or procedures

Failure to correct deficiencies identified during the semiannual evaluation in a timely manner

Serious Deviation from the Provisions of the Guide

Conditions that jeopardize the health or well-being of animals including accidents natural disasters and mechanical failures resulting in actual animal harm or death

Shortcomings in programs of veterinary care occupational health or training identified during semiannual program review and not corrected within the institutionally determined time frame

Suspension of an Activity by the IACUC

An IACUC intervention that results in the temporary or permanent interruption of an activity involving animals

IACUC suspends after review by a convened quorum with majority voting for suspension

IO in consultation with IACUC takes corrective action and reports to OLAW

Serious Noncompliance Must Be Reported

Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the Assured institution even if identified initially by other agencies site visitors or consultants such as

Other NIH site visitors funding component Office of Extramural Research grants officials

AAALAC (Association for the Assessment and Accreditation of Laboratory Animal Care Int

USDA

CDC

FDA

Semiannual Program Review and Facility Inspection

If the IACUC identifies a serious problem during the semiannual review a prompt report to OLAW is required

Semiannual reports are not routinely submitted to OLAW other than when non accredited institutions submit Assurances for review

Prompt Reporting

Self-reporting is a component of self-regulation

Report as soon as possible

Make initial report by telephone fax emailhellipdonrsquot wait until problem is solved

Donrsquot wait until Annual Report is due

Final report must contain specific and reasonable corrective plans and schedules

Funding Component Contact

Suspension of an animal activity by the IACUC must be reported to the PHS funding component

Provide clear statement of problem planned or completed corrective action

Include the length of suspension

Funding component may withhold funds for animal related work during suspension period

Common Compliance Issues - 1

Conduct of activities not approved by the IACUC

Failure to obtain initial approval

Conduct of activities after protocol expired

Conduct of activities during suspension

Implementation of an unapproved significant change

Common Corrective Actions - 1

Conduct of activities not approved by the IACUC

Stop unapproved activity

Place animals on holding protocol

Do not charge the PHSNIH grant

Counsel and retrain staff

Implement better laboratory oversight communication tracking understanding of protocol content

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 7: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Serious Deviation from the Provisions of the Guide

Conditions that jeopardize the health or well-being of animals including accidents natural disasters and mechanical failures resulting in actual animal harm or death

Shortcomings in programs of veterinary care occupational health or training identified during semiannual program review and not corrected within the institutionally determined time frame

Suspension of an Activity by the IACUC

An IACUC intervention that results in the temporary or permanent interruption of an activity involving animals

IACUC suspends after review by a convened quorum with majority voting for suspension

IO in consultation with IACUC takes corrective action and reports to OLAW

Serious Noncompliance Must Be Reported

Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the Assured institution even if identified initially by other agencies site visitors or consultants such as

Other NIH site visitors funding component Office of Extramural Research grants officials

AAALAC (Association for the Assessment and Accreditation of Laboratory Animal Care Int

USDA

CDC

FDA

Semiannual Program Review and Facility Inspection

If the IACUC identifies a serious problem during the semiannual review a prompt report to OLAW is required

Semiannual reports are not routinely submitted to OLAW other than when non accredited institutions submit Assurances for review

Prompt Reporting

Self-reporting is a component of self-regulation

Report as soon as possible

Make initial report by telephone fax emailhellipdonrsquot wait until problem is solved

Donrsquot wait until Annual Report is due

Final report must contain specific and reasonable corrective plans and schedules

Funding Component Contact

Suspension of an animal activity by the IACUC must be reported to the PHS funding component

Provide clear statement of problem planned or completed corrective action

Include the length of suspension

Funding component may withhold funds for animal related work during suspension period

Common Compliance Issues - 1

Conduct of activities not approved by the IACUC

Failure to obtain initial approval

Conduct of activities after protocol expired

Conduct of activities during suspension

Implementation of an unapproved significant change

Common Corrective Actions - 1

Conduct of activities not approved by the IACUC

Stop unapproved activity

Place animals on holding protocol

Do not charge the PHSNIH grant

Counsel and retrain staff

Implement better laboratory oversight communication tracking understanding of protocol content

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 8: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Suspension of an Activity by the IACUC

An IACUC intervention that results in the temporary or permanent interruption of an activity involving animals

IACUC suspends after review by a convened quorum with majority voting for suspension

IO in consultation with IACUC takes corrective action and reports to OLAW

Serious Noncompliance Must Be Reported

Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the Assured institution even if identified initially by other agencies site visitors or consultants such as

Other NIH site visitors funding component Office of Extramural Research grants officials

AAALAC (Association for the Assessment and Accreditation of Laboratory Animal Care Int

USDA

CDC

FDA

Semiannual Program Review and Facility Inspection

If the IACUC identifies a serious problem during the semiannual review a prompt report to OLAW is required

Semiannual reports are not routinely submitted to OLAW other than when non accredited institutions submit Assurances for review

Prompt Reporting

Self-reporting is a component of self-regulation

Report as soon as possible

Make initial report by telephone fax emailhellipdonrsquot wait until problem is solved

Donrsquot wait until Annual Report is due

Final report must contain specific and reasonable corrective plans and schedules

Funding Component Contact

Suspension of an animal activity by the IACUC must be reported to the PHS funding component

Provide clear statement of problem planned or completed corrective action

Include the length of suspension

Funding component may withhold funds for animal related work during suspension period

Common Compliance Issues - 1

Conduct of activities not approved by the IACUC

Failure to obtain initial approval

Conduct of activities after protocol expired

Conduct of activities during suspension

Implementation of an unapproved significant change

Common Corrective Actions - 1

Conduct of activities not approved by the IACUC

Stop unapproved activity

Place animals on holding protocol

Do not charge the PHSNIH grant

Counsel and retrain staff

Implement better laboratory oversight communication tracking understanding of protocol content

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 9: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Serious Noncompliance Must Be Reported

Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the Assured institution even if identified initially by other agencies site visitors or consultants such as

Other NIH site visitors funding component Office of Extramural Research grants officials

AAALAC (Association for the Assessment and Accreditation of Laboratory Animal Care Int

USDA

CDC

FDA

Semiannual Program Review and Facility Inspection

If the IACUC identifies a serious problem during the semiannual review a prompt report to OLAW is required

Semiannual reports are not routinely submitted to OLAW other than when non accredited institutions submit Assurances for review

Prompt Reporting

Self-reporting is a component of self-regulation

Report as soon as possible

Make initial report by telephone fax emailhellipdonrsquot wait until problem is solved

Donrsquot wait until Annual Report is due

Final report must contain specific and reasonable corrective plans and schedules

Funding Component Contact

Suspension of an animal activity by the IACUC must be reported to the PHS funding component

Provide clear statement of problem planned or completed corrective action

Include the length of suspension

Funding component may withhold funds for animal related work during suspension period

Common Compliance Issues - 1

Conduct of activities not approved by the IACUC

Failure to obtain initial approval

Conduct of activities after protocol expired

Conduct of activities during suspension

Implementation of an unapproved significant change

Common Corrective Actions - 1

Conduct of activities not approved by the IACUC

Stop unapproved activity

Place animals on holding protocol

Do not charge the PHSNIH grant

Counsel and retrain staff

Implement better laboratory oversight communication tracking understanding of protocol content

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 10: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Semiannual Program Review and Facility Inspection

If the IACUC identifies a serious problem during the semiannual review a prompt report to OLAW is required

Semiannual reports are not routinely submitted to OLAW other than when non accredited institutions submit Assurances for review

Prompt Reporting

Self-reporting is a component of self-regulation

Report as soon as possible

Make initial report by telephone fax emailhellipdonrsquot wait until problem is solved

Donrsquot wait until Annual Report is due

Final report must contain specific and reasonable corrective plans and schedules

Funding Component Contact

Suspension of an animal activity by the IACUC must be reported to the PHS funding component

Provide clear statement of problem planned or completed corrective action

Include the length of suspension

Funding component may withhold funds for animal related work during suspension period

Common Compliance Issues - 1

Conduct of activities not approved by the IACUC

Failure to obtain initial approval

Conduct of activities after protocol expired

Conduct of activities during suspension

Implementation of an unapproved significant change

Common Corrective Actions - 1

Conduct of activities not approved by the IACUC

Stop unapproved activity

Place animals on holding protocol

Do not charge the PHSNIH grant

Counsel and retrain staff

Implement better laboratory oversight communication tracking understanding of protocol content

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 11: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Prompt Reporting

Self-reporting is a component of self-regulation

Report as soon as possible

Make initial report by telephone fax emailhellipdonrsquot wait until problem is solved

Donrsquot wait until Annual Report is due

Final report must contain specific and reasonable corrective plans and schedules

Funding Component Contact

Suspension of an animal activity by the IACUC must be reported to the PHS funding component

Provide clear statement of problem planned or completed corrective action

Include the length of suspension

Funding component may withhold funds for animal related work during suspension period

Common Compliance Issues - 1

Conduct of activities not approved by the IACUC

Failure to obtain initial approval

Conduct of activities after protocol expired

Conduct of activities during suspension

Implementation of an unapproved significant change

Common Corrective Actions - 1

Conduct of activities not approved by the IACUC

Stop unapproved activity

Place animals on holding protocol

Do not charge the PHSNIH grant

Counsel and retrain staff

Implement better laboratory oversight communication tracking understanding of protocol content

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 12: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Funding Component Contact

Suspension of an animal activity by the IACUC must be reported to the PHS funding component

Provide clear statement of problem planned or completed corrective action

Include the length of suspension

Funding component may withhold funds for animal related work during suspension period

Common Compliance Issues - 1

Conduct of activities not approved by the IACUC

Failure to obtain initial approval

Conduct of activities after protocol expired

Conduct of activities during suspension

Implementation of an unapproved significant change

Common Corrective Actions - 1

Conduct of activities not approved by the IACUC

Stop unapproved activity

Place animals on holding protocol

Do not charge the PHSNIH grant

Counsel and retrain staff

Implement better laboratory oversight communication tracking understanding of protocol content

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 13: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Common Compliance Issues - 1

Conduct of activities not approved by the IACUC

Failure to obtain initial approval

Conduct of activities after protocol expired

Conduct of activities during suspension

Implementation of an unapproved significant change

Common Corrective Actions - 1

Conduct of activities not approved by the IACUC

Stop unapproved activity

Place animals on holding protocol

Do not charge the PHSNIH grant

Counsel and retrain staff

Implement better laboratory oversight communication tracking understanding of protocol content

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 14: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Common Corrective Actions - 1

Conduct of activities not approved by the IACUC

Stop unapproved activity

Place animals on holding protocol

Do not charge the PHSNIH grant

Counsel and retrain staff

Implement better laboratory oversight communication tracking understanding of protocol content

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 15: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Common Compliance Issues - 2

The IACUC

Lack of required membership

Absence of a quorum

Problems due to inadequate training or monitoring

Allowing conduct of animal related activities beyond expiration date (maximum 3 yrs)

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 16: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Common Corrective Actions - 2

The IACUC

Provide additional training for IACUC members eg OLAW tutorial IACUC 101 PRIMampR SCAW

Reapprove all official actions with appropriately constituted IACUCquorum

Provide adequate post-approval monitoring

Ensure adequate communication between IACUC and PIs

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 17: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Common Compliance Issues - 3

Clinical care

Inadequate pre- peri- and post-procedural care monitoring records analgesia

Failure to ensure death after euthanasia procedure

Failure to carry out veterinary orders

Chronic cage overcrowding

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 18: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Common Corrective Actions - 3

Clinical care Establish peri-operative SOPs and

assign dedicated personnel

Keep adequate records of procedures

Ensure adequate training

Ensure appropriate authority of vet

Establish SOP for timely separation of weaned rodents

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 19: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Recordkeeping Requirements

Animal Welfare Assurance

Minutes of IACUC meetings

Records of IACUC review of protocols

Semiannual reports including dissenting views

Accrediting body determinations (AAALAC status)

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 20: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Implications of Noncompliance

Corrective actions and improved systems

Restrict or withdraw approval of Assurance

Institute special terms or conditions of awards

Disallow costs

Suspend or terminate award

Criminal prosecution

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 21: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

How to Avoid Noncompliance

Clear institutional policies and procedures including mechanism to register concerns

Initial training at all levels

Continuing education

Effective intra-institutional communication

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 22: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Accountability

Institution is accountable for

Financial amp administrative aspects of the award

The animal care and use program (IACUC)

Investigator is accountable for

Conducting research within the parameters of the approved protocol

Compliance with animal care and use program

IACUC together with the IO exercises oversight over institutional animal care and use

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 23: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

NIH Expectations

Institutional climate that promotes compliance

Institutional policies

Institutional training

Checks and balances

Communication internal and with NIH

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 24: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Prompt Reporting Summary

Serious or continuing noncompliance with the PHS Policy

Serious deviations from the Guide Any suspension of an activity by the IACUC

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 25: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

Contact OLAW for Advice or Help

If unsure if an item is reportable - call or email

Better to ask or report than not

Consequences are less desirable if reportable event is withheld and discovered later

OLAW needs information on serious noncompliance to represent institution to PHS Congress press

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS

Page 26: Reporting Noncompliant Events to OLAW · Serious Noncompliance Must Be Reported Serious noncompliance with the PHS Policy and deviations from the Guide must be self-reported by the

OLAW Electronic Access

e-mail olawodnihgov

httpolawnihgov

ListServ

Receive current announcements notices policy interpretations

Register for ListServ on OLAW webpage

Coming soon OLAW RSS


October 20-21,2009 Agenda Item 6b.. Noncompliance Dischargers Section 123.45 of the FWPCA Regulations requires the status of noncompliance for NPDES permit.

October 20-21,2009 Agenda Item 6b.. Noncompliance Dischargers Section 123.45 of the FWPCA Regulations requires the status of noncompliance for NPDES permit.

Safety Defect and Noncompliance Report Guide for Vehicles ...

Safety Defect and Noncompliance Report Guide for Vehicles ...

tate Auditor’s Austin, Texas 78701 Office · Agency/University Market Value of Investments at August 31, 1999 Compliance Reported by Entity Instances of Noncompliance Comments From

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HIGHLIGHTS OF PRESCRIBING INFORMATION ......94 5.2 Serious Infections 95 Serious and sometimes fatal infections have been reported in patients receiving 96 immunosuppressive agents,

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Financial and Governance Noncompliance Policy for Charter Schools

Financial and Governance Noncompliance Policy for Charter Schools

Review of Procedures for of a Notice of Noncompliance and ... · Summary of key issues of a NONC • Notice of Noncompliance • Describes the noncompliance(s) • Identifies the

Review of Procedures for of a Notice of Noncompliance and ... · Summary of key issues of a NONC • Notice of Noncompliance • Describes the noncompliance(s) • Identifies the

C0934 - WSU Extensionextension.wsu.edu/.../2014/09/2016-10-Chelan-Dougla… · Web viewEvidence of noncompliance may be reported through your local Extension office. Reprinted November

C0934 - WSU Extensionextension.wsu.edu/.../2014/09/2016-10-Chelan-Dougla… · Web viewEvidence of noncompliance may be reported through your local Extension office. Reprinted November

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UIF NONCOMPLIANCE BY THE SMALL BUSINESS CATERING …

Income tax noncompliance in Germany, 2001-2014

Income tax noncompliance in Germany, 2001-2014

Estimating Tax Noncompliance in Latin America: 2000 – 2010

Estimating Tax Noncompliance in Latin America: 2000 – 2010

VEGETABLE GARDENING 101+ - s3.wp.wsu.edu · WSU Extension programs and employment are available to all without discrimination. Evidence of noncompliance may be reported through your

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Noncompliance and instrumental variables for 2K factorial ...

Noncompliance and instrumental variables for 2K factorial ...

Possible Noncompliance Review - FRCC Documents/RAM-200... · Possible Noncompliance Review Processing July 1, 2017 ... mitigating activities to be completed before the correct ...

Possible Noncompliance Review - FRCC Documents/RAM-200... · Possible Noncompliance Review Processing July 1, 2017 ... mitigating activities to be completed before the correct ...

ANIMAL HEALTH REQUIREMENTS FOR SHEEP MEAT TO BE … · 30/shouan/4316 9 January, 2019 3 3.4 A system-wide problem such as repeated serious noncompliance may result in the suspension

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Report on serious misconduct risks around v P } µ drugs in … on serious... · hospitals, Royal Perth Hospital (RPH), SCGH, and Fremantle Hospital (FH). These hospitals reported

Report on serious misconduct risks around v P } µ drugs in … on serious... · hospitals, Royal Perth Hospital (RPH), SCGH, and Fremantle Hospital (FH). These hospitals reported

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Corruption and Tax Noncompliance Variables: An Empirical ...

EPA’s Interim Significant Noncompliance Policy for Clean ...

EPA’s Interim Significant Noncompliance Policy for Clean ...

GAO-20-150, Accessible Version, MENTAL HEALTH …consumer complaints and other information about potential noncompliance. For example, DOL reported citing 113 violations of MH/SU parity

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9.1 AUTHORITY, RESPONSIBILITY AND CORRECTING …€¦ · 9.1 authority, responsibility and correcting noncompliance 9.2 ems procedure for investigating and correcting noncompliance

9.1 AUTHORITY, RESPONSIBILITY AND CORRECTING …€¦ · 9.1 authority, responsibility and correcting noncompliance 9.2 ems procedure for investigating and correcting noncompliance