STANDARD OPERATING PROCEDURES FOR MOI ......i. Members may resign from their post by giving a letter...

MTRH/MU IREC of 23 | Version 8 | May 2017

Moi University College of Health Sciences

P.O. Box 4606-30100 Eldoret, Kenya.

Email: [email protected]

Moi Teaching and Referral Hospital P.O. Box 3-30100

Eldoret, Kenya. Email: [email protected]

STANDARD OPERATING PROCEDURES

FOR

MOI INSTITUTIONAL RESEARCH

&

ETHICS COMMITTEE

mailto:[email protected]


Foreword

Biomedical research involving human beings has the potential for great good as well as

great harm to potential study participants. They are at risk of physical and emotional

exploitation. This is largely due to the high esteem in which health professionals and

researchers are held by the lay public, which can easily be abused. In addition, there

are, special groups including but not limited to minors, refugees and mentally unsound

who are even more prone to exploitation in research.

With increasing collaborative research involving external institutions/organizations of

diverse societal backgrounds, and different interpretations of ethical issues there is need

to regulate research activities and protection of research participants. Through the

Science, Technology and Innovation Act 2013, the National Commission for Science

Technology and Innovation (NACOSTI) was establishment to regulate research in the

country. To achieve this mandate NACOSTI facilitated the establishment of review

boards of which Moi University College of Health Sciences (CHS) and Moi Teaching and

Referral Hospital (MTRH) Institutional Research and Ethics Committee (IREC) is one of

them.

The activities of IREC especially in review of research proposals may be prone to various

forms of abuse that can inhibit rather than foster a research culture. It is therefore

important that the systems and procedure for receiving, reviewing, approving research

proposals and post-approval compliance monitoring are put in place. These systems

should be standardized so as to allow expeditious, objective and reproducible review of

proposals. The development and dissemination of the Standard Operating Procedures

(SOPs) of IREC must therefore be viewed as an important step in fostering an ethical and

humane research culture in our institutions. It is understood that, new ethical issues in

health related research will keep emerging and hence there will be need for regular

revisions of these SOPs to maintain their relevance to contemporary trends.

Chief Executive Officer, Principal,

Moi Teaching and Referral Moi University, College of Health


Hospital Sciences

List of Abbreviations

AOB – Any other Business

CD Rom – Compact Disc Read-Only Memory

C.E.O – Chief Executive Officer

CHS – College of Health Sciences

COBES – Community Based Education and Service

CV – Curriculum Vitae

IRB – Institutional Review Board

IREC – Institutional Research and Ethics Committee

MUCHS – Moi University, College of Health Sciences

MTRH – Moi Teaching & Referral Hospital

NACOSTI – National Commission for Science, Technology and Innovation

PI – Principal Investigator

SOPs – Standard Operating Procedures

TOR – Terms of Reference

USA – United States of America


Table of Contents

Foreword .......................................................................................................................................... 2

List of Abbreviations ....................................................................................................................... 3

1.0 ROLE OF IREC .................................................................................................................... 6

2.0 TERMS OF REFERENCE .................................................................................................. 6

3.0 MEMBERSHIP ..................................................................................................................... 6

3.1 Co-option ............................................................................................................................... 7

3.2 Appointments ........................................................................................................................ 7

3.3 Tenure and conditions of appointment ............................................................................. 7

3.4 Resignation, disqualification, replacement of members ................................................ 8

3.5 Honoraria ............................................................................................................................... 8

3.6 Review Fee ........................................................................................................................... 8

3.7 Contact Information for IREC ............................................................................................. 9

4.0 THE SECRETARIAT ........................................................................................................... 9

5.0 FUNCTIONS AND RESPONSIBILITIES ......................................................................... 9

5.1 Chair: ...................................................................................................................................... 9

5.2 Vice Chair .............................................................................................................................. 9

5.3 Secretary ............................................................................................................................. 10

5.4 Deputy Secretary ............................................................................................................... 10

5.5 Human Subject’s Administrator ....................................................................................... 10

5.6 Committee Members ......................................................................................................... 11

6.0 REGULAR IREC MEETINGS ...................................................................................... 12

6.1 Frequency ........................................................................................................................... 12

6.2 Quorum ................................................................................................................................ 12

7.0 CONDUCT OF IREC MEETINGS ............................................................................... 12

7.1 IREC Meeting Schedule and Distribution of Agenda ................................................... 12

7.2 Meeting Procedure ............................................................................................................ 12

7.3 Minutes of meetings .......................................................................................................... 13

8.0 SPECIAL MEETINGS ....................................................................................................... 13

9.0 SUBMISSION OF A NEW RESEARCH PROPOSAL ................................................. 13

Application Procedure .............................................................................................................. 13


10.0 TYPES OF REVIEW ...................................................................................................... 16

10.1 Expedited Review ............................................................................................................ 16

10.2 Full Review ....................................................................................................................... 16

10.3 Exempt review .................................................................................................................. 17

10.4 Continuing Review ........................................................................................................... 19

10.5 Review of Study Amendments ...................................................................................... 19

11.0 COMMUNICATION OF REVIEW DECISIONS ......................................................... 20

12.0 FOLLOW UP ................................................................................................................... 20

13.0 APPEAL AGAINST COMMITTEE DECISION .......................................................... 21

14.0 RESPONSIBILITY OF THE PRINCIPAL INVESTIGATOR IN THE REVIEW

PROCESS ..................................................................................................................................... 22

15.0 HANDILING RESEARCH MISCONDUCT ................................................................. 22

16.0 DOCUMENTATION AND ARCHIVING ...................................................................... 22

17.0 REFERENCES ............................................................................................................... 23


1.0 ROLE OF IREC

The Institutional Research and Ethics Committee (IREC), hereinafter called ‘The

Committee’, was constituted jointly by Moi University College of Health Sciences

(MUCHS) and Moi Teaching & Referral Hospital (MTRH). The Committee shall serve as

the regulatory entity for research at the MU and MT&RH and satellite areas and as an

independent representative and competent body to review, evaluate and decide on the

scientific and ethical merits of research proposals. It is committed to ensuring and

guaranteeing the rights, dignity, safety and protection of actual or potential individuals

and communities who participate in research. The Committee governs health research

as guided by applicable laws and regulations of the Kenyan and other relevant

international bodies. The Committee reviews and approves research proposals for and

on behalf of the National Commission for Science, Technology and Innovation which is

the legal entity authorized to review and approve research in Kenya under Cap 250 of the

Laws of Kenya.

2.0 TERMS OF REFERENCE

IREC shall work under the following terms of reference:

1. Review proposals and provide independent ethics and scientific review.

2. Have authority to approve (with or without modification) and disapprove research

proposals.

3. Conduct post approval compliance monitoring.

4. Make an annual report to the National Bioethics Committee.

5. Keep abreast with international developments in relation to health research and

associated ethical issues and liaise with relevant local and international

organizations

3.0 MEMBERSHIP

The Committee shall be composed of 7- 21 members, with 1/3 of the total being of either

gender, having core members from various disciplines including Biomedical, Clinical and

Social Sciences, Biostatistics, Law and a lay person(s).


3.1 Co-option

The Committee may co-opt member(s) at any one time for independent expertise

as and when required. The Committee shall determine the duration of the co-

option.

3.2 Appointments

The Committee members shall be appointed by the C.E.O, MTRH, and the

Principal CHS hereinafter referred to as the Appointing Authority. Appointment will

not take more than 90 days following the request letter done by the chair to the

C.E.O.

3.3 Tenure and conditions of appointment

1. IREC shall have a Chair, Vice Chair, and Secretary, Deputy Secretary, and

members and will be assisted by a secretariat consisting of the human subject

administrator, records personnel, IT, secretary, data entry personnel and

housekeeping staff.

2. Members shall be selected in their personal capacities, based on their interest,

ethical and/or scientific knowledge, and expertise, as well as on their

commitment and willingness to volunteer the necessary time and effort for the

Committee’s work.

3. Members shall be appointed initially for a period of three (3) years, renewable

once.

4. To maintain continuity in the operations of the Committee, at least a third of the

membership shall be retained.

5. The outgoing Chairperson shall be an ex-officio member in the incoming

Committee for one term.

At appointment;

i. Members shall sign a confidentiality agreement at the start of the term and

abide by the confidential agreement regarding meeting deliberations,

applications, protocol submissions, information on research participants and

related matters; which they have had privilege to as a result of being members


of the Committee. The confidentiality protects all the privacy and confidentiality

of all parties whose information may be disclosed to the Committee in the

course of its work.

ii. Members shall provide their updated bio-sketches annually and be willing to

publicize their identity; name, profession and affiliation to the Committee

iii. Members shall disclose in writing any interest or involvement - financial,

professional or otherwise - in a project or proposal under consideration.

iv. Any member who has vested interest in a proposal submitted to the

Committee- shall not participate in the deliberations of the protocol.

3.4 Resignation, disqualification, replacement of members

i. Members may resign from their post by giving a letter of resignation, at least

one month in advance, to the appointing authorities through the Chairperson.

ii. Members may also be disqualified from continuance following advice from the

committee.

iii. The Committee shall request for removal and replacement of any members

under the following circumstances

a. Persistent absenteeism of a member for more than three consecutive

meetings.

b. Voluntary withdrawal of a member.

c. Ethical/professional misconduct.

3.5 Honoraria

i. Honoraria shall be paid to the IREC members after every meeting.

ii. The community representative or any other temporarily co-opted non-

institutional member shall be paid a subsistence allowance which shall be

determined by the Committee from time to time.

3.6 Review Fee

The Committee shall charge a fee to cover administrative costs of research

proposal review. These fees shall vary from time to time as determined by the

Committee.


3.7 Contact Information for IREC

IREC shall have a designated physical address, telephone contact, website and e-

mail address. The Human Subject Administrator shall be the contact person.

4.0 THE SECRETARIAT

The Secretariat shall consist of the Secretary, Deputy Secretary, Human Participants

Administrator and support staff.

5.0 FUNCTIONS AND RESPONSIBILITIES

5.1 Chair:

The Chair shall:

i. Conduct meetings in accordance with the regulations

ii. Facilitate induction and training of new Committee members

iii. Facilitate continuing education for members

iv. Oversee the functions and activities of the Secretariat

v. Assign responsibilities and duties to any member of the Committee

vi. Sign the minutes of the Committee meetings

vii. Sign approval letters for research proposals on

viii. Upon the recommendation of the Committee, sign approval letters for

research proposals.

ix. Shall facilitate logistical support to the Secretariat to ensure prompt

execution of IREC mandate

x. Liaise with the National Commission for Science, Technology and

Innovation and other IRBs.

5.2 Vice Chair

xi. Perform all the functions and duties of the chair whenever the chair is

absent.

xii. Perform any other duties as assigned by the Committee or the chair


5.3 Secretary

The Secretary shall:

i. Be responsible for the safety and maintenance of Committee documents,

website and records

ii. Call meetings in consultation with the Chair

iii. Identify suitable reviewers in collaboration with the Committee

iv.Dispatch proposals to reviewers for scientific and ethical review

v.Receive reviewed proposals and monitor the review process of proposals to

ascertain comments from reviewers within the stipulated period.

vi. Prepare proposal review documents for discussion at regular Committee

meetings

vii. Design and disseminate templates for Committee submission documents,

including research protocols, informed consent materials, agreements and

periodic and final reports

viii. Oversee the functions and activities of the Administrator and the support

staff

ix. Record, process and circulate the minutes of the IREC meetings

x. Shall archive the official minutes of the meeting’s agenda and all relevant

attachments

xi. Disseminate SOPs and IREC guidelines

xii. Receive final reports from the PI (s)

xiii. Perform any other duties as assigned by the Committee or the Chair

5.4 Deputy Secretary

i. To officially deputize the Secretary

ii. Perform any other duties assigned by the Secretary

5.5 Human Participants Administrator

The Human Participants Administrator shall:

i. Perform day to day running of the IREC secretariat including financial

management with approval of the Committee

ii. Perform a pre-review of each protocol and categorize the proposals based


on risk levels and appropriate review for consideration to ensure

compliance with administrative submission requirements

iii. Liaise with the Secretary/Deputy Secretary ratify any ‘borderline protocol’ as

necessary

iv. Manage and maintain copies of all correspondences

v. Attend Committee meetings and assist in taking of minutes

vi. Assist the Secretary in drawing the agenda

vii. Circulate research proposals and minutes to Committee members

viii. Assist in preparation and submission of annual operating budget in

consultation with the Chair

ix. Design and maintain a system for collecting and filing all Committee

documents, including meeting minutes, member qualifications, protocol

submission versions, deviations from approved protocols, and periodic and

final reports

x. Maintain inventory of all office equipment

xi. Undertake all other administrative duties as assigned by the secretary.

5.6 Committee Members

Committee members shall:

i. Review, discuss and consider all proposals submitted for review.

ii. Consider decisions taken by the Chair on behalf of the Committee for

ratification

iii. Maintain confidentiality of documents and deliberations of the Committee

meetings.

iv. Declare conflict of interest whenever applicable

v. Participate in continuing education activities in biomedical ethics and

research

vi. Attend Committee meetings regularly and contribute constructively to the

deliberations

vii. Provide technical support to uphold the integrity of IREC

viii. Perform any other duties assigned by the chair


6.0 REGULAR IREC MEETINGS

6.1 Frequency

The Committee shall convene a meeting once a month, held every last Thursday

of the month at 9.00 am.

6.2 Quorum

Quorum shall be half (1/2) of IREC membership (including apologies) and at least a

third of the members physically present.

7.0 CONDUCT OF IREC MEETINGS

7.1 IREC Meeting Schedule and Distribution of Agenda

i. The Secretary shall notify and circulate the agenda, time, venue, and date

for the next meeting to all Committee members at least one week in

advance.

ii. The Secretary shall notify all Committee members of any changes of the

meeting time, venue, date or agenda within 24 hours.

7.2 Meeting Procedure

i. The Chair shall call the meeting to order

ii. The Chair shall request for adoption of the agenda

iii. The Standard agenda shall be as follows;

a. Prayers

b. Apologies

c. Communication from the chair

d. Declaration of Conflict of Interest.

e. Confirmation of minutes

f. Matters arising

g. Consideration of actions taken by the Chair on behalf of the

Committee

h. Receive and Consider Research Proposals

i. Receive and Adopt Reports


j. Any Other Business (A.O.B)

iv. Committee members with interests in any research proposal shall declare

the same and shall leave the meeting for the duration of the deliberations

on the proposal.

v. IREC may where necessary invite the Principal Investigator to the meeting

to clarify certain issues relating to their proposal.

vi. Decision making of the Committee shall be by consensus.

7.3 Minutes of meetings

i. The Chair shall review the minutes for accuracy and completeness then

sign/approve for circulation

ii. The minutes of each meeting shall be distributed to members within a

period of not more than two weeks after every meeting

iii. The minutes shall be confirmed at the next meeting

iv. The confirmed minutes shall be distributed to, the CEO, MTRH and the

Principal College of Health Sciences within two weeks after confirmation.

8.0 SPECIAL MEETINGS

i. Special meetings shall be called as deemed necessary

ii. Specific agenda shall be circulated in the meeting notice. Only specified agenda

items shall be discussed.

iii. There shall be no A.O.B.

9.0 SUBMISSION OF A NEW RESEARCH PROPOSAL

Application Procedure

The requirements for submission of a research project for ethical review are clearly

described in the application procedures available on the IREC Webpage www.irec.or.ke.

The required application forms and a checklist are available on the IREC webpage

http://www.irec.or.ke/


Application procedure chart

WHAT IS MY LEVEL OF

SUBMISSION?

Exempt review less than

“minimal risk” to human

subjects example: anonymous

response survey, focus group or

questionnaire, case reports

working with a completely

deidentified (anonymous)

secondary data set

WHAT FORMS DO I NEED?

Reviewer guideline &

abstract forms required

during submission to IREC

Vulnerable population form required when dealing with

vulnerable populations

Continuing review forms to

be filled when the study

periods is approaching an end

(at least 1 month before end

of study period)

Amendment forms when

making changes to a protocol

could be a minor or major

amendment.

Other Requirements to

accompany the forms include:

4 hard copies of research

proposal

Informed consent;

Assent form for

participation of minors (if

applicable)

Budget

Evidence of ethics

training

Biosketch/ CVs

Copy of grant application

or approval letter if

applicable Expedited Review “minimal risk” to

human subject’s examples

prospective or retrospective chart

review, surveys/questionnaires

collecting limited personal identifiers

or health information, any

intervention or interaction with the

subject.

Full review more than minimal risk to

participants any research project

involving human subjects not covered

under other review categories contact

with vulnerable populations working

with data that can be traced or linked to

individual participants’ interventions

involving physical or emotional. IMPORTANT review all paperwork

carefully before submitting to IREC.

“Minimal risk” means that the risk of harm anticipated in the proposed research are not greater, considering probability

and magnitude than those ordinarily encountered in daily life or during the performance of routine physical and

physiological examinations or tests (noninvasive examples, physical, blood pressure, EKG ).

“Vulnerable populations” include those whose interests require special protection, e.g. pregnant women/fetus, prisoners,

minors, subjects with psychiatric/mental disorders, etc.


A valid application is one which at the time of submission, is complete, with all the

necessary documents attached and is signed and dated.

The application should include the following information and materials:

i. The protocol in the required format (see annex 1) and other

accompanying/supporting materials

Four(4) hard copies of the proposal

A soft copy of the proposal (written on a CD or digital copy sent to

[email protected] ).

Four(4) copies of the reviewer guideline form

Four copies(4) of the abstract form

Vulnerable population form (4) copies in case the research involves a

vulnerable population.

Consent forms

Data collection instruments

Recruitment materials (e.g. fliers)

Detailed CV/Bio-sketch

Trans National Bank receipt produced on submission (externally funded

studies will be invoiced) payments expected once funds are availed.

ii. All applications will receive notification in writing of the decision of the IREC

Committee.

iii. Where IREC Committee requires supplementary information or changes to

documents from the applicant, the timeframe for this will be outlined in the letter of

notification.

iv. No revisions may be made, prior to the IREC Committee meeting, to an

application that has been accepted for review and assigned a reference number.

Where an applicant considers it necessary to revise the protocol or supporting

documents prior to review, the application should be withdrawn.

v. Studies are given approval for one-year

vi. Investigators wishing to continue research beyond their one-year approval time

period must submit a continuing review.

mailto:[email protected]


vii. IREC must approve any changes or amendments to an approved study before the

researcher implements such changes.

10.0 TYPES OF REVIEW

There shall be five (5) types of review, namely;

1. Expedited Review

2. Full Review

3. Exempt Review

4. Continuing Review

5. Review of Amendments to a previously approved Proposal.

10.1 Expedited Review

An expedited review shall be conducted by the IREC Secretary, Deputy Secretary

or Human Participant Administrator.

The above mentioned may assign the protocols if expert review is required.

The following categories of research proposal shall qualify for an expedited review

and approval:

i. Research investigation that present no more than minimal risk to the study

participants.

ii. Minor amendment in previously approved research during the period for

which approval was granted.

Definitions of “minimal risk” and “minor amendment” will be based upon accepted

guidelines/categories as defined in national and international guidelines.

10.2 Full Review

All other research proposals submitted for review, and which do not meet the

criteria for expedited and exempt review shall undergo of a full review process as

follows;

i. The Secretary of IREC shall identify at least two suitable experts within

and/or outside the committee to review the proposal.

ii. The administrator shall provide each reviewer a copy of the proposal and a

reviewer’s standard form to assist them in reporting their review findings.


iii. Simultaneously, the administrator shall circulate copies of the proposal

abstracts to the designated reviewer.

iv. The reviewer shall return the reviewer form, the proposal and any other

comments to the administrator within 2 weeks.

v. If after 2 weeks there shall be no response from the reviewer the proposal

shall be withdrawn and re-assigned to another reviewer.

vi. The Human Participant Administrator shall pool all the reviewers’

comments, edit and process, remove any reviewer identifiers, and hand

them over to the PI.

vii. The PI is required to address the concerns within a period of 2 weeks from

receipt date. Once the PI addresses all the reviewers’ comments, a revised

copy of the proposal shall be returned for re-review.

viii. The reviewer shall communicate their recommendations in writing to the

Secretary, who shall then advice the Committee to consider granting

approval to the PI to begin the research work.

10.3 Exempt review

Unless otherwise defined by the Committee and other relevant regulations,

research activities in which the only involvement of human subjects will be in one

or more of the following categories are exempt from these SOPs:

i. Research conducted in established or commonly accepted educational

settings, involving normal educational practices, such as

a. Research on regular and special education instructional strategies, or

b. Research on the effectiveness of or the comparison among

instructional techniques, curricula, or classroom management

methods.

ii. Research involving the use of educational tests (cognitive, diagnostic,

aptitude, achievement), survey procedures, interview procedures or

observation of public behavior, unless:

a. Information obtained is recorded in such a manner that human

participants can be identified, directly or through identifiers linked to

the subjects; and


b. Any disclosure of the human participants responses outside the

research could reasonably place the subjects at risk of criminal or civil

liability or be damaging to the subjects' financial standing,

employability, or reputation.

iii. Research involving the use of educational tests (cognitive, diagnostic,

aptitude, achievement), survey procedures, interview procedures, or

observation of public behavior that is not exempt under paragraph 10.4 (ii)

of this section, if:

a. The human subjects are elected or appointed public officials or

candidates for public office; or

b. Any laws / regulations require(s) without exception that the

confidentiality of the personally identifiable information will be

maintained throughout the research and thereafter.

iv. Research involving the collection or study of existing data, documents,

records, pathological specimens, or diagnostic specimens, if these sources

are publicly available or if the information is recorded by the investigator in

such a manner that subjects cannot be identified, directly or through

identifiers linked to the subjects.

v. Research and demonstration projects which are conducted by or subject to

the approval of department or agency heads, and which are designed to

study, evaluate, or otherwise examine;

a. Public benefit or service programs;

b. Procedures for obtaining benefits or services under those programs;

c. Possible changes in or alternatives to those programs or procedures;

or

d. Possible changes in methods or levels of payment for benefits or

services under those programs.

vi. Taste and food quality evaluation and consumer acceptance studies;

a. If wholesome foods without additives are consumed or

b. If a food is consumed that contains a food ingredient at or below the

level and for a use found to be safe, or agricultural chemical or

environmental contaminant at or below the level found to be safe, by


the any local or international regulatory body.

10.4 Continuing Review

Continuing Review submissions must include all current IREC approved study

documents, even if they have not changed since the last review:

The application for review of continuation of study should include the

following information and materials:

2 hard copies of the continuing review form

2 hard copies of the study proposal document

2hard copies of the consent forms

Recruitment materials

Data collection instruments (surveys, interview questions, stimuli, etc.)

Other forms or documents utilized with human subjects

DSMB/DSMP Report (if applicable)

Research personnel list for Continuing Review

All approvals shall be valid for a period of One (1) year. Studies that last for more

than 1 year shall apply for a continuing approval annually.

For all research studies that are likely to run for more than a year, the Principal

Investigators shall apply for continuing review two months before the expiry of the

IREC approval for their study.

10.5 Review of Study Amendments

Amendments are defined as any changes to an approved research protocol. All

amendments to the study proposal shall be communicated to IREC.

The application for review of amendment should include the following

information and materials:

A cover letter detailing the amendments.


2 hard copies of the amendment form

2hard copies of the revised proposal or other documents impacted by the

proposed research modification

2 hard copies of the newly developed documents that support the proposed

research modification

11.0 COMMUNICATION OF REVIEW DECISIONS

i. The Chair shall communicate within 2 weeks of the date of the decision to the

Principal Investigator on the review decisions.

ii. Communications shall be in writing through standard IREC documents bearing the

signature of the IREC Chair, or a designated officer appointed by the Chair.

iii. The final review decision shall be in the following format;

Formal Approval

Not Approved.

iv. When the decision is Not Approved, the reasons shall be given to the Principal

Investigator in writing.

v. The approvals shall be for one year period, renewable on application for

Continuing Review Approval.

12.0 FOLLOW UP

The Committee shall constitute a monitoring and evaluation sub Committee to monitor

post approval compliance and progress of approved research.

i. The monitoring and evaluation Sub Committee may follow up studies seeking

amendments that are likely to affect the rights, safety, and or well-being of the

participants or the conduct of the study

ii. The Sub Committee shall be expected to make a follow-up on serious and

unexpected adverse events related to the conduct of the study or study product

and the response taken by the investigators, sponsors and regulatory agencies.

iii. The Sub Committee shall be further expected to follow up any event or new

information that may affect the benefit/risk-ratio of the study


Follow up decisions will be communicated in writing to the investigator indicating either of

the following decisions

i. Approval of amendment

ii. Suspension of study processes

iii. Termination of study

The secretariat shall require the investigators to submit

i. Progress reports upon seeking renewal of their studies

ii. Final report and notification on study completion should also follow at the

conclusion of a project.

iii. Any publications of results emanating from the study.

13.0 APPEAL AGAINST COMMITTEE DECISION

An investigator who feels dissatisfied with a review decision has a right of appeal.

i. The aggrieved investigator shall be expected to lodge their appeal with IREC Chair

within 14 days of receiving the review decision.

ii. The IREC Chair shall then constitute an Appeals Sub-Committee of five,

consisting of the IREC Secretary, the Human Subjects Administrator, a member of

IREC with expertise in the subject matter or is content expert in the area of the

research proposal under review and two non–IREC content experts and one non-

IREC ethics expert in the subject matter of the proposal under review but who

MUST not have reviewed the proposal before the appeal.

iii. The IREC Secretary shall be the convenor and the chair of the Appeals Sub-

Committee shall be the non-IREC member.

iv. The IREC members will participate in the discussion BUT will not take part in the

decision making.

v. The IREC Chair shall ensure the Appeals Sub-Committee has access to the

proposal in dispute and request them to meet once to consider the appeals merits

and present their report at the next regular IREC meeting usually within one month

of the appeal being lodged with the IREC chair.

vi. The Committee shall consider the recommendations of the Appeals Sub-

Committee and IRECs decision at this point shall be final.


vii. If the appellant is dissatisfied with the decision of Committee, they have a right to

appeal to NACOSTI.

14.0 RESPONSIBILITY OF THE PRINCIPAL INVESTIGATOR IN THE REVIEW

PROCESS

i. The Principal Investigator shall be responsible for prompt response to reviewers’

comments, usually within one month of receiving the comments.

ii. The administrator shall remind the PI to respond to the reviewer comments after

the month grace period elapses.

iii. If after being reminded, the PI does not respond to the reviewer comments within a

further period of one month, the review shall be considered to have lapsed and the

PI shall be required to make a fresh submission for IREC review.

iv. The Principal Investigator shall submit a final report resulting from the study; in

hard and soft copies.

15.0 HANDILING RESEARCH MISCONDUCT

The Committee will conduct investigations into allegations of research misconduct and

make recommendations for determination of appropriate action to be taken by the

Appointing Authority.

16.0 DOCUMENTATION AND ARCHIVING

IREC shall document and archive the following documents:

IREC standard operating procedures

Duly signed confidentiality agreement forms

Bio-sketch/Curriculum vitae of members

One copy of all materials submitted by applicants

Correspondence by IREC members with investigators in regard to application

decisions and follow up

All correspondence and other materials received during follow-up

A list of IREC members

Records of income and expenditure


Agenda of meetings

Minutes of IREC meetings

All written documentation received during follow-up

Notification of completion, premature suspension or premature termination of a

study

Final report of a study

Documents shall be archived for minimum period of 3 years following the completion of a

study. After the expiry of storage period, the Kenya National Archives and Documentation

Services will be notified to carry out the disposal of the hard copies. The soft copies of

the documents shall continue to be archived.

17.0 REFERENCES

1. International Ethical Guidelines for Biomedical Research involving Human subjects. Council of

International Organization of Medical Sciences (CIOMS), 1993.

2. Standard Operating Procedures. Navrongo Health Research Center Institutional Review Board, 2001.

3. Operational Guidelines for Ethics Committees That Review Biomedical Research. (WHO), 2000.

4. The ENGAGE Guidelines for Good Clinical Practice Compliance and Quality Systems Auditing in

Conforming to the Note for Guidance on Good Clinical Practice.

5. World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving

Human Subjects. World Medical Association, Inc., 2000.

6. Code of Federal Regulations (Title 45, part 46). Department of Health and Human Services, National

Institutes of Health, Office for Protection from Research Risks, 2001.

7. The Republic of Kenya, National Council for science and Technology, 2004. Guidelines for ethical

conduct of Biomedical Research involving Human Subjects in Kenya. NCST NO. 45

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