The IRB Approval The IRB Approval ProcessProcess

Michael Bingham, JDMichael Bingham, JDAssistant Director, University of Assistant Director, University of

Wisconsin-Madison Education IRBWisconsin-Madison Education IRB608-262-9710 mbingham@education.wisc.edu608-262-9710 mbingham@education.wisc.edu

What Led Us to IRB Review?What Led Us to IRB Review?

Nuremberg CodeNuremberg Code Infamous Cases 1950’s through Infamous Cases 1950’s through

1970’s1970’s 1979 - Belmont Report1979 - Belmont Report 1981 - 45 CFR 461981 - 45 CFR 46

Is The Study Really Human Is The Study Really Human Subject Research?Subject Research?

The first step is to determine if the study The first step is to determine if the study qualifies as “Human Subject Research.”qualifies as “Human Subject Research.”– Human SubjectHuman Subject: 45 CFR 46.102(f) defines a : 45 CFR 46.102(f) defines a

human subject as “a living individual about human subject as “a living individual about whom an investigator (whether professional whom an investigator (whether professional or a student) conducting research obtains or a student) conducting research obtains (1) data through intervention or interaction (1) data through intervention or interaction with the individual, or (2) identifiable private with the individual, or (2) identifiable private information. information.

Is The Study Really Human Is The Study Really Human Subject Research?Subject Research?

““Intervention includes both physical procedures by Intervention includes both physical procedures by which data are gathered and manipulations of the which data are gathered and manipulations of the subject or the subject’s environment that are subject or the subject’s environment that are performed for research purposes.” (45 CFR 46.102(f))performed for research purposes.” (45 CFR 46.102(f))

““Interaction includes communication or interpersonal Interaction includes communication or interpersonal contact between investigator and subject.” (45 CFR contact between investigator and subject.” (45 CFR 46.102(f))46.102(f))

““Private Information includes information about Private Information includes information about behavior that occurs in a context in which an behavior that occurs in a context in which an individual can reasonably expect that no observation individual can reasonably expect that no observation or recording is taking place, and information which or recording is taking place, and information which has been provided for specific purposes by an has been provided for specific purposes by an individual and which the individual can reasonably individual and which the individual can reasonably expect will not be made public.” (45 CFR 46.102(f))expect will not be made public.” (45 CFR 46.102(f))

Is The Study Really Human Is The Study Really Human Subject Research?Subject Research?

– ResearchResearch: 45 CFR 46.102(d) defines research : 45 CFR 46.102(d) defines research as “A systematic investigation, including as “A systematic investigation, including research development, testing and evaluation, research development, testing and evaluation, designed to develop or contribute to designed to develop or contribute to generalizable knowledge.”generalizable knowledge.” - - Think of it this wayThink of it this way: A major goal of the activity is to : A major goal of the activity is to

learn something for the purpose of benefiting people learn something for the purpose of benefiting people other than the research subjects. Would this project other than the research subjects. Would this project be conducted as proposed if they project investigator be conducted as proposed if they project investigator knew that he or she would never receive any form of knew that he or she would never receive any form of academic recognition for the project, including academic recognition for the project, including publication or presentation of the project at an publication or presentation of the project at an academic meeting? academic meeting?

Why Does the IRB Need to Why Does the IRB Need to Review?Review?

If a study does not meet the If a study does not meet the elements of “Human Subject elements of “Human Subject Research”, it does not need to be Research”, it does not need to be reviewed by the IRB. reviewed by the IRB.

If a study does meet the elements, If a study does meet the elements, the IRB must review and determine if the IRB must review and determine if all required criteria are satisfied.all required criteria are satisfied.

Student ResearchStudent Research

All students conducting human All students conducting human subject research must obtain IRB subject research must obtain IRB approvalapproval– Senior ThesisSenior Thesis– Hilldale AwardsHilldale Awards– Independent StudyIndependent Study– Master’s ThesisMaster’s Thesis– Doctoral DissertationDoctoral Dissertation

What Now?What Now?

The IRB Staff will determine if a study The IRB Staff will determine if a study qualifies as exempt, expedited, or requires qualifies as exempt, expedited, or requires full committee review. full committee review.

If exempt, one member of the IRB will review, If exempt, one member of the IRB will review, request any modifications, and approve. request any modifications, and approve.

If expedited, a 3-person “sub-committee” will If expedited, a 3-person “sub-committee” will review, request any modifications, and review, request any modifications, and approve. approve.

If full committee, the entire IRB will review, If full committee, the entire IRB will review, request any modifications, and approve. request any modifications, and approve.

Review ScheduleReview Schedule

Exempt protocols are reviewed usually Exempt protocols are reviewed usually within a few days after receiptwithin a few days after receipt

The expedited sub-committee meets The expedited sub-committee meets once a month. Protocols must be once a month. Protocols must be submitted 2 weeks prior to the meeting submitted 2 weeks prior to the meeting date. date.

The full board also meets once a month. The full board also meets once a month. Protocols must be submitted 2 weeks Protocols must be submitted 2 weeks prior to the meeting date.prior to the meeting date.

Exempt ResearchExempt Research Falls within one of the six categories listed at Falls within one of the six categories listed at

45 CFR 46.101(b)(1-6)45 CFR 46.101(b)(1-6)– Examples: Examples:

Research Conducted in Normal Educational Research Conducted in Normal Educational Settings, involving Normal Educational PracticesSettings, involving Normal Educational Practices

Anonymous Educational Tests, Surveys, Anonymous Educational Tests, Surveys, Interviews or Public Observations (Not Interviews or Public Observations (Not applicable to studies that involve children as applicable to studies that involve children as participants)participants)

Collection Or Study of Existing Data: Only if the Collection Or Study of Existing Data: Only if the sources are publicly available or if the sources are publicly available or if the information will be recorded in such a way that information will be recorded in such a way that the subjects cannot be identified. the subjects cannot be identified.

Exempt ResearchExempt Research

Minimal RiskMinimal Risk Is human subject research, butIs human subject research, but Is “exempt” from the regulationsIs “exempt” from the regulations IRB - not the PI - determines IRB - not the PI - determines

exemptionexemption Does not require full IRB reviewDoes not require full IRB review

Expedited ResearchExpedited Research

Department of Health and Human Department of Health and Human Services regulations permit certain Services regulations permit certain types of research to be reviewed and types of research to be reviewed and approved by expedited review. approved by expedited review.

Expedited review is a type of review Expedited review is a type of review that is conducted by a rolling that is conducted by a rolling subcommittee of IRB members. The subcommittee of IRB members. The full IRB is then notified of all full IRB is then notified of all decisions.decisions.

Eligibility for Expedited Eligibility for Expedited ReviewReview

There are two general categories that There are two general categories that can qualify for expedited review: can qualify for expedited review:

1) Research activities that present no 1) Research activities that present no more than minimal risk AND are listed more than minimal risk AND are listed in a NIH Guidance Document as an in a NIH Guidance Document as an adjunct to the main regulations: adjunct to the main regulations: – Category 5: Research involving materials Category 5: Research involving materials

(data, documents, records, or specimens) (data, documents, records, or specimens) that have been collected or will be that have been collected or will be collected solely for nonresearch purposes. collected solely for nonresearch purposes.

Expedited Review Cont.Expedited Review Cont.– Category 6: Collection of data from voice, Category 6: Collection of data from voice,

video, digital or imaging recordings made for video, digital or imaging recordings made for research purposes. research purposes.

– Category 7: Research on group characteristics Category 7: Research on group characteristics (including, but not limited to, research on (including, but not limited to, research on perception cognition, motivation, identity, perception cognition, motivation, identity, language, communication, cultural beliefs or language, communication, cultural beliefs or practices and social behavior) or research practices and social behavior) or research employing survey, interview, oral history, focus employing survey, interview, oral history, focus group, program evaluation, human factors group, program evaluation, human factors evaluation, or quality assurance methodologies. evaluation, or quality assurance methodologies.

2) Minor changes in previously approved 2) Minor changes in previously approved research during the period for which research during the period for which approval is granted. approval is granted.

The IRB Is Required To The IRB Is Required To Determine That Numerous Determine That Numerous

Criteria Are MetCriteria Are Met There are 8 criteria that the IRB must There are 8 criteria that the IRB must

determine are satisfied in order for determine are satisfied in order for the IRB to grant approval. the IRB to grant approval.

1 – Risks to Participants Are 1 – Risks to Participants Are MinimizedMinimized

Is the proposed research design Is the proposed research design scientifically sound?scientifically sound?

Will this study unnecessarily expose Will this study unnecessarily expose participants to risk? participants to risk?

Is the hypothesis clear? Is it clearly stated? Is the hypothesis clear? Is it clearly stated? Is the study design appropriate to prove Is the study design appropriate to prove

the hypothesis?the hypothesis? Will the research contribute to Will the research contribute to

generalizable knowledge and is it worth generalizable knowledge and is it worth exposing participants to risk? exposing participants to risk?

2. Risks to Participants are 2. Risks to Participants are Reasonable in Relationship to Reasonable in Relationship to

Anticipated Benefits? Anticipated Benefits? Are the risks to participants Are the risks to participants

reasonable in relation to the reasonable in relation to the anticipated benefits, if any, to anticipated benefits, if any, to participants, and the importance of participants, and the importance of knowledge that may reasonably be knowledge that may reasonably be expected to result?expected to result?

What is the level of risk? What is the level of risk? Is there any prospect of direct benefit Is there any prospect of direct benefit

to the participant? to the participant?

3. Participant Selection is 3. Participant Selection is EquitableEquitable

Who will be enrolled (men, women, Who will be enrolled (men, women, ethnic minorities, children, ill ethnic minorities, children, ill persons, healthy persons)?persons, healthy persons)?

Are the participants appropriate for Are the participants appropriate for this protocol? this protocol?

What is the rationale for What is the rationale for inclusion/exclusion, and is it inclusion/exclusion, and is it appropriate? appropriate?

4. Informed Consent Will Be 4. Informed Consent Will Be ObtainedObtained

Informed consent will be obtained from Informed consent will be obtained from prospective participants or their legally prospective participants or their legally authorized representatives, unless waived in authorized representatives, unless waived in compliance with 45 CFR 46.116 (c) and (d). compliance with 45 CFR 46.116 (c) and (d).

Does the consent document include the Does the consent document include the eight required elements? eight required elements? – 1) Statement that the study involves research.1) Statement that the study involves research.– 2) Explanation of the purposes of the research2) Explanation of the purposes of the research– 3) Expected duration of the subject’s 3) Expected duration of the subject’s

participation in the researchparticipation in the research

Informed Consent Cont.Informed Consent Cont.

– 4) Description of the Procedures to be 4) Description of the Procedures to be followed. followed.

– 5) Identification of any procedures that 5) Identification of any procedures that are experimental (not typically are experimental (not typically applicable to Ed. Research)applicable to Ed. Research)

– 6) Description of any foreseeable risks 6) Description of any foreseeable risks or discomforts to the subjector discomforts to the subject

– 7) Description of any benefits to the 7) Description of any benefits to the subject or to others than may subject or to others than may reasonably be expected from the reasonably be expected from the researchresearch

Informed Consent Cont. Informed Consent Cont. – 8) Statement describing the extent, if any, to 8) Statement describing the extent, if any, to

which confidentiality of records identifying the which confidentiality of records identifying the subject will be maintained.subject will be maintained.

– 9) Explanation of whom to contact for answers 9) Explanation of whom to contact for answers to pertinent questions about the research and to pertinent questions about the research and research subject’s rights. research subject’s rights.

– 10) Statement that participation is voluntary, 10) Statement that participation is voluntary, that refusal to participate involves no penalty that refusal to participate involves no penalty or loss of benefits to which the subject is or loss of benefits to which the subject is otherwise entitled, and that the subject may otherwise entitled, and that the subject may discontinue participation at any time without discontinue participation at any time without penalty or loss of benefits to which the subject penalty or loss of benefits to which the subject is otherwise entitled. is otherwise entitled.

Informed Consent Cont.Informed Consent Cont.

Is the consent document Is the consent document understandable to participants? understandable to participants? – The IRB recommends writing each adult The IRB recommends writing each adult

consent document at an 8consent document at an 8thth grade level. grade level. Child assent should be written at the Child assent should be written at the level of the target group. level of the target group.

Who will obtain informed consent (PI, Who will obtain informed consent (PI, other study staff member) and in other study staff member) and in what setting?what setting?

5. Informed Consent Will Be 5. Informed Consent Will Be DocumentedDocumented

Informed consent must be Informed consent must be appropriately documented unless appropriately documented unless waived in compliance with 45 CFR waived in compliance with 45 CFR 46.117 (c). 46.117 (c).

Remember, a consent document Remember, a consent document (which must included all required (which must included all required elements) must still be given to elements) must still be given to participants; they simply do not sign participants; they simply do not sign this document. this document.

6. Research Plan Makes 6. Research Plan Makes Adequate Provisions To Adequate Provisions To

Monitor DataMonitor Data If appropriate, the research plan If appropriate, the research plan

makes adequate provisions for makes adequate provisions for monitoring the data collected to monitoring the data collected to ensure the safety of participants.ensure the safety of participants.

Does the research design minimize Does the research design minimize risks to subjects? risks to subjects?

Would use of a data & safety Would use of a data & safety monitoring board or other research monitoring board or other research oversight process enhance subject oversight process enhance subject safety?safety?

7. Adequate Provisions to 7. Adequate Provisions to Protect Privacy and Protect Privacy and

ConfidentialityConfidentiality Are there adequate provisions to protect Are there adequate provisions to protect

the privacy of participants and to the privacy of participants and to maintain the confidentiality of data?maintain the confidentiality of data?

Will personally-identifiable research Will personally-identifiable research data be protected to the extent possible data be protected to the extent possible from access or use? from access or use?

Are any special privacy & confidentiality Are any special privacy & confidentiality issues properly addressed? issues properly addressed?

8. Additional Safeguards for 8. Additional Safeguards for Vulnerable ParticipantsVulnerable Participants

Where applicable, are additional Where applicable, are additional safeguards, for participants likely to safeguards, for participants likely to be vulnerable to coercion or undue be vulnerable to coercion or undue influence, implemented? influence, implemented?

Are appropriate protections in place Are appropriate protections in place for vulnerable participants, e.g. for vulnerable participants, e.g. pregnant women, fetuses, socially or pregnant women, fetuses, socially or economically disadvantaged, economically disadvantaged, decisionally impaired persons? decisionally impaired persons?

Research Involving MinorsResearch Involving Minors

The Education Research IRB reviews many The Education Research IRB reviews many studies involving minors. There are special studies involving minors. There are special protections that must be in place before a protections that must be in place before a study involving children as research study involving children as research participants can be approved. participants can be approved.

Study must pose minimal riskStudy must pose minimal risk Students aged 11 and over must “assent” Students aged 11 and over must “assent”

to be in the studyto be in the study– Assent is defined as a “child’s affirmative Assent is defined as a “child’s affirmative

agreement to participate in research.” A child’s agreement to participate in research.” A child’s passive resignation to submit to an passive resignation to submit to an intervention or procedure must not be intervention or procedure must not be considered assent. considered assent.

Research Involving MinorsResearch Involving Minors

At least one parent/guardian must At least one parent/guardian must provide “consent” for the child to provide “consent” for the child to participate.participate.

SummationSummation

It is the duty of the IRB to determine It is the duty of the IRB to determine that all required criteria are met. that all required criteria are met.

April 21, Session on Informed April 21, Session on Informed Consent – Please visit Consent – Please visit http://http://www.grad.wisc.edu/research/wkshop/www.grad.wisc.edu/research/wkshop/index.html#HRPPSSindex.html#HRPPSS for more details. for more details.