IRB Review, Human Subjects Research & Oral History: Legal & Ethical Responsibilities Museology 588

IRB Review, Human Subjects Research & Oral History: Legal & Ethical Responsibilities

Museology 58810-17-08

Discussion with:Sharon Smith Elsayed, Asst. Dir. for Education & Communication

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Museology – 10-17-08

Session Goals• Clarify the role and authority of the Institutional Review

Board (IRB)

• Provide a brief historical context for the current review

process, compliance issues, and the context for review of

research using oral history interviewing.

• Explain basic regulatory requirements regarding human

subjects research.

• Explain the IRB application – forms, process, and changes

underway.

• Address some of the critical elements of human subjects

research and review, (i.e., risks and benefits, consent

forms and process, problems that occur, confidentiality of

data, etc.)

• Identify both IRB and researcher responsibilities.

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Institutional Review Board (IRB)What (and who) is the IRB?What (and who) is the IRB? IRBs at the UW partner with researchers to protect the rights and

welfare of human research subjects recruited to participate in research activities conducted under the auspices of the University of Washington.

The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within itsjurisdiction as specified by federal regulations,state law, and institutional policy.

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Institutional Review Board (IRB)Membership must meet federal (and UW)

requirements:

FR – 5 members (3 = quorum)

UW – 9 members (5 = quorum)

1 Scientist

1 Non-affiliated/community member

1 Non-scientist (must be present for meeting to

occur)

Members with sufficient and appropriate

expertise to review the research that

comes before the Committee.

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IRBs at (or affiliated with) the UWUW IRBs (http://www.washington.edu/research/hsd) Biomedical Committees: A, B, D Social/Behavioral Committees: C, G, J Veterans Administration IRBs: VA & V2 (Biomedical & Social/Behavioral

Committees) Subcommittees (Minimal Risk Review): E/A, E/B, E/C, E/J

Western IRB (WIRB) (http://www.washington.edu/research/hsd/policy_wirb.php)

Reviews sponsored clinical trials.

Cancer Consortium IRB (CC-IRB) (http://www.cancerconsortium.org/irb)

Reviews cancer research from consortium members.

Cooperative Agreements – Affiliated Institutions(http://www.washington.edu/research/hsd/coopag.php)

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Institutional Review Board (IRB)

What do the IRB committees look for?What do the IRB committees look for?

1.1. Risk of harm versus potential benefits of studyRisk of harm versus potential benefits of study(includes evaluation of study design / scientific merit when risk-benefit evaluation is (includes evaluation of study design / scientific merit when risk-benefit evaluation is

problematic)problematic)

2.2. Protections of subject privacy and confidentialityProtections of subject privacy and confidentiality(primarily within recruitment and data management)(primarily within recruitment and data management)

3.3. Consent processConsent process

Why?Why?

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Pre-WWII

Edward Jenner Edward Jenner (1789)(1789)

Smallpox VaccineSmallpox Vaccine

Claude Bernard Claude Bernard (1865)(1865)

Ethical MaximsEthical Maxims

Louis Pasteur Louis Pasteur (1885)(1885)

Rabies VaccineRabies Vaccine

Walter Reed (1900)Walter Reed (1900)Yellow FeverYellow Fever

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Lessons from Biomedical ResearchNazi War Crimes - WWII Willowbrook – 1950sJewish Chronic Disease Hosp. – 1960s

Tuskegee Syphilis Study – 1932-1972Jesse Gelsinger – 1999

Ellen Roche – 2001

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Vidich & Bensman (1958)Vidich & Bensman (1958)““Small Town in Mass Society: Class, Power and Religion in a Rural Small Town in Mass Society: Class, Power and Religion in a Rural Community.”Community.”

Milgram (1963)Milgram (1963)““Behavioral study of obedience.”Behavioral study of obedience.”

Humphreys (1970)Humphreys (1970)““Tearoom Trade:Tearoom Trade:Impersonal Sex in Public Impersonal Sex in Public

Places.”Places.”

Zimbardo (1971)Stanford Prison Experiment

Foulks (1979)Foulks (1979)Alcoholism in Barrow, AlaskaAlcoholism in Barrow, Alaska

Behavioral Research (just as culpable)

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The Belmont ReportEthical Principles and Guidelines

for the

Protection of Human Subjects of Research

The National Commission for the Protection ofHuman Subjects of Biomedical and Behavioral Research

April 18, 1979

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The Belmont Report

Basic Ethical Principles: Respect for Persons

Individual autonomy Protection of individuals with reduced

autonomy Beneficence

Maximize benefits and minimize harms Justice

Equitable distribution of research costs and benefits

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Application of the DHHS Regulations [45 CFR 46]to Oral History Interviewing (2003)

“Most oral history interviewing projects are not subject to the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46, subpart A, and can be excluded from institutional review board (IRB) oversight because they do not involve research as defined by HHS regulations.. . .

It is primarily on the grounds that oral history interviews, in general, are not designed to contribute to ‘generalizable knowledge’ that they are not subject to the requirements of the HHS regulations at 45 CFR part 46 and, therefore, can be excluded from IRB review.”

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Guidance on Oral History Interviews

"Oral History" is a general name for projects intending to elicit personal information from individuals. Similar to interviews, questionnaires or surveys, the oral history method may, or may not require IRB review.. . .

IRBs are charged with reviewing “research with human subjects”. Since both “research” and “human subjects” have a technical meaning in the context of the Federal regulations (specifically 45 CFR 46) that mandate IRB review, it is not always clear whether specific activities are covered by the regulations.

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So – defining what is research is pretty straightforward, isn’t it?1.1. Are you doing research?Are you doing research?““A systematic investigation, including research development, A systematic investigation, including research development,

testing and evaluation, designed to develop or contribute to testing and evaluation, designed to develop or contribute to generalizable knowledge.”generalizable knowledge.”

2.2. Are you doing research with humans?Are you doing research with humans?““A living individual about whom an investigator (whether A living individual about whom an investigator (whether

professional or student) conducting research obtains (1) data professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or 2) through intervention or interaction with the individual, or 2) identifiable private information.”identifiable private information.”

. . . and what difference does this make in what we . . . and what difference does this make in what we do?do?

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Are we clear on what oral history interviewingwould need IRB review – and what would not?

Give me some examples

or

Ask questions about some

ideas.

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When are oral history interviews defined as research?1. When they are systematic – meaning that the project is

structured to generate consistent and reliable information. Obtaining information collected in an unsystematic way is not designed to yield information that is representative. Rather, the results are most likely idiosyncratic, so that the results do not differentiate between the general and particular.

2. When the intent of the activity is to generate generalizable knowledge:a. Generalizable knowledge is knowledge that abstracts

away from the particular individual event. In order to be generalizable, the results of the investigation can be applied to other circumstances. Research involving human subjects would employ eliciting members of a population who are important only as representatives of that population, not because of their individuality. If the activities are designed to generate information that can validly be generalized, IRB review is required.

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When are oral history interviews defined as research?

b. If the oral history interview data are collected, at the onset, with the intent to compare, contrast, or establish commonalities between different segments or among members of the same segment (e.g., content analysis, discourse analysis, or coding for themes or other qualitative analysis methods) the data are likely being used to create generalizable knowledge. If the data are being collected with the intent of being used to create generalizable knowledge, the project is considered “research” under 45 CFR 46.102 and would require IRB review.

3. When they involve human subjects:a. Is the information individually identifiable?b. Is the information private?c. What is the intent of the “researcher”?

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Three types of research and levels of review:1.1. ExemptExempt/Departmental Approval with Administrative /Departmental Approval with Administrative

IRB Review IRB Review – Research that involves human subjects but meets – Research that involves human subjects but meets

regulations to be exempt from IRB review (six categories), as there is regulations to be exempt from IRB review (six categories), as there is

no risk to subjects. no risk to subjects.

2.2. Minimal Risk Minimal Risk (“Expedited”)/IRB Subcommittee (“Expedited”)/IRB Subcommittee

ReviewReview– Research that poses no more risk to subjects than would be – Research that poses no more risk to subjects than would be

encountered by the average person in his/her daily activities (nine encountered by the average person in his/her daily activities (nine

categories).categories).

3.3. More than Minimal RiskMore than Minimal Risk/IRB Full Committee /IRB Full Committee

ReviewReview– Research that poses – Research that poses moremore risk to subjects than would be risk to subjects than would be

encountered by the average person in his/her daily activities.encountered by the average person in his/her daily activities.

4.4. Not Human Subjects ResearchNot Human Subjects Research/???/???– Activities that do not fit the regulatory definition for “human” or – Activities that do not fit the regulatory definition for “human” or

“research”.“research”.

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One difference is in which form is used:1.1. Exempt Research Exempt Research Certificate of ExemptionCertificate of Exemption

2.2. Minimal Risk (Minimal Risk () & More than Minimal Risk ) & More than Minimal Risk

Human Subjects Review Application (UW 13-Human Subjects Review Application (UW 13-

11)11)

3.3. Medical Records Medical Records Medical Records Review Medical Records Review

FormForm

4.4. RepositoriesRepositories Repository Application FormRepository Application Form

5.5. Use of Biological Specimens Use of Biological Specimens Review Review

DeterminationDetermination

http://www.washington.edu/research/hsd/forms_paper.php

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What’s in the works on forms:1.1. Exempt Research Exempt Research IRB Application: Exemption Certificate of

Exemption

2.2. Minimal Risk (Minimal Risk () & More than Minimal Risk ) & More than Minimal Risk

IRB Application: Core Modules & Supplemental Sections

Certificate of Approval

3.3. Non-Human Subjects (BioS, PE, QA/QI, etc.) Non-Human Subjects (BioS, PE, QA/QI, etc.) Review

Determination Form

Notice of Determination

4. When “Conditional Approval” is granted

Conditional Approval Response Form + + Modification

5. Annually (or more often if required by the IRB) – Continuing Review

Form

6. Any time something changes – Modification Form

7. When something goes wrong – Problem Report

8. When the study is done – Closeout Report

http://www.washington.edu/research/hsd/forms_paper.php

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Criteria for IRB Approval of ResearchRisks to Subjects are Minimized• Procedures are consistent with sound research design and do not

unnecessarily expose subjects to risk. • By using procedures already being performed on the subjects for

diagnostic or treatment purposes. • Reasonable in relation to anticipated benefits, if any, to subjects, and the

importance of the knowledge that may be expected to result.Selection of Subjects is EquitableTaking into account:• the purposes of the research,• the setting in which the research will be conducted,• the special problems of involving vulnerable populations,• the recruitment procedures and the selection criteria. Safety MonitoringThe research plan makes adequate provision for monitoring the data collected

to ensure the safety of participants.

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Criteria for IRB Approval of ResearchPrivacy & ConfidentialityThere are adequate provisions to protect the privacy of subjects and to maintain

confidentiality of data. Protected & Vulnerable PopulationsWhen some or all of the subjects are likely to be vulnerable to coercion or undue

influence, such as:• children,• prisoners,• pregnant women,• mentally disabled or decisionally-impaired persons, or• economically or educationally disadvantaged persons, additional safeguards are included in the study to protect the rights and welfare of

these subjects. Informed Consent• Sought from each prospective subject or the subject’s legally authorized

representative. • The process provides all of the required and appropriate information, unless

some or all of this requirement is waived or altered by the IRB in compliance with appropriate regulatory criteria.

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Criteria for IRB Approval of ResearchAdditional considerations for initial review• Should review occur more often than annually?• If this is a multi-site study, will there be adequate management of

information that might be relevant to the protection of subjects?Additional considerations for continuing review• Should review occur more often than annually?• Should verification be obtained from sources other than the investigator

that no material changes have taken place since prior IRB review?• Is the consent document accurate and complete?• If information has arisen that might affect the willingness of participants to

continue to take part in the research, will it be provided to those participants?

Additional considerations for modifications• Should review occur more than annually?• Is the consent document accurate and complete?• If information has arisen that might affect the willingness of participants to

continue to take part in the research, will it be provided to those participants?

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Researcher ResponsibilitiesThe principal investigator (PI) is responsible for all aspects of

the study.

Though authority to perform certain aspects of the study may be delegated to others, the PI nonetheless retains full

responsibilityfor all study activities and obligations. 1. Conduct the research in accordance with the approved

protocol, applicable laws and regulations, and the principles of

research ethics as set forth in the Belmont Report.

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Researcher Responsibilities – specifics:

2. Unless consent has been waived, conduct the informed

consent process without coercion or undue influence, and

provide the potential subjects with sufficient opportunity to

consider whether or not to participate.

a. Use only the most current consent form bearing the

“APPROVED” stamp and date.

b. Provide non-English speaking subjects with a

translation of the approved consent form in the

subject’s first language. The translation must be

approved by the IRB.

c. Obtain pre-approval from the IRB for the use of all

recruitment materials and other materials provided to

subjects.

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3. Obtain pre-approval from the IRB for any planned modifications

or amendments, including additions of grant or contract

funding.

4. Promptly report to the IRB any new information, unanticipated

problems involving risks to subjects or others, or serious

adverse events that may adversely affect the welfare or safety

of the subjects, or the conduct of the research.

5. It is the researcher’s responsibility to seek renewal of IRB

approval by providing all required progress reports (i.e., Status

Reports) at least 6 weeks before current IRB approval expires.

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6. Retain copies of all materials provided to the IRB and all

correspondence with the IRB, for at least 3 years. The

researcher’s institution or the type of materials may

necessitate a longer retention period.

7. Ensure that there is a system is in place for promptly

responding to email or phone inquiries and messages from the

IRB.

8. Inform the IRB when the research has been completed, by

completing a Status Report form and checking the “Do Not

Renew” box.

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It’s in the details . . .

• A complete application greatly reduces review and revision.• Make sure that all necessary documents, attachment, etc. are

completed and included.• Don’t leave anything blank – at least type “NA” and, if

necessary, a brief explanation.

• Use 10pt, or larger, clear and professional font(no handwritten applications).

• Present information clearly – bulleted lists, tables, diagrams are very useful in conveying complex information clearly.

• Include tables and/or diagrams, flow charts.• Submit three (3) single-sides copies – one being an

original with inked signatures.

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Fundamentally . . .

Who is responsible for ethical work?

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Contact HSDUniversity of Washington, Human Subjects Division University of Washington, Human Subjects Division

http://www.washington.edu/research/hsd/index.php

Staff Contact Information: Staff Contact Information:

http://www.washington.edu/research/hsd/contact.html

To subscribe to To subscribe to e-e-News: News:

https://mailman1.u.washington.edu/mailman/listinfo/hsd-news

To request training/assistance: To request training/assistance:

[email protected]

To give us feedback on this session:To give us feedback on this session:

https://catalysttools.washington.edu/survey/selsayed/40135https://catalysttools.washington.edu/survey/selsayed/40135

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Online ResourcesBelmont Report - Belmont Report - http://

www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

University of Washington, Human Subjects Division University of Washington, Human Subjects Division

http://www.washington.edu/research/hsd/index.php

Office for Human Research Protections Office for Human Research Protections http://www.hhs.gov/ohrp

Food and Drug Administration Food and Drug Administration http://www.fda.gov/

Health Resources and Services Administration Health Resources and Services Administration http://

www.hrsa.gov/quality/hsrtraining.htm

Council for International Organizations of Medical SciencesCouncil for International Organizations of Medical Sciences

(CIOMS) (CIOMS) http://www.cioms.ch/frame_guidelines_nov_2002.htm

CITI – Course in the Protection of Human Subjects [International Course] CITI – Course in the Protection of Human Subjects [International Course]

https://www.citiprogram.org/default.asp [http://www.irbtraining.org] [http://www.irbtraining.org]

Educational Resources on International Research EthicsEducational Resources on International Research Ethics

http://www.nih.gov/sigs/bioethics/internationalresthics.html#research

Ethical Issues in International Health Research Ethical Issues in International Health Research http://

www.hsph.harvard.edu/bioethics/

Documents

IRB Review, Human Subjects Research & Oral History: Legal & Ethical Responsibilities Museology 588