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

1. Discussion with: Sharon Smith Elsayed, Asst. Dir. for Education & Communication IRB Review, Human Subjects Research & Oral History: Legal & Ethical Responsibilities Museology 588 10-17-08

2. 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.

4. Institutional Review Board (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 its jurisdiction as specified by federal regulations, state law, and institutional policy.

5. 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 appropriateexpertise to review the research thatcomes before the Committee.

6. IRBs at (or affiliated with) the UW UW 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)

7. Institutional Review Board (IRB) • What do the IRB committees look for? • Risk of harm versus potential benefits of study(includes evaluation of study design / scientific merit when risk-benefit evaluation is problematic) • Protections of subject privacy and confidentiality(primarily within recruitment and data management) • Consent process • Why?

8. Pre-WWII Edward Jenner (1789) Smallpox Vaccine Claude Bernard (1865) Ethical Maxims Louis Pasteur (1885) Rabies Vaccine Walter Reed (1900) Yellow Fever

9. Lessons from Biomedical Research Willowbrook – 1950s Nazi War Crimes - WWII Jewish Chronic Disease Hosp. – 1960s Ellen Roche – 2001 Tuskegee Syphilis Study – 1932-1972 Jesse Gelsinger – 1999

10. Behavioral Research (just as culpable) Vidich & Bensman (1958) “Small Town in Mass Society: Class, Power and Religion in a Rural Community.” Milgram (1963) “Behavioral study of obedience.” Humphreys (1970) “Tearoom Trade: Impersonal Sex in Public Places.” Zimbardo (1971) Stanford Prison Experiment Foulks (1979) Alcoholism in Barrow, Alaska

11. The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research April 18, 1979

12. 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

13. 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.”

14. 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.

15. So – defining what is research is pretty straightforward, isn’t it? • Are you doing research? • “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” • Are you doing research with humans? • “A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or 2) identifiable private information.” • . . . and what difference does this make in what we do?

16. Are we clear on what oral history interviewing would need IRB review – and what would not? Give me some examples or Ask questions about some ideas.

17. When are oral history interviews defined as research? • 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. • When the intent of the activity is to generate generalizable knowledge: • 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.

18. When are oral history interviews defined as research? • 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. • When they involve human subjects: • Is the information individually identifiable? • Is the information private? • What is the intent of the “researcher”?

19. Three types of research and levels of review: • Exempt/Departmental Approval with Administrative IRB Review – Research that involves human subjects but meets regulations to be exempt from IRB review (six categories), as there is no risk to subjects. • Minimal Risk (“Expedited”)/IRB Subcommittee Review– Research that poses no more risk to subjects than would be encountered by the average person in his/her daily activities (nine categories). • More than Minimal Risk/IRB Full Committee Review– Research that poses more risk to subjects than would be encountered by the average person in his/her daily activities. • Not Human Subjects Research/???– Activities that do not fit the regulatory definition for “human” or “research”.

20. One difference is in which form is used: • Exempt Research àCertificate of Exemption • Minimal Risk (þ) & More than Minimal Risk àHuman Subjects Review Application (UW 13-11) • Medical Records àMedical Records Review Form • RepositoriesàRepository Application Form • Use of Biological Specimens àReview Determination • http://www.washington.edu/research/hsd/forms_paper.php

21. What’s in the works on forms: • Exempt Research àIRB Application: ExemptionàCertificate of Exemption • Minimal Risk (þ) & More than Minimal Risk àIRB Application: Core Modules & Supplemental SectionsàCertificate of Approval • Non-Human Subjects (BioS, PE, QA/QI, etc.) àReview Determination FormàNotice of Determination • When “Conditional Approval” is grantedàConditional Approval Response Form + Modification • Annually (or more often if required by the IRB) – Continuing Review Form • Any time something changes – Modification Form • When something goes wrong – Problem Report • When the study is done – Closeout Report • http://www.washington.edu/research/hsd/forms_paper.php

22. Criteria for IRB Approval of Research Risks 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 Equitable Taking 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 Monitoring The research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.

23. Criteria for IRB Approval of Research Privacy & Confidentiality There are adequate provisions to protect the privacy of subjects and to maintain confidentiality of data. Protected & Vulnerable Populations When 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.

24. Criteria for IRB Approval of Research Additional 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?

25. Researcher Responsibilities The 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 responsibility for all study activities and obligations. • 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.

26. Researcher Responsibilities – specifics: • 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. • Use only the most current consent form bearing the “APPROVED” stamp and date. • 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. • Obtain pre-approval from the IRB for the use of all recruitment materials and other materials provided to subjects.

27. Researcher Responsibilities – specifics: • Obtain pre-approval from the IRB for any planned modifications or amendments, including additions of grant or contract funding. • 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. • 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.

28. Researcher Responsibilities – specifics: • 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. • Ensure that there is a system is in place for promptly responding to email or phone inquiries and messages from the IRB. • Inform the IRB when the research has been completed, by completing a Status Report form and checking the “Do Not Renew” box.

29. 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.

30. Fundamentally . . . Who is responsible for ethical work?

31. Contact HSD University of Washington, Human Subjects Division http://www.washington.edu/research/hsd/index.php Staff Contact Information: http://www.washington.edu/research/hsd/contact.html To subscribe to e-News: https://mailman1.u.washington.edu/mailman/listinfo/hsd-news To request training/assistance: hsdtrain@u.washington.edu To give us feedback on this session:https://catalysttools.washington.edu/survey/selsayed/40135

32. Online Resources Belmont Report - http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm University of Washington, Human Subjects Division http://www.washington.edu/research/hsd/index.php Office for Human Research Protections http://www.hhs.gov/ohrp Food and Drug Administration http://www.fda.gov/ Health Resources and Services Administration http://www.hrsa.gov/quality/hsrtraining.htm Council for International Organizations of Medical Sciences(CIOMS) http://www.cioms.ch/frame_guidelines_nov_2002.htm CITI – Course in the Protection of Human Subjects [International Course] https://www.citiprogram.org/default.asp [http://www.irbtraining.org] Educational Resources on International Research Ethicshttp://www.nih.gov/sigs/bioethics/internationalresthics.html#research Ethical Issues in International Health Research http://www.hsph.harvard.edu/bioethics/