Human Subject Protections Social & Behavioral Research: You & the IRB

1. Human Subject Protections Social & Behavioral Research: You & the IRB Sally Flanzer, Ph.D. Children’s Bureau-Region IX and Miguel Vieyra, MSW Children’s Bureau-Headquarters

2. What is “Human Subjects Protections” ? HSP is a system of processes that protect the rights, welfare, and information about the human beings who volunteer to participate in research. 17th National-2009

3. Federally funded research must comply with the Federal regulations for the protection of human subjects at 45 CFR 46. 17th National-2009

4. What is Protected? • Risk, voluntarism, expectations of privacy, parent-child relationships … • Inequalities, misunderstanding, deliberate invasions of privacy, unintended disclosures of identity and participation … • Denial of treatment or fear of denial of treatment … • Those already at some risk. 17th National-2009

5. Research withUnusual Risks The Havasupai tribe had been participating in a diabetes study with Arizona State University. When a graduate student used the stored blood samples from the diabetes study, she was able to trace the tribe’s roots to Asia, to the historic Bering Strait landmass migration. 17th National-2009

6. What is at risk? A Creation Story Rather than being delighted or intrigued by this new fact about their heritage, tribal members’ most basic beliefs about themselves and their heritage were undermined. 17th National-2009

7. Who is at risk? The Director of Student Housing at the university has noticed a lot of accidents after home football games. He is concerned about student safety and university liability. He asks the Resident Assistants to keep records of one kind of accident --student falls-- so he can design an evidence-based prevention campaign. 17th National-2009

8. Who is at risk? • Are this kind of record keeping and in-house analysis appropriate for the Director of Housing? Does the kind of accident matter? • What if he wants to do this in ten dorms? Or ten universities? What if he wants to publish an article about his findings? • What kind of study is this? • When does a useful and important quality improvement activity merit IRB review? 17th National-2009

9. Why is there risk? • Based on previous research, a child welfare agency has evidence that particular systemic improvements in hotline process improve initial risk assessment. But there is also evidence that some hotline workers are better at assessment than others. • Will better assessment tools (process) improve/ “take root” with all workers equally? • Is improved assessment the result of the tool, the training, or an outcome of good hiring practices? 17th National-2009

10. When good scientists went bad • Nuremberg – 1948 • Wichita Jury Study – 1955 • The Willowbrook Hepatitis Study – 1950s • Thalidomide Experience – 1962 • Jewish Chronic Disease Hospital – 1960s • Milgram Obedience Studies – 1960s • San Antonio Contraception Study 1970s • The Tearoom Trade – 1970s • Tuskegee – USPHS Natural History of Untreated Syphilis Study – 1932 to 1972 17th National-2009

11. “Fed World” • Federal Regulations • The Belmont Report • Institutional Review Boards • Related Issues & Vocabulary 17th National-2009

12. The 3-Legged Stool • The Belmont Report • Federal Regulations 45 CFR 46 • IRB and Responsible Researcher = Human Subjects Protections 17th National-2009

13. The Belmont Report • The Belmont Report serves as a guide to resolving ethical problems arising during research involving human subjects. • Federal regulations essentially operationalize the principles of the Report. 17th National-2009

14. The Belmont Report - Continued The Belmont Report outlines three ethical principles for conducting research: • Respect for Persons (Autonomy): The rights of each individual to make a fully informed and completely voluntary decision to participate in research or not. • Beneficence: The balance of risk and benefit from participation; awareness of the possibilities of harm. 17th National-2009

15. The Belmont Report - Continued • Justice: Equal opportunity to benefit from research and be protected from the abuse of power or privilege. No particular group of research participants should be unfairly burdened with the risks of participation or kept from sharing in the benefits of participation. These principles also have social context. 17th National-2009

16. Social Context & Justice • Prisoners merit protections from being used as research subjects only because they are a convenient source of available subjects. Yet, they should not be denied the opportunity to participate in research that might be beneficial to them as individuals. • Prisoners who were HIV positive fought successfully, through the courts, for the right to participate in HIV drug trials. Though previously, prisoners, as a group, had sought protections from being “guinea pigs.” 17th National-2009

17. Federal Regulation45 CFR 46 Federal Regulation 45 CFR 46 is divided into four subparts: • Common Rule (Subpart A) • Subpart B – additional protections – fetuses, pregnant women, in vitro fertilization • Subpart C – prisoners as subjects • Subpart D – children as subjects 17th National-2009

18. Federal Regulations • The goal of a human subject protections program is to create a safety net for research participants. • No one document, agency, or agent has full responsibility for, nor can one document, agency, or agent offer sufficient protections. • The Federal Regulations provide legal protections; the Belmont Report provides the ethical underpinnings for the regulations. 17th National-2009

19. Federal Regulations - Continued • Investigators and their agencies have obligations articulated in the Federal Wide Assurance (FWA) between the agency or research setting and the Office for Human Research Protections in the Office for the Assistant Secretary for Health, HHS. • The FWA is both a statement of the ethical principles underpinning the agency’s research program and an assurance of compliance with the Code of Federal Regulations, Title 45, part 46 (45 CFR 46). 17th National-2009

20. Federal Regulations – Continued • The agency is obligated to have an Institutional Review Board (IRB) review the research. • The IRB is designated in the FWA. It has the responsibility to review and monitor the agency’s compliance with the Federal Regulations and the investigators’ implementation of the regulations. 17th National-2009

21. Belmont Principles are the ethical foundation of federal regulations for research Respect for persons informed consent privacy & confidentiality Beneficence benefit/risk assessment Justice distribution of risk and benefit inclusion/exclusion 17th National-2009

22. Subpart D: Children 17th National-2009

23. A Vulnerable Population • age/status • potential harms from participation • multiple relationships • State statutes define “children” • “Permission” and “assent” 17th National-2009

24. Minimal Risk • a “floor” • additional levels of review • benefits to the individual child • benefits to class 17th National-2009

25. Relative and Uniform Risk • age appropriate • developmentally appropriate • equitable • experientially appropriate 17th National-2009

26. Potential Impacts of Participation • Unintended consequences • Emotional distress • Disclosing abuse 17th National-2009

27. Third Party Issues • intentions to report • data collection about a third party • Risk of civil proceedings 17th National-2009

28. Mandated Reporting • State laws – mandates/exemptions • Procedures • Getting a good night’s sleep 17th National-2009

29. Reporting • Certificates of Confidentiality • Reporting obligations • Ethical considerations 17th National-2009

30. Related Issues • §408 and §409- permission and wards • Public Use Data Sets • Use of Archived or previously collected Data 17th National-2009

31. Institutional Review Board (IRB) Established to provide ethical review of research for protections of human subjects Assure that federal regulations are followed Members include researchers, non-researchers and members of the local community 17th National-2009

32. Activities needing IRB approval RESEARCH – A systematic investigation designed to develop or contribute to generalizable knowledge. 45 CFR 46.102(d) HUMAN SUBJECT A living individual about whom an investigator…conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable personal information 45 CFR 46.102(f) 17th National-2009

33. Start with ‘research’ ‘Systematic’: use of data analyses, scientific methods – can include ‘nonresearch’ AND What about ‘generalizable’? Considerations: Intent to publish/present does not necessarily define a project as research – what is the intent? Is the intent to contribute to the knowledge base of your profession/discipline? A major goal of research is to benefit people other than the research subjects 17th National-2009

34. Generally NOT ‘generalizable’, • Quality improvement projects – designed with goal of improving institutional/organizational practice • Case report – if no systematic investigation, i.e. no statistical or data analysis; no outcome measures, case study, N=1, descriptive but unidentifiable • Public health practice – surveillance, program evaluation • Survey/questionnaire development – no data retained for research purposes 17th National-2009

35. What about ‘human subjects’? • Do you propose interventions or interactions with persons or using data that has personal identifiers? • Is the data about individuals (research) or from individuals (might not be research)? • Secondary data sets without ANY identifiers or codes generally do not involve human subjects 17th National-2009

36. Social Science projects that may require IRB review • Interviews – quantitative or qualitative approaches • Focus groups, staff groups, evaluations • Pretest – intervention – posttest • Surveys, including Internet-based surveys • Randomized intervention and control groups • Data analysis of primary or secondary data that contain identifiers or codes 17th National-2009

37. Submit if… • You are not sure • You want to claim an exemption • A project might become research • There is potential that it may contribute to generalizable knowledge and/or be published • (There may be a presumption of “research” for faculty) 17th National-2009

38. Assessing A Protocol for ETHICAL Treatment of Research Subjects • Respect for persons • Are individuals free to say no to all or some participation? • Is the consent form clear and understandable to this population? Is there an on-going consent process? • Does the consent process include all the necessary information about the study? • Beneficence • What is the balance of risks to benefits? • Have burdens and risks been minimized? • Justice • Are participants fairly selected for the study? • Who benefits from the study and who bears the risks? 17th National-2009

39. Types of IRB Review Level of potential risk to subjects determines type of review Exempt ---- Expedited ---- Full board Low risk ------------ High risk 17th National-2009

40. Definition of Minimal Risk45 CFR 46.102(i) “Minimal Risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests. 17th National-2009

41. Exempt • Reviewed for exemption from informed consent requirement and continuing IRB review • Involves a non-vulnerable population (does not include children, prisoners, decisionally impaired, economically or educationally disadvantaged) • Low-risk research • Does not include identifiers • Questions generally not sensitive • Fits one of 6 categories of research 17th National-2009

42. Exemption Categories: 45 CFR 46 101 (b) • Typical educational practices • *Educational tests, surveys, interviews, or observation of public behavior (non-sensitive, no identifiers) • Research with elected public officials, appointed public officials,candidate for public office) • *Existing data, documents, pathological specimens, if publicly available or unidentifiable • Evaluation of public benefit service programs • Taste and food quality evaluation and consumer acceptance studies 17th National-2009

43. The researcher may not make this decision themselves. A researcher claims an exemption. An IRB confirms an exemption. 17th National-2009

44. Informed Consent for Exempt Studies? • No formal document needed for ‘exempt’ research >>identifiers not collected • But…subjects deserve to know that they are participating in a research project, that their participation is voluntary, and that they do not need to answer every question • Include such information in a cover sheet or at the top of a survey or questionnaire 17th National-2009

45. Expedited Review • Meets federal criteria for minimal risk research • May include identifiers (direct or indirect) but topics not sensitive OR • May include some sensitive topics, but confidentiality securely protected • Need to consider a formal informed consent process OR justify a waiver of consent 17th National-2009

46. Materials (data, documents, specimens etc.) have been collected or will be collected for non-research purposes Collection of voice, video or digital data for research purposes Individual or group behavior, surveys, interviews, oral histories Categories for Expedited Review:(Initial Review) 17th National-2009

47. Full Board Review • If the research does not meet criteria for exempt or expedited review, it is classified as a Full Board study (it likely is greater than minimal risk) • Discussed at meeting of IRB panel and approval done by vote 17th National-2009

48. Researchers’ excuses: Trying to avoid an IRB review • I’m just doing a program evaluation • It’s only data, no live people • “They” don’t understand my research • “They” take too long • There aren’t any risks in my research 17th National-2009

49. Are there really risks in most social-behavioral research? • Risks of breach of confidentiality and violation of privacy • Financial, social, or psychological – to our dignity, self-image, or innocence • Retrospective risk, after participation in the research 17th National-2009

50. Common Causes for IRB Delays • Lack of information from the Investigator • An adversarial relationship between the IRB and the Investigator • Vulnerable subjects or sensitive topics (women, children, prisoners, genomics, HIV …) • Institutional concerns about liability 17th National-2009