Social and Behavioral Research and the IRB: History and Guidelines

1. Social and Behavioral Research and the IRB: History and Guidelines

2. Behavioral Research and the Belmont Report • “It is important to distinguish between biomedical and behavioral research.” • “The general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.”

3. Behavioral Research and 45 CFR 46 Definition of a “Human Subject” Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under federal regulations, they are defined as: living individual(s) about whom an investigator conducting research obtains: (1)data through intervention or interaction with the individual; or (2)identifiable private information.

4. What is research? • Research is a systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.

5. What is ethics? • Ethics is the “science of moral values and duties; the study of ideal human character, actions and ends.” (Webster’s New Collegiate Dictionary, Cambridge, MA, G & G Merriam Co., 1961).

6. What is research ethics? • Research ethics is therefore synonymous with both “values science and scholarship” and “standards of conduct and practice in science.” • Clearly, one is in agreement with the definition when one exhibits honesty and reliability, designs and performs experiments with skill and thoroughness, and is fair in dealing with students, co-workers and competitors, and assumes responsibility to people and institutions.

7. Why should we be concerned about research ethics? • You will do better science. • You may know what to do if an ethical problem arises. • Other scientists depend on your trustworthiness. • Scientific progress depends on it. • Public Welfare depends on it. • Your scientific reputation and career depend on it. • Science cannot work otherwise. • It is the right thing to do!

8. Nazi War Crimes WWII

9. NUREMBERG CODE1947 • Voluntary informed consent absolutely essential • Research should yield useful results • Base research on prior work • Avoid physical and mental suffering • No expectation of death or disabling injury • Risk must be outweighed by importance • Subjects must be protected from injury • Qualified scientists, adequate facilities • Subject free to stop at any time • Investigator must be ready to withdraw subject

10. DECLARATION of HELSINKI World Medical Association, 1964 updated in 2000 • Consent should be in writing • Research should build on previous work • Research must follow written protocol. • Review by an independent committee • Caution if subject is in dependent relationship with investigator • Subjects must receive best proven diagnostic and therapeutic methods revised 1975, 1983, 1989, 1996, 2000

11. Tearoom Trade StudyLaud Humphreys, 1970 • Sociological study of homosexual encounters • Several stages involving deception... • Observation in public restrooms • Obtaining names and addresses through license plates • In-home interviews

12. Milgram Shock Experiment • Involved deception of subjects • Subjects told to shock actors (unknown to subjects) • Study on obedience to authority

13. Stanford Prison Experiment • One group of subjects were “guards”; the other were “prisoners” • Principal Investigator acted as warden • Situation deteriorated quickly; prisoners abused by guards. • Long-term emotional distress by subjects especially prisoners.

14. Legacy of Tuskegee “The study continues to cast a long shadow over the relationship between African Americans and the bio-medical professions; it is argued that the studyis a significant factor in the low participation of African Americans in clinical trials, organ donation efforts, and routine preventive care.”

15. US National Research Act July 1974 • Established National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978) • The Belmont Report (1979) • Code of Federal Regulations (1981) • Institutional Review Boards (IRBs) • Informed consent • Common Rule (1991)

16. Charge to the National Commission • Identify the basic ethical principles which should underlie the conduct of biomedical and behavioral research involving human subjects • Develop guidelines to assure that such research is conducted in accordance with those principles National Research Act, 1974 (PL 93-348)

17. Belmont ReportEthical Principles and Guidelines for the Protection of Human Subjects of Research • Respect for Persons • Beneficence • Justice National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979

18. What are the main ethical issues in human subjects research? • The primary concern of the investigator and the IRB should be the safety of research participants. This is accomplished by carefully considering the risk/benefit ratio and continually monitoring the research as it proceeds. • The investigator must obtain informed consent. This must be obtained in writing (although sometimes oral consent is acceptable).

19. What are the main ethical principles governing research with human subjects? • The first ethical principle noted in the Belmont Report is autonomy. • The second principle is beneficence. • The third principle invoked is justice.

20. Translating Ethical Principles Into Regulations Regulatory requirements stem directly from ethical principles

21. Social & Psychological Risk Social and psychological risks are real risks.

22. Identifying Risks • Why IRBs do not rely solely on investigators to identify risks • No one can be objective about their own work • People underestimate the risks involved in things they are very familiar with • People overestimate the benefit of things that are important to them

23. Identifying Risks Examples of Social and Behavioral risk • Emotional Distress • Psychological Trauma • Invasion of Privacy • Embarrassment • Loss of Social Status • Loss of Employment

24. Identifying Risks The Primary source of social risk results from a breach of confidentiality. • Confidentiality and anonymity are not the same • Names are not the only identifiers • Subjects’ participation in the research may need to be kept confidential as well as their data

25. Role of the Institutional Review Board (IRB) 21 CFR 56.109 and 45 CFR 46.109 According to federal mandate “An IRB shall review and have authority to approve, require modification in (to secure approval), or disapprove all research activities covered by this policy”

26. So, What Is the IRB’s Purpose? The IRB’s Purpose and Responsibility Is to Protect the Rights and Welfare of Human Subjects. The IRB Reviews and Oversees Such Research to Ensure That It Complies With Federal Regulations, That Pertain to Human Subject Protection.

27. Federal Regulations • According to federal regulations, the activities that require IRB review include: • Any activities involving the collection of data through intervention or interaction with a living individual • Any activities involving identifiable private information regarding a living individual

28. Minimizing Risk There are three ways to minimize risk • Alternatives • Are there other procedures or methods that are less risky? • Precautions • Has the researcher included procedures to decrease the likelihood that harms will occur? • Safeguards • Are there procedures included to deal with harms if they occur?

29. Informed Consent • Consent process should empower subjects to make their own determination about risk • Risks should be explained in terms that the subjects can relate to - everyday life experiences • Consent process should not do more harm than the research

30. Common Rule The Common Rule provides sufficient flexibility for IRBs to effectively and efficiently review non- biomedical research • Exempt Research • Expedited Review • Waiver of Consent and/or documentation of informed consent

31. Expedited Review Research that may meet expedited review criteria include minimal risk studies and only those which fall under those categories : • Eleven specific categories most of which relate to medical samples. • The study of existing data, documents, records, pathological specimens or diagnostic specimens • Research on individual or group characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects’ behavior and the research will not involve stress to subjects

32. Exempt Categories • Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: • Research on regular and special education instructional strategies, or • Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

33. Exempt Categories Cont’d • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

34. Exempt Categories Cont’d • Research involving survey or interviewing procedures, except where all of the following conditions exist: • Responses are recorded in such a manner that the subjects can be identified, directly or through identifiers linked to the subject, • The subject’s responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing or employability,

35. Exempt Categories Cont’d • The research deals with sensitive aspect of the subject’s own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol. • All research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office.

36. Exempt Categories Cont’d • Research involving the observation (including observation by participants) of public behavior, except where all of the following conditions exist: • Observations are recorded in such a manner that the subjects can identified, directly or through identifiers linked to the subjects, • The observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing or employability, and

37. Exempt Categories Cont’d • The research deals with sensitive aspects of the subject’s own behavior such as illicit conduct, drug use, sexual behavior, or use of alcohol. • 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

38. Exempt Categories Cont’d • directly or through identifiers linked to the subjects. (Investigators must include with the IRB application a letter of approval for use or supply of the information material or specimens.)

39. Consent Requirements • Institutions are free to set their own consent requirements for exempt research.  • All consent requirements must be met in expedited review.

40. Research In Schools • The provisions of the Common Rule, Part A of 45 CFR 46, apply to all subjects regardless of age or circumstance, including public school students. • There are three direct references to children in the common rule, all of which identify children as vulnerable subjects. • Researchers and IRB members must be aware that there are vulnerabilities unique to school based research.

41. Vulnerabilities of Children in Research • Children may be vulnerable to undue influence and/or coercion. • When considering children as subjects researcher must take into account the purpose of the research and the setting in which it takes place.

42. Strategies to Minimize Undue Influence in School-Based Research • Researchers can provide attractive alternatives to participation for children who do not want to participate – not just time to do schoolwork. • Enlist Principals to identify classrooms where students are encouraged to make choices, rather than expected to participate in all activities. • If there is direct benefit, every effort should be made to enroll those students who will be most benefited by the research.

43. Exemptions in School-Based Research The following activities with school children do not qualify for exemption under 45CFR 46 Subpart D: • Research involving surveys. • Research involving interviews. • Observation of public behavior when the researcher participates in the activities being observed.

44. Exemptions in School-Based Research In contrast, the following research activities in schools may qualify for exemption: • Research conducted in established or commonly accepted educational settings involving normal educational practices. For example, research on regular or special education instructional strategies or research on the effectiveness of or comparison among instructional techniques, curricula, or classroom management methods • Research using educational tests, unless the disclosure of identifiable information would create the potential for harm.

45. Exemptions in School-Based Research • Observation of public behavior in which the researchers do not participate in the activities being observed. • Research involving the collection of study or existing data or records, if the data is publicly available or are recorded without identifiers. • Some food and taste studies.

46. What You Need to Know About School-Based Research • All research, including school-based research requires either a signed informed consent or waiver of informed consent or documentation of informed consent • All research using children as subjects requires parental consent and child assent . • Chicago Public Schools (CPS) has it’s own research review system, before designing your study check the CPS website for their requirements. Website: http://research.cps.k12.il.us/cps/accountweb/Requests/index.html

47. What You Need to Know About School-Based Research • Other school districts may have a similar process. Check district websites for research requirements. • When your proposal requires access to student records, review the following for requirements and compliance • Family Educational Rights and Privacy Act (FERPA) http://www.ed.gov/policy/gen/guid/fpco/ferpa/index.html • Illinois School Student Records Act (105 ILCS) at http://www.ilga.gov

48. Application of the Common Rule The effective and efficient application of the Common Rule to non-biomedical research requires that an institution must have: • An IRB that has sufficient expertise in social & behavioral research • An IRB that understands and utilizes the flexibility in the Common Rule • Investigators that understand the potential for social & psychological risk in their research

49. Reporting Requirements As part of the Institutional Review Board’s requirements, which are mandated by the regulations during the approval year, researchers are required to report to the IRB in the event of any of the following: • significant adverse reactions, (Yes, Social and Behavioral research can have adverse reactions) • Any changes to the study protocol, • Termination or closure of the study.

50. Investigator: Where Do I Begin? • I have an idea for research. • So, what do I do?