HRC 101 Workshop

1. HRC 101 Workshop Human Subject Protections in Research Tammy Felton-Noyle and Amy Gibbs January 25, 2006

2. Agenda • Introductions • History of Human Subject Research • Human Subject Compliance and Bioethics • Human Subjects Compliance in Social Behavioral Research • Informed Consent • UCB Specific Policies

3. Regulatory Guidelines The Common Rule 45 CFR 46 The Belmont Report In addition: Local and state regulations that may be applicable (International Conference on Harmonisation, Helsinki) Various professional organizations (Am. Psychological Association, Oral History Association, etc.)

4. History • Milgram Study Obedience to Authority (1961) • Volunteers were deceived into believing the research was about learning and memory. Subjects were told to teach a "student" and to punish errors by administering increasing levels of electric shocks. • Zimbardo’s Simulated Prison Study (1973) • Mock prison study included 21 healthy male participants who would participate for 2 weeks. 9 were selected as prisoners, the rest as guards. It was stopped 6 days later due to the escalating psychological effects on all participants.

5. HistoryRecent Human Subjects Research Cases • Virginia Commonwealth University: 1999 Mid-Atlantic Twin Registry (MATR) • Complaint by subject’s parent triggered an investigation that found the following: • Lack of parental informed consent • Obtaining identifiable private information about third parties without consent • IRB failed to approve modifications in MATR prior to implementation • IRB lacked an education program for IRB members, staff, and researchers • One IRB was insufficient to properly give oversight in VCU protocols • The research office lacked sufficient manpower for workload

6. Accountability Held in Regulations • Institutional Accountability • Investigator Accountability • IRB (or HRC) Accountability

7. Human Subjects Compliance in Social Behavioral Research • What is Social Behavioral Research? • Social and behavioral research refers to research dealing with human subjects and data from or about them that is focused on attitudes, beliefs, and behavior rather than biomedical • Exploratory Studies • Evaluation of Existing Programs • Comparison of Programs • Experimental Manipulations

8. Common Research Methods • Observational • Record Reviews/Historical • Survey, Questionnaire, Interview • Epidemiologic • Case-Control • Longitudinal

9. Human Subjects Compliance in Social/Behavioral Research Belmont Report • Respect for Persons • Respect for autonomy • Voluntariness • Freedom from coercion • Informed consent • Protection for those with diminished autonomy (vulnerable populations) • Full disclosure • Comprehensibility

10. Belmont Report Principles cont. • Beneficence • Do no harm • Maximize benefits and minimize risks to subjects • Justice • Fairness of subject selection • Equitable distribution of benefits and burdens in participating in research

11. Risks in Social Behavioral Research • Minimal risk: “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 examinations or tests” (45 CFR 46.102) • Whose daily life? • Risks need to be minimized to the extent possible

12. Risks cont. • National Research Council’s 6 Categories (IRB Ethics & Human Research, p. 12, vol. 26, 3). • Physical • Psychological: depression, altered self-concept, increased anxiety, decreased confidence in others, guilt, shame, fear, embarrassment, boredom, frustration, receiving unpleasant information about oneself • Social : stigma, decreased opportunities, negative changes in relationships (p.c.). • Economic • Legal • Dignitary

13. Other Risks • Discovery of illegal activities • Investigator may obtain Certificate of Confidentiality • Discovery of intent to harm self or others/Child Abuse • Mandatory reporting • Third party information • Minimize the risks of disclosure by not requesting identifying or easily identifiable information of third parties. • Use of Deception • Require that the subject is debriefed on the research protocol immediately following his/her participation. The HRC must review and approve the debriefing procedure/statement.

14. What is Research? • A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. • Systematic: a sufficiently organized manner of gathering data and thus able to be generalized so that the activity might be considered research. • Designed to: must reflect the deliberate intent to create or add to generalizable knowledge. • Generalizable: if it is relevant to more than the particular circumstance that produced it.

15. What is a Human Subject? • a living individual about whom an investigator conducting research obtains: • data through intervention or interaction with the individual; or • Identifiable private information [45 CFR 46.102(f)]

16. Is It Human Subject Research? Is there an interaction or intervention with a living person that would not be occurring, or would be occurring in some other fashion, but for this activity? Yes No Will private information or specimens be obtained (including observation)? No Yes Is the information individually identifiable (directly or indirectly)? No Yes Is the activity systematic, and designed to contribute to generalizable knowledge? No HRC review required No Yes HRC Review Required

17. Issues in Social Behavioral Research • Oral Histories • Undergraduate Classroom Projects • Unanticipated Use of Data

18. Steps for Investigators • Complete the CITI Program tutorial • http://www.citiprogram.org • Review the HRC web site • http://www.colorado.edu/VCResearch/HRC/index.html • Complete IRB Manager Request for Review and obtain approval PRIOR to starting any human subjects research project.

19. HRC Types of Review • Regular (by full panel) review • Expedited Review • Exempt Review Expedited and Exempt reviews are conducted by an appointed member of the committee and are done without a convened meeting.

20. Expedited Review (9 Categories) Criteria: Research involving only minimal risk Examples of some categories: • Use of existing data that was not collected for research purposes • Minimal risk survey, interview, program evaluation, QA research • Data from voice, video, digital, or image recordings made for research purposes

21. Exempt Categories (except with the use of prisoners, fetuses, pregnant women, or human in vitro fertilization, and surveying or observing minors except when the investigator is not actively involved in the activities being observed). • Examples could be: • Research involving normal educational practices • Research involving educational tests, surveys, interviews unless: • Data are not anonymous and results could be harmful to subjects • Observation of public behavior • Using existing data that is publicly available or anonymous

22. Vulnerable Populations defined by 45 CFR 46 • Incarcerated or institutionalized persons • Minors (state of Colorado age of majority is 18) • Pregnant women, fetuses, and in vitro

23. Vulnerable Populations protected by Subpart A of 45 CFR 46 • Those whose participation may be construed as coerced (students, employees, etc.) due to • Hope of benefit (better grades) • Excessive rewards (undue influence) • Threat of punishment, withholding of privileges, loss of status, or deprivation of benefits

24. Informed Consent Informed consent is a process that starts during the recruitment procedures. • Required elements of disclosure • Additional elements may be required, if applicable • Consent document written in a language understandable by subject

25. Issues in Informed Consent Audio/Video • Audio/Video is inherently identifiable • Informed consent should ask specific permission to audio/video tape. If the subject does not consent to be taped, the tape must have the blue dot, blurring of features, or distortion of sound, or any other arrangement to honor the individual’s choice. • Informed consent should state what will be done with the tapes, whether they will be destroyed/erased and when or whether they will be archived for future research purposes. Additional consent must be obtained from the subject to retain such identifiable data for future research purposes and this should be outlined in the consent form.

26. Issues in Informed Consent • Exculpatory Language is Not Permitted (examples) • “I agree that the medical center will not pay me for any injuries that I might sustain as a result of participating in this research” EXCULPATORY • The University of Colorado at Boulder has no policy or plan to pay for any injuries that you might receive as a result of participation in this research” TRUTH • “I understand that I will not sue the sponsor or the investigator for any negligence” EXCULPATORY

27. HRC 201 Informed Consent February 22, 2006 2:30PM ARC 150 You can sign up today.

28. University of Colorado at Boulder’s Policies • Vulnerable Populations not defined by 45 CFR 46 • Parolees or other institutionalized individuals not incarcerated • Cognitively impaired • Illiterate or non-English speaking • Those who would expose criminal or, otherwise, stigmatizing behavior • Employees • Students/Lab Assistants

29. UCB Policies cont. • If research is conducted at GCRC, SAC approval is required prior to HRC approval.

30. Case Study 1 • A researcher proposes to survey low-income families in Denver regarding the availability and adequacy of dental practitioners for elementary age children (7-10 years). The research includes parental consent for completing a 30-minute questionnaire on the child’s dental history and care and a brief evaluation of the minor’s teeth and gums. The entire research should take approximately 45 minutes. The researcher intends to offer to the parents $100 cash. • What procedures should be in place? • Are there any issues that should be discussed?

31. Case Study 2 • A graduate student would like to pose as a homeless person in various shelters in the Denver area. The graduate student will make observations of the shelter volunteers, the homeless individuals, and the various methods of aid offered. In addition, the student will use a false past in order to gain the confidences of the volunteers and shelter recipients in order to learn of the health care available to homeless and the lifestyle concerns. The student would then like to write a publishable paper on what was seen as effective in the shelters and what was not and identify areas of need for those homeless individuals. • Are there any concerns with this research? • How would you go about conducting such a research project?

32. Case Study 3 • A researcher proposes to monitor subjects’ emotional changes when watching various scenes from movies. After having subjects watch motivational scenes, the researcher would like to present a small story and find the perspectives of the subjects. Another group of subjects will watch violent scenes from movies and be presented the same small story. The researcher would like to find whether the different scenes affect their perspective of the essay. This researcher intends to use the psychology pool and will offer 1 credit for participation. The motivational scenes include those such as “What about Bob?” and “Scrooged.” The violent scenes include those from “Halloween” and “Faces of Death.” • What kind of screening would you do for participants? • What would be included in the consent? • Would this require a debriefing?