IRB/IRC Review of Social and Behavioral Research

1. IRB/IRC Review of Social and Behavioral Research SC Human Research Conference October 31, 2008

2. Challenges • “FDA” mindset • Social & Behavioral Research (SBR) expertise • Risks • Wide range of disciplines • Layers of regulations (i.e. DoEd, DoD) • Consent flexibility (aka waivers) • IRB/IRB forms - appropriateness

3. Expedited Review of Social and Behavioral Research Activities Social and Behavioral Research Working Group Human Subjects Research Subcommittee Committee on Science National Science and Technology Council June 2008

4. Social and Behavioral Research Working Group of the Human Subjects Research Subcommittee Jody Klein-Saffran, Ph.D., Bureau of Prisons Roger Cortesi, Environmental Protection Agency Susan G. Queen, Ph.D., Health Research and Services Administration Ronald Barnett, Ph.D., National Institutes of Health Deborah Olster, Ph.D., National Institutes of Health Kellina Craig- Henderson, Ph.D., National Science Foundation Stuart Plattner, Ph.D., National Science Foundation (retired) Mark L. Weiss, Ph.D., National Science Foundation Glen Drew, J.D., Office for Human Research Protections Ivor A. Pritchard, Ph.D., Office for Human Research Protections John Kraemer, Office of Management and Budget Karen Y. Matsuoka, Office of Management and Budget Diane C. DiEuliis, Ph.D., Office of Science and Technology Policy Howard Bradley, Social Security Administration Patty Decot, U.S. Department of Defense Caroline Miner, U.S. Department of Defense Jeffery W. Rodamar, ABD, U.S. Department of Education (Chair) Brenda Wolff, U.S. Department of Education Sue Allison, U.S. Department of Justice Patrick Clark, Ph.D., U.S. Department of Justice Cheryl Crawford-Watson, U.S. Department of Justice David Miller, Ph.D., U.S. Department of Veterans Affairs Genevieve Nowolinski, U.S. Department of Veterans Affairs Joan A. Porter, Ph.D., U.S. Department of Veterans Affairs

5. Four questions • What is “expedited review”? • What is “minimal risk”? • What kinds of social and behavioral research studies are eligible for expedited review? • What factors influence the successful implementation of the expedited review procedure?

6. What is “expedited review”? • An alternative to review by the full IRB/IRC at a convened meeting • Carried out by the IRB/IRC Chair, or by one or more experienced IRB/IRC members appointed by the Chair • With the same authorities as the full IRB/IRC to approve, modify, or attach conditions to proposed research activities, except the authority to disapprove a research activity • Must have procedures for notifying IRB/IRC members of research activities approved under the expedited review • Involves applying the same criteria for approval of research activities that are required for review by the full IRB/IRC Must satisfy two regulatory conditions in order to be eligible for expedited review: • The proposed research activity involves no more than “minimal risk” to the research subjects. • The proposed research activity must be included in a list of eligible research categories

7. What is “minimal risk”? To be eligible for expedited review, a research activity must be determined to be no more than “minimal risk,” : 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 examinations or tests.

8. What kinds of SBR is eligible for expedited review? 5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). 6. Collection of data from voice, video, digital, or image recordings made for research purposes. 7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

9. Category 5 Secondary analyses of existing or future data sets, such as databases containing medical records, criminal justice system records, education records, or survey data. These analyses may include studies where one or more data sets are combined. For example: An analysis of student educational records to explore the relationship between student mobility from district to district and student academic achievement for students from various economic and ethnic backgrounds. A study of prison administration records to explore the relationship between inmates’ individual background characteristics, type of criminal violation, and acquisition of a Graduation Equivalent Development (GED) credential. A study of medical records and survey data to compare people’s weight with the cultural attitudes of different subpopulations towards diet and exercise.

10. Category 6 Observational studies of human behavior and characteristics where personal identifiers are recorded and the data are not particularly sensitive in nature. For example: A study using video recordings to examine communication styles used by cooperating employees in a variety of business organizations. A laboratory study comparing patterns of eye movement and reading comprehension performance among novice and competent readers. [Cat. 6 or 7]

11. Category 7 Experimental studies of human behavior, attitudes, opinions, and decisions, where the experimental manipulation consists of subjects reacting to hypothetical or contrived situations that are not expected to have significant lasting effects on the subjects. For example: A study in experimental economics in which people play an economic game that involves offering and/or accepting amounts of cash provided as part of the experiment. A study of adults’ ability to identify accurately the perpetrators of staged thefts. A study attempting to validate a previously tested measure of extroversion/introversion with members of a previously untested cultural group.

12. Category 7 Survey research where the respondents are approached in a natural setting, either personally or through a communications medium (e.g., by mail, telephone, or the internet), and participation is voluntary. For example: A research study using telephone surveys of persons who provide their names and information about their background characteristics, political beliefs, and voting behavior. An online internet study in which undergraduate students view a video clip about economic theory and then respond to computer-simulated scenarios about individual spending decisions.

13. Category 7 Evolving research activities (such as ethnographic studies or focus group research) where the research activity is refined in various ways in response to earlier data collection, and the topics are not especially sensitive. For example: An ethnographic field study using un-structured interviews to explore the interrelationship between family life and involvement in religious activities. An ethnographic study using participant-observation where the researcher participates in the subject’s activities of daily life, such as an anthropologist studying an agrarian market place by sitting in the respondent’s market stall, observing interactions and sometimes selling items to help out.

14. What factors influence the successful implementation of the expedited review process? Challenges • Determining Eligibility • Deciding to use FBR • Identifying Submission Requirements • Appointing Reviewers • Using Consultants • “FDA” mindset • Social & Behavioral Research (SBR) expertise • Risks • Wide range of disciplines • Layers of regulations (i.e. DoEd, DoD) • Consent flexibility (aka waivers) • IRB/IRB forms - appropriateness

15. One example… William Logan, MD Johnell Brooks, PhD Department of Geriatrics Department of Psychology Lab mission:Help older adults maintain their independence as long as safely possible

16. Our rules to live by… • We recognize that living independently and driving are key considerations in health, quality of life, and safety of older adults. • We recognize there are limited options for seniors who can’t live independently and / or drive. • We recognize that the growing aging population will present serious challenges. • All of our research studies must aim to improve the quality of patients’ lives.

17. CS-PFP: Low effort tasks 2. Put on & remove a coat 1. Carry weights in a pot 4. Reach as high as you can 3. Pick up 4 scarves

18. CS-PFP: Medium effort tasks 6b. Remove laundry 7. Sit down and stand up 5. Sweep gravel off floor 6a. Put laundry in dryer

19. CS-PFP: Hard effort tasks 10. Load grocery bags & go for a walk 8. Go up & down stairs 9. Walk for 6 minutes

21. Our history • Home sim – Clemson • Installation: Fall 2006 • Start data collection: Spring 2007 • Home sim – Greenville Hospital System • Installation: January 2007 • Start data collection: Summer 2007 • New drive sim – Clemson • Installation: Summer 2007 • Start data collection: Fall 2007 • Drive sim – Greenville Hospital System • Installation complete: Fall 2007 • Anticipated data collection: Spring

22. Our study process • Study design • Clemson & Greenville Hospital System • Clemson • IRB approval • Reciprocal approval from GHS (HSSC) • Data collection • Students • Seniors • Greenville Hospital System • IRC approval (in progress) • Reciprocal approval from CU (HSSC) • Data collection • Non-clinical • Clinical

23. Our training process • Example: Home sim • CITI training • Clemson • GHS • Intensive weekend training • Train-the-trainer • Certification process • Collect data from students • Observe data collection with seniors • 3 students with assistant • 3 students • 3 seniors with assistant • 3 seniors • Meet with study leaders • Eligible for Greenville Hospital System data collection

24. Questions??