IRB/IRC Review of Social and Behavioral Research

SC Human Research ConferenceOctober 31, 2008

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

Expedited Review of Social and Behavioral Research

Activities

Social and Behavioral Research Working Group

Human Subjects Research Subcommittee

Committee on ScienceNational Science and Technology

Council

June 2008

Social and Behavioral Research Working Group of theHuman Subjects Research Subcommittee

Jody Klein-Saffran, Ph.D., Bureau of PrisonsRoger Cortesi, Environmental Protection Agency

Susan G. Queen, Ph.D., Health Research and Services AdministrationRonald Barnett, Ph.D., National Institutes of HealthDeborah Olster, Ph.D., National Institutes of Health

Kellina Craig- Henderson, Ph.D., National Science FoundationStuart Plattner, Ph.D., National Science Foundation (retired)

Mark L. Weiss, Ph.D., National Science FoundationGlen Drew, J.D., Office for Human Research Protections

Ivor A. Pritchard, Ph.D., Office for Human Research ProtectionsJohn Kraemer, Office of Management and Budget

Karen Y. Matsuoka, Office of Management and BudgetDiane C. DiEuliis, Ph.D., Office of Science and Technology Policy

Howard Bradley, Social Security AdministrationPatty Decot, U.S. Department of Defense

Caroline Miner, U.S. Department of DefenseJeffery W. Rodamar, ABD, U.S. Department of Education (Chair)

Brenda Wolff, U.S. Department of EducationSue Allison, U.S. Department of Justice

Patrick Clark, Ph.D., U.S. Department of JusticeCheryl Crawford-Watson, U.S. Department of Justice

David Miller, Ph.D., U.S. Department of Veterans AffairsGenevieve Nowolinski, U.S. Department of Veterans AffairsJoan A. Porter, Ph.D., U.S. Department of Veterans Affairs

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?

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:1. The proposed research activity involves no more than “minimal risk” to the

research subjects.2. The proposed research activity must be included in a list of eligible research

categories

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.

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.

Category 5Secondary 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.

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]

Category 7Experimental 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.

Category 7Survey 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.

Category 7Evolving 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.

What factors influence the successful

implementation of the expedited review process?

• Determining Eligibility• Deciding to use FBR• Identifying Submission

Requirements• Appointing Reviewers• Using Consultants

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

One example…Johnell Brooks, PhD

Department of Psychology

William Logan, MD

Department ofGeriatrics

Lab mission:Help older adults maintain their

independence as long as safely possible

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.

1. Carry weights in a pot 2. Put on & remove a coat

3. Pick up 4 scarves 4. Reach as high as you can

CS-PFP: Low effort tasks

5. Sweep gravel off floor

7. Sit down and stand up6b. Remove laundry

6a. Put laundry in dryer

CS-PFP: Medium effort tasks

9. Walk for 6 minutes

10. Load grocery bags & go for a walk

8. Go up & down stairs

CS-PFP: Hard effort tasks

Our history1. Home sim – Clemson

• Installation: Fall 2006• Start data collection: Spring 2007

2. Home sim – Greenville Hospital System• Installation: January 2007• Start data collection: Summer 2007

3. New drive sim – Clemson• Installation: Summer 2007• Start data collection: Fall 2007

4. Drive sim – Greenville Hospital System• Installation complete: Fall 2007• Anticipated data collection: Spring

Our study process1. Study design

• Clemson & Greenville Hospital System

2. Clemson• IRB approval

• Reciprocal approval from GHS (HSSC)• Data collection

• Students• Seniors

3. Greenville Hospital System• IRC approval (in progress)

• Reciprocal approval from CU (HSSC) • Data collection

• Non-clinical• Clinical

Our training processExample: Home sim1. CITI training

• Clemson • GHS

2. Intensive weekend training• Train-the-trainer• Certification process

3. Collect data from students• Observe data collection with seniors• 3 students with assistant• 3 students• 3 seniors with assistant• 3 seniors

4. Meet with study leaders5. Eligible for Greenville Hospital System data collection

Questions??