Social and Behavioral Science in Medical Research

1. Social and Behavioral Science in Medical Research Judy Birk, JD IRBMED Director Cindy Shindledecker, CIP IRB-HSBS Director

2. Objectives Define Social / Behavioral Science (SBS) as a component of medical research Examples Perceptions / challenges Data collection formats Special considerations for study teams and the IRB JB

3. Social/Behavioral Science (SBS) Research • What is SBS research? • Study of human behavior and relationships • Applies scientific logic and methods to the study of social phenomena • Importance in medical research • Collects information other than objective clinical/lab values • Identifies barriers to • Improving overall human health • Research participation including recruitment, enrollment, and retention JB

4. SBS Contributions to Medicine • Human factors/decision-making • Increased safety in healthcare settings for patients / providers • Health policy • Anti-smoking campaigns • Education • Cancer prevention, screening, and control • Epidemiology • Patterns, causes, and effects of disease conditions in defined populations JB

5. AAMC Report Recognizing SBS • Behavioral and Social Science Foundations for Future Physicians (2011) • Over 50 percent of premature morbidity and mortality is caused by behavioral and social determinants of health such as smoking, diet, exercise, and socioeconomic status • While complex and not easily remedied, each of these phenomena is amenable to behavioral and social sciences study and intervention. • Behavioral and social science knowledge and skills can support health and wellness, explain disease etiology, improve adherence rates to existing treatments, and develop new interventions. JB

6. AAMC Report • Smoking as an example • To best serve their patients, physicians need to understand why patients choose to smoke and how to facilitate behavioral change through building intrinsic motivation. • Physicians with behavioral and social science knowledge also appreciate social factors, such as peer pressure and advertising, that promote smoking, and the policy interventions, such as tobacco taxes, that greatly curtail smoking rates. • Moreover, prevention or treatment of nicotine addiction requires knowledge of the health care system, referral resources, adherence promotion, and effective relationships with allied addiction counselors. JB

7. NIH: Office of Behavioral and Social Sciences Research There is a growing recognition that most major threats to the public’s health – including: and more—are complex in the sense that each one arises from an intricate mix of behavioral, economic and social factors interacting with biological factors, as well as each other, over the lifespan and across an array of settings (e.g., home, school, workplace, neighborhood, etc.). Cardiovascular disease Pulmonary disease Cancer Diabetes Mental health problems HIV Substance abuse Violence Emerging infectious diseases Obesity Sedentary lifestyle Poor diet Sleep disorders JB

8. Academic Model: University of MichiganMedical School Center for Bioethics and Social Sciences in Medicine • CBSSM is a multidisciplinary unit integrating bioethics with research, education, policy work, and public outreach in areas of: • Doctor-patient communication • Psychological adaptation to disability • Health care rationing • Social cognition • Decision aids to communicate risk • Informed consent • Deliberative democracy JB

9. Academic Model: Northwestern University Feinberg School of Medicine Department of Medical Social Sciences • In support of clinical research and integrated biomedical and social science to improve health and healthcare delivery: • Health measurement • Quality of life measures • Outcomes science • Statistical tools JB

10. Academic Model: King’s College of London Department of Social Science, Health and Medicine • Ageing & Society • Biomedicine, Ethics & Social Justice • Biotechnology, Pharmaceuticals & Public Policy • Culture, Medicine & Power JB

11. Why, then, is this so challenging? • Medical Research • Social Science Research JB

12. Perceptions and Challenges of SBS Research • Unfamiliarity of clinicians with techniques • In conflict with standard medical practices • Privacy and confidentiality for subjects • Sensitive information needs to be managed outside of the medical record • Alterations to the informed consent process • Different formats • Level of disclosure • Assessing and assigning subject risk • Assessments may be more difficult; subjective JB

13. Special Considerations in SBS Research Points to remember: • Risks associated with SBS research are primarily psychological, financial, employability, reputational or legal • Most common risk is breach of confidentiality CS

14. Forms of SBS Data Collection Interviews (1:1 direct interaction) Focus groups (Moderated, group discussions) Surveys (Telephone, online, paper-based, mobile devices) Observation of online behavior (social networking, educational web resources) CS

15. Interviews • Benefits • Allows for greater, subjective exploration of topics • Opportunity for establishing a connection with the researcher • Challenges • Interview may deviate from the planned, IRB-approved question set • Participant may disclose sensitive information not contemplated CS

16. Focus Groups • Benefits • The moderated group discussion permits introduction and explorations of view points among the group • Challenges • Maintaining confidentiality of the discussion • Consider use of pseudonyms, particularly when sensitive topics will be explored • Consent should disclose the uncontrolled nature of the discussion and should not promise confidentiality CS

17. Surveys • Benefits • Allows for disclosure of information in a more protective manner (surveys may be completely anonymous or coded) • Data are more objectively recorded (not biased by interviewer) and easily compiled and analyzed • Easy to reach a large audience • Challenges • Knowing your subject (especially on-line) • Data security of online survey tools CS

18. Observation of Online Behavior • Benefits • Web-based health interventions • Facilitate the collection of survey data and observation of online user behavior • Social networking tools • Use of social networking tools to remind patients to take meds, report mood information, etc. • Challenges • Public vs. private behavior • Obtaining informed consent • Data security issues CS

19. Deception and Concealment Studies:Definitions • Not all information is disclosed to potential and actual participants • Deceptionin human subjects research means deliberately misleading subjects about the nature of a study • Concealment means deliberately withholding certain information CS

20. Deception and Concealment Studies • Why is this type of research necessary? • Full disclosure of information about the nature of the study might bias the response if subjects knew the true purpose of the research CS

21. Deception and Concealment Studies: IRB Considerations • Increased scrutiny by the IRB • Review of study design • There is no other way to answer the research question • Informed consent waiver • Full or partial • Debriefing • Whenever possible, disclosure of the true purpose of the study as soon as possible after their participation is completed • Allow the subject to continue to have their data used CS

22. Deception and Concealment Studies:IRB Regulatory Authority • 45 CFR 46.116(d) An IRB may approve a consent procedure which does not include, or which alters some of the elements of informed consent . . . provided the IRB finds and documents that: (1) The research involves no more than minimal risk to the subjects (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects (3) The research could not practicably be carried out without the waiver or alteration (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation CS

23. Deception and Concealment Studies: Examples in Medical Research • Placebos • Subjects are told they will receive drugs, but only receive placebo. • The subject is given a skin crème that does not contain any active ingredients • Neuroscience • Subjects are primed with one stimulus but studied for another purpose • The subject is told they are receiving acupuncture to study the analgesic effect of traditional Chinese acupuncture • Instead they were given a placebo acupuncture to study expectation effects (with an fMRI) JB

24. Special Considerations in SBS Research • Informing subjects • Prepare participants for sensitive topics • Provide resources if questions will be upsetting • For web-based surveys on sensitive topics, provide instructions regarding security on public computers • Disclose plans for reporting harm to self or others • Waiving documentation of informed consent may be appropriate • Interviewer training • For interviews or focus groups involving sensitive topics, provide information regarding interviewer training CS

25. Special Considerations in SBS Research • When preparing the eResearch application, give extra consideration to • Privacy • Location of interviews • Mailings that reveal diagnoses • Confidentiality • Minimize the collection of personal identifiers • Survey construct (paper, phone, web-based, mobile devices) • Data security provisions • Obtain a Certificate of Confidentiality where questions are sensitive, particularly questions about illegal behaviors JB

26. Questions / Discussion