Social and Behavioral Science in Medical

Research

JUDY BIRK, JD IRBMED DIRECTOR

CINDY SHINDLEDECKER, CIP IRB-HSBS DIRECTOR

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Objectives

Define Social / Behavioral Science (SBS) as a component of medical research

ExamplesPerceptions / challengesData collection formatsSpecial considerations for study teams and

the IRB

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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

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SBS Contributions to Medicine

Human factors/decision-making Increased safety in healthcare settings for patients /

providersHealth policy

Anti-smoking campaignsEducation

Cancer prevention, screening, and control Epidemiology

Patterns, causes, and effects of disease conditions in defined populations

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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.

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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.

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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

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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

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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

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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

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Why, then, is this so challenging?

Medical Research

Social Science Researc

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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 recordAlterations to the informed consent process

Different formats Level of disclosure

Assessing and assigning subject risk Assessments may be more difficult; subjective

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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

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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)

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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

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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

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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

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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

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Deception and Concealment Studies:Definitions

Not all information is disclosed to potential and actual participants

Deception in human subjects research means deliberately misleading subjects about the nature of a study

Concealment means deliberately withholding certain information

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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

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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

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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

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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)

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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

appropriateInterviewer training

For interviews or focus groups involving sensitive topics, provide information regarding interviewer training

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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

Questions / Discussion