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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
h
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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
CS
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