Social and Behavioral Research in the Medical Setting

Report
Social and Behavioral Science in
Medical Research
JUDY BIRK, JD
IRBMED DIRECTOR
CINDY SHINDLEDECKER, CIP
IRB-HSBS DIRECTOR
Objectives
 Define Social / Behavioral Science (SBS) as a
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component of medical research
Examples
Perceptions / challenges
Data collection formats
Special considerations for study teams and the IRB
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 / providers
 Health policy
 Anti-smoking campaigns
 Education
 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)
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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.
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.).
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Cardiovascular disease
Pulmonary disease
Cancer
Diabetes
Mental health problems
HIV
Substance abuse
Violence
Emerging infectious diseases
Obesity
Sedentary lifestyle
Poor diet
Sleep disorders
Academic Model: University of Michigan
Medical School
Center for Bioethics and Social Sciences in Medicine
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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
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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
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Ageing & Society
Biomedicine, Ethics & Social Justice
Biotechnology, Pharmaceuticals & Public Policy
Culture, Medicine & Power
Why, then, is this so challenging?
Medical
Research
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Social
Science
Research
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
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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
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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
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
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Facilitate the collection of survey data and observation of online
user behavior
Social networking tools
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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
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Deception in human subjects research means deliberately
misleading subjects about the nature of a study
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Concealment means deliberately withholding certain
information
Deception and Concealment Studies
 Why is this type of research necessary?
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Full disclosure of information about the nature of the study
might bias the response if subjects knew the true purpose of
the research
Deception and Concealment Studies:
IRB Considerations
 Increased scrutiny by the IRB
 Review of study design
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Informed consent waiver
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There is no other way to answer the research question
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.
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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
appropriate
 Interviewer 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
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Privacy
Location of interviews
 Mailings that reveal diagnoses
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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
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Questions / Discussion

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