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Human Subjects Research
at UCAR
Overview of the Process
September 9, 2014
Meg McClellan
UCAR Chief Legal Officer
OVERVIEW
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UCAR HSC
HSC Approval Process
How do I comply? . . . Procedures
Important Concepts
- Informed Consent
- Confidentiality & Privacy
- Risk
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Exceptions
Manual
NIH Training/Certification
UCAR HSC
UCAR Human Studies Committee (HSC) is
UCAR’s IRB
 Goal: researchers follow the regulations
 Goal: protect interests and well-being of
research participants
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HSC
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Michael Thompson, NCAR Deputy Director & COO – [email protected]
Katy Schmoll, VP F&A/Ethics Officer – [email protected]
Meg McClellan, General Counsel – [email protected]
Greg Byrd, UCP Rep. – [email protected]
Mary Hayden, NCAR Rep. – [email protected]
Kathleen Miller, NCAR Rep. – [email protected]
Lecia Barker, University of Texas at Austin, Outside Rep. –
[email protected]
HSC Administrator: Cindy Worster
HSC AT UCAR
https://ncar.ucar.edu/human-subjects-committee/
human-subjects-research
PROCEDURES
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Protocol form and submission (HSC website)
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The “protocol” is the researcher’s response to
specific questions about the human subjects
research
HSC reviews online
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HSC primary contact (rotates based on the month)
Review and communicate electronically
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Approval
Provisional approval with required changes
List of required changes and request for resubmission
After approval: submit final electronic copies
WHAT NEEDS TO BE REVIEWED?
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Any research (as defined in the regulations) that involves
human subjects
A living individual about whom a researcher conducting
research obtains:
- data through intervention or interaction with the individual
Or
- identifiable private information
BASICS OF THE REGULATION
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Based on federal regulation known
as the Common Rule (45 CFR part
46)
NSF Regulation 45 CFR part 690
Research
Human subjects
Ethics, values and respect
HUMAN SUBJECTS
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When people are not identified (are anonymous)
research may not fall within the regulations
Collecting data with no personally identifiable
information
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No names
No audio, video recording
Privacy and other confidentiality concerns may
still exist
THE ETHICS OF HUMAN RESEARCH MEANS
SUPPORTING SUCH VALUES AS . . .
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Respecting people and their communities
Protecting research participants
Benefiting individuals and society
Valid design, sampling, data collection,
analysis, interpretation, and presentation
Disseminating findings effectively, including
data sharing
Facilitating the application of findings
INFORMED CONSENT
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What is it?
- Consent to participate in research that is voluntary, made
by the person (or one with authority to decide for that
person), and informed
- It is voluntary, when it is not coerced
- Informed – you need to tell them in plain language what
you are doing (but there’s more . . .)
INFORMED CONSENT
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When is it required?
- All research involving human subjects requires
informed consent from participants
- Exception is for exempt research (more on this
to follow)
HOW TO: ELEMENTS OF INFORMED
CONSENT
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No “Legalese”
Identification of Researcher
Explanation of the purpose of the research
Duration of research participation
Request for participation, including the right to withdraw
at any time
Explanation of research procedures
Description of how confidentiality will be maintained
ELEMENTS OF INFORMED CONSENT
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Right of refusal without penalty
Risks - explain
Benefits - any feedback or benefits to
participants
How to contact persons designated to answer
questions the participants (or guardians) might
have
Participants (or guardians) may keep copy of
consent
Written (or oral where appropriate)
DOCUMENTATION OF INFORMED CONSENT
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Written form approved by HSC
Verbal consent approved by HSC
Signed and dated by person or legally
authorized representative
Signed and dated by researcher obtaining
consent
Copy given person/representative
Checklist, sample forms
CONFIDENTIALITY & PRIVACY
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Confidentiality is about data, agreements and
procedures for limiting access of others to data
Privacy refers to persons and their interest in
controlling access of others to themselves.
Neither term is defined in the regulations
Both terms have legal definitions depending on
the context
MORE ON CONFIDENTIALITY
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Don’t assure confidentiality unless you
can really keep it
To maintain confidentiality:
 Anonymity
in data collection
 Procedures that eliminate linking data to
unique identifiers
 Data sharing techniques
 Data storage (electronic and hard copy)
CONFIDENTIALITY IN THE DIGITAL WORLD
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GIS
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Exempt, confidential or anonymous data, becomes
discernable
Industry standards in reporting out data
Social media
Third party survey services
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One step removed from researchers
Online
Contractual obligations
MORE ON PRIVACY . . .
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Be sensitive to the “privacy” expectations of the
people that you are studying by asking:
 Someone who works with the population
(teachers, doctors)
 An investigator who has research experience with
the population
 Members of the population what others in their
group consider private
 Embarrassment
Understand privacy requirements of any institution,
laws
RISKS
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Researchers and the HSC must assess the risk
involved
Minimal risk?
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Minimal risk occurs when 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 test.
RISKS
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Psychological Risk – mental stress and/or emotional
distress
Sociological Risk – relational stress and/or positional
distress
Physiological Risk – bodily harm to self and/or others
Spiritual Risk – individual faith/work stress and/or
religious community distress
3 CATEGORIES OF REVIEW
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Exempt*
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Expedited*
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Only HSC can determine (not researcher)
Review by HSC on call and/or experienced member
Review by HSC Chair and experienced member
Full Review
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Review by entire committee
*Entire HSC is informed, may weigh in; only full committee can
disapprove
EXEMPT RESEARCH
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Conducted in established or commonly accepted
educational settings
Use of educational test, survey procedures,
interview procedures or observations of public
behavior if:
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Anonymous, or unidentifiable; and
Exposure of responses outside research does not pose
risk of civil or criminal liability, or damage to subject’s
financial standing, employability or reputation; and
Not under 18, or vulnerable class
EXEMPT RESEARCH (CONT.)
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Use of educational tests, survey or interview
procedures or observations of public behavior
that is not otherwise exempt (as outlined above),
if:
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Elected or appointed public officials or candidates for
public office; or
Federal statutes require that the confidentiality of the
personally identifiable information will be maintained
throughout the research.
Agency program manger or director may waive
some or all requirements (rarely happens)
EXPEDITED REVIEW
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Research that is exempt, involves minimum risk,
minor changes in prior approved research
HSC chair or experienced member may review
and approve (without full HSC)
HSC reviewer may exercise all the authority of the
full HSC, except to disapprove the protocol; that
must be done by full HSC
FULL REVIEW
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Requires Full HSC review and formal
meeting
Researcher can attend and present
HSC REVIEW
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Risks to subjects are minimized
Risks to subjects are reasonable in relation to benefits and
importance of knowledge to be gained
Selection of subjects is equitable
Informed consent is adequate
Informed consent will be documented
Research plan adequately monitors, collects and stores data
to protect privacy and confidentiality
Additional safeguards are included for vulnerable
populations, situations
RESEARCHER BEST PRACTICES
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PI certification
http://phrp.nihtraining.com/users/login.php
Plan ahead – timing is important
Involve an HSC member early
Consider all aspects of study
Data access, transmission, storage are important
Record Keeping
http://www.ucar.edu/hsc/RFK.htm