Human Subject Protection Issues Thoughts from OHRP

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Human Subject Protection Issues Thoughts from
OHRP

• Bernard A. Schwetz, D.V.M., Ph.D.
• Director, Office for Human Research Protections
• Department of Health and Human Services
• Bernard.Schwetz_at_hhs.gov
• The New York Academy of Medicine and
• The Metropolitan Ethics Network
• New York City, NY
• June 7, 2007

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Topics

• SACHRP
• Outreach to Institutional Signatory Officials
• Alternatives to local IRBs
• Incidental findings
• Informed consent document and process

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SACHRP Activities - Completed

• Recommendations on Subparts C and D
• HRPP Accreditation
• Harmonization of HIPAA and the Common Rule
• Greater Involvement of IOs in the HRPP
• Workshop and Conference on IRB Review Models
• International Research

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SACHRP Activities - Ongoing

• New Chair Dr. Sam Tilden, Univ. of Alabama
• Recommendations on Subpart A
• continuing review -informed consent
• expedited review - institutional responsibilities
  -exemptions
• OHRP Guidance on Adverse Event Reporting
• Subcommittee on Inclusion of Individuals with
  Impaired Decision Making Capacity
• Responsibilities and Training of Investigators

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Outreach to Institutional Signatory Officials

• Where is the greatest risk to subjects of
  research?
• answer investigators
• How do I reach investigators?
• answer with great difficulty
• An alternate pathway to reach investigators?
• answer Institutional Signatory Officials

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Why outreach to institutional signatory officials?

• They
• set the culture of the institution
• are responsible for
• training of investigators
• behavior of investigators

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Alternatives to local IRBs

• Why are cIRBs so underutilized?
• e.g. NCI adult oncology cIRB
• SACHRP recommended a conference
• workshop, November, 2005
• national conference, November, 2006

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Report of the conference

• links to the report
• http//www.aamc.org/research/irbreview/start.htm
• OHRPs homepage under Special Issues
  http//www.hhs.gov/ohrp/

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Why is this controversial?

• issues related to liability
• sharing authority and responsibilities
• quality of review, local context
• costs, timing, loss of revenues
• Look at the report!

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Incidental Findings

• definition a finding concerning an individual
  research participant that has potential health or
  reproductive importance and is discovered in the
  course of research but is beyond the aims of the
  study.
• _______________
• Susan M. Wolf et.al., University of Minnesota,
  May 1, 2007

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Incidental Findings, cont.

• not a new issue a large literature exists
• renewed interest driven partly by new
  technologies
• imaging neuroimaging, CT colonography
• genomic microarrays
• secondary research on archived datasets
• archived samples, scans
• DNA databanks

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Issues related to IFs

• do researchers have an obligation to look for
  IFs?
• if they suspect an IF, must they seek a
  consultant?
• what, if anything, should be disclosed to the
  subject?
• what should research protocols and consent forms
  say about how IFs will be handled?

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OHRP/HHS Position on IFs

• HHS regulations no specific mention of IFs,
  however
• investigators and IRBs need to be sensitive to
  issues related to IFs
• relevant institutional policies should be
  considered

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Basis for an action by an investigator or an IRB

• Scientific, ethical, and clinical considerations
• probability of an IF
• severity
• sensitivity of the method
• false negative generally has serious
  implications, but this is an IF
• specificity of the method
• false positive may drive an inappropriate action
• consequence?
• agreement on the clinical implication of the
  finding
• consequence of ignoring the finding
• financial considerations

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Implications to consider

• Investigators
• disincentive for physician investigators
• lengthen and complicate the informed consent
  document/process
• research with children, could trigger need for
  expert panel (407)
• IRBs
• require full board review of minimal risk
  research based on potential IFs?
• should IRBs oversee how investigators handle IFs?

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Informed Consent Document and Process

• Another old but very important issue!
• Do we get informed consent or just consent?
• Are subjects sufficiently informed to be
  protected?
• many say no

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Problem

• research has gotten more complex
• informed consent documents (ICDs) have gotten too
  long
• ICDs lengthened to protect institutions, not
  subjects
• literacy is low 50 lt 8th grade level
• ICDs are hard to read low comprehension

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What accounts for low health
literacy?

• low capacity to read, write, express oneself
• lack of understanding among literate people
• concepts of health, therapy, prevention, research
• vulnerable groups
• young, mentally handicapped/decisionally
  impaired, prisoners, emergency situation patients
• literate with misinformation
• Internet, representing research as treatment

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Current efforts to help

• research continues, need more
• conference on Use of Short and Readable ICDs
• Howard Dickler, AAMC, May 30, 2007
• Subpart A Subcommittee of SACHRP will review
  informed consent

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Caution as we proceed

• its easy to focus on the ICD because it can be
  compared to regulatory requirements
• However, the IC process contributes more to the
  understanding of a prospective subject than the
  ICD
• lets not just focus on the document as we try to
  improve the informed part of the informed
  consent

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Closing thoughts

• SACHRP continues to be very productive
• trust of the public depends on how well we
  protect subjects of research
• focus on ethics, not just compliance

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How to contact OHRP?

• Address
• Office for Human Research Protections
• 1101 Wootton Parkway, Suite 200
• Rockville, Maryland 20852
• PhoneToll-Free Telephone within the U.S. (866)
  447-4777 Main Number [phone]
• Fax [phone]
• Email
• ohrp_at_osophs.dhhs.gov
• Website
• http//www.hhs.gov/ohrp/