Informed Consent for Registries and Genetic Research by 68nwIAo

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									Informed Consent for Registries
            and
      Genetic Research
        Laura Carey Miller, MSHA
                IRB Manager
           Inova Health System
        Institutional Review Board
          Laura.Miller@inova.org
              (703) 776-3167
 Tissue and Genetic Research
 Protection  of data related to sample
 Will data be identifiable
 Who will have access to samples
 Enrolling children or decisionally impaired
  in tissue research
 Provisions for consent when turning 18, or
  regaining capacity, etc.
    Unresolved Regulatory and
          Ethical Issues
 PRIM&R    March 2007 Working Group
  Report provides overview and
  recommendations for standardized
  regulations
 SACHRP July 15-16, 2008 meeting
  discussed recommendations from the
  White Paper
            Barriers Identified by
           PRIM&R Working Group
   Differing and confusing regulatory requirements
    for obtaining informed consent for the use of
    specimens in research.
       Informed consent is process by which subjects are
        informed about risks and benefits from research
        project
       Authorization is solely a permission to allow
        researchers to use or disclose PHI
   There are two points when consent/authorization
    must be considered.
                 Tissue Source                                         Tissue Recipient
                                                   IRB Approval


                                                                     3            Identifiable
                                                                                    Tissue
                   Tissue Obtained Solely   1      Tissue Bank
                        For Research
                                                       With
                                                                     4              Coded
                                                                                    Tissue

                                              Identifiable 5                   Limited Data Set
                       Tissue Originally    2   Tissue
                         Collected for                     6                     Anonymous/
                         Clinical Care                                           anonymized



                                                                             IRB approval – informed
                                                                         3   consent/authorization or waiver
         IRB approval – informed
    1    consent/authorization                                               No additional IRB approval –
                                                                         4   letter of agreement about code
         IRB approval – informed
    2    consent/authorization                                           5
                                                                             No additional IRB approval –
                                                                             Data Use Agreement

        *Specific Consent at 1 or 2 will usually suffice.                6   No additional IRB approval
Source of Diagram: www.hhs.gov/ohrp/
SACHRP Meeting July 15-16, 2008, TISSUE BANKING: Challenging to Say the Least, by P. O’Rourke
  HHS regulations define human
   subject at 45 CFR 46.102(f)
 Human  subject means a living individual
 about whom an investigator (whether
 professional or student) conducting
 research obtains
    (1) data through intervention or interaction
     with the individual, or
    (2) identifiable private information.

 http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf
   Human Subject Research?
 In general, OHRP considers private
  information or specimens to be individually
  identifiable as defined at 45 CFR 46.102(f)
  when they can be linked to specific
  individuals by the investigator(s) either
  directly or indirectly through coding
  systems.


       http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf
              HIPAA Privacy Rule
   The Privacy Rule permits covered entities under the Rule to
    determine that health information is de-identified even if the health
    information has been assigned, and retains, a code or other means
    of record identification, provided that:

    (1) the code is not derived from or related to the information about
    the individual;
    (2) the code could not be translated to identify the individual; and
    (3) the covered entity under the Privacy Rule does not use or
    disclose the code for other purposes or disclose the mechanism for
    re-identification

               http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf
         Will data be identifiable,
 Is   tissue stored with identifiers
      Stored with Limited Data Set?
 Is   the tissue coded?
      Who has the code?
      Is the code still linked?
   tissue anonymized?
 Is
 Was tissue collected without identifiers?
                 Tissue Source                                         Tissue Recipient
                                                   IRB Approval




                    Tissue Obtained Solely   1     Tissue Bank
                         For Research                  With
                                                                     2        De-identified tissue
                                                    NO                          Anonymous/
                                                                                 anonymized
                                                 Identifiable
                       Tissue Originally
                         Collected for
                                                   Tissue
                         Clinical Care




         IRB approval – informed                                             No additional IRB approval and
    1    consent/authorization                                           2   no letter of agreement




Source of Diagram: www.hhs.gov/ohrp/
SACHRP Meeting July 15-16, 2008, TISSUE BANKING: Challenging to Say the Least, by P. O’Rourke
       Waiver of Consent under
           Common Rule
 Research involves no more than minimal risk to
  participants
 Waiver will not adversely affect the rights and
  welfare of participants
 Research could not practicably be carried out
  without the waiver
 Whenever appropriate, the participants will be
  provided with additional pertinent information
  after participating
     • 45 CFR 46.116(d); 21 CFR 50.23, 50.24,
     • FDA regulations only provide for waiver of informed consent
       in limited emergency situations
         Recommendations by
        PRIM&R Working Group
 OHRP   should issue guidance clarifying
 when waiver of informed consent for
 collection, storage, distribution and use of
 specimens for research is appropriate.
    When is research using biological specimens
     considered minimum risk
    Guidance on interpreting “practicability” for
     waiver of informed consent
        More Recommendations from
                 PRIM&R
   OHRP’s interpretation of the Common Rule allows
    generalized informed consent for future research use of
    specimens and associated data.
       Model NCI Breast Cancer Consent form used extensively
       Guidance from OHRP on the use of these consents and
        endorsement requested
   FDA has no provisions for Waiver of Consent.
    Approaches should be explored to allow minimal risk
    research involving specimens to be conducted without
    informed consent
       For example, research use of excess specimens from routine
        clinical care should be permitted since risks to subjects are
        minimal.
Protection of data related to sample
 HIPAA privacy rules – HIPAA authorization is
  tied to original research consent
 Is it necessary to have separately signed
  research consent and HIPAA Authorization?
 Who will have access to samples and what data
  will be provided
 Database containing PHI related to tissue needs
  to be stored on the HIPAA compliant servers of
  the covered entity, not on Investigator personal
  computer
 Waiver of HIPAA Authorization
IRB shall apply the following criteria for granting
   waivers of HIPAA authorization under the Privacy
   Rule:
 no more than minimal risk to privacy;
 a plan to protect PHI from improper use/disclosure and
   a plan to destroy identifiers as soon as possible; and
 use/disclosure of PHI will not occur except as required
   by law and for the specific research study (or studies)
   approved by the IRB. Also, the researcher must confirm
   in writing that the research cannot be done without
   waiver and without this specific PHI.
    Broader HIPAA Authorization
 Current interpretation of the HIPAA Privacy Rule
  requires that an authorization must be study
  specific and does not permit authorization for
  future unspecified use of PHI
 PRIM&R recommends revising Privacy Rule to
  allow authorization for use of PHI collected as
  part of a clinical trial to cover both research and
  banking activities
 DHHS/OCR should explore approaches for
  removing the requirement that the authorization
  for research use of PHI obtained from research
  repository or database be study-specific.
        Basic Elements of Consent for
           Research 21 CFR50.25(a)
   Consent must indicate that the study involves
    research, the tissue is being used for a research
    study
       Is excess tissue being collected for the research or is
        the tissue leftover from a clinical procedure?
       Tissue consent separate from consent for clinical
        research
       What is the procedure for release from Pathology?
       Are there blood draws or additional collections of
        blood or tissue not related to clinical procedure?
   Duration of study and length of subject’s
    participation, one time collection or follow up
            Basic Elements of
           Consent for Research
              is voluntary and subject may
 Participation
 leave the study at any time
     Participation in a clinical study should not be
      contingent on participation in tissue bank.
     Contact information for subject to request
      removal of tissue from bank
     Statement regarding the inability to exclude
      already de-identified tissue
           regarding any alternative
 Disclosure
 procedures or treatments
               Basic Elements of
              Consent for Research
 Description of study procedures related to the
  tissue collection
 Description of any possible benefits to the
  subject or others, will research tests results be
  available to the subject or personal physician?
 Description of any foreseeable risks and
  discomforts
       Confidentiality Risks
       Risks of information regarding genetic test results
            Basic Elements of
           Consent for Research
 Confidentialityof records
 Cost of research study to subject, if any
 Payment to subjects, if any
     Indicate if subject will or will not be
      reimbursed or paid
     Amount should not be so great as to be
      perceived as enticement
     Any additional cost to the subject as a result
      of participation in the study must be disclosed
          Basic Elements of
         Consent for Research
 Contact  information for questions or in the
  event of research-related injury
 Statement of compensation and
  availability and extent of any medical
  treatment if injury occurs. Who is
  responsible for bills related to injury?
Who will have access to samples?
   Tissue consent identifies the research use of the sample
   Permission for future uses of the sample
        Checkbox approach
        Separate signed consent?
   What are requirements for accessing tissue for future research?
   How can the samples be accessed
        Who can access?
        Are there institutional restrictions related to access
        What information will be retained
   Can recipient contact the tissue donor or have access to PHI?
        What review is required, Who?
        Any new consents
        New HIPAA Authorization?
  Enrolling children or decisionally
    impaired in tissue research
 Should   minors be reconsented when they
  reach age 18 for continued use of their
  tissue for research?
 Is it appropriate for a legally authorized
  representative to consent for preservation
  of tissue for a tissue bank?
 Should leftover Newborn Blood
  Specimens required by state law be used
  for research purposes?
    Ethical Issues Related to Tissue
         and Genetic Research
   Confidential information about families or racial
    and ethnic groups
   Genetic information linked to diseases
   Potential that DNA linked to identifiable
    information could end up used by law
    enforcement
   Ownership of tissue
   Use of pathologic specimens or leftover blood
    from blood tests
   Incidental Findings
           regarding recommendations
 Discussion
 from PRIM&R and ethical issues
                         References
   Report of the Public Responsibility in Medicine and Research
    (PRIM&R) Human Tissue/Specimen Banking Working Group,
    http://www.primr.org
   Research Repositories, Databases, and the HIPAA Privacy Rule:
    http://privacyruleandresearch.nih.gov/research_repositories.asp
   National Cancer Institute Best Practices for Biospecimen Resources
    http://biospecimens.cancer.gov/global/pdfs/NCI_Best_Practices_060507.pdf
   Best Practices for Repositories I: Collection, Storage, and Retrieval
    of Human Biological Materials for Research", International Society
    for Biological and Environmental Repositories (ISBER):
    http://www.isber.org/Pubs/BestPractices.pdf
   OHRP Informed Consent Frequently Asked Questions:
    http://www.hhs.gov/ohrp/informconsfaq.html
   SACHRP Meeting July 15-16, 2008:
    http://www.hhs.gov/ohrp/sachrp/mtgings/mtg07-08/present.html

								
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