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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

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informed consent for registries and genetic research
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
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
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
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.
slide5

Tissue Source

Tissue Recipient

IRB approval – informed consent/authorization or waiver

3

IRB approval – informed consent/authorization

1

No additional IRB approval – letter of agreement about code

4

IRB approval – informed consent/authorization

2

No additional IRB approval – Data Use Agreement

5

*Specific Consent at 1 or 2 will usually suffice.

No additional IRB approval

6

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
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
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
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
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?
  • Is tissue anonymized?
  • Was tissue collected without identifiers?
slide10

Tissue Source

Tissue Recipient

IRB approval – informed consent/authorization

No additional IRB approval and no letter of agreement

1

2

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
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
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
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
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
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
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
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
Basic Elements of Consent for Research
  • Participation is voluntary and subject may 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
  • Disclosure regarding any alternative procedures or treatments
basic elements of consent for research19
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 research20
Basic Elements of Consent for Research
  • Confidentiality of 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 research21
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
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
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
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
references
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