CRA Informed Consent
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Which 3 cases were used to develop ownership of biological specimens?
- Moore vs. Reagents of the University of California
- Greenberg vs. Miami's Children Hospital Research Institute
Washington University vs. Catalona - individuals cannot direct or authorize the transfer of their biological materials to a third party.
What are the principles governing ownership of biological specimens?
- A researcher must disclose his/her financial interests in the research subject only if the researcher and the subject are in a doctor-patient relationship.
- A research subject does not retain any ownership rights to his/her tissue samples.
- Absent an agreement to the contrary, a research subject does not retain any right to the financial benefits arising from patents and commercialized products derived from his/her tissue samples.
- Informed consent forms, MTAs and institutional policies help to document and inform ownership issues
OHRP Policy and guidelines: <http://www.hhs.gov/ohrp/policy/reposit.html>
- Identifies and clarifies issues for specimen collectors, IRB’s and specimen recipients “Issues to consider in the Research Use of Stored Data or Tissues” (Nov. 7, 1997)
- Defines if research involves humans or not: <http://www.hhs.gov/ohrp/policy/cdebiol.html> if private information or the specimens can be linked directly/indirectly to the subject then the research is involving humans.
- If private info or specimens were not collected through an interaction with a living person for the proposed research and there are mechanisms to prevent the identity of the person becoming known then research is NOT involving humans.
- OHRP is authorized to oversee compliance and enforcement through federal wide assurance.
There is no direct action against the investigator (compare to FDA).
FDA Informed Consent:
- FDA informed consent is the same as common rule except:
- Confidentiality statements must include disclosure that the FDA may inspect the records (21 CFR SS 50.25(a)(5)) and that a description of the clinical trial is available on www.clinicaltrials.gov (contains a summary of the results of the trials and does not include PPI).
“Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are not individually Identifiable” (April 25, 2006).
- Outlines FDA enforcement discretion when certain human specimens are used for in vitro device investigations.
- Provides factors to determine whether the enforcement discretion will apply to specimens.
- Permits use of specimens without informed consent in certain, limited instances.
FDA-regulated research is monitored through:
- Onsite inspections and data audits
- Bioresearch Monitoring Program (BIMO) by FDA investigators & FDA scientists through several compliance programs:
- Good Laboratory Practices Program for non-clinical studies;
- Clinical Investigator Program and IRB program.
Things to know about FDA informed consent:
- (1) which regulations apply
- (2) understand when informed consent is required and when it is not
- (3) ensure that the informed consent satisfies all required elements, as applicable and clearly addresses the use of specimens
- (4) understand enforcement authority and scope and the consequences for failure to comply.
Informed consent is legally effective if (common rule):
- it is obtained from the subject or the subject’s legally authorized representative; and
- it is documented in a manner consistent with the federal regulations on protection of human subjects (DHHS, FDA) and with applicable laws of the jurisdiction in which the research is conducted,
- it is obtained under circumstances that provide prospective subject or the legally authorized representative sufficient opportunity to consider whether to participate in the research; minimize the possibility of coercion or undue influence, and respects the privacy of the potential participant by taking place in a setting that is not open to the public
Two possible mechanisms for obtaining informed consent from a research participant:
- consent documented by having the appropriate person sign a written IRB approved consent document,
- an oral consent process that has been approved by the IRB
An IRB approved consent document contains:
- all the required elements, and all appropriate optional elements, approved by the IRB prior to use.
- the date of IRB approval signature and date of the participant (or the participant's representative) before any research procedures (including screening) or research data collection can begin.
- Signature and date of the individual who obtains the participant’s consent
An investigator may request the IRB waive requirement for written informed consent and approve an oral consent process for some or all potential research participants. What is the IRB oral consent process?
- Submit request for oral consent with the e-IRB application and must include a script used by the consent designee with participants. This script must include all required consent elements and elements required for HIPAA privacy authorization (when PHI is to be collected).
- If oral consent is obtained details about that consent (time, date, identity of consent designee) should be recorded in the study record by consent designee.
- If project involves clinical care details about the consent should be added to the clinical record.
The IRB may approve a request for oral consent for non-FDA regulated studies under two circumstances:
- The only record linking the participant to the research would be the consent document and, the principal risk to the participant would be potential harm resulting from a breach of confidentiality. In this case, each participant will be asked if he/she wants documentation linking him/her to the research and the participant’s wishes will govern;or
- The research presents no more than minimal risk to the participants and involves no procedures for which written consent is normally required outside of the research context.
Institutional Review Boards require investigators to include the consent
requirements established by DHHS (45 CFR 46.116) and FDA regulations (21 CFR 50.20). These include the following eight required elements:
- 1) statement that study involves research, purposes of the research; duration of participation; procedures to be followed; identification of any experimental procedures
- 2) A description of any reasonably foreseeable risks or discomforts to the participant
- 3) benefits to the participant or to others which may reasonably be expected from the research
- 4) disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant
- 5) A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained; if the research is subject to FDA regulation, a statement that notes the possibility that the FDA may inspect study records (Research is FDA regulated if it involves the use of any drugs or medical devices other than the use of approved drugs and medical devices in the course of medical practice, or if the data will be submitted to or held for inspection by the FDA.)
- 6) For research involving more than minimal risk, an explanation as to whether any compensation is available; an explanation as to whether any medical treatments are available if injury occurs; If so, what they consist of, or where further information may be obtained;
- 7) An explanation of whom to contact for answers to pertinent questions about the research and research participants' rights; Whom to contact in the event of a research-related injury to the participant;
- 8) A statement that participation is voluntary and that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled; and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
In research involving humans, what is the Common Rule?
The Common Rule is a federal policy regarding Human Subjects Protection that applies to 17 Federal agencies and offices. It does not apply to federal agencies that have not signed the agreement (e.g., Department of Labor, etc.)
In human subjects research what are the main elements of the Common Rule?
- Requirements for assuring compliance by research institutions
- Requirements for researchers' obtaining and documenting informed consent Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping
Protections of the human subjects research common rule:
- protections for pregnant women, in vitro fertilization, and fetuses
- protections for prisoners
- protections for children.
Three major cases in the development of biological ownership rights are:
- Moore v. Regents of the University of California
- Greenberg v. Miami Children’s Hospital ResearchInstitute, Inc.
- Washington University v. Catalona
Moore v. Reagents of University of California
- Moore retained neither a possessory interest nor an ownership interest in his cells after they were removed. See id. at 487-89.
- – The threat of liability will have a chilling effect on research.
- – The patented cell line is distinct from the cellsremoved from Mr. Moore’s body.
Greenberg v. Miami Children’s Hospital Research Inst.,Inc., 264 F. Supp. 2d 1064 (S.D. Fla. 2003)
Unanswered question after Moore: would the Court’s decision have differed if the researcher and the tissue donor were not in a doctor-patient relationship?
- No duty to disclose their economic interests in research to research subjects. See Greenberg, 264F. Supp. 2d. at 1069-70.
- Imposition of such a duty would have a chilling effect on medical research.
- NOTE: The Court found that “in certain circumstances a medical researcher does have a duty of informed consent” with respect to other (non-economic) interests. See id. at 1070.
- • Citing Moore, the Court concluded that the families had nopossessory or ownership interest in their donated tissues. Seeid. at 1074-76.
Washington Univ. v. Catalona, 437 F. Supp.2d 985(E.D. Mo. 2006), aff’d 490 F.3d 667 (8th Cir. 2007).
Unanswered Questions after Greenberg… If the research subjects don’t own their tissue samples, who does?
Dr. Catalona, a respected urologic surgeon at Washington University, conducted prostate cancer by collecting blood and tissue samples from his surgical patients for research use. He helped to establish the Genito-Urinary (GU) Repository at Wash U. to hold the collected samples. Patients contributing to repository executed informed consent forms. In 2003, Dr. Catalona transferred to Northwestern University and sought to take the GU Repositorysamples with him. Wash U. filed a law suit to establish ownership.
- The Court held that individuals who make an informed, voluntary decision to contribute their biological materials to a particular research institution for the purpose of medical research do not retain an ownership interest in those materials.
- • Individuals cannot direct or authorize the transfer of their biological materials to a third party.
- – Under Missouri law, the Washington University exhibited ownership.– The contributions were inter vivos gifts to Washington University.
- – Pursuant to the informed consent forms, patients retained only the right to withdraw
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