Appendix H Guidance on Informed Consent for Tissue Repositories Office for Human Research Protections (OHRP) In an August 1996 memo included as part of a 1997 guidance document, “Issues to Consider in the Research Use of Stored Data or Tissues,” the Acting Director of the Office for Human Research Protections (OHRP; then Office for Protection from Research Risks, or OPRR) delineated the following points to be considered in developing informed consent as part of the operation of human cell repositories: Written informed consent should be obtained from each donor-subject in accordance with HHS regulations 45 CFR 46.116, (ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.116). Included among the basic elements of informed consent should be a clear description of (1) the operation of the cell repository; (2) the specific types of research to be conducted; (3) the conditions under which data and specimens will be released to recipient-investigators; and (4) procedures for protecting the privacy of subjects and maintaining the confidentiality of data. Informed consent information describing the nature and purposes of the research should be as specific as possible. Where human genetic research is anticipated, informed consent information should include information about the consequences of DNA typing (e.g., regarding possible paternity determinations). Informed consent documents may not include any exculpatory language through which subjects are made to waive or appear to waive any legal rights. OPRR recommends that the cell repository develop a sample collection protocol and informed consent document for distribution to collector-investigators and their local institutional review boards (IRBs). A written submittal agreement for collector-investigators should require written informed consent of the donor-subjects utilizing an informed consent document approved by the local IRB. It should also contain an acknowledgment that collector-investigators are prohibited from providing recipient-investigators with access to the identities of donorsubjects or to information through which the identities of donor-subjects may readily be ascertained. National Bioethics Advisory Commission (NBAC) In 1999, following careful consideration of the ethical issues involved, the NBAC made a series of recommendations for the use of human biological materials in research. In their recommendations for informed consent in the collection, storage, and use of human biological materials, they noted that consent forms should be developed to provide potential donors with a sufficient number of consent options from which to choose, to help them understand clearly the nature of the decision they are about to make. They suggested that such options might include, for example: Refusing the use of their biological materials in research Permitting only unidentified or unlinked use of their biological materials in research Permitting coded or identified use of their biological materials for one particular study only, with no further contact permitted to ask for permission to do further studies Permitting coded or identified use of their biological materials for one particular study only, with further contact permitted to ask for permission to do further studies Permitting coded or identified use of their biological materials for any study relating to the condition for which the sample was collected originally, with further contact allowed to seek permission for other types of studies Permitting coded use of their biological materials for any kind of future study The NBAC pointed out that the last option, “permitting coded use of biological materials for any kind of future study,” is problematic because it is impossible to foresee what kind of research the biological materials may be needed for in the future. This is particularly the case when a patient has identified a certain kind of study as objectionable. The primary concern of the NBAC is that informed consent is truly informed. In cases in which potential donors cannot be given a complete picture of what might happen to their tissues, the consent given for tissue use is not considered to be truly informed.

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