Ethical, Legal, and Policy Best Practices

Informed consent (pursuant to the human subjects regulations at 45 CFR Part 46 Subpart A) is designed to present potential human research participants with sufficient information—including anticipated procedures, risks, and benefits—to make an informed decision about whether to participate in research studies. Obtaining informed consent for the collection, storage, and future research use of biospecimens can be challenging because the specifics of the future research often are not known at the time of biospecimen collection. In addition, under DHHS regulations at 45 CFR Part 46 Subpart A, informed consent may not be required even if the research is considered human subjects research if (1) the human subjects research is exempt from the regulations at 45 CFR § 46.101(b) or (2) the research is nonexempt human subjects research that has been granted a waiver of the requirements for informed consent by an IRB under 45 CFR § 46.116(c) or (d).

C.2.1. Federal Regulations and Guidelines Pertaining to Informed Consent

• C.2.1.1.
  DHHS-conducted or -supported research on human research participants is regulated by 45 CFR Part 46. The DHHS regulations describe both when informed consent is required and what elements must be in an informed consent process and document. The biospecimen resource should track whether appropriate informed consent is present or the reason why informed consent is not necessary and should seek to resolve any discrepancies in the consent status for stored biospecimens (See the Office for Human Research Protections [OHRP] Web site for guidance on informed consent: http://www.hhs.gov/ohrp/policy/index.html#informed.)
• C.2.1.2.
  The OHRP has issued guidance on regulatory requirements that must be satisfied by biospecimen resources (available at http://www.hhs.gov/ohrp/humansubjects/index.html).The OHRP recommends that the following be included in informed consent documents for biospecimen collection:
  • A clear description of the operation of the biospecimen resource. This description could include details that may be of interest to human research participants, such as whether identifiable information will be maintained by the biospecimen resource and/or whether research results will be linked to the biospecimen. (See Section C.1, Principles for Responsible Custodianship, for NCI recommendations.)
  • The conditions under which samples and data will be released to recipient investigators. (See Section C.4, Access to Biospecimens and Data, for NCI recommendations.)
  • Procedures for protecting the privacy of human research participants and confidentiality of data. (See Section C.3, Privacy and Confidentiality Protections, for NCI recommendations.)
  • Specific descriptions of the nature and purpose of the research.
  • Information about the consequences of DNA typing if human genetic research is anticipated.
• C.2.1.3.
  FDA regulations regarding informed consent should be considered when applicable, particularly when human specimens are used for in vitro diagnostic device studies. (See 21 CFR Part 812, 21 CFR Part 50, and 21 CFR Part 56.) The FDA may exercise enforcement discretion as to the requirement for informed consent for in vitro diagnostic device studies that utilize "leftover" biospecimens (e.g., remnants of biospecimens collected for routine clinical care or analysis or biospecimens previously collected for another research purpose) that are not individually identifiable if certain conditions have been met.⁴

⁴ Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078384.htm.