What is a tissue repository?
Human Tissue Repositories collect, store, and distribute human tissue materials for research purposes. Repository activities involve three components: (i) the collectors of tissue samples; (ii) the repository storage and data management center; and (iii) the recipient investigators.
How does OHRP define research?
Background: HHS regulations define research at 45 CFR 46.102(d) as follows: Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Is informed consent required for tissue research?
FDA Issues. If the tissues are used to test an FDA regulated IVD, then IRB review is required. If the tissues are identifiable, then subjects must provide consent for the secondary use and that consent must cover the elements of consent in 21 CFR 50.25.
Do registries need IRB approval?
Do registry activities require IRB approval under the Common Rule? No. Even if protocol is non-exempt human subjects research, registry is only linking to respond to a request for releasing information to researchers.
Which choice best describes the purpose of most pharmacogenomic research?
Which choice best describes the purpose of most pharmacogenomic research? To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs.
Should tissue be removed from a patient without consent for research?
If a researcher takes tissues specifically for research and the “donor’s” name is attached, federal law requires informed consent. But if the tissue is taken for some other purpose—a routine biopsy or a fetal blood test—as long as the patient’s identity is removed from the sample, consent isn’t required.
What is a repository protocol?
A repository protocol may be submitted to the IRB either to: Define the operating parameters for establishing and maintaining a research repository; or. Convert an existing research database, non-research database, or non-research repository into a research repository.
Do registries require informed consent?
In fact, registries are increasingly being used for research purposes even when initially developed for clinical purposes, and thus it is suggested that in all cases, consideration should be given to the informed consent issues, as well as HIPAA privacy requirements, discussed in this chapter.
What does OHRP consider involvement in the conduct of research?
OHRP does not consider the act of solely providing coded private information or specimens (for example, by a tissue repository) to constitute involvement in the conduct of the research.
What is OHRP’s policy on coding private information?
OHRP recommends that investigators not be given the authority to make an independent determination that research involving coded private information or specimens does not involve human subjects.
How does OHRP interpret human biological specimens?
OHRP interprets human biological specimens to be private information. If an investigator obtains a specimen from a living individual through a research intervention or interaction, the research involves human subjects.
What is a OHRP database used for?
OHRP: Research Use of Human Biological Specimens and Other Private Information Databases, registries (data banks), and repositories (tissue banks) all involve the collection and storage of information and/or biological specimens over time. Some registry/repositories serve diagnostic or clinical purposes, while others are solely for research.