Guidelines for Human Tissue Repository
National Heart, Lung, and Blood
Institute National Institutes of Health
Revised: April 14, 2000
Various issues regarding use of stored tissue are
covered in a November 7, 1997 issuance from OPRR (http://grants.nih.gov/grants/oprr/humansubjects/guidance/reposit.htm).
Research Involving Human Biological Materials: Ethical Issues and Policy
Guidance). A draft of a document being developed by the NIH (Research on Human
Specimens) also covers these issues (http://www-cdp.ims.nci.nih.gov/policy.html).
NCI has developed sample consent documents for repository activities (http://www.napbc.org/napbc/consent.htm
and http://www.napbc.org/napbc/q&a.htm).
Discussions of additional issues can be found in the
August, 1999 report from the National Bioethics Advisory Commission. Go to the
National Bioethics
Advisory Commission page, select Reports, and scroll down to Ethical Issues
in Human Stem Cell Research, September 1999. (All these files are in Adobe PDF
format.)
The following operating principles and NHLBI staff
responsibilities are consistent with these documents, in particular the OPRR
regulations. Operating Principles:
- The concept of a tissue repository may include two
kinds of samples: a) those collected with the expressed purpose of distribution
to investigators, and b) those collected by individual investigators, and not
originally intended to be shared with others, but which are subsequently shared
as part of a repository. Any collection which contains specimens that are
potentially identifiable and are distributed to someone other than the
investigator (or, in the case of a multi-investigator study, other than any of
the identified investigators) making the collection, regardless of the original
intent, may be considered to be a repository.
- Any identifiable tissue (included coded tissue)
that is collected requires IRB review at the site of collection (even if
different from the site of the repository) and, under most circumstances,
written informed consent from the subject. Where possible, informed consent
should include information about the repository and the conditions under which
tissues will be shared. (For example, see NCI sample consent
above.)
- Any tissue repository that distributes materials
requires an IRB, convened under an OPRR-approved assurance, that lays out the
conditions under which the tissue will be shared. These conditions must
consider the privacy of the individuals from whom the tissue came, what the
informed consent permitted, and the intent of the person to whom the tissue is
sent.
- A committee, established under the repository IRB's
guidelines, must evaluate each request for samples to see if the request is
consistent with the IRB's conditions for sharing samples and with the original
informed consent. The IRB at the repository institution may choose to perform
this committee's functions itself.
- The recipient of the tissue samples must abide by
the conditions specified by the repository IRB. This need not, but may, include
review and approval by an IRB at the recipient's organization.
- Exemptions to the need for IRB review and informed
consent may be made if the tissue samples are truly unable to be tied to an
individual. Samples that are coded do not qualify for an exemption, as someone
has the key to the code.
- Even if the samples do not formally constitute a
repository, IRB approval at the institution where the samples are stored is
required if the collector/distributor is an NIH employee or if the storage is
for the purpose of sharing and that sharing is supported by funds from the
Department of Health and Human Services. The need for IRB approval in other
situations depends on the institution's OPRR-approved Assurance.
Implementation:
- The above Operating Principles will be broadly
disseminated to the research community, including to investigators who do not
currently distribute tissue samples, but might do so in the future. The
Operating Principles would be put on the NHLBI public web site.
- NHLBI staff will ensure that any funded study
involving the collection of specimens from human beings has IRB
approval.
- NHLBI staff will ensure that any tissue repository
has an approved IRB that has developed conditions for distribution of samples,
which are consistent with the informed consents under which the tissue is
collected.
- NHLBI staff will ensure that any tissue repository
has a committee that reviews requests for samples.
- NHLBI staff are not responsible for ensuring that
each individual sample that is distributed receives IRB approval when it is
appropriate. That is the responsibility of the investigator and the IRB at the
investigator's institution.
Examples:
- The NHLBI funds an investigator to perform research
on patients. Part of the research includes analysis of blood specimens.
Aliquots of the specimens are stored, using some of the NHLBI grant money.
Three colleagues of the investigator (from other institutions) learn of the
specimens and ask for samples, as they would be useful for their own research.
This is not a formal repository. Whether or not the investigator needs
IRB approval to provide the samples depends on her institution's OPRR-approved
Assurance. If IRB approval is needed, the nature of the review may differ
depending on factors such as what the informed consent says, the nature of the
research that the colleagues wish to perform, and privacy protection for the
patients. NHLBI staff would not be involved in these decisions.
- The NHLBI funds an investigator to perform research
on patients. Part of the research involves storage of and special analyses on
biopsy specimens. The investigator subsequently realizes that the collection of
specimens from patients with a particular condition is larger than most and
possibly important for future research. He applies to the NHLBI for additional
support to maintain the collection and to distribute samples to other
investigators. This would be considered as a repository. The investigator's IRB
would need to review the conditions under which the specimens are distributed.
A formal process for deciding on the appropriateness of providing specimens
would need to be established. A factor in the process would be whether or not
the specimens can be linked to individual patients. NHLBI staff would be
involved in assuring that there is a process for specimen distribution.
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