Biological Specimen & Tissue Storage

Guidance on Coded Data/Human Specimens

The Office for Human Research Protections (OHRP) has issued guidance on research involving coded private information or human biological specimens. The document also references pertinent requirements of the HIPAA Privacy Rule that may be applicable to research involving coded private information or specimens. You can find the guidance document, Guidance on Research Involving Coded Private Information or Biological Specimens at www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf.

OHRP welcomes comments on this document: please go to the OHRP website at www.hhs.gov/ohrp  and click on "Public Comments" in the left menu.

Confidentiality

The confidentiality risks of research participation may extend beyond the duration of the subject’s direct participation in research. This is common when records or samples with identifiers are retained by the investigator. These new confidentiality risks and/or new disclosure concerns are important to consider because:

1. there has been litigation surrounding the subject’s right (or non-right) to a property interest in the outcome of research – for example, if a patentable product is derived from the subject’s tissues ;
2. there have been attempts to gain research data for risk assessment in denying insurance or employment, as well as for paternity testing;
3. the ability to re-test samples containing extractable DNA has made it possible that retained samples may contain information that cannot be foreseen at the time of initial collection, but that may eventually be of great importance or sensitivity;
4. the ability to test for things like cancer risk genes raises the possibility that additional use of specimens – beyond those of the original research consented to.

IRB Recommendations for Storage

• If the experimental design allows it, the surest protection is for all identifiers to be stripped from the stored samples or data, such that they can never be traced to the individual.
• If the experimental design requires that the samples be referable back to an individual subject, the fact of their retention creates a durable confidentiality risk that must be both controlled and disclosed.
• If the need to link data to the individual is time limited, stripping identifiers (rendering the samples truly anonymous) is appropriate once the time window of need has closed.
• Storage with easily traceable identifiers such as patient names or initials or social security numbers or medical record numbers is almost never appropriate.

Additional Resources

Research on Human Specimens: Are You Conducting Research Using Human Subjects?
National Institutes of Health (NIH)

Research Involving Human Biological Materials: Ethical Issues and Policy Guidance
August 1999
Report and Recommendations of the National Bioethics Advisory Commission (NBAC)

Human Specimen Resources
National Cancer Institute (NCI)

Example Consent Form and Brochure for Use of Tissue For Research (pdf)
National Cancer Institute

Bioethics Resources on the Web about the Use of Human Tissue

Suggestions for Informed Consent

Subjects need to know if they’ll get results back from any research testing. If subjects are to get information back, this needs to be planned for adequately — remembering:

1. that providing for continued ability to contact the subject may increase the confidentiality risk,
2. that the information may be complex or uncertain in its import, such that skilled presentation by trained people such as genetic counselors may be necessary,
3. that the importance of the information may not be realized for a long time, so study personnel may have changed or the study may even have been terminated [can be wise to set a time limit and disclose it in the consent process].

OHRP also recommends that a Certificate of Confidentiality be obtained to protect confidentiality of human cell repository specimens and data.

Subjects may have objections to certain areas of research, or may only wish to support research relating to their condition. If samples are liable to re-use, that should be disclosed and be clear whether the re-use consent sought is broad or limited.
Example: The most common objection we’ve encountered is people who do not want their tissues used in research related to fertility or abortion, or that would involve use of tissue from abortuses.

Additional Consent Form Guidance

Written informed consent should be obtained from each donor-subject in accordance with HHS regulations at 45 CFR 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 documents may not include any exculpatory language through which subjects are made to waive or appear to waive any legal rights.

Where human genetic research is anticipated, informed consent information should include information about the consequences of DNA typing (e.g., regarding possible paternity determinations).

When tissues are being obtained for a sample bank, the routine wording in a surgical consent form – allowing use of waste for research or teaching, and providing for "routine" tissue disposal – is typically not sufficient for the retention of samples with traceable identifiers.

A separate consent process and form is required. Ideally, this is carried out before the sample is obtained, but this may not be possible (an emergency laparotomy may yield a diagnosis appropriate for the tissue bank, or it may not be clear whether appropriate excess tissue will be available in advance).

Example Consent Form Language

"Your samples will be kept in our laboratory for up to ten years, after which they will be destroyed. They will be identified only by a code number, and only the project director will have access to the code. We may use them for other research related to your disease. Because the tests we do are research tests, we won’t know for a long time whether they are meaningful to patient care. Therefore, the results will not be given back to the patients or other subjects in this study."

Also see Example Consent Form and Brochure for Use of Tissue For Research (pdf)
- from the National Cancer Institute

Sources:
Durable Confidentiality Risks, Sample/Data Banks and DNA Testing
Dale Hammerschmidt M.D.

Issues to Consider in the Research Use of Stored Data or Tissues
Office for Human Subject Protection
November 7, 1997

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