Background

There has been increasing concern in the biomedical community about the use of biological specimens obtained during clinical research. Current Federal regulations set out criteria for the use of participant specimens. These criteria include (1) participant specimens can only be used for research that is described in the protocol and consent; and (2) any new research use of identifiable specimens must be approved by the IRB. Furthermore, the National Bioethics Advisory Commission (NBAC), which was established by the President to make recommendations concerning bioethical issues arising from research on human biology and behavior, has released its recommendations on stored biological specimens.

Purpose

The following guide is provided for investigators who anticipate

• Using remnant (leftover) biological specimens that contain identifiers or are coded in any way that can be traced to the participant, or
• Taking extra biological specimens (in addition to what is needed for protocol-defined research), whether they are identifiable or anonymized.

These recommendations are based on current federal regulations and the NBAC recommendations.

Definitions

Biological specimens:

Tissues, bodily fluids (such as blood, saliva), and excreta (such as, stool and urine).

Microbial organism specimens:

Bacteria, fungi, virus and parasitic specimens that are stored in artificial culture or biological cell culture

Identifiers:

Data that directly identify the individual from whom a sample is obtained, such as, name, initials, Social Security Number, Hospital Patient Number, address, telephone number or a code number linking the individual to the data.

Identifiable specimens:

Biological specimens that are identified either directly or through a code. It is possible to determine the individual’s identity from the identifying information.

Coded specimens:

Biological specimens that are identified only by a code key that can be linked to the individual directly or through an intermediary (e.g., a repository). These are identifiable specimens.

Anonymized specimens:

Biological specimens that have been stripped of all identifiers (including codes) that would link directly to the individual. Please note that health and demographic data may be retained, such as height, weight, diagnosis, socio-ethnic group, zip code, etc.

Guidance

The IRB recommends that consent for retention and future use of biological specimen taken in conjunction with a clinical protocol be incorporated into the study consent form rather than being a separate consent document. As with any consent document, it must be reviewed and approved by the IRB before use. At the close of the study, these consents should be placed in a file and retained under lock by investigator/facility responsible for their use and maintained for at least two years after the last specimen has been used.

Anonymized biological specimens

Additional consent is not required for the use of biological specimens that have been anonymized. However, consent to obtain biological specimens is required if the specimens are being obtained outside of the study protocol or in addition to specimens obtained for study related purposes, even if these specimens are then anonymized.

Consenting Participants

It should be made clear to participants that they may refuse permission for future research use of their biological specimens without affecting their participation in the study or their care by the health provider. It should also be made clear to participants that they may change their mind and refuse to permit their specimens to be used at some time in the future.

Reconsenting Participants

By not requesting and obtaining proper consent from the participants at the time that the specimen is obtained, an investigator runs the risk of not being able to use valuable biological specimens later without re-consenting the participants—a procedure that may be problematic because it may be construed as a breach of confidentiality. If re-consenting a participant is planned, it is important to include in, preferably, the main protocol consent form rather than in a separate consent, permission to recontact the participant for future studies of stored biological specimens.

Minors as Participants

If a parent or guardian on behalf of a minor child gave consent, the child participant as an adult may rescind the permission to use the identifiable biological specimens (just as adult participants could change their mind about use of their biological specimens). In the event that recontact is required for the research, the investigator would need to attempt to contact the child/now adult whose identifiable biological specimens were kept.

Research Populations

Special consideration should be given to the handling of the information obtained from research with biological specimens, even if not individually identified, in cases in which the participants’ socio-economic or ethnic community might be harmed by the disclosure of data for that community as a group (for example, a study linking incidence of a specific disease with participant zip codes, or with an ethnic group). A statement that there might be unintended harm to the individual or group as a result of disclosure of data or research results should be included in the Risk section of the supplemental consent.

Previously Collected Biological Specimens

If the investigator plans to use already collected identifiable biological specimens in research not specifically defined in the protocol, the investigator must consult with the IRB. If the IRB finds that an existing consent covers the intended research use, then further action may not be necessary. If there was no prior consent, or if the IRB finds that the consent does not cover the intended use, then consent must be obtained, or waived by the IRB, as appropriate.

Microbial Organisms Derived From Biological Specimens

No additional consent is required for microorganisms that are stored with no information that identifies the participant or link to an identified specimen after the study is completed. Permission to retain microorganisms with participant identifying information after the study is completed must be included in the consent form document. This includes organisms that are linked to identifiable specimens.

Storage of Biological Specimens

If no biological specimens are to be stored after a study is completed, then there needs to be a statement in both the protocol and informed consent that all biological specimens will be destroyed at the end of the study or at a specified time (e.g., after analysis).

If biological specimens are to be kept for non-protocol-defined research, the investigator should create a consent document covering each of the sections in the consent template attached. Samples of acceptable statements are included for each paragraph or section. At the very least, participants should be told:

• What kind of specimens will be collected and the means of collection.
• What type of research will be done with the specimens.
• Whether the biological specimens will be shared with other investigators,
• Whether biological specimens will be coded or anonymized (no way of tracing back to participant/uncoded or code destroyed).
• Whether the participant may be contacted for additional consent.
• How long, if known, the biological specimens will be stored. (Short-term: current protocol only or other current research; Long-term: future studies on disease or condition, repository, etc.).
• Foreseeable risks or benefits to participants in the collection, storage and subsequent research use of specimens.
• What will be done with the biological specimens if the participant refuses permission (“anonymized”—stripped of identifiers--or destroyed?).
• What will be done with the research results. (Research results should not be placed in the individual participant’s medical record.)

The IRB staff can assist in developing the consent if you call and schedule an appointment at least 1 week prior to the deadline for submission.