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Use and collection of biospecimens
- Guidance Contact:
IU Human Research Protection Program (HRPP)
IU Human Research Protection Program (HRPP)
Many investigators conduct research that involves the use and collection of biospecimens. The following guidance is intended for all research with biospecimens.
Under the Common Rule and IU HRPP Policy, IRB review is required for all human subjects research:
In addition, the FDA requires IRB review for the use of de-identified human specimens in clinical investigations of medical devices when the research may generate or collect data that may be submitted to the FDA for review.
Examples of biospecimen research requiring IRB review (exempt, expedited, or full board review):
Examples of research NOT requiring IRB review (Application for Not Human Subjects Research is available if needed, but not required)
Some funding agencies may require IRB approval for research projects that are not regulated by the Common Rule or the FDA. In these cases, investigators are encouraged to speak directly with HRPP staff to determine the best course of action.
The federal regulations generally require subjects voluntarily consent to participate in research; however, the regulations also allow a waiver of this requirement for research that meets certain criteria. The decision regarding whether consent must be obtained is made on a case-by-case basis and is dependent on the type of research being conducted.
Biospecimen research can be categorized into three common groups:
Prospective studies are those that ask a question and look forward, and are generally designed before any information is collected. Study subjects are identified (workers with low-back injury claims) and followed forward to see if the outcome of interest (return to work) happens over time. This outcome is assessed relative to the intervention factor (physiotherapy). Prospective research with biospecimens occurs when subjects are identified, and then a biospecimen is collected from the subjects as part of the research interventions.
For prospective research with biospecimens, the IU IRBs will generally require that consent be obtained from subjects prior to the collection of the biospecimen. Specifically, consent is likely to be required when the following are true:
Biospecimens are often collected for clinical or diagnostic purposes, and then used for research purposes at a later time. For example, a remnant sample refers to the leftover biospecimen from a sample collected for clinical or diagnostic purposes. A waste sample is a biospecimen obtained during a clinical procedure that is not needed for a therapeutic or diagnostic purpose and will be otherwise discarded. Collection and use of these samples for research purposes may not require prospective consent if the investigators can provide justification that all of the following are true:
When an investigator uses previously-collected biospecimens for a secondary, new/different research project, it is likely that additional consent for the secondary use will not be required. Subjects may have provided consent for use of their biospecimens during the initial collection. The HRPP or IRB may need to determine whether the specimens were collected in accordance with an IRB approval and, if the secondary investigator has access to identifiers, whether the secondary use is consistent with the subjects' original consent and HIPAA authorization.
Informed consent documents for research with biospecimens must include all elements of a research consent required by the Common Rule as well as additional elements to address the specific considerations of research with biospecimens. If the research project is a stand-alone repository/banking protocol, a stand-alone consent is most appropriate. If, however, biospecimens are being collected as part of a larger research protocol, consent for collection may be incorporated into the main informed consent document.
The consent form should provide subjects with an understanding of how the biospecimens will be used and for what purpose, with as much specificity as possible given the investigator's research plan. Therefore, it is extremely important that investigators consider possible future uses of the biospecimens being collected. If the consent form describes uses of the specimens that are limited to a specific purpose or type of research, any future use of the biospecimens must be limited to research of that type or purpose. If the investigator envisions future unspecified research using the biospecimens, that possibility must be clearly stated.
In addition to the elements of consent required by the IU HRPP Policy on Informed Consent, consent for collection and use of biospecimens should address all of the following topics:
Further points to consider and sample informed consent language may also be found in the National Institutes of Health Guidance on Informed Consent for Secondary Research with Data and Biospecimens.
Biospecimens are often stored in repositories for future research uses, including unspecified future research. In these situations, investigators (who may or may not be part of the repository team) collect biospecimens per an IRB-approved protocol and consent, and submit them to the repository for storage and distribution to other investigators for future research. Repository teams should consider the following when accepting and distributing biospecimens.
When a repository accepts biospecimens from submitting-investigators, the repository protocol to be reviewed by the IRB should include:
There are several ways of ensuring that collection of specimens is consistent with the repository protocol and consent. The following are three examples but are not all-inclusive.
Before accepting biospecimens from submitting-investigators, the repository and the submitting-investigators should enter into a submittal agreement. This agreement, which may be a material transfer agreement, should include the following provisions:
When a repository will distribute biospecimens to recipient-investigators for research purposes, the repository protocol to be reviewed by the IRB should include plans for the following:
Repositories are encouraged to create an oversight committee to handle the above functions, including evaluating scientific validity of research projects, reviewing proposed use of the specimens, and determining whether the proposed use is consistent with the scope of the original consent form. A material transfer agreement between the repository and recipient-investigators should be signed prior to distribution of any samples.
Investigator is evaluating the efficacy of fluoride varnish. The study involves application of the fluoride to extracted teeth specimens to determine the effect of the varnish under various conditions. The teeth specimens are provided to IU by clinicians who have extracted the teeth for clinical purposes and would otherwise have been discarded. Instead, the samples are sent to IU without identifiers for use as needed (education, research, clinical comparison, etc.). Clinicians from all over the state of Indiana participate by donating these waste biospecimens.
Q. Is informed consent required for collection of the teeth specimens?
No—a waiver of consent is likely to be approved. Since there are no research procedures and no identifiers accompany the samples, the collection is minimal risk for the donors. The number of samples collected is extremely high, as is the number of collection sites. All biospecimens are collected per standard practice with no additional procedures to facilitate research. In addition, all samples exist due to a clinical procedure. Assuming the study team can justify that subjects' rights and welfare are not adversely affected by the collection and use of the teeth, the balance of the three practicability considerations (scale, standard practice, and clinical sample) indicate that the study could not practicably be conducted without the waiver.
Investigators are collecting blood for use in studying diabetes. When potential subjects are seen by the diabetes clinic and a blood draw is ordered, staff will draw an extra vial of blood that will be provided to the study team for purposes of the research. Up to 100 subjects will be enrolled at this specific clinic.
Q. Is informed consent required for collection of the additional vial of blood?
Yes—a waiver of consent is unlikely to be approved. Blood draws are generally minimal risk; however, based on the practicability considerations (scale, standard practice, and clinical sample), it is unlikely that the investigator can justify that the study could not practicably be conducted without the waiver. Enrollment of 100 subjects is unlikely to be considered enough to justify an unreasonable burden. The sample is collected using common clinical procedures during a time when those procedures are already being conducted; however, the extra vial of blood is not a clinical sample because it is not necessary for clinical purposes.
The following is a specific scenario that has been addressed by the HRPP. Decisions regarding this scenario are provided below in order to provide additional guidance to investigators; however, decisions are extremely fact-specific. Investigators should not attempt to extrapolate these decisions to additional scenarios. Instead, investigators are encouraged to contact the HRPP with additional questions and scenarios.
Collection of umbilical cord blood is not considered human subjects research as long as the study team cannot identify the donor and does not receive identifiable information about the donor. The research must be carefully designed to ensure the study team does not view or access any identifying information about the donor during the collection. Any screening for eligible subjects must be done by individuals who are not part of the study team.