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 and data research can be categorized into three common groups:

• Prospective collection of data or biospecimens for research purposes
• Use of clinical data or samples in a research project
• Secondary use of previously collected data or biospecimens

Prospective collection of data or biospecimens for research purposes

Prospective studies are those that ask a question and look forward and are generally designed before any information is collected. Study subjects are identified and followed forward to see if the outcome of interest happens over time. This outcome is assessed relative to the intervention. Prospective research with data or biospecimens occurs when subjects are identified, and then data or biospecimens are collected from the subjects as part of the research interventions.

For prospective research with data or biospecimens, the IRB will generally require that consent be obtained from subjects prior to the collection of the data or biospecimen. Specifically, consent is likely to be required when the following are true:

• Subjects are identified prospectively prior to collection of the data or biospecimens
• At the time of collection, the investigators know and intend that the data or samples will be used for research purposes

Use of clinical data or samples in a research project

Biospecimens and data are often collected for clinical diagnostic purposes and then used for research purposes as well. Collection and use of these samples and corresponding clinical data for research purposes may not require prospective consent if the investigators can provide justification that the criteria for waiver of informed consent have been met. For more information on waiver criteria, see HRP 410-WORKSHEET-Waiver or Alteration of Consent Process.

Secondary use of previously collected data or biospecimens

When an investigator uses previously collected data or 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 data or biospecimens during the initial collection. The IRB may need to determine whether the data or biospecimens 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.