Researchers who collect data or biospecimens that may be used in future research must include a description of this activity in the IRB application. Often, investigators or sponsors would like to keep data or biospecimens that are collected during a research study for further scientific research. Participants may consent to the collection of data or samples for future use when participating in a research study. Before retaining/storing or contributing data and/or biospecimens for future use in a repository, specific information must be provided in the IRB application and in the consent and authorization document.
The ERICA application asks investigators if the study involves creating or sending data and/or samples to a repository to be saved for future research uses. If data or biospecimens will be kept or sent to a repository for future use, an additional page must be completed. The questions should be answered from the point of view of the repository, even if the investigator will not be managing the repository.
- What will be stored for future use?
- What type(s) of future research will be allowed on the data/samples?
- Who manages the repository and where will the data/samples be storied?
- Will data/samples be identifiable or de-identified?
Identifiable means that the participant can be identified by the repository using information kept with or linked to the data/sample.
- Who will manage and have access to the identifiable data? Where will the data be kept? How will the data be kept confidential?
- Who will de-identify the data/samples? When will the data/samples be de-identified?
- Will participants be able to withdraw data/samples from the repository?
- Will future research results or findings be communicated to participants?
- How will researchers obtain data/samples from the repository for use in future research?
Consent & Authorization
Informed consent and authorization for the collection of data and/or biospecimens within the covered entity for future use must be accounted for in one of the following ways:
- Full informed consent and authorization (for information or samples collected within the covered entity)
- Waiver of consent plus a method to account for authorization (for example, left-over pathology samples or de-identified samples)
Consent and authorization must be obtained from participants or their legally authorized representatives for use and/or collecting of their data and/or samples, except where waivers or non-human subject determinations apply.
The consent must clearly articulate what the investigator is doing NOW versus what may be done under the auspice of “future research”. The NOW must be specific, requiring a study design, aims/objectives/hypothesis, methods, an analysis plan.
Consent and authorization documents should include the following information:
- Data and/or Biospecimen Use Description
The consent form must describe that the information and/or sample will be collected and used for future research. Please see the "Future Use of Private Information or Biospecimens" section on the Consent Document Checklistas a guide for the specific requirements or use the Model Consent Language for Future Use of Biospecimens or the Model Consent Language for Future Use of Information.
- Note that treatment/intervention trials must allow participants to choose whether to participate in the biospecimen repository. Investigators may not condition participation in a treatment/interventional trial upon mandatory participation in a biospecimen.
- If use of the sample involves genetic testing, the investigator must also include language regarding the disclosure of results as outlined in the IRB guidance on Genetic Research.
- Authorization language for use and disclosure of information
Authorization determines who can have access to participants' protected health information (PHI). This language is outlined in the HIPAA Authorization section of our Consent Document Checklist on the IRB website. It is important to consider how each sample and the accompanying information can be disclosed in the future. Some important considerations include:
- What protected health information (identifiable or non-identifiable) will accompany samples?
- Who will be allowed to receive the samples with the accompanying health information - only individuals within the University of Utah and its covered entity, or others from outside entities and institutions (e.g., sponsor, FDA, NIH, etc.)?
A waiver of consent and authorization may be requested for obtaining data or samples for future use. However, a waiver is only appropriate if it is impossible or impractical to get consent from the participants. For example, left-over pathology samples or de-identified samples.
- A waiver of consent may be requested for the use of data and/or biospecimens. The IRB will approve a waiver if the study meets criteria, as outlined in 45 CFR 46.116(f)(3).
- A method to account for authorization must be used in conjunction with a waiver of consent. The following methods may be used:
- Waiver of authorization
- Limited data set
- Safe Harbor De-identification