When reviewing a research study, the IRB will consider whether appropriate provisions are in place to protect the privacy interests of research subjects, the confidentiality of the research data, and the security of the data and biospecimens. The IRB will consider the following when determining whether a research study has adequate provisions to protect research subjects’ privacy interests, confidentiality of data, and security of data and specimens:
- Risk/Benefit assessment,
- Location of the data collection,
- Sensitivity of the data being collected,
- The identifiability of the data and biospecimens.
The IRB requires detailed information on the confidentiality and security of biospecimens and data to be used in research. The following is a list of items to describe in the submission materials for IRB review. For additional guidance, please see HRP 503a-TEMPLATE PROTOCOL-Registries and Repositories.
- Describe any procedures that will be used for quality control of collected data and/or biospecimens.
- Describe the steps that will be taken to secure the data and specimens (e.g., training, authorization of access, password protection, encryption, physical controls, and separation of identifiers and data) for storage and use.
- Describe how and where data and/or biospecimens will be stored and maintained throughout the life of the study. Reference any relevant storage standard operating procedures, including how the data and specimens will be tracked.
- Explain whether anyone, including the lead researcher, can identify the participants. Explain whether there will be a unique code on the biospecimens/dataset that can be used to link to a participant’s identity, but will not, by itself, reveal who the participant is.
- Describe the procedures in place to protect participants’ privacy. By privacy, this means a person’s desire to place limits on with whom they interact or to whom they provide personal information.
- If you will be collecting sensitive information (e.g., sexual health information, communicable disease status, genetic test results), provide a justification for this.