Yes (TCPS2 (2022) Chapter 3 and Chapter 5). Researchers often wish to collect and archive personal information from human participants. Personal information can take a number of forms. For the purposes of this FAQ, ‘Personal Information’ will be used to indicate identifiers or human tissue samples, cellular and molecular fractions, or derivatives of human tissue. Such an archive constitutes a database and requires approval from the Research Ethics Board since it would not necessarily be covered by an active ethics certificate for a particular research project.
In applying for and maintaining clearance for a database the following should be taken into consideration:
1. Collection
Written permission must be obtained from the participant for their personal information to be archived in a database. A separate consent form can be used, or a paragraph can be added to an existing consent form to cover the collection of personal information for the database. The consent form should cover:
- Possible future uses of the personal information
- Possible genetic testing of the personal information in the case of tissue.
- Who has access to the personal information
- Who will not have access to the personal information
- The name and contact information of the person responsible for the personal information.
- How the personal information will be stored
- Where the personal information will be stored
- How long the personal information will be stored
2. Use
When obtaining permission to archive personal information, the participant must be told the possible future uses of this information. Examples might be:
- Names and telephone numbers will be used to contact participants for future research projects about Topic A.
- Blood samples will be kept for future studies in the area of Disease B.
The range of access must be clearly stated. For example:
- Tissue samples will be available for future research in the lab of Dr. Smith.
- Personal contact information will be held in the Institute for Aging for use by researchers in that Institute, but will not be released to anyone outside the Institute.
3. Storage
The archivist must clearly state how the personal information will be stored.
- Paper copy – must be stored in a locked cabinet with limited access, preferably on campus.
- Electronic data – must be stored in a password protected, non-portable hard drive and preferably be encrypted. The hard drive must be located in a secured room.
- Tissue – stored under appropriate and stated conditions under lock and key with limited access.
4. Stewardship
A single individual must be named as the steward of the data base. This individual is responsible for ensuring that the data are stored as indicated in the protocol. In addition, this individual is responsible for ensuring that stewardship is transferred to some other appropriate individual if the circumstances warrant, and that this transfer is clearly documented and filed with the REB.
5. Disposal
The steward is responsible for ensuring that archived personal information is disposed of appropriately as soon as it is no longer required. In addition, the steward is responsible for ensure that this disposal is consistent with the information initially given to participants regarding how their data would be managed. The method of disposal will be dictated by the physical nature of the information. [link to] FAQ Disposal of Data lists the appropriate forms of disposal of paper and electronic information. Paper should be cross-cut shredded. Human biological material should be disposed of according to biosafety guidelines and the personal information attached to the human biological material should be removed and destroyed.
6. Continued Certification
The steward of the database must submit an annual report to the REB requesting continuance of approval for a further year.