Definition of Data
“Data” refers to recorded information, regardless of form or the media on which it may be recorded. (Interagency Advisory Panel on Research Ethics, 2005).
Data Retention under the TCPS
The TCPS underscores the importance of considering data retention by research ethics boards (REBs) in their reviews of studies that collect identifiable personal information about research participants: “Researchers shall secure REB approval for obtaining identifiable personal information about participants. Approval for such research shall include such considerations as… (c) Limits on the use, disclosure and retention of the data…” (TCPS article 3.2 [c]). This is to ensure that the appropriate safeguards for security and confidentiality of the collected information are in place.
The TCPS does not specify a required length of time for retention of research data. Data retention periods tend to vary depending on the research discipline, research purpose and kind of data involved.
Under the TCPS, REBs typically apply guiding principles and/or address issues relevant to data retention, such as respect for free and informed consent (Section 2); respect for privacy and confidentiality, and principles for the secondary use of data (Section 3); and respect for applicable laws and regulations. The “legal context for research involving human participants is constantly evolving, and varies from jurisdiction to jurisdiction.” (TCPS, i.8).
(Interagency Advisory Panel on Research Ethics, 2005).
Considerations Concerning Length of Retention
Throughout the TCPS, a number of factors are relevant to defining periods of data retention. These include the following:
- Purpose of retaining data: What is the purpose and use of retention? For example, is the retention necessary to achieve the specific purpose for which the data were gathered and used? Is its retention for, and necessary to, secondary uses?
- Type of data collected: Are they sensitive data? Are participants identifiable? What is the effect on the participants, etc., of conservation of data?
- Nature of research under review: Does the field require retention of data for the continuity of scientific research, such as in the case of historical or statistical research? What are the professional standards for the relevant discipline?
- Informing participants: Have the participants provided informed consent to the purposes, uses and retention of the data collected? Have they been informed of any potential for secondary use of such data?
- Access to data: Who is authorized to have access to the data? How will access be managed?
- Data storage, security, and protection: Will the data obtained be stored securely and protected with all the precautions appropriate to the sensitivity of the data?
- Confidentiality and anonymity of data: Have the researchers taken appropriate measures to preserve anonymity, consistent with the presumption that anonymity accords with the privacy preference of participants?
The Researcher must also consider legislation around retention of personal information. The Freedom of Information and Protection of Privacy Act, section 31, states that, “public bodies must keep personal information for a year where it has been used to make a decision that affects the individual”.
The onus is on researchers to justify their case and address all consent, confidentiality and security issues to the satisfaction of their local REB. (Interagency Advisory Panel on Research Ethics, 2005).
Researchers at Vancouver Island University must be aware of data parameters associated with the project in which they are engaged.
Disposal of Research Data
Unless a researcher has received approval from participants to archive their data, he or she is eventually faced with the task of destroying the data. The following is a rough guideline for destruction of data.
|
Medium |
Recommendation |
|---|---|
|
Audiotapes |
Methods for destroying/disposing of audiotapes include recycling (tape over) or pulverizing. Commercial shredding companies will often accept audio tapes for destruction – keep separate from paper shredding caches. |
|
Computerized Data/ Hard Disk Drives |
Methods of destruction/disposal should destroy data permanently and irreversible. Methods may include overwriting data with a series of characters or reformatting the disk (destroying everything on it). Pulverizing the hard disk is the best method of destroying hard disk data. |
|
Computer Diskettes |
Methods for destroying/disposing of diskettes include reformatting, pulverizing, or magnetic degaussing. Commercial shredding companies will often accept computer disks for destruction – keep separate from paper shredding caches |
|
Laser Disks |
Disks used in “write once-read many” (WORM) document imaging cannot be altered or reused, making pulverization an appropriate means of destruction/disposal. |
|
Microfilm/microfiche |
Methods for destroying/disposing of microfilm or microfiche include recycling and pulverizing. |
|
Public Health Information Labelled Devices, Containers, Equipment |
Reasonable steps should be taken to destroy or de-identify any PHI information prior to disposal of this medium. Removing labels or incineration of the medium would be appropriate. |
|
Paper Records |
Paper records should be destroyed/disposed of in a manner that leaves no possibility for reconstruction of information. Appropriate methods for destroying/disposing of paper records include: burning, shredding then cross shredding, pulping, and pulverizing. |
|
Videotapes |
Methods for destroying/disposing of videotapes include recycling (tape over) or pulverizing. Commercial shredding companies will often accept video tapes for destruction – keep separate from paper shredding caches |
(Adopted from UOG – REB GUIDELINE 4-G-011, December 2006)