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What records must I keep, and what can I throw away?

Reader Question: I’m wary of throwing away research records, but they’re overtaking my small office space. I’ve been the PI on nearly 20 protocols during the past 15 years. Most of them have involved mice, but we used dogs for approximately four studies. Are there any guidelines regarding record retention when studies use mice or dogs? And specifically who is responsible for keeping those records?

Expert Comments:

First, you should check your institution’s record-retention policy, which may specifically address some of your points.

After that, here are some general guidelines that apply to dogs, mice and other species:

• The Animal Welfare Regulations (AWR) 2.35 (f) require that you maintain all records and reports pertaining to AWA species (this would include dogs) for at least three years. The regulation also states that you must keep records relating directly to proposed activities and proposed significant changes to ongoing activities — once reviewed and approved by the IACUC — for the duration of the activity. It further indicates that you keep these records for an additional three years after completing the activity. PHS policy (which applies to mice) follows the same requirements.

• Institutions need to define the “duration of activity” (e.g., protocol approvals and complete study duration). The IACUC office will then keep official protocol records according to the institution’s record-retention policy, which again must be at least three years.

• According to the AWR, your institution’s laboratory-animal facility will retain animal acquisition, medical, transportation and disposition records for at least three years. And you need to retain Good Lab Practice (GLP) study records for two years after FDA approval or five years after FDA submission.

• The PI must retain case histories for two years after FDA marketing approval, discontinuation of investigation or if no application is filed.

As for who must keep the records, the PI in most cases is responsible for keeping his/her study records — generally for at least three years after project completion. But again, check your institution’s policy, state laws and your funding agency’s requirements. There may be some differences. NIH-funded PIs should always review the NIH Grants Policy for guidance on compliance: http://grants.nih.gov/grants/policy/nihgps_2010/index.htm.

Many different factors come into play regarding research data retention. The length of time — and what — you must keep might depend on whether they are needed for future publications, institutional policies, state laws or funding agencies.

One way to eliminate paper records and free up space in your office is to scan them and keep them electronically.

Expert comments Sally E. Light, IACUC Administrator, Michigan State University.

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