The Medical Library Association (MLA) and Association of Health Sciences Libraries (AAHSL) have commented on the National Institutes of Health (NIH) Proposed Rule, Federal Policy for the Protection of Human Subjects. The proposed rule would update the 1991 "Common Rule" and strengthen protections for human subjects.
MLA and AAHSL believe that knowledge is essential to making informed health care decisions. For this reason, the associations have recommended that:
- Research study participants must have a clear understanding of what they are agreeing to before signing up for a study;
- Study participants should be given information written in plain language that describes the study's scope, its risks and benefits, and alternatives to particpating in the study; and
- ClinicalTrials.gov should be used as the repository where the informed consent forms are stored to ensure that all information related to the study is available in one location.