Regulatory Knowledge

Overview

The regulatory unit activities serve to ensure that establishment of new processes and procedures associated with human subjects research are in line with current regulations. Increased investigator and staff training at the institution will result in greater protections for participants in research studies.

Regulatory Knowledge and Support Aims

Aim 1:

Identification of a Unit leader to serve as the liaison for this domain.

Aim 2:

Identification of specific components in each aim that comprise this domain. Each component is listed as an activity with performance measures on the activity report.

Aim 3:

AAHRPP accreditation - A task force has been established that is composed of faculty and staff from areas of the institution that serve in protecting human research subjects. These members are assigned to help address one or more of the domains associated with the AAHRPP self study. This group has met several times and has completed the initial draft of the self study. The group is currently working to address elements that need to be improved at the institution.

Aim 4:

MiDr-CAREER (i2b2) - The items relating to human subjects protections concerning the i2b2 database have begun to be discussed and reviewed. A provisional IRB approval has been issued for funding agency notification and for the development of infrastructure policies. This includes development of policies to address maintenance, access and use of the data repository.

Aim 5:

Collaboration and Partnerships, IRB reciprocity agreements - A representative from MSM has been identified to serve on the RTRN Ethics and Regulatory subcommittee. The current focus of this group is IRB harmonization. Association with this group will help in the cultivation of relationships between institutional IRB's and facilitate establishment of reciprocity agreements where needed.

Aim 6:

Biostatistics, Research Design and Data management, Develop & implement educational programs in research ethics -

  1. Educational training sessions for IRB members occurs at the monthly IRB meetings. A Board member or guest presents material relevant for continuing educational training in areas applicable to IRB reviews.
  2. IRB web site transformation has been initiated. This re-design provides easier access to the required ethics training course. It will also provide access to other training resources for all investigators, staff and IRB members. Development of courses and training materials by MSM faculty and staff will also be available from the web site.