To: MCW Faculty
Research Staff
Institutional Review Board Members

From: William R. Hendee, PhD
Senior Associate Dean, Research
Medical College of Wisconsin

Marjorie A. Cage, PhD
Director, Human Research Protection Office
Medical College of Wisconsin

Date: June 21, 2004

Re: MCW Human Research Protection Office (HRPO) Certification Plan

Beginning July 1, 2004, all persons involved in the design, conduct, or review of human research carried out by MCW faculty investigators or reviewed by MCW or FMLH IRBs must be certified under a new education plan. This plan encompasses, and is not limited to, IRB & DSMB committee members, investigators, coordinators, pharmacists, fellows, students, and any other research team members who interact with study participants and/or access their data and identifiers.

The purpose of certification is threefold:

1. Responsible Conduct in Research - to assure a thorough and universal foundation in the ethical and legal principles guiding human participant research.

2. Scientific Integrity - to enhance the awareness of, and sensitivity to research integrity issues such as conflict of interest.

3. Public Duty - to demonstrate to our study volunteers, the community, and research sponsors that we have the training and expertise necessary to protect the rights and welfare of research participants.

The Certification Plan requirements include reading the Belmont Report and key MCW research documents and policies, and completing the required modules of the Collaborative IRB Training Initiative (CITI) Program. The CITI program is a collaboration between the University of Miami and the Fred Hutchinson Cancer Research Center to offer a web based training program in human research participant protections. The program is used by other academic medical centers and has received favorable evaluation. The program is divided into a biomedical track and a social/behavioral track. The total time to complete the certification program is approximately 4 to 6 hours and the modules can be completed in multiple sittings. The CITI program is web-based and can be accessed from any computer via the internet. The instructions are found on the HRPO web page by clicking on "Certification Program" in the left-hand menu. The modules are optional if comparable training has been completed - e.g., VAMC, but not NIH - within the past 2 years.

The timeline for completion is:

Group I - by June 30, 2005
Anyone involved in the design, conduct, or review of human research carried out by MCW faculty investigators at MCW or FMLH. This includes

  • Everyone listed on the MCW /FMLH Registry of Research Personnel
  • MCW and FMLH IRBs, DSMC, DSMBs, GCRC: committee members and staff

Group II - by December 31, 2005
Anyone involved in the design or conduct of human research carried out by MCW faculty investigators at other institutions. For example, at CHW, Zablocki VAMC, or Community Memorial Hospital.

New Faculty and Staff involved in the conduct of human research and starting after the applicable compliance date above will have a grace period of 90 days from date of hire. During this time all conduct of research activities must be supervised. An investigator may not be a Principal Investigator until certification is completed.

Once initial certification is completed, biennially everyone must read the documents required for initial certification and take the CITI Refresher Course. In addition, on an annual basis investigators and coordinators must complete three human research protection trainings from among the following options. All others must complete one.

  • 1 CITI Basic Course module not done for initial certification (from either track)
  • 1 CITI Refresher Course 1 module not required for biennial recertification
  • Attend 1 hour MCW program in human research protections
  • Attend 1 hour of external program human research protections
  • Complete NIH's computer based training

We recognize that everyone is busy, and that the HRPO Certification Plan will require some time and effort. But if MCW is going to do its best to protect the safety of participants in human research, comply with federal regulations, measure up to what other institutions are doing, and ultimately apply for accreditation of the College's human research protection program, we must do a better job of providing and documenting the training of those engaged in such research.

Thank you for your cooperation.