JHM IRB NEWS

July 29, 2002

Dear Colleagues,

As you know, we have made a lot of changes in the process of human subjects research review over the past year. This rapid rate of change has created some confusion and, I am sure, made your life more difficult; but the changes were a necessary part of our institutional improvements in the human subjects protection program. I am writing to summarize some recent developments and to let you know about some enhancements to be implemented in the very near future that, I think, will facilitate the IRB review process.

OHRP SITE VISIT To recap a little of the history of the past year, the Office of Human Research Protections (OHRP) suspended our Multiple Project Assurance on July 19, 2001 after an onsite review of our procedures. The Multiple Project Assurance is a document on file with the Office of Human Research Protections at DHHS that provides an institutional IRB with the authority to oversee human subject research. Due to a Herculean effort on the part of a number of administrative staff, it was reinstated 3 days later but with multiple restrictions, including strict oversight by OHRP. Recently, OHRP conducted a repeat site visit and evaluation of our system for protecting human research subjects. We discussed in detail the institution’s and the faculty’s commitment to the principles of the Belmont Report as well as the changes in our review processes, procedures, and staffing levels made since the OHRP action to suspend the Assurance in July 2001. I am very pleased to inform you that the OHRP staff was very positive about what we have accomplished in a relatively short period. We have just filed our quarterly progress report to OHRP, required as part of our corrective action plan and we are hopeful that OHRP will be equally positive.

NO MORE DUAL REVIEW Senior officials of all of the institutions covered by the Multiple Project Assurance (the School of Medicine, The Johns Hopkins Hospital, Bayview Medical Center, the School of Nursing, Howard County General Hospital, Kennedy Krieger Institute, National Institute of Aging Gerontology Research Center at JHBMC, JHCP Wyman Park Medical Associates, and the Applied Physics Laboratory) as well the Bloomberg School of Public Health have agreed to grant reciprocity for IRB review. This agreement will greatly simplify the IRB application submission process for faculty/staff who want to conduct research at multiple sites. An IRB in the Johns Hopkins Medicine system or one of the BSPH IRBs can now approve a study for conduct at all participating sites. MULTIPLE IRB APPLICATIONS AND SEPARATE CONSENT FORMS FOR EACH HOSPITAL IN THE JHM SYSTEM ARE NO LONGER REQUIRED. Please note, however, that approval by an IRB will only apply to the site(s) that are listed on the application. Sites may not be added automatically by an investigator without seeking an amendment to the study.

NAME CHANGE The names of the IRBs will change as of 8/15/2002. The Joint Committee on Clinical Investigation was the name applied to the original human subjects research committee before federal regulations were adopted and required formal appointment of IRBs. Given that we now have multiple IRBs and that they are located both on the East Baltimore and Bayview campus, the name “JCCI” will no longer be used. The JCCIs will be known as the Johns Hopkins Medicine Institutional Review Boards. Therefore, JCCI 1 will be JHM IRB #1; JCCI 2 will be JHM IRB #2, JCCI 3 will be JHM IRB #3, JCCI 4 will be JHM IRB #4; and the JHBMC IRB will be JHM IRB #5. The sixth IRB in the JHM system will remain WIRB in Olympia, Washington. The offices that house the Baltimore IRBs will become the Offices of Human Subjects Research, and Barbara Starklauf’s title will change to Assistant Dean for Human Subjects Research. By the end of September, the current Web sites (one for the JCCIs and the one for JHBMC IRBs) will be replaced with a new, single site containing up to date information on policies, processes, and forms.

WEB-BASED ACCESS TO IRB DATA A new Research Protocol Management System web site will be available to faculty and staff on September 1, 2002. The site will allow faculty and departmental staff to review the status of applications in process, check approval dates, and determine which JHM IRB is reviewing the application. An announcement with the URL will be forthcoming in late August. In 2003, we plan to bring on line an electronic application submission program. The goal is to eliminate the mounds of paper associated with submission and processing of applications.

“HOW TO” INFORMATION In September, the Associate IRB Managers and Assistant Dean for Human Subjects Research will hold a series of informational sessions for staff and faculty on the JHM IRB review processes. The sessions will be held at the East Baltimore and JHBMC locations; a schedule will be provided in August. In addition, Barbara Starklauf and I will schedule time at each department’s faculty meeting to address issues and concerns about the IRB processes.

Sorry for such a long letter, but there was a lot to say. Everyone at Hopkins involved with human subjects—faculty, coordinators, IRB leadership, and the administrative staff—has worked hard over the last year to revamp the entire process of research review. We have made great strides. It is now time to catch our breath, make sure that we are all on the same page, and think about where we need to go over the next year. As always, I welcome your input. Thanks for your help and patience.

Sincerely,

Michael J. Klag, M.D., M.P.H.
Vice Dean for Clinical Investigation