Human Subjects Research

September 2002


	September 2002 articles:

HUMAN SUBJECTS RESEARCH - Back

OHRP Site Visit

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 institution's Multiple Project Assurance in July 2001. We are 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 IRB 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

As of 8/15/2002 the name "JCCI" (Joint Committee on Clinical Investigation) will no longer be used. The JCCIs will be known as the Johns Hopkins Medicine Institutional Review Boards (IRBs). 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 is now available to faculty and staff. The site allows faculty and departmental staff to review the status of applications in process, check approval dates, and determine which JHM IRB is reviewing the application. The site is now available to faculty and to administrative staff who are authorized by a department to access protocol information for grant purposes. Department administrators who wish access for their staff should send the list of individuals to Barbara Starklauf, Assistant Dean for Human Subjects Research (bstark@jhmi.edu), with justification for the request. Once such authorization has been granted, the departments are responsible for assuring that only authorized individuals have access to the site. The Web address is: https://www.insidehopkinsmedicine.org/rpms/ . Faculty members may search for and view only the protocols for which they are the listed principal investigator. Designated administrators may search for and view protocols for the department. Access requires use of a JHED ID. Individuals who do not have a JHED ID may request permission to access the site as an investigator, but must provide justification for this request. The information is located on a secure server that will allow access only from Hopkins' workstations. The site will provide a history of materials received and actions taken since January 1, 2002.

For further details about this new site, click here: http://www.insidehopkinsmedicine.org/news/
leadershipcorner/090302.cfm 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 Sessions

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. In addition, Barbara Starklauf and Vice Dean Michael Klag will schedule time at each department's faculty meeting to address issues and concerns about the IRB processes.

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	HUMAN SUBJECTS RESEARCH

-	OHRP Site Visit
-	No More Dual IRB Review
-	Name Change
-	Web-based Access to IRB Data
-	"How-To" Information Sessions

	ANIMAL RESEARCH

-	Change in PHS Policy on Humane Care and Use of Laboratory Animals

	LICENSING AND BUSINESS DEVELOPMENT

-	Help is on the Way!!-In Sending Out Your Biological Materials, Anyway

	RESEARCH COMPLIANCE

-	School of Medicine Adopts New Policy on Conflict of Interest

	FUNDING OPPORTUNITIES

-	Internal Funding Opportunity: Molecular and Cellular Engineering Pilot Program
-	CAM Research Funds Available

	GRANTS AND CONTRACT PROCEDURES

-	New Internal Deadline for Grant and Contract Proposals
-	NIH Discontinues Preprinted Face Pages

	EDITORIALS

-	ICE Update - from Dr. Chi Dang, Vice Dean for Research