Changes in Johns Hopkins Medicine Protocol Review by WIRB

In 2001 we contracted with the Western Institutional Review Board (WIRB) to conduct review of all human subjects protocols while the JHM IRB system was rebuilt. At that time WIRB became the sixth IRB in the JHM system. Over the last several years, we have been gradually modifying the agreement to bring back research applications for internal JHM IRB reviews. Presently, WIRB is only reviewing new studies with commercial funding support in excess of $10,000 and conducting review of amendments and continuing reviews for studies already approved by WIRB.

Due to additional institutional resources and the dedication and hard work of the leadership and staff in the Office of Human Subjects Research, the JHM IRBs are able to conduct reviews in a timely fashion and in accord with DHHS and FDA regulations. The JHM IRBs now review protocols as quickly as WIRB. In addition, the eIRB database is becoming a valuable tool for the review and conduct of clinical research throughout the Johns Hopkins system. When protocols from Johns Hopkins are reviewed at WIRB, these protocols do not become part of the eIRB database. Therefore the eIRB database is not as useful in facilitating and tracking research. I am planning to have the JHM IRB review all new applications and only use WIRB for reviewing protocols they have already reviewed.

As of July 1, 2006, SOM faculty have the option of submitting all new applications to the JHM IRBs for review, regardless of the source of support for the project. Effective January 1, 2007, all new applications for human subjects research must be submitted to the JHM IRBs for review. We will no longer have WIRB review new protocols. For commercially funded studies with support of more than $10,000, JHM IRB initial review fees of $2000 and continuing review fees of $1000 will be charged against the applicable study budget. We will not charge for amendments. We will continue our contractual relationship with WIRB as they will continue to review amendments, change in investigators, continuing reviews, etc. for studies originally approved by them. During the transition we will carefully monitor review times of the IRB committees and make changes to the process if necessary. If you want to read more about the rationale for this decision please go to our website (jhmirb@jhmi.edu).

WIRB has provided valuable support and resources as we progressed in our journey from shut-down to full AAHRPP accreditation. We appreciate WIRB's excellent service and their professionalism as they partnered with the JHM IRBs and the Office of Human Subjects Research in our mission to protect the rights and welfare of the human subjects of research conducted by faculty and staff at the JHM Institutions. Any questions regarding the upcoming change in the relationship with WIRB should be directed to either Ms. Judith Carrithers (Director of Operations, Office of Human Subjects Research; jcarrit1@jhmi.edu), or Ms. Barbara Starklauf, (Assistant Dean for Human Subjects Research Compliance; bstark@jhmi.edu).

OHSR Guidance on Research Databases

The Office of Human Subject Research (OHSR) has posted a guidance called "Research Databases" to help investigators sort through the regulatory requirements associated with different research activities. (See: http://irb.jhmi.edu/Guidelines/
researchdatabases.html.) The guidance clarifies which projects require submission of an eIRB application and which do not. Please read the guidance and contact the OHSR at jhmirb@jhmi.edu if you have any questions.

If appropriate for your research, you might also review the recently posted revised guidances on Human Biological Materials (http://irb.jhmi.edu/Guidelines/biomats.html) and Pathology (http://irb.jhmi.edu/Guidelines/pathologyguidelines.html).

Course on Research Ethics (C.O.R.E) Reminder

The next Course on Research Ethics (C.O.R.E) will be offered on May 31st, 2006. PIs must complete the new C.O.R.E. training or its equivalent by June 30, 2006. All other faculty who participate in clinical research should complete C.O.R.E. as soon as possible. Fellows who participate in clinical research must complete C.O.R.E. training before completing their fellowship. In addition, completion of both the morning and afternoon sessions of C.O.R.E. fulfills Kirschstein-NRSA responsible conduct of research training requirements.

Registration for C.O.R.E. is handled by the Office of Continuing Medical Education (CME). Registrations must be received 10 days prior to the course. To register, please visit CME's C.O.R.E. webpage at: http://www.hopkinscme.net/etrakwebapp/Meeting
Detail. aspx? MeetingCode=06-511470&sessioncode=

For additional information regarding the School of Medicine Research Compliance Training requirements, please visit: http://www.hopkinsmedicine.org/Research/ora/
training/compliance_reqs.html

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