HUMAN SUBJECTS RESEARCH - Back

OHRP Lifts Restrictions

The Office for Human Research Protections (OHRP) conducted a follow-up on-site evaluation of our human subject protection procedures in June. Based upon observations made during its site visit, as well as its review of all documents provided with our previous progress reports, OHRP stated that the JHUSOM has “developed and implemented a markedly enhanced system for protection of human subjects and has adequately completed all required actions” stipulated by OHRP last summer. Among the many enhancements noted by OHRP are the following:

1. Development of our multifaceted education program to ensure that all IRB members, all IRB staff, and all research investigators are educated on an ongoing basis about the ethical principles and regulatory requirements for the protection of human subjects.
2. We have expanded the number of IRBs from two to four, with an additional IRB at Bayview, resulting in a significant reduction in the volume of research protocols reviewed and overseen by each IRB. The IRB Chairs and members were deemed “highly committed to the protection of human subjects and demonstrated an enhanced knowledge of the ethical issues and regulations related to the protection of human subjects.”
3. We have expanded the resources of our IRB offices. OHRP notes that additional staff have been hired to assist the IRBs and the overall administration of the system for the protection of human subjects.
4. We have developed and implemented new procedures for the operations of our IRBs, including procedures for IRB meeting format; conduct of IRB review of protocols; and documentation of IRB activities.

As a result of the above determinations, effective immediately, OHRP has removed the restriction on the SOM’s Multiple Project Assurance and the institution no longer needs to submit quarterly progress reports to OHRP. Furthermore, OHRP states that there should be no need for their further involvement in this matter.