Research conducted at Johns Hopkins produces life-saving and life-enhancing discoveries. To ensure the safety of those who participate in this research, Johns Hopkins is putting in place significant new safeguards that have been endorsed by the federal government and an external review committee. These safeguards include:

• Expanding the number of institutional review boards (IRBs) charged with research oversight. Hopkins has added three IRBs, increasing the total used for the re-review process to six, and pledged at least four permanent IRBs.
• Intensifying training for all IRB members, in cooperation with the Office for Human Research Protections (OHRP). Six hours of on-site OHRP instruction took place for IRB members and staff. The sessions were videotaped for viewing by future staff and IRB members.
• Supplementing Web-based instruction for faculty and staff on use of humans in research by presenting at Hopkins the nationally acclaimed PRIMIR course IRB 101.
• Requiring prior academic review of research protocols before they are submitted to IRBs. This review will include examination of scientific worth, validity of study design and safety.
• Implementing the full convened IRB meeting review process to ensure full IRB review, discussion and documentation of each protocol.
• Working with OHRP to develop an approved checklist to guide re-review of protocols, as well as discussion of new and renewal protocol review.
• Establishing a committee chaired by Ruth Faden, executive director of the Johns Hopkins Bioethics Institute and a national authority on the ethics of human participation in research, to review and revise policies for participation of employees and students as normal volunteers in research.
• Taken steps to ensure timely, written documentation of IRB deliberations.
• Designated a staff member as consent form reviewer to aid investigators in developing consent forms that provide all necessary information regarding the purpose, risks, and benefits of the research.
• Requiring investigators to collaborate with a librarian and a pharmacist to strengthen literature searches regarding previous studies for any substances for which the FDA does not require an IND. The goal of the collaboration is for both the librarian and pharmacist to help search appropriate databases for potential side effects.
• Establishing a policy of querying the FDA in all instances when a non-approved substance is specified in a protocol to determine if an IND is required. If the FDA does not require an IND, the investigator must provide sufficient evidence that the substance in question is safe for human use, including safety data generated by an outside organization, when pertinent, regarding animal studies, purity of the substance, and whether the material meets requirements for human use.
• Reminded all Hopkins faculty of institutional policies regarding IRB notification of (1) changes in protocols and (2) adverse events.
• To further insure sufficient oversight of studies that administer drugs or other substances into humans in research studies, initiating policies requiring wider use of the Investigational Drug Service (IDS) by faculty based at both Hopkins Hospital and the Johns Hopkins Bayview Medical Center. The new policy requires that a pharmacist be involved in the preparation of any materials to be used in humans in such studies.
• Increased random quality control checks of ongoing research protocols to ensure safety and adherence to best practices.

Beyond these specific actions, Johns Hopkins recognizes the need for a broad and long-term educational effort, at al levels of the institution, to ensure a full appreciation of he ethical obligations inherent in research involving humans. This broader effort will be pursued aggressively in the coming academic year.

In the wake of the tragedy of the death of a healthy volunteer in a Hopkins research study, we are fully engaged in improving our processes and strengthening our safeguards to reduce the chance of such an event occurring again. We are very proud of the Hopkins research that has done so much to improve health and extend life here in the United States and around the world. As we raise the bar on research safety, we believe these changes will enhance our research efforts.