September 7, 2001
MEDIA CONTACT: Joann Rodgers
HOPKINS RESPONSE TO FDA OBSERVATIONS
Johns Hopkins officials said today that receipt of the U.S. Food and Drug
Administration (FDA) report on the agency’s observations of the events
surrounding the death of a healthy research volunteer reinforces Hopkins’
commitment to improving its research protection system. "We appreciate the
hard work FDA has done and the guidance it has given us to further improve our
processes for conducting research involving human volunteers," according to
Chi Dang, vice dean for research at The Johns Hopkins University School of
The 483, received September 7, involves issues that Hopkins has been
reviewing and addressing throughout the summer. Hopkins already has implemented
corrective action for most of the observations cited in the 483 and plans to
address the remainder are already underway. (See below.) In addition, the
institution will continue to cooperate fully with FDA and other federal agencies
in efforts to insure the safety of all research involving human volunteers.
ACTIONS TAKEN TO STRENGTHEN RESEARCH OVERSIGHT AT
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
- 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
- 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
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.