Sometimes our researchers need to ask ordinary people if they would be willing to participate in studies that can help us determine whether certain drugs or other treatments in development are effective. The steps that we must take to involve human subjects in our research are highly regulated, and for good reason. However, one does not have wait very long to see in the news a story about an institute or hospital somewhere in the world that failed to create or adhere to practices designed to ensure compliance with such regulations and the safety of human subjects. This page provides resources that can help you to understand the laws and other standards that apply to the involvement of human subjects at JHU and the practices that we adopted to ensure our compliance with them.
Protecting Research Participants
If your research potentially includes the involvement of human subjects, it is important for your activities to be reviewed by your division’s Institutional Review Board (IRB). More information is available on each of the IRB’s individual websites:
Pursuant to the federal Common Rule, 45 CFR 46.114(b), all institutions located in the United States that are engaged in cooperative research conducted or supported by a Federal department or agency, must include in their grant applications for multi-site, non-exempt human subject research studies a proposal for the use of a single IRB (“sIRB”) to review the research for all participating domestic sites. When sIRB services are required by a Sponsor, and a JHU PI wants JHU to serve as the study’s sIRB, the SOM IRB will review all requests for sIRB services, and if approved, will serve as the University’s sIRB for all divisions. In circumstances where the SOM IRB determines that it cannot serve as the sIRB, the divisional IRB will assist with identifying an appropriately qualified sIRB. SOM IRB has signed on to the SMART IRB Reliance agreement, and its investigators are urged to make sure that their collaborators have either signed on to this form of reliance agreement, or are willing to sign on.
All Planning Phase and New Applications that involve Hopkins as the reviewing sIRB must submit a “Reliance Request” through an on-line SOM IRB query portal available on this page. Reviewers will evaluate and act on the request. SOM faculty will use the same portal for applications seeking to rely on an external sIRB.
JHSPH and Homewood investigators preparing grant submissions and new applications that propose relying on an external sIRB should contact the JHSPH (firstname.lastname@example.org) or Homewood IRB for further guidance.
All other reliance requests will be managed by the IRB associated with the PI’s division. Please contact JHMIRBreliance@jhmi.edu with questions about the SOM IRB sIRB process.
Certificates of Confidentiality
Effective October 1, 2017, all ongoing or new research funded wholly or in part by NIH as of December 13, 2016 that is collecting or using identifiable, sensitive information is automatically issued a Certificate of Confidentiality (Certificate) as a term and condition of NIH grant awards. Learn more
Good Clinical Practice (GCP) Training
In addition to satisfying any requisite IRB obligations, JHU staff members involved in clinical trials are required to receive training for Good Clinical Practices (GCP). The NIH recently issued a policy requiring all NIH-funded investigators and their research staff who are involved in the conduct of clinical trials, as defined by the NIH, to complete GCP training. The policy is effective January 1, 2017, and applies to both new applications and ongoing programs.
NIH defines a ‘clinical trial‘ as “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” Note that the definition includes trials that do not involve drugs or devices, and thus the training requirement also applies to NIH-funded studies that are only studying behavioral interventions. In addition, all members of the research team who may be engaged in the research must complete the training.
In order to comply with the NIH GCP training requirement, JHU investigators and their staff who may be subject to this requirement should complete the CITI GCP training module, which is available through MyLearning, or may demonstrate compliance through providing a certificate of other acceptable GCP training to ORA and/or the JHM IRB.
For Bloomberg School of Public Health investigators, training may be accessed through the School’s CITI training account. When you log into the CITI site (selecting Johns Hopkins Bloomberg School of Public Health as your institution), select “Add a Course,” and then, under “Question 2,” select the first Learner Group that offers GCP training. An additional course targeting social/behavioral clinical trial investigators and staff is in development and will be available through CITI in the near future.
For more information, including NIH’s recently expanded definition of “clinical trial staff” as well as links to the appropriate courses to be taken, please read the GCP FAQs. If you have any questions regarding this new requirement, please contact your JHURA representative or Joan Petit.