The Johns Hopkins University is committed to protecting the rights and welfare of individuals participating as subjects in research. All human participant research conducted under the auspices of the University is evaluated by an Institutional Review Board (IRB) to ensure that the rights and welfare of participants are fully protected.

The Homewood Institutional Review Board (HIRB) serves the Krieger School of Arts and Sciences, Whiting School of Engineering, School of Education, Carey Business School, Nitze School of Advanced International Studies, and Peabody Institute. HIRB is responsible for reviewing all research projects involving human participants conducted in these divisions. This policy applies to all faculty, staff, and student research projects, whether or not a project is funded and regardless of the location at which the research will be conducted.

This site provides resources to help guide investigators through the HIRB application and review process.

FWA #: FWA00005834

Documents & Resources

  • Educational & Ethical Principles

    An introduction to the Homewood IRB (HIRB) can be found by reviewing the document: Navigating the IRB.

    Investigators and HIRB Members are required to understand and apply the highest ethical standards to the review and conduct of human participant research. To ensure these objectives, investigators and HIRB members are required to complete training in the protection of human research participants through the online course offered by the Collaborative Institutional Training Initiative (CITI) and should select the most appropriate module under “Human Subjects Research”.

    Proof of completed training must be on file with or provided to HIRB before applications will be approved. Certification must be renewed every five years. The IRB does not require training in Responsible Conduct of Research (RCR) or Good Clinical Practice (GCP), although you may be required to take this for other purposes or may choose to take one or both of these for your own personal knowledge.

    Investigators from other institutions should contact the HIRB office for alternative training options.

    Additional educational opportunities include briefings by the HIRB office; local, regional, and national meetings and courses; and online forums, newsletters, and other publications. For more information about these resources, contact the HIRB office at hirb@jhu.edu or 410-516-6580.

    The rights and safety of individuals participating in research are assured through adherence to widely-accepted ethical principles that have been established for biomedical experiments and extended to behavioral research. These ethical principles are set forth in The Belmont Report, the Declaration of Helsinki, and The Nuremberg Code.

  • NIH Policy on Issuing 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. Identifiable, sensitive information is information about an individual, gathered or used during the course of biomedical, behavioral, clinical or other research, through which the individual is identified, or there is at least a very small risk that the identity of an individual could be identified.

    Under the new Policy:

    • Certificates will no longer be issued in a separate document. The Notice of Award and the NIH Grants Policy Statement will serve as documentation of the Certificate protection.
    • Researchers are required to determine whether their research records generated with NIH funding are covered by a Certificate.
    • The scope of research protected by Certificates extends beyond “human subjects research” and includes research: 1) in which identifiable, sensitive information is collected or used, 2) that collects or uses human biospecimens that are identifiable or that have a risk of being identifiable; 3) that involves the generation of individual level human genomic data; and 4) that involves any other information that might identify a person.
    • Certificates will be issued to recipients for applicable research regardless of the country where the investigator or the protected information resides. However, Certificates may not be effective for data held in foreign countries.
    • Information protected by a Certificate and all copies are subject to the protections of the Certificate in perpetuity. Therefore, if a secondary researcher receives information protected by a Certificate the secondary researcher is required to uphold the protections of the Certificates.
    • When a researcher is issued a Certificate and the researcher will be obtaining informed consent from participants, subjects must be told about the protections afforded by the Certificate and any exceptions to those protections. The Homewood IRB, the School of Medicine IRB, and the Johns Hopkins School of Public Health IRB have developed template language to be used in consent forms to address the new policy.

    The NIH has provided useful FAQs and information about the new Policy at: https://humansubjects.nih.gov/coc/NIH-funded.

    Should you ever receive a subpoena or other legal process seeking disclosure of research records, please contact the Johns Hopkins University Office of the Vice President and General Counsel (OGC) immediately, and prior to disclosing any records or information. OGC will assist researchers with responding to the legal request for records, and with enforcing the privacy protections of Certificates of Confidentiality. OGC contact information may be found on the OGC website at: http://web.jhu.edu/administration/general_counsel/index.html .

  • NIH-Funded Clinical Trials

    NIH-Funded Human Subjects Research: As of January 1, 2017, NIH-funded investigators and their research staff who are involved in the conduct of clinical trials (both FDA regulated drug or device studies, as well as behavioral interventions), as defined by the NIH, must complete Good Clinical Practice (“GCP”) training.

    This policy is effective and applies to both new applications, and on-going programs.

    The NIH definition of a clinical trial is “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.”

    This definition encompasses trials that do not involve drugs or devices, and investigators should review the NIH definition for more detail.

    JHU investigators and their research staff who may be subject to this NIH requirement should complete the CITI GCP training module in myLearning, or demonstrate compliance through providing a certificate of other acceptable GCP training to ORA and/or the JHM IRB.

  • Responsible Conduct of Research Policy

    This page explores the purpose and scope of the Responsible Conduct of Research Policy, along with policies for the Krieger School of Arts & Sciences, and the Whiting School of Engineering.

    Read Additional Responsible Conduct of Research Policy Information

Related Documents & Resources

  • Data Use Agreements (DUA)

    Where faculty are receiving or sharing human subject data as part of a research collaboration, they will need to ensure that an appropriate Data Use Agreement or other form of research collaboration or confidentiality agreement is in place.

    Faculty-led research: All DUAs should be reviewed and signed by Johns Hopkins University Research Administration (JHURA) or Business and Research Administration Office (BARA).

    Student-led research: DUAs are subject to Johns Hopkins University Research Administration (JHURA) or Business and Research Administration Office (BARA) signature when the research is sponsored through JHU or is intended to be submitted in satisfaction of a JHU degree requirement. Faculty PI mentors of the student’s protocol must also review these agreements as part of their mentor responsibilities, and they must also be reviewed and signed by Johns Hopkins University Research Administration (JHURA) or Business and Research Administration Office (BARA).

  • For Student Researchers

    Undergraduate students conducting research without “on-the-ground” oversight by the PI are only permitted to conduct research that meets one of the exempt categories.

    All students conducting research without “on-the-ground” oversight of the PI are highly encouraged to contact the HIRB as soon as they start seriously considering their research topic. At this point, the HIRB can guide the student on the type of research that will fall into one of the exempt categories and will also guide the student on how to minimize risks to participants.

    IRB applications involving student-initiated international research must be submitted to the HIRB at least eight weeks in advance of the planned start date, although students are highly encouraged to contact the IRB well in advance of the eight-week period. Student-initiated international work submitted less than eight weeks in advance of the proposed start date will likely not be approved by the IRB in time. Students should not make travel arrangements or purchase airline tickets until their IRB protocol is approved.

  • HIRB Glossary

    This is a glossary of IRB-related terminology.

    View the Document
  • HIRB Standard Operating Policies & Procedures

    The Homewood Institutional Review Board (HIRB) Standard Operating Policies & Procedures manual contains guidelines for the operation of HIRB. HIRB is the central component of the Human Research Protection Program (HRPP) for those divisions within Johns Hopkins served by HIRB. The manual is an important resource for HIRB and HRPP members, investigators, and HIRB staff.

    Please note that the Policies and Procedures manual is currently under revision, but a previous version is below.

    View the Document
  • Instructions for HIRB Training Through CITI

    All faculty, staff, and students who conduct human subjects research must complete the CITI training. In addition, Homewood IRB members must also complete CITI Training. Please read the instructions so you take the correct CITI training.

    View the Document
  • Policy on Recruitment of Employees

    If you plan to include Johns Hopkins employees in your human subjects research, please refer to this policy.

    View the Document
  • Policy on Recruitment of Students

    If you plan to include Johns Hopkins University students in your human subjects research, please refer to this policy.

    View the Document
  • Research Review Agreements

    As part of the responsibility for safeguarding the rights and welfare of human participants, the Homewood IRB has the option of participating in cooperative research projects by entering into joint review arrangements, relying upon the review of another qualified IRB, or making similar arrangements for avoiding duplication of effort.

    Under these agreements applications for the conduct of human subject research shall be assigned to an IRB for review. Procedures for assignment are governed by written review agreements, contractual terms, or internal guidelines issued by the IO.

    Homewood IRB agreement(s) include:

    Johns Hopkins Medicine IRB

    Effective March 1, 2006 JHM and the JHU Homewood IRB entered into a cooperative amendment to their respective Federal Wide Assurances. This amendment outlines the IRB review responsibilities that will govern projects conducted on both the JHU campus and at JHM sites.

    View the Document