Investigators

The JHU Homewood Institutional Review Board (HIRB) is charged with assuring that human participant research studies conducted at JHU Homewood, by JHU affiliated individuals, or studies specifically recruiting individuals affiliated with JHU comply with JHU policies and federal regulations designed to protect human participants. This charge extends to social and behavioral research conducted at certain institutions affiliated with JHU or research conducted by personnel of those institutions working elsewhere, specifically the Applied Physics Lab (APL), the Nitze School of Advanced International Studies (SAIS), and Peabody. Medical research should be reviewed by either the JHU School of Medicine IRB or the Bloomberg School of Public Health IRB on the East Baltimore campus.

Please note: 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 investigators and research team members must complete training in the protection of human research participants prior to submission of applications for HIRB approval. The Collaborative Institutional Training Initiative (CITI) offers a training module that can be completed online. Investigators should select the human subjects training that is most applicable to their research project, or, if unsure, should complete the Social/Behavioral Training module or call the HIRB to ask which training is the most appropriate. You do not need to complete the Responsible Conduct of Research Training for IRB purposes. Training is valid for five years. Please read the PDF Document: Instructions for HIRB Training Through CITI.

 

Documents & Resources for Investigators

Related Documents & Resources

  • Educational & Ethical Principles

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

  • 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
  • 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.

  • 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
  • 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
  • SACHRP Guidance on Internet Research

    Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, with Revisions

    Final document, approved at SACHRP meeting March 12-13, 2013

    The purpose of PDF Document: this document is to provide a starting point for the development of FAQs and/or Points to Consider regarding the conduct and review of Internet research.