This document describes preparation for the European Union (EU) General Data Protection Regulation (GDPR) that standardizes data protection law across all 28 EU countries and imposes strict new rules on controlling and processing of personal information. The law is in effect as of May 25, 2018.

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Please review this Q&A for practical guidance on compliance with GDPR.

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Under the Revised Common Rule, research that includes access and/or use of identifiable “Publicly Available” datasets or biospecimens may be exempt from IRB review. The purpose of this guidance is to help define what constitutes Publicly Available data or biospecimens to establish if a project may qualify for exempt determination under category 4(i).

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In addition to HIRB Standard Operating Policies & Procedures, other resources for HIRB members include:

• Office for Human Research Protections (OHRP) IRB Guidebook
• OHRP Policy Guidance Webpage
• OHRP Home Page
• FDA Guidance for Institutional Review Boards and Clinical Investigators
• Final Revisions to the Common Rule

The HIRB office also maintains a library of books and journals about human participant research and IRBs that is available for the use of all HIRB members.

Review the IRB Guidance: Use of Student Education Records in Research to understand how FERPA and PPRA may apply to the review of school-based or educational research.

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Johns Hopkins maintains data sets for its own institutional and compliance purposes in a number of domains that may be of interest to researchers. These data sets are often subject to laws or policies that are distinct from the Common Rule or HIPAA, or may be information that Johns Hopkins considers  proprietary. In recognition of our role as a research institution, access to these data sets may be permitted for JHU researchers under protocols approved by a JHU Institutional Review Board (“IRB”), and with the additional review and approval of the offices outlined below for the various data categories. Access to these data sets is conditioned on researchers demonstrating appropriate data security practices, removing identifiers to the maximum extent practicable and requiring any collaborators outside of Johns Hopkins to enter into appropriate Data Use Agreements. Compliance with FERPA policies (if applicable), and the JHU Policy on Personally Identifiable Information must be demonstrated by the researcher requesting data access.

Please click here to identify the institutional party responsible for different data types.

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When a human subjects research study produces knowledge or suspicion of reportable child abuse or neglect, JHU policy requires reporting to the local authorities and to the JHU General Counsel’s Office. If the report is about a Baltimore resident or occurs within the Baltimore jurisdiction, the PI should report the incident to Baltimore CPS and to the jurisdiction where the abuse alleged occurred (if different than Baltimore City). The full policy is located here: https://policies.jhu.edu/?event=render&mid=774&pid=32000&fid=policy_32000.pdf&_=0.0785759651667 .

Here are the standard instructions for reporting.

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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 [email protected] 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.

• The Belmont Report
• Declaration of Helsinki
• The Nuremberg Code
• Code of Federal Regulations 45CRF46

eHIRB is a paperless, electronic method to submit, track, and review the scientific, regulatory, and compliance information required for the safe conduct of human subjects research at Homewood. The system provides a platform for the IRB and other research compliance committees to share critical information regarding the submission and review of new applications, amendments, continuing reviews, reportable events, and study closures.

Read Additional Electronic Homewood Institutional Review Board (eHIRB) Information

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Investigators conducting research in foreign countries may find the following resources useful when planning their IRB applications. Please submit applications for international research 12 weeks in advance of planned study implementation.

• Guidance for International Research
• Investigator Checklist for HSR in International Settings

In addition, the following resources may also be helpful:

• World Health Organization Research Ethics for International Research
• OHRP  International Compilation of Human Subject Research Protections

Some research projects that will eventually involve human subjects research include an initial planning phase which will not involve human subjects. This document provides Homewood IRB investigators with guidance, compliant with 45 CFR 690.118, regarding the process for obtaining administrative approval for projects that immediate plans for involvement of human subjects, their data, or their specimens.

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Please see attached for social media research.

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This is a glossary of IRB-related terminology.

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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.

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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.

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A Primer for Students, Faculty Members Acting as the PI of a Student Initiated Project, and Individuals New to Human Participants Research.

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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 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.

The JHU Policy on IRB Authority vests the appropriate authority in each Institutional Official and IRB appointed under this Policy to review and approve (or not approve) any proposed human subjects research conducted by any University faculty, staff or student when acting in their University role.

Click here to read the Policy on IRB Authority.

Please review the attached slidedeck for training information about privacy law basics for research access to identifiable data.

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This document outlines the procedures for paying research participants.

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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 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.