JHU Compliance: Human Participants

OBJECTIVE

Johns Hopkins protects the welfare and the rights of all individuals who agree to participate as subjects in research projects conducted by the University. Any research project involving human subjects must first be approved by at least one Institution Review Board depending upon the subject and the division in which the project is conducted.

JHU CONTACTS
JHU POLICIES AND DIVISIONAL REVIEW BOARDS
DOCUMENTS AND RESOURCES
TRAINING AND EDUCATION
PROFESSIONAL ORGANIZATIONS

JHU CONTACTS

University Administration SCOTT L. ZEGER Vice Provost for Research 265 Garland Hall - Homewood Campus 3400 North Charles Street Baltimore, MD 21218 410-516-8770 E-mail: szeger@jhsph.edu
Homewood MICHAEL McCLOSKEY, Ph.D. Chair, IRB Phone: 410-516-5325 Fax: 410-516-8020 michael.mccloskey@jhu.edu	School of Medicine BARBARA L. STARKLAUF, M.A.S., C.I.P. Assistant Dean for Human Subjects Research Compliance 1620 McElderry Street Reed Hall, Suite B-130 Baltimore, MD 21205-1911 Phone: 410-955-3008 FAX: 410-955-4367 jcci@jhmi.edu	Bloomberg School of Public Health TBA Director, Office for Research Subjects Phone: 410-955-3193 Fax: 410-502-0258

JHU POLICIES AND DIVISIONAL REVIEW BOARDS

Johns Hopkins University Policy Governing the Recruitment and Enrollment of Employees in Research Involving Human Subjects (.pdf)

Johns Hopkins University Policy Concerning the Recruitment and Enrollment of Students in Research Involving Human Subjects (.pdf)

Homewood Institutional Review Board (HIRB)
This website provides policies and procedures for the Homewood IRB that serves the following Hopkins divisions:

Krieger School of Arts & Sciences
Whiting School of Engineering
Peabody Institute
School of Professional Studies in Business and Education
Nitze School of Advanced International Studies

Johns Hopkins Medicine Institutional Review Boards (JHM IRB)
This website covers Johns Hopkins medical institutions:

Johns Hopkins School of Medicine
Johns Hopkins School of Nursing
Johns Hopkins Hospital
Johns Hopkins Health Systems
Johns Hopkins Bayview Medical Center
Howard County General Hospital
The Kennedy Krieger Institute
Johns Hopkins Community Physicians

Committee on Human Research at Bloomberg School of Public Health

NOTE: besides policies and procedures for Bloomberg School of Public Health, the website also includes information on the Cooperative Agreement with Medical Institutions and Federal Wide Assurance 00000287.

DOCUMENTS AND RESOURCES

U.S. Department of Health and Human Services
- Code of Federal Regulations, Part 45 Part 46
HHS Fact Sheets
National Institutes of Health
Office for Human Research Protections
- Policy Guidance
- IRB Guidebook
Centers for Disease Control
US Food and Drug Administration
- Guidance for Institutional Review Boards and Clinical Investigators
- Information for Health Professionals
National Science Foundation
- Code of Federal Regulations, Part 45
Notice of Action under the NIH Guidelines for Research Involving Recombinant DNA Molecules

TRAINING AND EDUCATION

JHU Online Courses
- School of Medicine Research Compliance Training Courses
- Bloomberg School of Public Health Online Human Subjects Training Module
Other JHU Resources
- The Johns Hopkins Center for Clinical Trials
Federal Tutorials and Instructional Resources
- Office of Research Integrity - Responsible Conduct of Research
- National Institutes of Health's Tutorial: "Human Participant Protections Education for Research Teams"

PROFESSIONAL ORGANIZATIONS

Council on Governmental Relations (COGR) White Papers and Comments
- General
- Documents restricted to member institutions
Public Responsibility in Medicine and Research (PRIM&R)
Applied Research Ethics National Association (ARENA) - membership arm of PRIM&R
The National Academies - Institute of Medicine
- Committee on Assessing the System for Protecting Human Research Subjects
National Committee for Quality Assurance
National Association of IRB Managers (NAIM)