HSC TRAINING REQUIREMENTS

Harvard Ethics Training in Human Research (HETHR)

HETHR is Harvard's new online training program in human subjects protections. HETHR launched January 27, 2006. Please review all instructions and the animated demonstration when using HETHRdev for the first time, and contact Justin Fendo with any questions. Please note: HETHR baseline and refresher certification are valid for two years.

HETHR is made possible in part by a grant from the NIH. It is the product of collaboration among the Office of the Provost and the three Harvard IRBs. The School has also contributed significant support in many ways.

• First-time trainees: Please complete HETHR baseline training: all Basics topics, all Vignettes, and four Electives (see details below).
• For refresher training: Please complete HETHR refresher training: all Basics topics, all Vignettes, and two Electives.
• ALL baseline and refresher trainings are now valid for two years from the date of completion (if taken after July 1, 2005).

Technical problems?  Please consult the HETHR FAQ page. If you have remaining questions that are not answered in the FAQ, please contact the University Information Systems Helpdesk (not the School IT Helpdesk): helpdesk@harvard.edu, or (617) 496-2001.

HSC continues to accept some alternative programs: CITI; HPM 292 Research Ethics, taught at HSPH (see below); the NIH online training, and others on a case-by-case basis.

Who needs training?

• Anyone working directly with human subjects, data, or tissue that he or she can link back to individual subjects, MUST fulfill human subjects training requirements every two years. All Principle Investigators (PIs) and Co-Investigators must complete training regardless of whether or not they have access to identifiable data/tissue or contact with subjects. Please see below for categories of trainees and requirements:

Frequently Asked Questions

When and where are reseach ethics workshops held?

Workshop schedules are posted on the calendar page. Special sessions for classes or groups may be arranged upon request. Please contact Leslie Howes: lmoser@hsph.harvard.edu, or (617) 384-5487.

Does HSC accept completion of other human subjects training?

Yes. HSC grants two years of credit (from date of completion) for the CITI online module required by Partners HealthCare Systems; the NIH online training; or the "Research Ethics" seminar offer by HSC in the Spring if taken for credit (1.25 credits) or audited (see below). Other human subjects trainings are accepted on a case-by-case basis, depending on the rigor of the course, with documentation.

Does HETHR automatically issue certificates of training?

Yes! Certificates for alternative training programs, however, continue to require HSC staff assistance.

Questions?

• For technical problems, please see the HETHR FAQ page, or contact the UIS Helpdesk (not the School's IT Helpdesk): helpdesk@harvard.edu, or (617) 496-2001.

  For questions about certificates or other aspects of the training program, please contact Justin Fendo at (617) 998-1082 or email jfendo@hsph.harvard.edu.

Guidelines for HSPH students doing classroom-based research

Follow these guidelines to ensure that research projects for HSPH classes will not need prior approval from the Human Subjects Committee.

Selected Educational Materials

FAMILY HEALTH INTERNATIONAL RESEARCH ETHICS ONLINE TRAINING:

English Version

Spanish Version

Portuguese Version

French Version

THE BELMONT REPORT
Required reading for all researchers

THE BELMONT REPORT (French Version)

THE BELMONT REPORT (Arabic Version)

CODE OF FEDERAL REGULATIONS:  Categories of Research That May be Reviewed By the Institutional Review Board (IRB) through an Expedited Review 

CODE OF FEDERAL REGULATIONS: Title 45 (Public Welfare), Part 46 (Protection of Human Subjects), Subparts A-D

THE NUREMBERG CODE
Required reading for all researchers

US FOOD AND DRUG ADMINISTRATION -- GUIDANCE FOR INSTITUTIONAL REVIEW BOARDS AND CLINICAL INVESTIGATORS
Web Sites of Interests for Good Clinical Practice and Clinical Trial Information

WORLD MEDICAL ASSOCIATION -- DECLARATION OF HELSINKI
Required reading for all researchers doing international work

"CRITICAL RESEARCH ETHICS ISSUES IN THE ERA OF HIV IN TANZANIA"

Photos and presentation materials for the two workshops on "Critical Research Ethics Issues in the Era of HIV in Tanzania" that HSPH co-directed with Dartmouth University, Duke University, Kilimanjaro Christian Medical Center, and Muhimbili University College of Health Sciences.  Sponsored by the Human Subjects Administration, HSPH, and NIH.

This page is maintained by HUMAN SUBJECTS COMMITTEE. To contact us with suggestions, comments, and questions, please e-mail: hsc@hsph.harvard.edu.

Human Subjects Committee
1552 Tremont Street, Boston, MA 02120
Phone: (617) 384-5480
Fax: (617) 384-5484