Human
Investigation Committee
Yale University
School of Medicine
47 College Street,
Suite 204
New Haven, CT
06520-8010 USA

Phone:
(203) 785-4688

Fax:
(203) 785-2847

Guidelines and training requirements

Yale University and the Human Investigation Committee are committed to educating the research community as well as HIC members on regulatory and institutional policies and ethical concerns regarding human subject protection.

The Guidelines For Investigators and Yale University HIC Policies are provided by the HIC to assist researchers in preparing their application for review of research involving human subjects in accordance with federal regulations and University policy. Note that guidance provided in the Guidelines for Investigators is for general informational purposes only. Please refer to the Yale University HIC Policies section of our website to obtain the most updated information. Checklists and document templates are also provided to assist investigators in meeting their regulatory obligations in the most efficient manner.

Investigators and study personnel involved in human subject research are reminded that requisite training sessions must be completed prior to submitting a protocol for approval or reapproval. Please refer to this website to determine whether you have complied with current regulatory and institutional requirements.

Who has to obtain training?

All people identified as study personnel in the application who are involved in the design and/or conduct of research involving human subjects. The definition includes all investigators involved in the design, performance, data acquisition or analysis of the study. The definition also includes any person who may have significant contact with a human subject or identifiable information or data about the subject during the course of the study. These personnel may include student assistants, nurses, technicians, study coordinators and general assistants.

The requirement extends to all funding mechanisms: grants, contracts, fellowships, training grants, etc., as well as to subcontractors on any such awards.

What effect does training have on the protocol?

Protocols and amendments submitted to the Human Investigation Committee for approval or reapproval will not be authorized until all study personnel have provided proof of completion of the human subjects protection training requirement.

How can this training requirement be met?

The training requirement can be met by completing one of the following options:

Complete the Yale web-based training program.
Complete the Protecting Human Research Participants training program.
Provide documentation and certification of completion from some other training provider, i.e., another University's training program.

What documentation is required and when is it to be submitted?

Proof of training completion must be submitted to the HIC office on or before the request for protocol approval, reapproval or submission of an amendment for approval. The proof of completion is entered into a Human Subjects Protection Training database and is accessed and reviewed by the Human Investigation Committee and Grants and Contracts offices. Therefore, study personnel need only provide this information initially. Once the data has been entered it will be reviewed for future protocol and grant activity as well.

Study personnel who opt to take Yale's on-line IRB tutorial will automatically have their name and completion date populated into the Human Subjects Protection Training database.

Study personnel who opt to take another on-line tutorial or who have received training from another institution are required to provide a copy of the completion certificate to the HIC Office. This documentation can be submitted with the application for protocol approval or reapproval or faxed to 785-2847. HIC office personnel will enter their names into the Human Subjects Protection Training database.

Last modified: Thursday, 20-Mar-2008 12:44:05 EDT. (LMc)