Training

The National Institutes of Health (NIH) requires all researchers, students, and staff involved with human subjects to complete human subjects protection training. To avoid discriminating between externally and internally funded principal investigators, the HSRC asks that all researchers provide evidence of training at the time their protocol is submitted. To facilitate this process, the National Institutes of Health on-line training course may be accessed at: http://phrp.nihtraining.com.

The entire review/exam process takes up to 1 hour but can be taken and saved in 20-minute segments. At the successful end of the exam, the NIH program provides a certificate of completion. A copy of this certificate must accompany each research protocol submitted to the HSRC as evidence that the training requirement has been fulfilled.

Note: The Human Subjects Review Committee does not meet during the summer to review protocols requiring full board review. Projects eligible for exemption or for minimal risk (expedited) review procedures are processed during the summer. If you think your project may require full-board review, please submit your Human Subjects Activity Review form and all materials to the Office of Research and Sponsored Programs by May 15 at the latest to insure processing before the end of Spring Quarter.

Policy/Guidance

Title 45, Part 46

The Belmont Report

Human Subject Policies in Foreign Countries

Forms

There are a variety of ways in which human subjects are used in research involving different levels of risk to the individual. The form you use to request review of your project depends on what type of activity you are proposing.

Human Subjects Activity Review Form

Projects involving more than minimal risk (a greater level of risk than what they would encounter in their day to day lives) and/or where subjects are members of a protected group (children, pregnant women, prisoners, etc.).

Human Subject Research Exemption Form

Minimal risk projects where the research subjects will not be exposed to risks greater than those they would encounter in their day-to-day lives. Interview/survey projects are often exempt when questions are not of a sensitive nature and subjects' identities remain confidential.

Human Subjects Protocol Modification Form

For any modification to an existing approved protocol, including revisions to the approved informed consent document. Modifications must be approved prior to implementation.

Human Subjects Protocol Continuing Review Form

Full committee or expedited sub-committee review of projects involving human subjects will be conducted by the HSRC at least annually, or more frequently if the situation calls for it.

IRB Protocol Review Standards

Used by the committee to review protocols and may be helpful as a guide to write protocols.

Informed Consent

Informed Consent Requirements

Informed Consent Requirements Checklist

Please use this checklist as a guide to developing your consent document.

Sample Templates

The HSRC Committee has created two sample informed consent forms, a standard consent form and another for when the subject is a child and requires parental consent and child assent.

Additional Links

Office of Human Research Protections
Tips on Informed Consent
Institutional Review Board (IRB) Guidebook Online