CHS News - 9 December 2011

NEW! REVISED POLICIES AND FORMS Policies: CHS Policies and Procedures have been revised to include changes to requirements associated with initial submission, amendment and renewal, and students joining existing projects. Forms: A new supplemental form, called the Data Security Plan form is in place to assist Invesigators in developing a data security plan. The following additional CHS Forms have been updated to incorporate policy changes: Amendment Form CHS Initial Application Continuation Form Determination Form Exemption Determination Form File Closure Form Forms D and C HIPAA Waiver of Authorization Personnel Roster

OHRP National Research Community Forum in Boston

On June 21, 2011 OHRP will host:

"Protection of Human Subjects Research:
Blending Regulatory Requirements and Best Practices"

At the Joseph B. Martin Conference Center, Harvard Medical School. Please visit the Forum homepage for registration information.

 

AARHPP Poster Presentation

CHS Staff were invited to the 2011 AAHRPP Conference to present our noteworthy process of pre-review.

 

REVISED POLICIES, REPORT ON ACTION, AND FORMS

Policies: CHS Policies and Procedures have been revised to include new information about where to find Investigator Responsibilites.

Report on Action and Responsibilities of the Investigator: The format of the CHS Report on Action has been revised to include a link to the Responsibilities of the Investigator. This information was previously included as the last page of the Report on Action.

Forms: Selected CHS Forms have been updated to include confirmation that the Principal Investigator has read the Responsibilities.

 

Revised Policies and Forms

Policies: CHS Policies and Procedures have been revised to include new requirements regarding study data security, document translation, human subjects payment, and renewal and closure.

Forms: All CHS Forms have been updated to include the revised policies, and are presented in an new format for easy completion.

New Form G is available to provide information regarding the inclusion of minors in a research study.

 

AAHRPP Re-Accrediation

On 17 September 2010, the Harvard University Faculty of Medicine received notice of re-accreditation of its Human Research Protection Program (HRPP) which encompasses the Committee on Human Studies (CHS, aka the IRB) as well as all members of the human research community including investigators, sponsored programs and the departments and administration within the Institution that support such research.

Please see the AAHRPP website for additional information.

 

CITI Training Now Available

The Harvard University IRBs (Faculty of Medicine, School of Public Health, and the Harvard University Cambridge/Allston Area)  are switching their online training requirement from HETHR to the Collaborative Institutional Training Initiative, also known as CITI.

CITI is hosted by the University of Miami and is used by the majority of the Harvard-affiliated institutions and other major institutions in the US and abroad. CITI is a more comprehensive training than HETHR, offers a helpdesk dedicated to assisting in the learning experience of its users, and is available in several languages in addition to English.

Individuals with training on-file with the CHS Office will not be required to take CITI until their existing training is due to expire (3 years from the last training completion), however the CITI training may be taken at any time, regardless of training expiry date.

Please visit our Required Training page for more information about human subjects training requirements.

 

New Regulatory Binder Tool, and Follow us on Twitter!

New Regulatory Binder Tool: The Regulatory Binder Tool is available to help study sites achieve and maintain regulatory compliance and adhere to high standards of practice in the conduct of research involving human subjects. Please see the Active-Study Record Management page for details.

Follow us on Twitter! For the most up-to-date information about forms and guidelines, you can now follow us on Twitter

If you'd like to keep up with our Twitter updates without logging in, try subscribing to Twitter via rss feed. You can subscribe to our updates in a feed reader. Find an rss feed for a Twitter page in:

• the sidebar of our profile page, under the 'Following' pictures; or
• by clicking the rss icon in the address bar at the top of the browser (look for the rss icon at the end of the browser's URL field: you can click the blue icon in Safari, or the orange one or RSS button in Firefox.)

 

 

Updated: 09-Dec-2011