The Committee for the Protection of Human Subjects

The Committee for the Protection of Human Subjects (CPHS) is the Institutional Review Board (IRB) at Dartmouth College - a federally mandated committee with the charge of overseeing institutional research projects involving human participants. The CPHS serves as the IRB for Dartmouth College. 

The mission of the CPHS is to protect the rights and welfare of research participants.

The CPHS relies on the ethical principles identified in the Belmont Report in its review of research projects. These principles are respect for persons, beneficience and and its corollary non-maleficence, and justice.

The CPHS also adheres to applicable federal regulations for human subject protection. These regulations include 45 C.F.R. 46 and, when applicable, 38 C.F.R. 16, and 21 C.F.R. Parts 50 and 56. The CPHS recognizes and applies when appropriate the guidance of the International Committee on Harmonization (ICH), and Good Clinical Practices (GCP) as acknowledged by the Food and Drug Administration.

All submissions to CPHS must be completed via RAPPORT. RAPPORT is a web-based integrated research administration system that will manage submissions and correspondence with CPHS. Access RAPPORT at the link below.

RAPPORT

DARTMOUTH-HITCHCOCK HEALTH (D-HH) IRB transition overview

Dartmouth-Hitchcock Health (D-HH) and Dartmouth College are in the process of transitioning oversight of active human research studies meeting certain criteria from the CPHS to D-HH's newly established IRB.

 

As of July 1, 2019, please refer to these criteria for determining whether a new project should be submitted to the D-HH IRB rather than CPHS:
https://med.dartmouth-hitchcock.org/research/irb-submission.html

 

Please note: Following the transition, Dartmouth College CPHS will continue to maintain an office and committee to review human research studies that will not be transitioning to the D-HH IRB.

 

The D-HH IRB website:
https://med.dartmouth-hitchcock.org/research/hrpp-irb.html

 

Contact Information for the D-HH IRB

IRB@hitchcock.org
(603) 650-1846

https://med.dartmouth-hitchcock.org/research/irb-contact-us.html

 

Request to Rely on the Dartmouth CPHS as the IRB of Record for a multi-site study.

1. Send each potential external site the Request to Rely on Dartmouth CPHS Form to complete. It is important to indicate the research being conducted at each site (e.g. data analysis only, full protocol). The Request to Rely Form is to be completed with each site and their local IRB if needed.

2. Upload the Request to Rely form with the local consent form (if applicable) to CPHS Rapport with the initial study submission or via a modification request.

The CPHS will review the Request to Rely Form and proceed with the IRB Reliance Agreement process. The completed IRB Reliance Agreement or SMART IRB Acknowledgement Form can then be sent to the local site by the research team.

Important notes:
a. If the external site is part of the SMART IRB consortium, the SMART IRB process and reliance form may be followed. The SMART IRB Acknowledgement Form is signed /clicked. This process may (or may not) also include use of the SMART IRB portal.

b. If the external site submits their own IRB Reliance Agreement. Dartmouth will consider utilizing it with a completed 'Request to Rely on Dartmouth CPHS Form" and 'Dartmouth: Responsibility and Communication Plan' attached and referred to in the Reliance Agreement with signature.

c. There may be a fee involved to request the use of the CPHS as the IRB of Record. Please contact the CPHS Office for current pricing.

Announcements:

 

1)  Regulatory Update:

The compliance date for the Revised Common Rule is January 21, 2019. The regulatory changes primarily impact new studies.

The major changes for studies initially reviewed after January 21, 2019 include:

    -Elimination of requirement for annual renewal of studies that are minimal risk, eligible for expedited review and meet certain criteria. Please note that review of study modifications is still required for federally funded studies. Approval letters for new studies will indicate whether the study requires submission of renewal materials for review.

    -New and updated categories of research eligible for Exemption from further review. The CPHS Application for Exemption has now been updated with the categories that will be implemented locally.

    -Some consent forms will need to include an introductory summary and meet additional regulatory requirements for clarity. Our consent form templates have been updated, please download the most recent version from our website or Rapport as you prepare new studies for submission.

Please note that the OHRP single IRB policy will not be effective until January 20, 2020.

As always, please contact us with any questions or concerns.

 

2)  Human subjects protection (HSP) training requires a three (3) year refresher course available on CITI.

3)  Update on NIH Single IRB of Record (sIRB)

4)  Are YOU on the CPHS - ANNOUNCEMENTS Listserv? If not, please email our office and let us know you would like to receive our announcements. Contact us here

5)  RAPPORT is a web-based integrated research administration system that manages submissions and correspondence with CPHS. RAPPORT must be used for all submissions, including initial applications, renewals, revisions, SAEs, protocol deviations, etc.