Materials submitted for full committee review are new studies, all continuing reviews, revision requests that exceed minor changes, SAEs, previously reviewed expedited materials, and any other matters about which the chairperson believes requires consideration by the full committee.  The administrator shall review all submitted materials to assure that they are in compliance with the applicable portions of He-M 206.00.  If materials are not complete, the administrator will contact the PI to request the missing materials.

Submission Deadline:  Second Thursday of each month.
Items received after this deadline may or may not be included in that month's review, depending on the lateness of their receipt.

Submission Requirements:

1. Copy of the summary protocol in the NH CPHS format.
2. A copy of any grant application or protocol for the same study submitted to the U. S. Department of Health and Human Services or FDA, if applicable.
3. Completed and signed Human Subjects Review Form.
4. Copy of any applicable investigator's brochures.
5. Copy of the consent form; in NH CPHS format.
6. Letters of support from all sites under jurisdiction of the NH CPHS.
7. Copies of written materials used in the study and to which subjects might be exposed, such as assessment tools that are not standard, scripts, treatment manuals that are not standard, advertisements; or handouts.
8. Data Safety & Monitoring Board Plan (new submission)/Summary (renewals)

Sample Forms & Documents
The following pdf forms can be completed online and printed for mailing, but can not be saved. Please use the print option before exiting the form.  

Full Committee Review Submission Checklist (pdf - 2 pages)

Human Subjects Review Form (pdf - 2 pages)

CPHS Study Plan Template (pdf - 11 pages -sample)

CPHS Consent Form Template (pdf - 11 pages-sample)

Continuing Review/Termination Form (pdf - 3 pages)

Revision Request Form (pdf - 1 page)

 

MS Word Available -  If you would like to complete the forms and templates electronically, MS Word versions are available by request.  Please contact nhcphs@mhcgm.org 
or by phone: 603-668-4111 ext 5301 

Frequently Asked Questions

What if the meeting date is not held on its regular fourth Thursday of the month.  Does this change the submission date?  No, the submission deadline for all full committee reviews is always the second Thursday of the month regardless of the date of the meeting.

 

How do I determine if my review is suitable for a Full Committee Review or an Expedited Review? The CPHS office will review all submissions and will determined whether or not a study is suitable for expedited review. 

 

Investigator Educational Requirements?  All investigators, new investigators, and their research staff involved in human subject research must attend education and training sessions on human subjects protections.  These sessions must be documented.  Please see the links provided under "resources" on the OHRP or NIH websites for available on-line tutorials and certificates.  No new study or continuing review will be approved unless there is documentation of training in human subjects protections.

 

Educational Requirements

 

NIH: On-line Tutorial for Research Investigators

NIH: IRB Guidebook, 1993
NIH: NIH Center for Scientific Review (CSR)

NIH: The National Human Genome Research Institute

OHRP: Human Subject Protections (includes Decision Charts)

FDA: IRB Operations and Clinical Investigation Requirements

FDA: Clinical Investigator Resources

FDA: Good Clinical Practice