Institutional Review Board

Researcher Responsibilities

1. To conduct research according to ethical principles, federal regulations, and internal procedures.    
2. To document Human Subjects Protections Educational Training.
3. To comply with all applicable Federal and State laws/regulations impacting protection of human subjects.
4. To ensure all research involving human subjects is submitted and approved by the appropriate IRB.
5. To comply with all IRB policies, procedures, decisions, and conditions or minor required revisions.
6. To ensure participants are informed prior to consent/assent in accordance with Federal Regulations and IRB approval
7. Document consent/assent and ensure that communication continues throughout the study (keep consents for at least 3 years).
8. To protect the rights and welfare of human research participants.
9. To keep Co-investigators and all research staff informed about the nature and goals of the project.
10. To obtain CPHS approval for revisions prior to initiation.
11. To report progress in a continuing review of approved research to the CPHS Office at least once a year.
12. To report to the CPHS any serious injuries or other unanticipated problems involving risks to participants or others.

Investigator Required Record-Keeping

1. Investigators must retain copies of documents approved by CPHS (as required by federal regulations), and communications with CPHS
2. Investigators must implement a system to comply with yearly reporting and maintenance of updated study documents including use of approved documents.  In particular, consent form expiration dates must be monitored and only current consent forms used to document informed consent. 
3. In addition to providing a copy of the signed and dated consent form to each subject, a copy must be placed in the subject's site medical record (if the subject is a patient), and a copy must be retained by the investigator in accordance with federal regulations and/or the sites’ record keeping policies, whichever is longer.
    

Consent

The consent process must provide potential participants with sufficient information to make informed choices about either beginning or continuing participation in research. The process involves a dynamic and continuing exchange of information between the research team and the participant throughout the research experience. The consent form is a tool to assist the researcher.

Meeting Dates and Deadlines

The deadline for the submission of study materials for full committee review is the first Wednesday of each month at noon. Items received after this deadline may or may not be included in that month's review, depending on the lateness of their receipt. 

Full Committee meetings are held the third Wednesday of the month unless otherwise specified. These meetings are open to the public to attend. They are held at 105 Pleasant St. Concord in the Main Building from 12 noon until 2:00 PM.

The meetings scheduled for 2025 are:

• January 15, 2025
• February 19, 2025
• March 19, 2025
• April 16, 2025 - CANCELLED
• May 21, 2025
• June 18, 2025 - CANCELLED
• July 16, 2025
• August 20, 2025
• September 17, 2025
• October 15, 2025
• November 19, 2025
• December 17, 2025

Cancellations

It is important that anyone planning to attend the meeting call the voicemail box (603-668-4111 ext. 4670) the morning of the meeting to verify that the meeting has not been cancelled. Any cancellation of a meeting will be included in the voicemail message. Meetings can be cancelled due to weather, lack of studies to review, insufficient quorum, or other urgent/emergent issues. We will also make notation of cancellations in the below schedule as soon as possible. There may be a delay in posting with last minute cancellations. It is therefore best to check the voicemail box the morning of the meeting.

Guide to the NH IRB Review Procedures and Related Activities

• Full Committee Review
  Materials submitted for full committee review are new studies, all continuing reviews that were initially reviewed by full committee, revision   requests that exceed minor changes, previously administratively reviewed serious adverse events, previously reviewed expedited   materials, and any other matters about which the chairperson believes requires consideration by the full committee. If materials are not   complete, the administrator will contact the PI to request the missing materials.
• Expedited Review
  Research activities that present no more than minimal risk to human subjects may be eligible for review through the expedited review procedure.
• Revision/Addendum Request 
  Federal regulations state that the CPHS must approve any change in protocol prior to the initiation of the change.  This includes any type of change, ranging from a simple administrative change in telephone numbers to a complex change in the design of the protocol. PI's are educated about this requirement by a statement on the letter of approval.  
• Eligibility Exception Request
  Individuals who do not meet study-specific, CPHS-approved eligibility criteria may not be enrolled into the study. An investigator may, however, request CPHS approval for an exception to the eligibility criteria. Absent this approval, the only exception to eligibility criteria is that situation in which the eligibility exception deviation is necessary to eliminate apparent immediate hazards to the human subject. The CPHS would then be notified under these circumstances. 
• Protocol Deviation Report
  Any activity or circumstance that is not specifically described in the study plan. Investigators must report protocol deviations to the CPHS. 
• Serious Adverse Events
  Prompt reporting to the IRB is required when any unanticipated problem involving risks to subjects or others occurs. Investigators must also promptly report to the CPHS any unexpected or serious adverse event.
• Serious Adverse Events
  Prompt reporting to the IRB is required when any unanticipated problem involving risks to subjects or others occurs. Investigators must also promptly report to the CPHS any unexpected or serious adverse event.

This includes study-related events which are previously unknown reactions that are more severe than mild, as well as expected or well-described reactions that are either life-threatening or fatal. Investigators should be aware that drug company sponsors often use more inclusive definitions of adverse events (e.g., any event which leads to hospitalization); these definitions should be used if called for by the sponsor. The investigator is responsible for reporting to other agencies involved if applicable. (i.e.: sponsor to FDA) 

• Continuing Review
  Investigators must report the progress of the research to the CPHS in the manner and frequency prescribed by the CPHS, Ongoing research studies must be submitted by investigators and reviewed by the CPHS at least annually or as directed, or more often if the IRB finds that the degree of risk to subjects warrants more frequent review. This renewal must take place prior to the approval expiration date noted on the approval letter; otherwise, patient accrual must be suspended and, if the research is HHS-sponsored, the Agency must be notified.  Please note that studies requiring full committee review will need to be scheduled on the agenda the month prior to their expiration.  Annual expedited reviews require at least ten business days for review. 

CPHS accepts online submissions only, please click to access and register with the www.irbnet.org. Researchers can access and download forms, submit online, and a variety of other activities.

Any questions, please contact the CPHS at 603-668-4111 ext. 4670.