Definition of "Research"
The CPHS determines if a study meets the federal definition of research: "a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
- To conduct research according to ethical principles, federal regulations, internal procedures and document Human Subjects Protections Educational Training.
- To comply with all applicable Federal and State laws/regulations impacting protection of human subjects.
- To ensure all research involving human subjects is submitted and approved by the appropriate IRB.
- To comply with all IRB policies, procedures, decisions, and conditions or minor required revisions.
- To ensure participants are informed prior to consent/assent in accordance to Federal Regulations and IRB approval
- Document consent/assent and ensure that communication continues throughout the study (keep consents for at least 3 years).
- To protect the rights and welfare of human research participants.
- To keep Co-investigators and all research staff informed about the nature and goals of the project.
- To obtain CPHS approval for revisions prior to initiation.
- To report progress in a continuing review of approved research to the CPHS Office at least once a year.
- To report to the CPHS any serious injuries or other unanticipated problems involving risks to participants or others.
Investigator Required Record-Keeping
- Investigators must retain copies of approved IRB documents, and implement a system to comply with approval expiration dates.
- 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 state & local regulations and/or the sites record keeping policies, whichever is longer.
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.
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, 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.
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, IRB-approved eligibility criteria may not be enrolled into the study. An investigator may, however, request IRB 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 IRB 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 IRB.
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 IRB 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 IRB in the manner and frequency prescribed by the IRB, but no less than once a year. Ongoing research studies must be submitted by investigators and reviewed by the IRB at least annually, 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.
NH 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 NH CPHS at (603) 668-4111 ext. 5216 or at NHCPHS@mhcgm.org
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