The Committee for the Protection of Human Subjects (CPHS) reviews research for compliance with applicable institutional, local, state, and federal regulations protecting human subjects involved in research. Compliance with international guidelines is deferred to OHRP's International Program at: https://www.hhs.gov/ohrp/international/index.html.
Other laws, policies, regulations and "standards of professional conduct and practice" pertaining to the research and/or subjects (e.g.: Family Educational Rights and Privacy Act - FERPA) , are authorized subsequent to CPHS approval. Individuals who authorize these activities typically require CPHS review and determination first.
The CPHS determines whether the proposed research exceeds Minimal Risk as defined in §46.102 in consideration to the procedures proposed and subject population to be involved in the research.
§46.111 Criteria for IRB approval of research.
(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:
(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
There are three different levels of Human Subjects Research review determination: Exempt, Expedited, and Full Board or Convened Meeting Review. The appropriate review procedure is determined by federal regulations §46.104 Exempt research and Expedited Review Categories. If the research doesn't meet any categories of Exempt or Expedited research, then it is automatically reviewed by the Full Board (the CPHS at a convened meeting).
One CPHS member reviews research that is Exempt determining one of the following categories:
Two CPHS members review research that is Expedited determining one of the following categories:
Research which is neither Exempt nor Expedited (e.g.: involves more than minimal risk) must be reviewed by the Full Board (CPHS convened meeting). Research protocols reviewed during the convened monthly meeting must be accessible to the CPHS members approximately 20 days in advance of the meeting. Protocols submitted for convened committee review must be received on or before the posted deadline date, which is usually two weeks before the scheduled convened committee meeting. A primary reviewer is identified to present a specific protocol to other members in attendance. Following presentation and discussion, the committee will vote on a motion to either: 1) approve the protocol as it stands; 2) request revisions to the protocol to secure approval; 3) request that additional information be provided prior to further review by the convened committee; or 4) disapprove the protocol.
Per §46.109 IRB review of research the CPHS has the authority to approve, require modifications (to secure approval), or disapprove all research activities involving humans as subjects.
During a protocol review, the CPHS may identify changes that must occur or clarification that is needed prior to approving the protocol. The researcher is notified electronically of the revisions needed for approval to occur. Similarly, if a determination for approval cannot be made due to pertinent information missing from the protocol, the researcher is notified electronically of the content needed for approval to occur.
In either case, research may not commence until the revision has been accepted by a CPHS representative (staff or member). The researcher is provided with a 30-day time period within which the conditions must be addressed. The researcher returns to the protocol under development to document and satisfy conditions.
The CPHS may require as a Condition of Approval that the researcher:
The CPHS may designate any staff or member individual(s) with appropriate expertise or qualifications to review responsive materials from the researcher and determine that the conditions have been satisfied.
The researcher receives electronic notification from the CPHS specifying the terms and conditions of approval. The researcher is provided with a time-period within which the conditions must be addressed commensurate with the protocol. The researcher submits an amendment (i.e.: modification request) to document and satisfy conditions.
The researcher receives electronic notification from the CPHS stating the approval date and terms of approval. Research activities, including subject selection and consent procedures may commence after receiving a CPHS approval notification.
Approval in Principle may be appropriate if the research meets §46.118 Applications and proposals lacking definite plans for involvement of human subjects). This process allows for the researcher to disclose plans to conduct research and to demonstrate understanding that human involvement in the research cannot occur until CPHS approval is secured. This occurs when the research plan has not been completely developed or material development will occur prior to any involvement with subjects.
Certain types of applications for grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by the CPHS before an award may be made. No human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the CPHS, as provided in this policy, and certification submitted, by the institution, to the Department or Agency.
The researcher receives electronic notification from the CPHS specifying the terms and conditions of approval. The researcher is provided with a time-period within which the conditions must be addressed commensurate with the protocol. The researcher submits an amendment (i.e.: modification request) to document and satisfy conditions.
Although any CPHS member-reviewer may disapprove research, typically it is read by the Full Board before a disapproval determination is issued. If the research is disapproved, the researcher may not conduct the research. The CPHS will provide the researcher with the reason for its decision. The researcher may resubmit a protocol to the CPHS for review if the reasons given for disapproval can be corrected and addressed.
For research meeting Exempt or Expedited determinations, the review process typically takes three to four weeks. If the research requires review by the Full Board, the protocol will be scheduled for the next monthly meeting date and the researcher will be notified of the determination within one week following the convened meeting.
Researchers who are certain their protocol will require review by the Full Board should submit no later than 20 days prior to the scheduled monthly board meeting date in order for pre-review to take place. At least one CPHS member will review it in advance of the convened meeting to verify it actually requires Full Board review.
Meeting dates can be obtained by contacting CPHS@csumb.edu or (831)582-5130. Deadline dates pertain only to protocols that require review by the convened committee. Exempt and Expedited reviews are conducted continuously in the order received.
The CPHS is not required to review protocols in conjunction with external funding proposals or awards. That said, it is the researcher's responsibility to disclose all laws, policies, regulations, and "standards of professional conduct and practice" applicable to the research so that CPHS is cognizant of additional compliance requirements at the time of review.
If the research lacks definite plans for involvement of human subjects, an Approval in Principle may be appropriate (45 CFR 46.118). This process allows for the researcher to disclose plans to conduct research and to demonstrate understanding that human involvement in the research cannot occur until the CPHS approval is secured. This occurs when the research plan has not been completely developed or material development will occur prior to any involvement with subjects.
45 CFR 46.118: Certain types of applications for grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by the CPHS before an award may be made. No human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the CPHS, as provided in this policy, and certification submitted, by the institution, to the Department or Agency.
Exempt protocols may be approved with up to no end date. Expedited protocols are valid for a time period specified on the approval notification. Full Board or Convened Meeting protocols are valid for up to one year from the date of approval (45 CFR 46.109) at which point the researcher may request an extension via the Continuing Review periodic report form. The length and terms of approval is determined by the CPHS based on project complexity, degree or type of risk associated with participation, and the researcher's history of compliance with ethical practices.
If the researcher is not satisfied with the decision of the CPHS, or with the process by which a decision is rendered, an appeal process may be enacted. To initiate the appeal of a CPHS decision, the researcher must submit a statement to the CPHS noting areas of contention. If the issue is not resolved through the CPHS, the appeal will be forwarded to the Provost for review.
Communications between the CPHS reviewer(s) and the researcher will occur within Kuali Protocols. Official correspondence regarding the protocol status (submission and determination) are processed through Kuali Protocols and a copy is sent to the researcher via email. Once the researcher has received notification that the protocol is Approved (as is), research may begin. If the approval is Conditional or In Principle, the correspondence will detail the items that require a response prior to research commencing.