Institutional Review Board (IRB)

The IRB reviews proposals for human subjects research to be conducted by employees or students of Allan Hancock College as well as research projects occurring on the Allan Hancock College campus, off-campus sites, or virtual classrooms. Exempt status criteria is available on this site for your review. 

 To request review by the Institutional Review Board, please provide the following information to the Office of Institutional Effectiveness :

 Letter of Intent

• Identify who will be conducting the research
• Give a brief summary of the planned research including its purpose and intended outcomes
• The letter of intent should be no more than a few paragraphs in length

 Surveys or interview questions

• Provide copies of survey or interview questions to be used in the research

 Protocol or research plan

• Describe in more detail how the research will be conducted (such as the proposed participant populations, size of study, inclusion/exclusion criteria for participation, recruitment/data collection procedures, timelines, etc.)
• Describe any potential risks to participants
• Describe any anticipated benefits to participants
• Describe how confidentiality will be maintained
• Include any other relevant information that would allow independent determination of whether there is a risk to human subjects

 Other committee approvals, if available

Although the category is called "exempt," this type of research does require IRB review and registration. To qualify, research must fall into one of 8 (eight) federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects.

Some examples of Exempt research are:

• Anonymous or identifiable surveys or interviews
• Passive observation of public behavior with or without the collection of identifiers
• Retrospective and prospective medical chart reviews (allowable under specific criteria for UCI Healthcare Workforce)
• Analyses of specimens that are publicly available or if not publicly available, where the identities of the subjects cannot be readily ascertained

Hancock Exempt Protocol Form

To qualify for an expedited review, research must fall into nine (9) federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. Some examples of expedited research are:

• Studies involving collection of hair, saliva or dental plaque samples,
• Studies of blood samples from healthy volunteers
• Analyses of voice recordings
• Studies of existing pathological specimens with patient identifiers

Expedited review as defined by federal regulations allows the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB to evaluate and approve specific types of research. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When a subcommittee cannot approve the research under expedited review, the study is referred to the full Committee for review.

Applicability of Expedited Review

• Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
•  The categories in this list apply regardless of the age of subjects, except as noted. (see list below)
• The expedited review procedure may not be used where identification of the subjects and/or their responses
  would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. The expedited review procedure may not be used for classified research involving human subjects.
• IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review utilized by the IRB (i.e., expedited or full committee review).

Hancock Expedited Review Form

Categories of Research for Expedited Review

  Membership of the IRB

1. The IRB is composed of at least five voting members. Alternates and non-voting members may also be appointed, with alternates authorized to vote at convened meetings only in the absence of the member for whom they are the designated alternate.  Although an alternate may be designated for more than one IRB member, each alternate may represent only one regular member at a convened meeting.  All appointments are reported to the Office of Human Resource Protections (OHRP).
2. The IRB is composed of members with varying backgrounds and expertise in special areas to provide complete and adequate review of the research. Committee members should possess not only broad specific competence sufficient to comprehend the nature of the research, but also other competencies necessary for judgments as to acceptability of the research in terms of Hancock’s regulations, relevant law, ethical standards, and standards of professional practice.  Consultants may be used to review proposals for which additional expertise is needed.
3. The IRB must include both men and women, at least one member whose primary concerns are in science areas, one whose primary concerns are nonscientific areas, and at least one member who is not otherwise affiliated (either directly or through immediate family) with Allan Hancock College.
4. No person shall be excluded from serving on the IRB based on sex, race, color or national origin.