Institutional Review Board for the Protection of Human Participants

The Institutional Review Board for Protection of Human Participants reviews and approves all human participant research prior to the commencement of research activities. The Board may approve, request modification, or disapprove research projects. Long-term research projects must seek continuing review of the research activities once each year

The IRBPHP must have a minimum of five members with varying backgrounds and provide discipline expertise for proposals coming before the Board. The Associate/Vice President for Academic Affairs appoints the members for staggered three-year terms. If the IRBPHP is reviewing a proposal funded by a federal grant, one member not otherwise affiliated with Dominican University of California will be added to the Board. The five- member Committee includes the Associate/Vice President for Academic Affairs who is the authorized institutional official with responsibility for the oversight of research and IRBPHP functions. IRB members are expected to complete NIH approved training every three years.

If the IRBPHP reviews research that involves a vulnerable category of participants, such as children, prisoners, pregnant women, handicapped or mentally disabled persons, consideration shall be given to the inclusion of an individual who is knowledgeable about and experienced in working with these participants.

An investigator may be a member of the IRBPHP but may not participate in the review of proposals pertaining to research with which they are directly or indirectly involved except to provide information requested by the IRBPHP.

The IRBPHP may invite individuals with competence in special areas to assist in the review of particular research proposals. These individuals do not vote with the IRBPHP.

5.1 IRBPHP Meetings

The IRBPHP meets as needed. Most applications are reviewed electronically. In addition to ongoing review the IRBPHP may meet several times each semester to discuss policies, human participant’s complaints, and to review controversial or sensitive applications. Due to the confidential nature of the items discussed at these meetings they are closed to non-IRBPHP members.

5.2 IRBPHP Functions and Operations

Documentation of IRBPHP activities will be maintained, including copies of all research proposals reviewed, minutes of IRBPHP meetings, records of continuing review activities, copies of all correspondence between the IRBPHP and investigators, and statements of significant new findings provided to participants.

Minutes of the meetings must include attendance at each meeting, actions taken, votes on actions taken (including the number of members voting for, against, and abstaining), changes required for approval, reasons for disapproval, and written summaries of controversial issues and their resolution.

Records will be maintained for three years after completion of the research. The date of graduation will be considered completion date for students.

Except for exempt and expedited review (see below), review of proposals requires a majority of members of the IRBPHP present, including one member whose primary concern is nonscientific areas. In order for the research to be approved, it must receive approval of a majority of the members present.

5.3 Categories of Review

The three categories of review are exempt, expedited and full board review.

5.3.1 Exempt and Nonexempt Research

Certain research is considered exempt from IRBPHP review. The word “exempt” may be misleading. It does not imply that the activity is not reviewed, only that the activity is not participant to further full Board review if exemption is granted. Applications for exempt status are reviewed by the Chair of the IRBPHP or a person from the Board appointed by the Chair.

Exemptions do not apply to research using vulnerable populations as participants.

The exemptions are found in the Code of Federal Regulation and for ease of access, excerpted below.

Research activities in which involvement of human participants falls into the following categories are exempt:

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless the information identifies the participants and disclosure could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation. Subpart D amends this exemption, in part: If the participants are children, research involving interview, survey procedures or observations of public behavior (in which the researcher(s) participate in the activities being observed) are not exempt. However, research involving the use of educational tests and research involving observations of public behavior in which the researcher(s) do not participate in the activities being observed are exempt.
Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in a manner that participants cannot be identified, directly or through identifiers linked to participants.
Research involving survey or interview procedures, except where responses are recorded in such a manner than the human participants can be identified, directly or through identifiers linked to the participants, and either:
1. The participant’s responses, if they become known outside the research, could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant’s financial standing or employability, or
2. The research deals with sensitive aspects of the participant’s own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.
Research involving the observation (including the observation by participants) of public behavior, except where observations are recorded in such a manner that the human participants can be identified, directly or through identifiers linked to the participants, and either:
1. The participant’s responses, if they become known outside the research, could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant’s financial standing or employability, or
2. The research deals with sensitive aspects of the participant’s own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.
Research involving elected or appointed officials or candidates for public office.

Additional exempt categories are described in the Code of Federal Regulation http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html . These categories include: use of educational tests where research is designed to study public benefits or service programs; and taste and food quality evaluation and consumer acceptance studies. If research involves these areas please review federal regulations to determine exempt/nonexempt status.

The research listed above poses little or no risk of physical or mental harm to human participants. Risk is for the IRBPHP to decide. Therefore, THE RESEARCHER MUST SUBMIT DOCUMENTATION TO VERIFY THAT THE PROJECT IS INDEED EXEMPT FROM REVIEW USING THE SAME PROCEDURE AS FOR RESEARCH THAT IS NOT EXEMPT.

5.3.2 Expedited Review Procedures

The IRBPHP may use an expedited review when it is determined that the research involves no more than minimal risk and it falls into one of nine research categories which may be reviewed at the Web address below. The two categories that principally relate to the majority of research conducted at Dominican are:

Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

Expedited review may also occur when minor changes in previously approved research is requested during the one-year period for which approval had been granted.

It is expected that expedited review will be prompt. Review is expedited not because there is a different application or procedure involved since the Common Rule specifies “the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review” but because fewer people are reviewing the documents. The chairperson or board member of the IRBPHP, carries out an expedited review. A single expedited reviewer may not disapprove of the research. A research activity can only be disapproved after review by the entire IRBPHP in accordance with non-expedited procedures. For additional information regarding research categories (especially medical research categories) authorized for expedited review see 45CFR 46.110 and 21CFR 56.110 at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.110

5.3.3 Full Board Review Criteria

If research involves more than “minimal risk” to participants the project will require a full board review. Full board review is required for any of the following:

Minor participants (children 17 years of age or younger)
Special populations (prisoners, pregnant women, individuals with disabilities, specific ethnic groups)
Use of video-or audiotape to record participants
Asking questions that may be embarrassing or compromising such as questions regarding sexual behavior, sexual orientation, alcohol consumption, illegal drug use, medical conditions, violation of the law, personal finances, problems in the workplace, etc.
Exposing participants to graphically violent or pornographic materials
Inflicting physical pain upon, attaching electrodes to, or injecting any substance into participants
Creating high levels of stress, fear, discomfort, or tension
Threatening participants in any way
Causing participants to violate laws or official university regulations
Providing some participants with benefits denied to others (this includes payments or rewards for participation, e.g., offering extra credit to participants, etc.)
Causing physical or mental exhaustion or engaging participants in intense exercise
Placing individuals in confining physical settings or attaching other devices
Exposing participants to extreme conditions (e.g., bright lights, loud noise, intense pressure, strong odors, complete darkness, extreme heat or cold, sudden movements, etc.)
Leaving participants alone for periods of longer than 20 minutes
Taking hair samples or nail clippings for participants
Taking human tissue samples, drawing blood, or sampling any other bodily fluid

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