15.3 Request for IRB Review - 3 Levels

Request for IRB Review

There are three levels of IBR Reviews:

• Exempt Review: Research that which involves little to no risk to participant(s) (Limited Exempt)
• Expedited Review:  Research which involves only “minimal risk” to participant(s)
• Full Review: Research which involves risks greater than “minimal” to the participant(s)

Level 1.  Exempt Research

• Exempt studies must be submitted to the IRB for review and granted exemption status by the IRB chair before data collection begins.
• Exemption refers to relief from the requirement of continuing IRB oversight but not from the requirement that the investigator inform potential subject of proposed procedures and their rights as subjects in accordance with the standards established in that investigators’ discipline. Limited Exempt Review may be determined leading to a more focused review by the IRB to ensure privacy safeguards and data confidentiality are adequate. The conditions for exemption are:

Part A (ALL items must apply for exempt status)

1. The research does not involve prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults as participants.
2. The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the individual’s financial standing, employability or reputation.
3. The research does not involve the collection of information regarding sensitive topics or personal aspects of the subject's behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
4. The research does not involve subjects under the age of 18 (except as they are participating in projects that fall under categories 1,3,4 and/or 5 in Part B).
5. The research does not involve deception.
6. The research does not require a waiver from informed consent procedures.
7. The procedures of the research are generally free of foreseeable risk to the participant. Risk can be mental, physical, psychological or social. In Minimal risk, harm or discomfort anticipated in the proposed research is no greater than an individual would normally encounter in his/her everyday life or during the performance of routine physical or psychological examinations or tests.

Part B (at least one (1) must apply for exempt status)

1. Educational research in an educational setting using normal educational practices (e.g., research on regular and special education instructional strategies, research on instructional techniques, curricula or classroom management methods)
2. Research using survey procedures, interview procedures, observing public behavior or using educational tests where the information is recorded anonymously (i.e. so that the subject cannot be identified directly or indirectly through identifiers linked to the subject). All survey/interview/observational research in which elected or appointed public officials or candidates for public office serve as participants is exempt, whether or not data collection is anonymous.
3. Research involving collection or study of existing data, documents, records or diagnostic specimens. These sources must be publicly available or the information must recorded by the investigator anonymously (in such a manner that the participants cannot be identified, directly or through identifiers linked to the participant).
4. Research (and demonstration projects) conducted by or subject to the approval of department or agency heads and designed to study evaluate or otherwise examine a) public benefit or service programs, b) procedures for obtaining benefits or services under those programs, c) possible changes in or alternatives to those programs or procedures, or d) possible changes in methods or levels of services under those programs.
5. Research involving taste and food quality evaluations or consumer acceptance studies, if wholesome foods without additives are consumed or foods which contains additives at or below that level and for a use found to be safe by the FDA, or approved by the EPA or the food safety and inspection service of the U.S. Department of Agriculture.

Level 2.  Expedited Review

• Expedited proposals are reviewed by the Chair or by one or more designated experienced reviewer from the committee.  Research submitted for Exempt Review may be bumped to Expedited by the review(s) if they determine participant risk level to be minimal.

Part A (ALL items must apply for exempt status)

1. The research does not involve prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults as participants.
2. The research does not involve the collection or recording of behavior that, if known outside the research, could reasonably place the participants at risk of criminal or civil liability or be damaging to the individual’s financial standing employability or reputation.
3. The research does not involve the collection of information regarding sensitive or personal aspects of the subject's behavior (i.e. drug or alcohol use, illegal conduct, sexual behavior).
4. The procedures of the research present no more than minimal risk to the participant. Risk can be mental, physical, psychological or social. In minimal risk, harm or discomfort anticipated in the proposed research is no greater than an individual would normally encounter in his/her everyday life or during the performance of routine physical or psychological examinations or tests.

Part B (at least one (1) must apply for exempt status)

1. Research that involves existing non-public identifiable data, documents, records or specimens that have been collected or will be collected in their entirety prior to the research or for a purpose other than the proposed research (such as medical research or diagnosis). Although confidentiality will be strictly maintained, information will not be recorded anonymously (use will be made of audio or video records, names will be recorded even if not directly associated with the data).
2. Research on individual or group characteristics or behavior (including but not limited to study of perception, cognition, motivation, identity, language, communication, cultural beliefs or practices and social behavior) and/or research employing surveys, interview focus group program evaluation, human factors evaluation or quality assurance methodologies that involve adults where: 1) the research does not involve stress to the participants and identification of the participants and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the participant’s financial standing employability or reputation; 2) involve children where the research involves neither stress to participants nor sensitive information about themselves or their family; no alteration or waiver of regulatory requirements for parental permission has been proposed; and identification of the participants and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the financial standing, employability, or reputation of the participants or their family members.
3. Collection of data from voice, video, digital or image recordings made for research purposes where identification of the participants and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability or reputation.
4. Collection of data through use of the following procedures: 1) noninvasive procedures (not involving general anesthesia) routinely employed in clinical practice, but not involving x-rays or microwaves; 2) physical sensors applied either to the surface of the body or at a distance and that do not involve input of significant amounts of energy into the participant or an invasion of the participant’s privacy; 3) weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, echography, sonography, ultrasound, magnetic resonance imaging, diagnostic infrared imaging, Doppler blood flow and echocardiography; 4) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing involving healthy subjects.
5. Prospective collection by noninvasive means of biological specimens for research purposes (ex. Hair clippings, saliva, buccal scraping); research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required; collection of blood samples by finger stick or venipuncture.
6. Research that involves deception. Deception must be scientifically justified, and  debriefing procedures must be outlined in detail.
7. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures or observation of public behavior where although confidentiality will be strictly maintained, information will not be recorded anonymously (use will be made of audio or video records, names will be recorded even if not directly associated with the data).
8. Research previously approved by the IRB 1) where a) the research is permanently closed to the enrollment of new subjects b) all subjects have completed all research related interventions and c) the research remains active only for long term follow-up of subjects, 2) where the remaining research activities are limited to data analysis or 3) where no new subjects have been enrolled and no additional risks have been identified.

Level 3.  Full Review

• Any research that does not fall into any of the categories explicitly identified as qualifying for exempt or expedited status. Convened meetings are necessary when a proposal goes through full review. In order for action on a proposal, a majority of the members of the IRB must be present, including at least one member whose primary concerns are in non-scientific areas. A proposal must receive the approval of a majority of those members present at the meeting. Meetings may be conducted by conference call or by email, provided that each participating IRB member has received all pertinent material prior to the meeting and can actively and equally participate in the discussion of all protocols.  Conditions for full review are:

Part A (Research must not fall into any of the categories identified as qualifying for exempt or expedited status.)

Part B (If any of the following apply.)

1. Any research involving the use of vulnerable participants (participants who may not be able to make fully informed consent). Vulnerable populations include children under the age of 18 (unless as described previously), prisoners, fetuses, pregnant women, seriously ill, mentally or cognitively compromised adults, persons under treatment for an illness relevant to the project and individuals who may risk retribution by a person with authority over them as a consequence of participation or non-participation in the study. Additional protections as delineated in subparts B (pregnant women and fetuses) and C (prisoners) will be used in studies involving these vulnerable populations.
2. The research involves the collection of information regarding or recording of behavior which if known outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability or reputation
3. The research involves the collection of information regarding sensitive aspects of the subjects’ behavior (e.g. drug or alcohol use, illegal conduct, sexual behavior)