Source: http://www.webster.edu/irb/policy/categories_of_review.html
Timestamp: 2020-08-06 20:00:58
Document Index: 113035602

Matched Legal Cases: ['§46', '§46', '§46', '§46', '§56', 'art 312', 'art 812', '§46', '§50', '§46', '§50']

Categories of Review | Webster University
Home Institutional Review Board Irb Policy > Categories of Review
There are three categories of IRB reviews: exempt, expedited, and full board review. Only the Chair and the Expeditor may determine the category assigned to individual projects. Exempt review does not imply that the research does not need to be submitted to the IRB. It is exempt from review by the full board review.
Exempt – Does not require review by the full board. The review period can take up to two weeks.
Expedited – Minimal risk to human subjects. The review period can take up to two weeks.
Full Board Review – Proposed research involving human subjects that does not qualify for exempt or expedited review must be reviewed by the IRB at a convened meeting (Full IRB Committee). The review period can take up to four weeks.
For additional information link to the specific categories. Reference to the OHRP regulations are included.
Following submission, the application is reviewed by the IRB Chair/Expediter based on the IRB guidelines. The Chair/Expediter then determines whether the IRB application is complete and appropriate for review. Proposals must be submitted using the most current forms. Incomplete or poorly prepared proposals will be returned unreviewed.
45 CFR §46.104 Although called "exempt," this type of research does require IRB review. The exempt process is much less rigorous than an expedited or full board review. Reviews are completed by the IRB Chair or one reviewer designated by the Chair. To qualify, research must fall into seven (7) federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects because they involve either collection of anonymous or publicly-available data, or conduct of the least potentially-harmful research experiments. Some examples of exempt research are:
The following are the federally defined exempt categories:
research on instructional strategies
This does not include questionnaires distributed in an educational setting which do not relate to the points above.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) if information taken from these sources is recorded in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.
Survey/Interview Procedures
Research involving survey or interview procedures with legally competent non-institutionalized adults, except where either of the following conditions exist:
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 reputation, financial standing or employability or
the research deals with sensitive aspects of the participant's own behavior, such as illegal drug conduct, drug use, sexual behavior, or the use of alcohol.
Surveys and interviews conducted with children do not qualify for exempt status.
Research involving observation (including observation by participants) of public behavior except where any of the following conditions exist:
the observations recorded about the individual, 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 reputation, financial standing, or employability or
the research deals with the observation of the public behavior of children where the investigator participates in the activities being observed.
Research involving the collecting or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded in such a manner that participants cannot be identified, directly or indirectly, through identifiers linked to the participants.
Evaluation of Federal Research and Programs
Research and demonstration projects which are conducted by or subject to the approval of the Department of Health and Human Services, and which are designed to study, evaluate, or otherwise examine:
programs under the Social Security Act or other public benefit or service program,
possible changes in or alternatives to those programs procedures, or
food ingredients are at or below the safe level as designated by the Food and Drug Administration or the Food Safety and Inspection Service.
45 CFR §46.110 An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR §46.110.
Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When a reviewer cannot approve the research under expedited review, the study is referred to the full Committee for 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. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
Categories one (1) through nine (9) pertain to both initial and continuing IRB review.
The following are the federally defined expedited categories:
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (g) sputum collected after saline mist nebulization.
Proposed human subject research which does not fall into either the exempt or expedited review categories must be submitted for full committee review. These studies have been determined to be more than minimal risk. Federal regulation define “minimal risk” as: “The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” This is the most rigorous level of review and, accordingly, is reserved for research projects that present more than minimal risks to subjects.
Categories that require full board review include:
Biomedical protocols (medical research/clinical trials/experimental therapies)
Research with vulnerable populations. Vulnerable populations are those research participants who are likely to be vulnerable to coercion or undue influence or lack decision-making capacity, including children, prisoners, pregnant women, neonates, mentally disabled persons, or economically or educationally disadvantaged persons, and those who may be vulnerable because of a physical condition, severe illness or pain, psychological or emotional condition, status relationship with a member of the research team, cultural or political factors or other circumstances
Projects that involve deception of subjects
Projects that plan to use procedures that are personally intrusive, stressful or potentially traumatic(stress can be physical, psychological, social, financial, or legal)
(a) Federal Regulations regarding "Children" (both 45 CFR §46 and 21 CFR §50) state, "'Children' are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." Thus, who qualifies as a "child" depends on local laws.
(b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. The goal of the assent process is to involve children in discussions and decisions about research participation.
(d) Parent means a child's biological or adoptive parent. Because children cannot legally provide consent for research on their own behalf, permission by at least one parent or legal guardian is required prior to enrollment of a minor in a research study.
For additional information on research with children refer to 45 CFR §46.404 and 21 CFR §50.51