The type of review each study receives is decided by the IRB based on Federal Regulations. There are three possible decisions:
- Exempt from IRB Oversight
- Expedited Review
- Full Board Review
1. Exempt Proposals
Case studies: The use of a single subject in research activity (n = 1) can constitute research that is subject to IRB review and approval when there is a clear intent before recruiting or interacting with the subject to use systematically collected data that would not ordinarily be collected in the course of daily life in reporting and publishing a case study. As a general rule, when a series of subject observations are compiled in such a way as to allow possible extrapolation or generalization of the results from the reported case, that activity constitutes research that must be reviewed by the IRB. Additionally, this type of activity must always be reviewed by the IRB when there is intent to publish or disseminate the data or findings. Even when a case study is not considered to be research subject to IRB review (because it is not intended to contribute to generalizable knowledge or otherwise does not meet the definition of research), these projects should follow the same guidelines for the protection of people’s privacy, dignity, and welfare as if they required IRB review and approval.
If an investigator believes the proposed research may qualify for an exemption from Federal Regulations and IRB oversight, the investigator should submit a Request for Exemption (Form 5). Attach any necessary documents which clearly define the proposal, and document the qualification for exemption. The IRB will consider such requests promptly. The investigator will be notified in writing within ten working days of the IRB's decision.
IRB options in response to requests for exemption include; agreement with exempt status, request for additional information, or referral for full board or expedited review. The IRB reserves the right to request additional information and, when there is concern, the investigator may be requested to submit such proposals to the board for full or expedited review.
If the IRB determines that the study is exempt from IRB oversight, the investigator will receive a Letter of Determination from the IRB showing that they reviewed the study and made this determination based on the current Federal Regulations.
Below are abbreviated descriptions of the types of research that are exempt from IRB oversight. For the full description, please see the Federal Regulations at 45 CRF 46: 101 b:
1) Research conducted in established or commonly accepted educational settings involving normal educational practices. See regulations for details and exceptions.
2) Research involving the use of education tests, survey procedures, interview procedures, or observation of public behavior. See regulations for details and exceptions.
3) Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph 2 above if: (1) the human subjects are elected or appointed public officials or candidates for public office; (ii) federal statutes require without exception that the confidentiality of the personally identifiable information be maintained throughout the research and thereafter.
4) 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 such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
(Please refer to section on Privacy Rule for clarification of this type of research)
5) Research and demonstration projects which are conducted by or subject to the approval of Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine public benefit or service programs. See regulations for details and exceptions.
6) Taste and food quality evaluation and consumer acceptance studies. See regulations for details and exceptions.
2. Proposals Qualifying for Expedited Review:
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 and 21 CFR 56.110.
A. 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 an expedited review procedure. 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.
B. The categories in this list apply regardless of the age of subjects, except as noted.
C. 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 protection will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal,
D. The expedited review procedure may not be used for classified research involving human subjects.
E. Standard requirements for informed consent (or its waiver) apply regardless of the type of review.
F. Categories of Research that Qualify for Expedited Review:
1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met:
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
(b) Research on medical devices for which (1) an investigational device exception 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
2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) From healthy, non-pregnant females who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
(b) From other adults and children, considering the age, weight and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
3) Prospective collection of biological specimens for research purposes by noninvasive means:
(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) Placenta removed at delivery;
(g) Amniotic fluid at the time of rupture of the membrane prior to or during labor;
(h) Supra- or subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
(i) Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
(j) Sputum collected after saline mist nebulization.
4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications).
(a) Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subjects privacy;
(b) Weighing or testing sensory acuity;
(c) Magnetic resonance imaging;
(d) Electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
(e) Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
5) Research involving materials (data, documents, records or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects [45 CFR 46.101(b)(4)]. This listing refers only to research that is not exempt.). (Please refer to the section on Privacy Rule for clarification of research in this category)
6) Collection of data from voice, video, digital or image recordings made for research purposes.
7) 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. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects [45 CFR 46.101(b)(2) and (b)(3)]. This listing refers only to research that is not exempt.).
Requests for expedited review should be submitted on Form 1 with all attachments as required on Form 1. Within approximately ten days following IRB receipt of the proposal for expedited review, the investigator will be notified of the IRB's decision concerning the proposal. Proposal will be assigned to one of three categories by the IRB:
1) Approved: The proposal is approved and the investigator may begin the study.
2) Approved with provisos: Approval is contingent upon specific modifications or clarifications. The investigator will be notified in writing as to the nature of the required modifications or clarifications. As soon as the investigator responds positively to the contingencies (provisos) and notifies the IRB of same in writing, a final approval letter will be issued to the investigator and the study may begin.
3) Referred for full IRB review: The IRB has a significant concern and has determined that the proposal should be reviewed by the full IRB. The expedited reviewer may not disapprove a protocol, only the full Board may take this action.
Expedited proposals require submission of the original application and one additional copy.
3. Proposals Requiring Full Board Review
A. All research proposals which do not qualify for exempt status or expedited review must undergo full board review. The submission requirements for expedited as well as full board review are the same. Therefore, the advantages of expedited review are that it may be accomplished in less time than full board review and fewer copies are required.
B. Request for full board review should be submitted on Form I with all attachments as noted on the form. Investigators will be notified in writing as to the Board's action within seven days following Institutional Review Board meetings. Proposals will be assigned to one of four categories by the IRB:
1) Approved: The proposal is approved and the investigator may begin the study.
2) Approved with provisos: The proposal is approved contingent upon specific modifications or clarifications. The investigator will be notified in writing as to the nature of the required modifications or clarifications. As soon as the investigator complies in writing with all requirements, final written approval will be issued. The study may not begin until final approval is issued.
3) Deferred: The Board requires a significant amount of additional information and/or has serious concerns. The investigator will be notified in writing of the additional information required and/or the serious concerns. In addition, if appropriate, the IRB Chairman, or a senior member of the Board will discuss the proposal with the investigator.
4) Disapproved: If the proposal is disapproved, the investigator has the right of appeal to the IRB. When necessary, the IRB will seek consultation from nationally recognized experts in the field, other IRB's, or the Office for Human Research Protection (OHRP). Every attempt will be made to resolve the identified problem(s). The IRB, however, retains final authority over whether or not a proposal can be approved.
Full board proposals require submission of the original application and 20 copies.
4. IRB Submission Deadlines
The meeting schedule and submission deadlines are posted on the IRB website. (Requests for exemption and expedited review applications may be submitted at any time).
5. Additional Requirements for Full Board or Expedited Review Proposals:
1. Expedited review applications require one original and one copy of the following: application, protocol, consent, study budget, grant application, subject surveys or diaries, advertising and the study budget.
2. Submission requirements for full board review are listed on page 3 of SOP 03.
Children are defined in the HHS regulations as "persons who have not attained the legal age for consent for treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a)