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V. CATEGORIES OF INITIAL REVIEW

5.1 GENERAL Review Requirements for Submission

Each Principal Investigator planning to conduct human research must submit to the IRB, a "Request for Project Review" form identifying the type of review sought and including the materials specified for that type of review (outlined in following sections). The IRB coordinator will provide guidance concerning the type of review or classification of a study as "human research." The IRB coordinator will consult with the IRB Chair, IRB Co-Chairs, Sinai Health System Research Institute's Chair, and/or the legal department to determine if a study is classified as a human research study. If a study is not considered "human research," a response will be issued to the Principal Investigator in writing documenting the inquiry process and recommended action. If the study is considered "human research," the IRB coordinator will provide the type of forms needed for the review. A review date will be issued to the Principal Investigator after the required forms are completed.

5.2 Primary Review

The IRB Chair may appoint a primary reviewer for a research project. The primary reviewer must not have a conflict of interest relating to the proposed research may serve as a primary reviewer. The primary reviewer will determine whether or not the protocol qualifies for Expedited Review or requires Full Review. The primary reviewer may contact the Principal Investigator for questions concerning the study during the course of the review. The IRB coordinator will facilitate the primary review process by coordinating communication, documenting the review process and providing all relevant forms.

5.3 Exempt Review

Research protocols in which the involvement of human subjects will be in one or more of the following categories may be EXEMPT from review by the IRB, unless the research is covered by other statutes and/or regulations requiring review. Only the IRB may deem a research project to be exempt from IRB review.

5.3.1. Categories of Exempt Review

Under federal regulations, research may be deemed exempt from review when the only involvement of human subjects in the research falls into one of the following categories:

(a) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

(b) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

(c) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not otherwise exempt if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

(d) 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.

(e) Research and demonstration projects which are conducted by or subject to the approval of the appropriate federal official and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

(f) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Certain research which is eligible for exemption for adult subjects is not eligible for exemption when children are involved.

5.3.2. Submission Procedure for Research Exempt from Board Review

A Principal Investigator requesting an exemption from review by the IRB for a research protocol must complete "Request for Project Review" application and the research protocol including any subject recruitment materials, data collection or survey tools and/or questionnaires, and a budget for the conduct, follow-up and analysis for the proposed study to the IRB Coordinator.

5.3.3. Notification of Exempt Review\

Currently, the request is reviewed by the IRB Chair; however, the IRB Chair may decide to forward the request to an experienced member of the IRB for review. If the Chair and/or reviewer classifies proposal as "exempt", the Principal Investigator is notified in writing, noting the specific category of research justifying the exemption. The Principal Investigator is notified of the determination and given specific instructions that he/she may not deviate from the protocol without IRB review. Research which is not exempt may be submitted under the expedited review procedures (provided it meets requirements.)

5.4 REVIEW USING EXPEDITED REVIEW PROCEDURES

Under federal rules, certain research proposals may not require review by the full, convened IRB and may be reviewed by the Chair, Co-Chair or by a designated IRB member through the expedited review process. The results can be reported at the next convened IRB meeting.

 

5.4.1 Federal Approved Categories for Expedited Review

IRB is authorized to conduct expedited review when minor change are proposed for a previously approved research protocol during the period of (one year or less) for which approval is authorized or when the proposed research involves no more than minimal risk and which the only involvement of human subjects will be in one or more categories described in the following section:

(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 (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. (Need to decide if IRB will require regular full review for all FDA research studies)

• Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: i) from healthy, non-pregnant adults 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 (ii) 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.
• Prospective collection of biological specimens for research purposes by noninvasive means. Examples include: (i) hair and nail clippings in a nondisfiguring manner; (ii) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (iii) permanent teeth if routine patient care indicates a need for extraction; (iv) excreta and external secretions (including sweat); (v) 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; (vi) placenta removed at delivery; (vii) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (viii) supra- and 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; (ix) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (x) sputum collected after saline mist nebulization.
• 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.) Examples include: (i) 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 subject's privacy; (ii) weighing or testing sensory acuity; (iii) magnetic resonance imaging; (iv) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (v) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
• 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.)
• 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. (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.)

In addition, under the following limited circumstances, expedited review may be appropriated for continuing review for a study previously approved by the IRB where:

• Projects in which (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
• Projects in which no subjects have been enrolled and no additional risks have been identified; or
• Projects in which the remaining research activities are limited to data analysis.
• Projects in which continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. (pulled from regulation --- IRB to determine policy on this area) The expedited review process 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 subject's 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 process may not be used for classified research involving human subject

5.4.2. Procedure for Expedited Review

The Principal Investigator should indicate on the "Request for Project Review" application the specific category under which the investigator believes the research is eligible for expedited review. The Chair or designee reviews the Principal Investigator's request and determines whether the expedited review process is appropriate. If the research clearly qualifies for expedited review, the reviewer conducts the expedited review and documents the determination of minimal risk and specific permissible category of research justifying the expedited review. If the research does not clearly qualify, the reviewer refers the application for a full IRB review. The Principal Investigator is notified in writing of the decision. The final decisions are reported at the next convened meeting of the IRB and included in the minutes.

5.5 FULL REVIEW

The IRB shall conduct a full review of all research involving more than minimal risk to human subjects. Specifically, this shall include all research not described in the categories of exempt or expedited review and studies involving the use of investigational new drugs or investigational devices. Full review also applies to protocol amendments that increase the risk to human subjects or where serious adverse events have been reported in connection with the protocol.

5.5.1. Procedure for Full Review

To apply for full review, a Principal Investigator must submit

1. Completed Project Review Form
2. A copy of his/her research protocol with a review of relevant literature, complete methodology, references and measures (if applicable.)
3. Curriculum vitae, experience/and or documentation confirming professional qualifications for conducting the proposed research study
4. Completed budget for short-term and long-term research initiatives
5. Subject recruitment materials with the criteria for selection and exclusion of subjects
6. Justification for the use of vulnerable categories of subjects (if applicable)
7. Appropriate informed consent forms and patient education materials
8. Professional qualifications for the Principal Investigator to conduct the research including signature from department Chair
9. Signatures from appropriate Departmental Chair (s) of cooperating Department if project requires multiple departments (Included in Review Form)
10. Evidence that the individual proposing to conduct research is a Principal Investigator or authorized co investigator
11. Completion of the NIH web-based training for researchers and SHS' web-based HIPAA training
12. Provisions for managing adverse reactions
13. Descriptor of necessary support services and facilities
14. Completed budged for the conduct, follow-up and analysis for the proposed study.
15. Sinai Health System Research Institute Application

5.5.2. Presence of the Principal Investigator at the Meeting

The Principal Investigator or a designated representative familiar with the research is expected to attend the meeting at which the protocol will be reviewed. He/She will be required to answer questions, and provide additional information upon request. In the event the Principal Investigator or his/her representative is unable to attend the meeting, the Principal Investigator may apply to the Chair of the IRB to participate by means of a teleconference call. The decision is allowed or disallowed at the Chair's discretion. The Board may elect to review and approve the protocol in the absence of the Principal Investigator or his/her representative or the IRB may defer action upon the review in the event the IRB requires additional information from the Principal Investigator (45 CFR 46.109; 21 CFR 56.109)

5.5.3. Request for Additional Information

The IRB may, at any time, during its review of a project, request additional information regarding the project from the investigator(s). Such requests shall be requested in writing within 5 days of the oral request.

5.5.4. Notice of Decision

The IRB shall notify the Principal Investigator in writing within five (5) working days of its decision. If the IRB disapproves the project, it shall include in is written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. If the investigator does not respond or make his or her intention to respond known to the IRB, the decision will become final.