IRB Review Process
Review and approval of proposed research activities that involve the use of human subjects is required prior to the start of data collection. Projects which are not reviewed and approved prior to the start of data collection cannot receive "retroactive" approval.
For all projects the department chair (or authorized departmental reviewer) is required to conduct a thorough review and sign the application; a student project also requires the signature of the student's faculty advisor. Regardless of review category, review forms must be submitted to the Office of Research Compliance (301 Lowden Hall) promptly upon completion of the departmental review.
Note- The email statements confirming that the application is complete and accurate and that it is ready for IRB review may be sent in an email in lieu of signatures. A single email chain from PI (and advisor if relevant) to ADR to ORCIS would be best.
Projects that qualify for Administrative Review (Exempt) or Subcommittee Review (Expedited) do not need to wait for a convened IRB meeting although the Board ultimately receives all applications and may review any or all of them. Generally, the approval process takes about a week for Exempt protocols and two to four weeks for Expedited protocols. Bear in mind that the IRB makes the final determination of the review category that a project requires.
Research activities in which the only involvement of human participants will be in one or more of the following categories:
Research in Established or Commonly Accepted Educational Settings
Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.
Educational Tests, Surveys, Interviews, Observations of Public Behavior
Research that includes only interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of 3 criteria are met:
i. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
ii. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; OR
iii. The information obtained is recorded by the investigator in such a manner that the identity of human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited review to make the determination required by 45 CFR 46.111(a)(7) (which relate to there being adequate provisions for protecting privacy and maintaining confidentiality) AND the research is not subject to subpart D.
Benign Behavioral Interventions in Conjunction with the Collection of Information from Adult Subjects
Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
i. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects;
ii. Any disclosure of the subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; OR
iii. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subject, and an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7)
Secondary Research for Which Consent Is Not Required
Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
i. The identifiable private information or identifiable biospecimens are publicly available; OR
ii. The information is recorded by the investigator in such a way that the identity of the subjects cannot readily be ascertained directly or through identifiers linked to the subjects, and the investigator does not contact subjects, and the investigator will not re-identify subjects; OR
iii. The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under HIPAA (i.e., the use is regulated for purposes of “health care operations” or “research” or for “public health activities and purposes” as those terms are defined at 45 CFR part 164) ; ORiv. The research is conducted by or on behalf of a federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with certain federal statutes.
Research and Demonstration Projects Conducted or Supported by a Federal Department or Agency
Applies to research and demonstration projects that are conducted or supported by a federal department or agency, or otherwise subject to the approval of department or agency heads. Applies to activities that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including, but not limited to: procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs.
Each federal dep’t/agency conducting or supporting research & demo projects must establish, on a publicly accessible federal website or in another appropriate manner, a list of the research & demo projects the federal dep’t/agency conducts or supports under this provision. The project must be published on this list before beginning the research involving human subjects. Dep’t/agency heads can determine what sort of information will be included on this list and maintain its oversight. HHS will develop a resource that all Common Rule dep’t & agencies can use to satisfy this requirement.
Taste and Food Quality Evaluation and Consumer Acceptance Studies
This exemption applies if wholesome foods without additives are consumed, or 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 FDA or approved by the EPA or the USDA’s Food Safety and Inspection Service.
Storage or Maintenance for Secondary Research Use for which Broad Consent is Required
Exemption Category 7 applies to storing and maintaining identifiable private information/specimens for secondary research use.
Secondary Research Use of Identifiable Private Information or Identifiable Biospecimens for which Broad Consent is Required
Exemption Category 8 applies to the secondary research use of identifiable private information/specimens for specific secondary research studies.
Exemption Category 8 applies to secondary research studies that involve use of identifiable private information/specimens, provided the following criteria are met:
i. Broad consent for storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with 45 CFR 46.116(a)(1)-(4), (a)(6), and (d);
ii. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with 45 CFR 46.117;
iii. An IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7), and to make the determination that the research to be conducted is within the scope of the broad consent; AND
iv. The investigator does not include returning individual research results to subjects as part of the study plan. However, it is permissible under the exemption to return individual research results when required by law regardless of whether or not such return is described in the study plan.
(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 the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.
(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 protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
- 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.)
- 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.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
- from healthy, nonpregnant 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
- 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.
(a) hair and nail clippings in a non-disfiguring 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 gum base or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) 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; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) 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: (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 subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, 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.
- 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). ( This rule applies if the data is not anonymous).
- 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.
- Continuing review of research previously approved by the convened IRB as follows:
- where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; (iii) the research remains active only for long-term follow-up of subjects; or
- where no subjects have been enrolled and no additional risks have been identified; or
- where the remaining research activities are limited to data analysis.
- 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.
Other projects requiring full IRB review should be submitted to the ORC by the researcher as soon as possible, but no less than ten days before the next scheduled IRB meeting date. IRB meetings are generally held on the second and fourth Wednesdays of the month except during holiday and university break periods.
Please note that copies of all documentation related to a project should be retained in a secure location for at least three years after its conclusion. Also, because a copy of the consent form used in any project must be given to the subjects involved, it is recommended that a line is included in the consent form for the subject to acknowledge receipt of a copy. Sample consent forms are also available on the ORC website.