Determining the level of review for individual research project proposals is generally the responsibility of the investigator in consultation with their faculty advisor or department chair, as appropriate. All investigators are strongly encouraged to take formal training pertaining to the protection of human subjects in research. This includes determination of research review classification.
There are three levels of review, and each level poses different requirements for investigators and reviewers. The review level determination is made on a number of factors, but primarily focuses on the potential risk to research subjects.
Exempt research determinations are issued by the Office of Research Compliance and Integrity (ORCI) and are required in order to maintain compliance with university policy. Researchers may not make this determination independently.
Important notes regarding exemptions:
For further clarification, check out the Decision Chart created by the Office for Human Research Protections, regarding exempt procedures.
The following amendments to exempt studies require a change in approved protocol submission in order to confirm continued exemption eligibility:
Category 1 Research conducted in established or commonly accepted educational settings, involving normal educational practices such as: 1) research on regular and special education instructional strategies or 2) research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.
Category 2 Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior UNLESS: a. The information taken from these sources is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects; and b. 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. (Also see Expedited category 2-7.)1
Category 3 Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior IF the human subjects are elected or appointed public officials or candidates for public office.
Category 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. (Also see Expedited Category 2-5)
Category 5 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: 1) public benefit or service programs; 2) procedures for obtaining benefits or services under those programs; 3) possible changes in or alternatives to those programs or procedures; or 4) possible changes in methods or levels of payment for benefits or services under those programs.
Category 6 Taste and good quality evaluations and consumer acceptance studies, 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 the FDA or approved by the EPA/USDA.
1 Category 2 cannot be used for research involving children, except for use of educational tests (cognitive, diagnostic, aptitude, achievement)or research involving observations of public behavior when the investigator(s) do not participate in the activities being observed. Children are defined in the HHS regulations as "persons who have not yet 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." However, the HRRC has expanded application of this category to seventeen year old regularly enrolled GVSU students when the research is conducted on GVSU campuses (excludes studies receiving federal funding or that are FDA regulated).
Categories 1 through 6 cannot be used for classified research or research involving prisoners.
Categories 1 though 5 cannot be used for research to which FDA regulations and policies apply.
Expedited reviews must fit into 1 of 9 categories and must be minimal risk studies. They are reviewed by HRRC members.
Expedited reviewed studies require documentation of informed consent from participants or legal guardians (including legally authorized representatives), unless a waiver or alteration is approved. Additional information regarding informed consent may be found under Planning Your Research. Additional regulatory and university criteria to protect vulnerable populations is applied to this level of research.
Serious or ongoing noncompliance of expedited studies may result in reports to the federal Office for Human Research Protections, regardless of funding.
For further clarification, check out the Decision Chart created by the Office for Human Research Protections, regarding expedited procedures.
Category 1 Clinical studies of drugs and medical devices only when (a) research on drugs for which an investigational new drug application is not required. 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. Or (b) research on medical devices for which (i) an investigational device exemption application 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.
Category 2 Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) 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 (b) from other adults and children1, 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.
Category 3 Prospective collection of biological specimens for research purposes by noninvasive means. 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 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.
Category 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 indication.) 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 subjects privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging (MRI); (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.
Category 5 Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (Also see Exempt from Full Board Review category 4)
Category 6 Collection of data from voice, video, digital, or image recordings made for research purposes.
Category 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. (Also see Exempt from Full Board Review category 2)
Category 8 Continuing review of research previously approved by the convened IRB as follows: (a) Where (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 (b) Where no subjects have been enrolled and no additional risks have been identified; or (c) Where the remaining research activities are limited to data analysis.
Category 9 Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories 2-2 through 2-8 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.
1 Children are defined in the HHS regulations as "persons who have not yet 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."
Categories 1 through 9 cannot be used for classified research.
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 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.
Any covered human subjects research project that is not determined to be exempt or is not eligible under an expedited category must be reviewed by the HRRC at a convened meeting. Typically, the researcher and authorizing official (along with any team members selected) are invited to attend the committee meeting in order to represent the study and engage in Q&A with the board.