University of New Mexico Health Sciences Center
Not all projects fit the federal regulatory definitions of human subject research or clinical investigation (45 C.F.R. 46.102, 21 C.F.R. 56.102) which require HRRC review. The federal regulations do not apply to such projects that meet neither definition; however, HRRC recommends that anyone who is unsure whether their project requires HRRC review contact the HRRC office for guidance. There are several ways an investigator can submit such inquiries to the HRRC: Send an email to HRRC@salud.unm.edu which includes the project title, the Principal Investigator’s name, and a brief but detailed description of the project, call the HRRC office at 272-1129 and ask to speak to the New Studies Operations Team, or submit an Exempt Review Application to the HRRC office. Qualified HRRC staff or an HRRC Chair will determine if the project is human subject research and requires approval by the HRRC. When a written determination of the HRRC’s findings is required by the investigator, a written request for determination must be submitted.
Not all human subject research or clinical investigations require review and approval by the fully convened HRRC. Some research is "exempt" from the federal regulations and may be granted a determination of exempt status by an experienced reviewer. However, investigators are required to submit all human subject research to the HRRC Support Office and the HRRC will determine whether it may issue a written notice of exemption or requires review under the federal regulations. Investigators may apply for each category of review as follows:
The NIH defines a case study as "an uncontrolled (prospective or retrospective) observational study involving an intervention and outcome in a single patient."
For individual case studies, the HRRC has determine that:
Under the HHS regulations (45 C.F.R. 46.101(b)), some research is exempt from having to meet the requirements set forth in the regulations. These exemptions do not apply to research involving prisoners. Further, the exemption for certain research involving surveys or interviews (Section 5.1.2) does not apply to research involving children. No research involving FDA regulated products is exempt under FDA regulations except for those involving taste and food quality evaluation as indicated in Section 5.1.3.
The most commonly cited exemption for research at UNMHSC is found at 45 C.F.R. 46.101(b)(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.
This provision permits the HRRC to grant an exemption only when the data, specimens, etc. that the investigator proposes to use for the study already exist (i.e., are "on the shelf") at the time the investigator submits the proposal. If any specimens, data, etc., will be collected after the proposal is submitted--even if it is collected for non-research purposes--the research is not exempt. Similarly, if the data recorded can be linked back to the subject (i.e. by codes), the research does not fall into this category (though it may qualify for expedited review). This exemption does not apply to research involving FDA regulated products (e.g., medical device development).
This exemption, found at 45 C.F.R. 46.101(b)(2), is available for research falling in these categories involving adults unless the information is both recorded in such a way that the human subjects can be identified (by links or otherwise) and the disclosure of the 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, insurability, or reputation. Thus, surveys involving sensitive topics (such as drug or alcohol use, sexual habits, etc.) where there is any code or other link between the information and the subject is not exempt. However, research under this category that would not otherwise be exempt is exempt if it involves elected or appointed public officials or candidates for public office. The exemption does not apply to research involving children, except for research involving educational tests (cognitive, diagnostic, aptitude, achievement), and observations of public behavior when the investigator does not participate in the activities being observed. This exemption does not apply to research involving FDA regulated products (e.g., medical device development).
Other categories of exemptions include 1) research conducted in established or commonly accepted educational settings involving normal educational practices (45 C.F.R. 46.101(b)(1)); 2) research and demonstration projects which are conducted by or subject to the approval of department and agency heads and which are designed to study, evaluate, or otherwise examine: public benefit or services programs; 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 (45 C.F.R. 46.101(b)(5); and 3) taste and food quality evaluation and consumer studies if a) wholesome foods without additives are consumed or b) 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 Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. (45 C.F.R. 46.101(b)(6) and 21 C.F.R. 56.104(d)).
An investigator seeking an exemption should submit one HRRC Exempt Review Application and include the material requested therein to allow the Chair or Executive Chair to determine whether an exemption may be granted. This application also requires that the investigator submit any interview or survey questions, and any consent form that might be considered. Changes to studies which have been previously exempted must be submitted to the HRRC for review prior to being implemented.
If the proposed research is minimal risk and it is of a type of research that falls into one of the categories of research listed in table below and published in the Federal Register by HHS and FDA, the Chair or Executive Chair (or an experienced reviewer designated by one of them) may review and approve the research. This responsibility would only be designated to a voting member who is deemed by the Chair to have sufficient expertise and experience in IRB review to ensure review in accordance with 45 CFR 46.110.
"Minimal risk" means "that 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 examination or tests." (45 C.F.R. 46.102(i)). Investigators should note that "risks" include more than just physical risks, thus risks due to possible breaches of confidentiality, social/economic or psychological repercussions, etc. must be considered in determining the degree of risk as well. For this reason, although research on specimens may require only minimal intervention (or no intervention where specimens may be archived), some such research may not fall into this category of review.
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Clinical studies of drugs and medical devices only when condition (a) or (b) is met. |
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(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.) |
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(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 |
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Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: |
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(a) 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. |
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(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. |
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Prospective collection of biological specimens for research purposes by noninvasive means. Examples: |
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(a) hair and nail clippings in a non-disfiguring manner; |
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(b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; |
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(c) permanent teeth if routine patient care indicates a need for extraction; |
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(d) excreta and external secretions (including sweat); |
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(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; |
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(f) placenta removed at delivery; |
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(g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; |
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(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; |
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(i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; |
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(j) sputum collected after saline mist nebulization. |
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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: |
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(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; |
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(b) weighing or testing sensory acuity; |
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(c) magnetic resonance imaging; |
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(d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, |
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(e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate weight, and health of the individual. |
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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). |
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Collection of data from voice, video, digital, or image recordings made for research purposes. |
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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. |
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Continuing review of research previously approved by the convened IRB as follows: |
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(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 |
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(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. |
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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. |
Additional items which may undergo expedited review:
In addition, the HRRC may approve minor changes to already approved projects through expedited review (e.g., changes of an administrative nature, minor revisions in the text of an informed consent document or advertisement, corrections in the text of documents, and other minor changes), provided that the changes do not increase the risks involved. Similarly, Adverse Event Reports (Section 8.2) that in the judgment of the Chair or Executive Chair (or an experienced reviewer designated by one of them) do not appear to be serious or to be occurring with some frequency, and do not appear to affect the degree of risk to subjects, may be reviewed by expedited review. Continuing review may be conducted by expedited review only where the study falls into one of the above categories and is minimal risk, or where a study has been closed to accrual, and intervention has been completed, but the investigator is still collecting follow-up data.
An investigator may apply for expedited review, or the designated HRRC member may review a full submission by expedited review if it meets the regulatory criteria. If the reviewer determines that the project submitted for expedited review requires full board review, the investigator will be notified and the investigator may be required to submit the information requested in Section 5.3.
An HRRC member who reviews research under this expedited process may not disapprove the research protocol or minor changes through this process. Instead, if he/she disagrees with the submission, the materials will be submitted to a full HRRC committee for review and decision.
A principal investigator requesting expedited review for an initial study must fill out, submit a Full/Expedited Review Application, and include the material requested therein.
All other research related issues will be reviewed by the full HRRC. To obtain such review, investigators must submit a completed Full/Expedited Review Application and include the material requested therein.