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Review Processes Other Than Full-Board

Summary

Federal regulations under Title 45 CFR Part 46 apply to research involving human subjects. Research involving human subjects requires review by an Institutional Review Board. While many protocols submitted to the IRB require full-board review and/or continuing IRB oversight, some protocols the IRB receives do not involve research or human subjects. Others may constitute human subjects research but may qualify for exemption from IRB review under 45 CFR 46.101 or for expedited review under 45 CFR 46.110.

IRB Member's Role

When reviewing protocols that may not involve human subjects research or may qualify for exemption from further IRB review or expedited review, IRB members must pay particular attention to the additional regulatory requirements outlined in 45 CFR 46. In order to exempt the protocol, IRB members must assess the proposed project to determine whether it fits into one of the categories for review processes other than full-board review described below and meets ethical standards for the protection of human subjects.

Human Subjects Research

As noted above, federal regulations under 45 CFR 46 applies to research involving human subjects. Therefore, if a project does not involve research or include human subjects, typically, it does not require IRB oversight. While some projects clearly do not constitute research or involve human subjects, other projects are not as straightforward (e.g. quality improvement projects, program evaluation, use of coded data or specimens). Subsequently, these projects may require assessment by IRB members as to whether the project fits the definition of research and/or human subjects and ultimately requires IRB oversight.

46.102(d): Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

46.102(f): Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information. Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Exempt from 45 CFR 46

Some protocols may qualify for exemption from the federal regulations under 45 CFR 46. Although the regulations do not stipulate who makes this determination, University of Nevada, Reno policy requires that the IRB make this determination, not investigators. Aside from meeting the specific federally defined categories of exemption, the research must pose minimal risks to subjects. Under the DHHS regulations (Common Rule) minimal risk is defined as 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 examinations or tests [45 CFR 46.402(i)]. NOTE: The HIPAA Privacy Rule requirements still apply to exempt research.

The most common categories of exemption are:

46.101(b): Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from 45 CFR 46:

1. 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.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
   1. 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.
3. 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.

Federally funded human subjects research involving prisoners cannot be determined to be exempt. In addition, research that may fall under exemption category 2 that involves children cannot be determined to be exempt from IRB review.

Expedited Review

Federal regulations allow for expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. Expedited reviews are conducted for continuing review for certain types of protocols or protocols at certain stages (see below) and minor changes to approved research.

The relevant DHHS regulations related to expedited review follow.

46.110(a): DHHS has established a list of categories of research that may be reviewed by the IRB through an expedited review procedure. This list applies to both initial and continuing review and includes:

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
   1. 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.)
   2. 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.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
   1. 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
   2. 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.
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.
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).
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.
8. Continuing review of research previously approved by the convened IRB as follows:
   1. 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
   2. where no subjects have been enrolled and no additional risks have been identified; or
   3. where the remaining research activities are limited to data analysis.
9. 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.

FDA Requirements

Protocols that require FDA oversight must also follow FDA review process requirements. The required review processes for expedited review under FDA regulations [21 CFR 56.110] are similar to those under the Common Rule. However, the definitions of research and human subjects, as well as criteria for exemption, differ from the Common Rule. Therefore, protocols that may qualify for exemption under the Common Rule, may still require FDA oversight and full-board review by the IRB. Of note, protocols that involve humanitarian use devices and which do not constitute research under FDA regulations can qualify for expedited continuing review. For further information, please refer to the Fact Sheet for IRB Members regarding FDA regulations.