When a research protocol and HSRC application materials are submitted to the Human Subjects Review Council Office, the HSRC administrator will review the protocol and determine whether it is Exempt from Further Institutional Review, or requires either a Minimal Risk ("expedited") or Full Council Review. If the protocol is, in fact, exempt, the HSRC administrator will send a letter of institutional approval to the Principal Investigator, indicating that the research is exempt from review. Following receipt of this letter, the investigator may implement the study-related procedures.
Research protocols that do not meet the requirements for an exemption may be reviewed in one of two ways. If the research protocol is eligible for a Minimal Risk Review, the investigator's materials will require review by a subcouncil of the HSRC. Although this minimal risk or "expedited" review usually takes less time than review by the full HSRC council, it is only available to research activities meeting specific criteria. Second, those protocols not eligible for an expedited review should be submitted for review at a convened meeting of the Human Subjects Review Council.
The federal regulations (45 CFR 46.101) specify the criteria by which a research protocol is eligible for an exemption from institutional review. The following excerpts from the federal regulations define the categories used to determine such exemptions.
- "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 or comparison among instructional techniques, curricula, or classroom management methods."
- "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 indirectly 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 subject's financial standing, employability, or reputation."
- "Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, 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."
- "Research involving the collection of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or indirectly, through identifiers linked to subjects."
- "Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, 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 these programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs."
- "Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed, or (ii) if 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."
Note: All research proposals must be submitted for review by either the HSRC administrator or the Council. Investigators who believe their research protocols meet the criteria for exemption from further institutional review may submit the Request for Exemption Form rather than the lengthier initial application for HSRC approval.
What is "Minimal Risk Review"?
Minimal Risk Review (sometimes referred to as "Expedited Review") is intended to provide a review for research projects that pose only a minimal amount of risk to subjects. A minimal amount of risk is equivalent to that which would be encountered by an average person in their daily life. Rather than requiring a meeting of the full Human Subjects Review Council, Minimal Risk review is conducted by a subcouncil of its members. Typically, members of the subcouncil independently review the application materials and forward their recommendations to the HSRC Chair. The proposal is approved if all members of the subcouncil approve it; otherwise it is referred for "Full Board Review" at a scheduled meeting of the Human Subjects Review Council.
Investigators should consider submitting a research protocol for "Minimal Risk" (i.e., expedited) review only after carefully evaluating whether or not the proposed study meets the criteria for such a review (see next question). Investigators should note that when proposals are improperly submitted for Minimal Risk Review, the review process may actually be slowed. Any doubts about submission can be addressed by the administrator of the review program.
What are the Criteria for Minimal Risk Review?
According to the Federal regulations, a research protocol qualifies for Minimal Risk (Expedited) review if it involves "no more than minimal risk" as defined by specific categories [see the Expedited Review Categories for more information]. These categories include, but are not limited to:
- "Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth is patient care indicates a need for extraction."
- "Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor."
- "Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves)."
- "Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant."
- "Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques."
- "Voice recordings made for research purposes such as investigations of speech defects." NOTE: In other words, voice recordings in which the information of interest is produced by the process of speaking itself, without regard to what is being said.
- "Moderate exercise by healthy volunteers."
- The study of existing data, documents, records, pathological specimens, or diagnostic specimens. NOTE: Research of this type is appropriate for expedited review rather than exempt review if there are identifiers linked to the subject, and if data cannot be considered archaeological or historical data.
- "Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects." NOTE: The information gathered under this provision would not be as much personal as situational; such information, were it to become known, would not usually affect the social standing or credibility of the subjects. NOTE: The term "manipulate" here should be interpreted to include some behavior that would be considered deceptive outside of the research context.
It is important to remember that it is not the presence of the above activities that qualifies an application for Minimal Risk Review, but the absence of anything beyond such activities. If the study involves any activities that are more intrusive, more personal, or more risky than the above, it is unlikely to qualify for Minimal Risk Review. Instead, such research protocols would receive a Full Board review at a convened meeting of the Human Subjects Review Council (HSRC).
How do I Apply for a Minimal Risk Review?
If, after carefully reviewing the criteria for minimal risk, or "expedited review" described in the Federal regulations, an investigator should submit the Initial Application for HSRC Review application. On the first page of the application form, the first section provides an opportunity for the investigator to request an minimal risk (or "expedited") review of the research protocol and application materials. Please note that the "Request for Exemption" form should not be used when applying for a "Minimal Risk Review."
Any research protocol that does not fall into one of the other two categories (i.e., "exempt" or "minimal risk") shall be submitted for Full Council Review. The principal investigator will be requested to submit one signed hard copy of the HSRC Application form and supporting documents along with an electronic copy of entire packet for review by the full council. HSRC approval is usually valid for one year and may be amended or modified using the requisite applications forms (e.g., Request for Continuing Approval, Request for Approval of Modifications).