Exempt Status
Exempt studies include:
- Research which is conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
- Research on regular or special education instructional strategies, or
- Research on the effectiveness of or comparisons among instructional techniques, curricula, or classroom management methods.
- All of the research is conducted in a commonly accepted educational setting (e.g., public school).
- The research involves normal educational practices (e.g., comparison of instructional techniques).
- The study procedures do not represent a significant deviation in time or effort requirements from those educational practices already existent at the study site.
- The study procedures involve no increase in the level of risk or discomfort associated with normal, routine educational practices.
- The study procedures do not involve sensitive subjects (e.g., sex education).
- Provisions are made to ensure the existence of a non-coercive environment for those students who choose not to participate.
- The school or other institution grants written approval for the research to be conducted.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
- Information obtained is recorded in such a manner that human subjects can be identified, directly, or through identifiers linked to the subjects; and
- Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk for criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
NOTE: Sensitive survey research is not exempt. A sensitive survey is one that deals with sensitive or highly personal aspects of the subject's behavior, life experiences or attitudes. Examples include chemical substance abuse, sexual activity or attitudes, sexual abuse, criminal behavior, sensitive demographic data, detailed health history, etc. The principal determination of sensitivity is whether or not the survey research presents a potential risk to the subject in terms of possible precipitation of a negative emotional reaction. An additional risk consideration is, of course, whether or not there is risk associated with a breach of confidentiality should one occur. With respect to potential psychological risk associated with a survey, the presence or absence of subject identifiers is not necessarily a consideration since the risk may be primarily associated with the sensitive nature of the survey as opposed to being dependent upon confidentiality. Subject identifiers do, however, become a factor when confidentiality is an issue.
NOTE: When children are involved as subjects in research using survey or interview procedures, the research is not exempt.
NOTE: When children are involved as subjects in research using observation techniques, the research is not exempt.
NOTE: Observation research involving sensitive aspects of a subject's behavior is not exempt.
- 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 2 of this section, if:
- The human subjects are elected or appointed public officials or candidates for public office; or
- Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information is maintained throughout the research and thereafter.
- 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.
- 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: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; and/or (d) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies: (a) if wholesome foods without additives are consumed; or (b) 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 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.
>> See process for full review
Expedited Review
Research proposals that fall under one of these categories may be subject to expedited review. These categories may not apply to pregnant women, children, prisoners, mentally disabled persons, and other classes of human subjects considered vulnerable.
- Minor modifications or additions to existing approved studies;
- 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;
- The study of existing data, documents, records, pathological specimens, or diagnostic specimens;
- Voice recordings made for research purposes such as investigations of speech defects;
- Moderate exercise by healthy volunteers;
- 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 who are in good health and not pregnant;
- Nondisfiguring collection of hair, nail clippings, and deciduous teeth; and permanent teeth if patient care indicates a need for extraction;
- Collection for analysis 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 noninvasive 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. (These procedures include weighing, testing sensory acuity, electrocardiogram, electroencephalogram, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range, i.e. x-rays, microwaves.);
- 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; and
- Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
>> See process for full review
Full Review Status
Research proposals that do not fall into the categories described for Exempt or Expedited Status under are subject to full review by the entire HSRC. Studies that apply to pregnant women, children, prisoners, mentally disabled persons, and other classes of human subjects considered vulnerable must be considered in a full review.