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Regulations for the Protection of Human Subjects in Research
New Federal regulations have eased the procedures for reviewing research concerning the use of HUMAN SUBJECTS. It is, and has been, the policy of the University to implement a review process for ALL RESEARCH so involved. What follows is a summary statement of the new procedures that the University Committee for the Protection of Human Subjects will follow. These changes incorporate the new designations of "Research Exempt From Review" and "Research Suitable for Expedited Review." The category of "Full Committee Review" remains for research not suited to either of the above. Research means a systematic investigation, including development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for the purposes of this policy, whether or not they are supported under a program which is considered research for other purposes. --- 45 CFR46.102(d) Human subject means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. --- 45 CFR 46.102(f)(1),(2) Exempt ResearchThe principal investigator and the department chairman will make preliminary determination as to whether the project is exempt from Institutional review; however, the final determination rests with the Committee for the Protection of Human Subjects. The investigators will prepare a claim for exemption form furnished by the Office of Research Services. (Questionnaires as appropriate must be submitted with the forms.) Research qualifying for exemption will usually be of the anonymous survey or interview type, or research conducted in traditional educational settings for evaluation of instructional programs, etc. The Committee reserves the right to review at length any such claim, but it anticipates that those instances will be rare. Data collection may begin as soon as the claim has received committee approval and has been properly filed with the Secretary, Committee for the Protection of Human Subjects, Office of Research Services, Holden Hall, Campus (2-3884). Research Exempt from ReviewResearch activities in which the only involvement of human subjects will be in one or more of the following categories: (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) if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (3) Research involving survey or interview procedures, except where all of the following conditions exist: (i) responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, (ii) the subject's responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and (iii) the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol. All research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office. (4) Research involving the observation (including observation by participants) of public behavior, except where all of the following conditions exist: (i) observations are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, (ii) the observations recorded about the individual, if they become known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and (iii) the research deals with sensitive aspects of the subject's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol. (5) 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 indirectly, through identifiers linked to the subjects. Proposals of the above types which cannot protect subjects' anonymity and/or pose no more than minimal risks to subjects may be suitable for expedited review. Expedited ResearchCertain research projects are now suited for expedited review. In essence, this means that a single member of the Committee may approve, but not disapprove, a project. Most of the projects that fall into this category of research have minimal or no risk for the subjects. The expediting reviewers and their areas of responsibility are: Dr. Richard McGlynn (2-3729/MS 2051)...Psychology Investigators from other departments may send their proposals to the Chairperson of the Committee, Dr. Richard McGlynn, or Elizabeth Johnston (Office of Research Services, MS 1035) who will route their project to one of the Committee members. It should be noted that research suitable for expedited review will still require appropriate informed-consent forms, together with a full description of the project, as required in the past (rationale, subjects, apparatus, procedures, etc) . The suggested format for the preparation of these materials may be requested from the Secretary of the Committee. Essentially, these are the same forms that have been used in the past. Reprinted below is an expanded summary of the criteria for research projects to be considered in the Exempt or Expedited category. The net impact of these new regulations and procedures should be a significant reduction in the time it takes to complete the review process, or a complete elimination of review in some instances. Examples of Research Qualifying for Expedited ReviewApplicability (A) Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.101 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. (B) The categories in this list apply regardless of the age of subjects, except as noted. (C) 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 subjects' 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. (D) The expedited review procedure may not be used for classified research involving human subjects. (E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB. (F) Categories one (1) through seven (7) pertain to both initial and continuing IRB review. Research Categories (1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (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.) (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. (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 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. 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 gumbase 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. (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 indications.) 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 subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (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. (5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.) (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. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.) (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. (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. |
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Last Updated: Tuesday, October 28, 2003 15:01:09 Copyright©2000, Office of Research Services
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