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Southern Polytechnic State University Policy and Procedure Manual P&P Number: 604.0 |
Original Date: May 2003 Previous Revision: none Approved June 15, 2005 |
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Institutional Review Board |
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Contents |
The P&P includes the following main sections: q Background q Goals q Membership q Functions q Submission Process q Principles: Human subjects and vertebrate animals |
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Background |
This P&P provides the charge for the Institutional Review Board (IRB). It is the responsibility of the principal investigator, employee, or agent to initiate and follow the procedures described below to ensure the safety and rights of the human and animal participants. |
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Goals |
The Southern Polytechnic State University Institutional Review Board (SPSU-IRB) reviews for approval and monitors for progress all research protocols and instructional experimentation in which human subjects, human biological samples or animals are involved. The SPSU-IRB is charged with the following responsibilities: · To protect the rights of human participants in research studies, including their rights to give informed consent and to have their safety protected from undue risk. · To ensure the humane care and use of humans and animals in research and teaching, and to approve only those experiments using animals which are justified by overriding benefits for teaching and new or applied knowledge. · To assist the vice president for academic affairs as requested with allegations of misconduct in research. The specific evaluation of risk involves estimating the potential for injury to the subject by reason of direct application of an experimental procedure or circumstance, or by reason of the subject’s exclusion from ordinary standards of practice or care. Rights of human subjects regarding confidentiality and access to professional care and counsel are included in deliberations so that human dignity, rights, and physical, behavioral, and social welfare are protected. |
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Membership |
The SPSU-IRB is composed of at least five members from the University, representing diverse backgrounds and disciplines. The Board will include one appointed member representing each of the four Schools and will be chaired by a member of the SPSU academic affairs administrative staff. All members will be appointed by and serve at the discretion of the vice president for academic affairs.
Each member of the SPSU-IRB is normally appointed to serve a 2-year term that may be renewed. The vice president for academic affairs shall appoint the SPSU-IRB chair for a term of up to 3 years that may be renewed. |
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Functions |
SPSU-IRB will review each proposal and take one of the following actions: a. Determine the research as exempt from the need for approval. Research in the exempt-from- approval category represents projects which involve minimum risk to the participants. b. Approve the research. Although the research may involve some risk to the participants, the SPSU-IRB may find that the risk is minimal, and that the investigator has taken all practical steps to minimize the risk. c. Conditionally approve the research. This action entitles the investigator to proceed with the project provided that certain conditions are fulfilled as specified by the SPSU-IRB. Conditions may include items such as revising the consent form to explain the procedure more clearly or adding a foreign language version of the consent form, etc. Failure of an investigator to fully meet the established conditions means the project is not approved. d. Disapprove the research. This occurs when the SPSU-IRB believes that the project does not meet the University’s requirements, it has insufficient information to take action, or when it feels the research design contains flaws or characteristics that should be revised to reduce risks to participants. The SPSU-IRB may ask the investigator to provide additional information, such as emergency back-up medical care, further steps to protect the confidentiality of the participants, or a substitute procedure. The chair of the IRB will be responsible for maintaining complete documentation and records for the committee’s activities. |
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Submission Process |
The SPSU-IRB requires completion of a research protocol form. The form contains explanatory information about the specific requirements. SPSU-IRB approval is required for all research involving human subjects. In addition, the SPSU-IRB requires that everyone dealing with human subjects must receive training in research ethics. All requests for SPSU-IRB approval must be submitted to the SPSU-IRB Chair at least 4 weeks prior to the start of the actual research and be in the format as outlined in the Application for SPSU-IRB Approval (Appendix 1). Note: Grant applications require this approval prior to submission. |
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Principles |
Principles for the Utilization of Human Subjects in Research SPSU is guided by the ethical principles set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” also known as "The Belmont Report." (available at http://ohsr.od.nih.gov/guidelines/belmont.html)
The University is committed to compliance with federal rules for the protection of human research subjects. In general, the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (45 CFR Part 46), known as the "Common Rule," are followed by SPSU regardless of the source of project funding. This commitment is in compliance with the Office for Human Research Protections (OHRP, formerly OPRR) now under the direction of the Office of the Secretary, Department of Health and Human Services. This commitment requires SPSU to comply with the comprehensive regulations published in the Common Rule which require that all research projects involving human subjects be approved by an Institutional Review Board (SPSU-IRB). The federal policy is accessible online at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research 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.
The federal regulatory requirements are applicable to all University authorized activities which in whole or in part involve research with human subjects if any of the following conditions apply: · The research is sponsored by this University. · The research is conducted by or under the direction of any employee or agent of the University in connection with his or her institutional responsibilities. · The research is conducted by or under the direction of any employee or agent of this University using any property or facility of this University. · The research involves the use of the University's non-public information to identify or contact human research subjects or prospective subjects. · The research involves students, faculty, or staff as subjects, regardless of sponsorship.
In accordance with federal regulations, all research at SPSU involving human subjects must be reviewed by the SPSU-IRB.
If a project does not initially include human subjects, but human subject participation is needed at later time, the researcher must submit a protocol and obtain SPSU-IRB approval prior to initiating the research activities involving human subjects.
Usually, SPSU-IRB approval is granted for a period of one year. For projects of longer duration, the researcher must submit a renewal application. Each SPSU-IRB conducts continuing review of all research involving human subjects at intervals appropriate to the degree of risk, but not less than once per year, depending on the nature of the research and the risks to human subjects. In accordance with federal regulations, the SPSU-IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the SPSU-IRB's decisions, conditions, and requirements, or that has been associated with unexpected serious harm to subjects.
Changes in research protocols, which may alter the risks to the research subjects and occur during the period for which SPSU-IRB approval has already been given, must not be initiated by the researcher until the proposed changes are approved by the SPSU-IRB. An exception is made for changes necessary to eliminate apparent immediate hazards to the subjects, but the SPSU-IRB must be notified immediately of these changes.
Human research involves risks that may be social, psychological, financial, or physical. Others, in addition to the research subject, also may be at risk, including persons discussed in the study, the investigator, society at large, and SPSU. The SPSU-IRB does not expect research to be free from risk, but does expect the investigator to be aware of the risks, to minimize risk when possible, and to take appropriate precautions whenever necessary.
Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training
The development of knowledge necessary for the improvement of the health and well-being of humans as well as other animals requires in vivo experimentation with a wide variety of animal species. Whenever agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered; and whenever these agencies actually perform or sponsor such procedures, the responsible institutional official shall ensure that these principles are adhered to:
1. The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C. 2131 et.sep.) and other applicable Federal laws, guidelines, and policies* 2. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society. 3. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered. 4. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals. 5. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on anaesthetized animals paralyzed by chemical agents. 6. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure. 7. The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian. *For guidance throughout these Principles the reader is referred to the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources, National Academy of Sciences, which is available on-line at http://www.nap.edu/readingroom/books/labrats/ |
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