ࡱ> QSP#` +&bjbj\.\. 78>D>D+PPPPPPPd$dj02:RRRR-v$///////$1h4X0Pd--dd0PPRR$0dRPRPR/d/-PP1/R  `>.U./:00j0i.\4\4(1/1/0\4Pa/);00 j0dddddddH dddH dddPPPPPP  GA: 3018, p. 1 Institutional Review Board and Human Subject Research Scope: This policy applies to all employees, students and visitors. Definitions: Institutional Review Board (IRB): a specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research. IRBs' composition and responsibilities are established in the Federal Policy for the Protection of Human Subjects (often referred to as the Common Rule), and codified for the DHHS at Title 45 CFR Part 46. Research: means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Systematic investigation: is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question. Generalizable knowledge: is knowledge related to a topic that is intended to be extended beyond the sample or internal program. Examples of activities which are typically considered research include: planned interviews or surveys of peoples personal views with an intention to present or publish the information outside the college. An example of activities that typically are not generalizable and therefore not considered research include: biographies oral histories that are designed solely to create a record of specific historical events service or course evaluations, unless they can be generalized to other individuals and where it is not the intention to share the results beyond the 鶹ֱ community classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the 鶹ֱ community NOTE: Thesis or dissertation projects conducted to meet the requirement of a graduate degree are usually considered generalizable, and require IRB review and approval. GA: 3018, p. 2 Policy: The 鶹ֱ encourages and supports the scholarly endeavors of students, faculty, and staff of the college. Pursuit of scholarly work and research will often involve the use of human subjects for data collection and analysis. The 鶹ֱs Institutional Review Board (IRB) reviews human subjects research proposals to ensure that the rights and welfare of human subjects used in research studies by college personnel are protected; that risks have been considered and minimized; that the potential for benefit has been identified and maximized; that all human subjects only volunteer to participate in research after being provided with legally effective informed consent; that any research is conducted in an ethical manner and in compliance with established standards. Those individuals seeking to conduct such research may not solicit subject participation or begin data collection until they have obtained clearance by the 鶹ֱs Institutional Review Board. Some research projects involving human subjects are exempt from IRB approval requirements. The types of research generally exempt from IRB approval requirements include normal educational practices such as work undertaken as a part of a course; educational tests when the subjects are not identified; course evaluations; and surveys or interviews in which the subjects volunteer and are not personally identified. The Institutional Review Board (IRB) for Human Subjects Research at the 鶹ֱ has responsibility to oversee procedures for carrying out the colleges commitment to protect human subjects in research. The role of the IRB is to review proposed research projects that involve the use of human subjects; ensure that the individuals involved in the project are treated ethically; ensure that all subjects are provided with substantial information about the study and consent to be a subject in the study; and that all private information will be handled with confidentiality. The IRB is authorized to review, approve, require modifications in, or disapprove research activities conducted by or through the college using human subjects. The IRB does not assume the role of evaluating the soundness of the proposed research study, the merits of the research design, nor the potential contribution of the research to the scholarly literature. Rather, the IRB is charged with evaluating each projects compliance with ethical standards in regard to issues such as informed consent, confidentiality, and any risk to the participants. Procedures: The 鶹ֱs Institutional Review Board Charter and Standard Operating Procedures ( HYPERLINK "http://info.csmd.edu/committees/irb/鶹ֱ_IRB%20Charter.pdf" http://info.csmd.edu/committees/irb/鶹ֱ_IRB%20Charter.pdf) establishes and empowers the 鶹ֱ (鶹ֱ) human subjects protection committee. Those individuals seeking to conduct such research may not solicit subject participation or begin data collection until they have obtained clearance by the GA: 3018, p. 3 鶹ֱs Institutional Review Board through the procedures outlined in the Charter and Standard Operating Procedures. Prior to conducting a survey or beginning any research-type activity, the following steps should be followed (the complete process is described in the IRB Charter and Standard Operating Procedures): Discuss the survey or research project with the most appropriate college executive (e.g. president or vice-president). The college executive will determine if the proposed project meets the definition of research and requires IRB review. Most service/course evaluations, classroom exercises, and process improvement activities are not considered research under this policy and will not require IRB review. If the project requires IRB review, the principle investigator should determine, based on IRB guidelines, whether the project may be Exempt from Review by the full IRB, may be eligible for Expedited Review, or may require Full Committee Review. The IRB chair can assist principal investigatorswith deciding which type of reviewtorequest. The appropriate IRB forms should be downloaded from the IRB Web-site ( HYPERLINK "http://info.csmd.edu/committees/irb/" http://info.csmd.edu/committees/irb/) and filled out. Attached to the forms should be: a BRIEF description of the participants, the location(s) of the project, the procedures to be used for data collection, whether data will be confidential or anonymous, disposition of the data, who will have access to the data, and a copy of the Informed Consent Form and/or the measures (questionnaires) to be used in the project. Forms and supplemental material should be submitted to the IRB chair for review. Projects that are eligible for Exempt or Expedited Review are usually processed within 2-3 weeks. If the project requires Full Committee Review it may take longer (up to four weeks). The principle investigator will be contacted concerning the results of the review process. Reference: 鶹ֱ Institutional Review Board Charter and Standard Operating Procedures can be found on the college Intranet under Committees/Councils or by following this link:  HYPERLINK "http://info.csmd.edu/committees/irb/鶹ֱ_IRB%20Charter.pdf" http://info.csmd.edu/committees/irb/鶹ֱ_IRB%20Charter.pdf For more information contact: Planning, Institutional Effectiveness, and Research Department (PIR), ext. 7624. PRI: 9/08 HIN@ K S T m n  " #  . 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