Office of Research Please select one of the options below Additional Information Am I an investigator engaged in human subjects research? The federal government provides six areas that defines when an individual is engaged as a research investigator: (1) An employee or agent that receives an award through a grant, contract, or cooperative agreement directly from HHS for the non-exempt human subjects research (i.e. awardee institutions), even where all activities involving human subjects are carried out by employees or agents of another institution. (2) An employee or agent that intervenes for research purposes with any human subjects of the research by performing invasive or noninvasive procedures. Examples of invasive or noninvasive procedures include drawing blood; collecting buccal mucosa cells using a cotton swab; administering individual or group counseling or psychotherapy; administering drugs or other treatments; surgically implanting medical devices; utilizing physical sensors; and utilizing other measurement procedures. (3) An employee or agent that intervenes for research purposes with any human subject of the research by manipulating the environment. Examples of manipulating the environment include controlling environmental light, sound, or temperature; presenting sensory stimuli; and orchestrating environmental events or social interactions. (4) An employee or agent that interacts for research purposes with any human subject of the research. Examples of interacting include engaging in protocol dictated communication or interpersonal contact; asking someone to provide a specimen by voiding or spitting into a specimen container; and conducting research interviews or administering questionnaires. (5) Employees or agents that obtain the informed consent of human subjects for the research. (6) Employees or agents that obtain for research purposes identifiable private information or identifiable biological specimens from any source for the research. **It is important to note that, in general, employees or agents that obtain identifiable private information or identifiable specimens for non-exempt human subjects research are considered engaged in the research, even if the employees or agents do not directly interact or intervene with human subjects. In general, obtaining identifiable private information or identifiable specimens includes, but is not limited to: observing or recording private behavior; using, studying, or analyzing for research purposes identifiable private information or identifiable specimens provided by another institution; and using, studying, or analyzing for research purposes identifiable private information or identifiable specimens already in the possession of the investigators. Am I a student researcher? Student researchers are: (1) An employee or agent who's engaged in one of the research activities as it is defined in the "Am I an investigator engaged in human subjects research?" Tab (2) An employee or agent who's primary research goal is to complete a requirement for degree advancement (such as a master's thesis, doctoral dissertation, etc.); AND (3) An employee or agent who's job does not include duties such as conducting institutional research. What are IRB Members? IRB Members serve on the Kaweah Delta Health Care District Institutional Review Board. Members bring the expertise to fulfill mandates set forth by the federal government through 45 CFR 46. IRB membership (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects. (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. (d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. (e) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. If you are interested in becoming an IRB Member please download the application, follow all instructions and return to firstname.lastname@example.org. IRB Member Application What is the research portal? Investigators TheResearch Portal is used to submit research protocols for initial review, modifications to approved studies, and close out completed studies. To request log-in credentials, please follow the Research Portal link and follow the instructions to request an account. Please be advised that log-in credentials cannot be completed until all required training has been completed. IRB Members The Research Portal is used to review submitted research protocols, submit comments, review meetings minutes and agendas, submit attendance to meetings, and all other IRB related actions. ROC Members The Research Portal is used to review submitted research protocols, submit comments, review meetings minutes and agendas, submit attendance to meetings, and all other Research Oversight Committee (ROC) related actions. When should I contact the Office of Research?