All human subjects research, and all other activities which in part involve human subject research, regardless of sponsorship, must be reviewed and approved by the CHR. All research (including interviews, surveys, and questionnaires) involving human participants must be reviewed by the CHR.
All faculty and staff (both full-time and part-time) using human subjects or identifiable, private information about human subjects to conduct research within the course and scope of their duties are required to have prior approval from the IRB before research is initiated. Projects must be approved regardless of whether or not the research is funded and regardless of the source of funds. This policy also applies to students whose research is conducted under the advisement of a faculty member. However, the faculty member is primarily responsible for obtaining IRB approval and the conduct, supervision and administration of the research.
Levels of CHR review
There are three levels of CHR review:
Exempt Status (Level I review)
Research is reviewed for exempt status by an IRB committee member if it involves minimal or no risk. In general, research which does not propose to disrupt or manipulate the normal life experiences of subjects, incorporate any form of intrusive procedures, or involve deception will be exempt from expedited or full committee review. Projects that involve more than absolutely minimal risk and those that include any degree of deception do not qualify for exempt status.
Please note that all of the rights and protection afforded to human subjects in research are required in exempt status cases. Researchers engaged in human subjects research that qualifies for exempt status must still complete a full application form and prepare an informed consent statement. Researchers must engage in practices that minimize risk, maximize benefit and ensure privacy. In short, research with exempt status is exempt only from full committee review.
Expedited Review (Level II review)
Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the entire IRB. The term “expedited” can be misleading: Reviews of this type are not “quicker” or conducted with less rigor, but fewer reviewers are required for approval.
Full Review (Level III)
All research not qualifying for Exempt status or Expedited review and most research involving protected classes of subjects requires Full (Level III) review. In general research requiring Full review places the subject at greater than minimal risk. Full review means that the research protocol is read, discussed and voted upon by the full IRB committee.
KOÇ UNIVERSITY POLICIES AND PROCEDURES GOVERNING THE USE OF HUMAN SUBJECTS IN RESEARCH (HUMAN RESEARCH PROTECTION PROGRAM)
1. Human Subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
In addition; Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. Subject means a human who participates in an investigation, either as a recipient of the investigational new drug or as a control. A subject may be a healthy human or a patient with a disease.
Subject means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.
2. Institutional Review Board (IRB) is the generic name for any board, committee, or other group formally designated by Koç University Office for the Protection of Research Subjects to review the conduct of Research.
Within this context, Committee on Human Research (CHR) is the administrative body at Koç University, established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of Koç University.
3. Clinical Investigation means any experiment that involves a test article and one or more human subjects.
Clinical trial means any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy.
4. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
5. 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.
6. Human subjects research is any research or clinical investigation that involves human subjects.
7. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
8. Interaction includes communication or interpersonal contact between investigator and subject.
9. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
10. IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional regulations and legal requirements.
11. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
12. Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.
13. Principal Investigator Principal investigator means an individual primarily responsible for the conduct, supervision and administration of the Sponsored Research.
Investigator means a doctor or a person following a profession agreed for investigations because of the scientific background and the experience in patient care it requires. The investigator is responsible for the conduct of a clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the leader responsible for the team and may be called the principal investigator.
14. Sponsor is a person or other entity that initiates but does not actually conduct the investigation. An entity other than an individual (e.g., a corporation or an agency) which uses one or more of its own employees to conduct an investigation that it has initiated is considered to be a sponsor, not a sponsor-investigator, and the employees are considered to be investigators.
Sponsor is an individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial.
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Committee on Human Research E-mail : firstname.lastname@example.org
Animal Research Local Ethics Committee E-mail : email@example.com
SECRETARY OF COMMITTEE ON HUMAN RESEARCH
Koç University / School of Medicine
Rumelifeneri Yolu, 34450 Sarıyer İstanbul, TURKEY
Phone : +90 212 338 1176
Fax : +90 212 338 1165