FOR THE PROTECTION OF HUMAN SUBJECTS

If you are uncertain about whether your planned project requires IRB review, please complete the checklist on the next page of this document. You may also wish to consult with experts within your own department, or with members of the IRB. The IRB welcomes submissions even when a project does not require review; in other words, investigators should be strongly biased in favor of review. 

Application Procedures 

1. You may submit your proposal to the IRB at any time. Please complete the attached proposal (Form A), and send the original and two copies to the IRB Chair. During the 2007-2008 academic year, the IRB Chair is Dr. Bryan Schaffer, Management & Accountancy Dept., CPO #1850, UNC Asheville, One University Heights, Asheville, NC 28804.
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2. Proposals will be evaluated initially by the IRB Chair to determine whether review can be expedited. Expedited review is possible when proposals present no more than minimal risk to human participants. Research meets the criterion of "minimal risk" when "the probability and magnitude of harm or discomfort…(is) not greater…than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (45 CFR 46). Most research conducted at UNCA in the past has been eligible for expedited review.

If expedited review is granted, the Chair and at least one other member of the IRB will review your proposal, and a decision will be made within 1-2 weeks of submission. If full review (review by the entire IRB committee) is necessary, decisions will require up to 4 weeks. 

3. You will receive a letter from the IRB informing you of the committee decision. Research may be approved without changes, approved contingent on changes, or not approved. If your proposal is not approved, the IRB will suggest changes, and you may resubmit your proposal at a later time. 

4. If any aspect of your research project is modified subsequent to IRB approval, you must complete the protocol modification form (Form B) and forward it to the IRB as soon as possible. 

Informed Consent 

Appendix A contains a model informed consent form, which should be followed in all UNCA research projects that require a signed informed consent document. Such forms are mandatory for all studies involving greater than minimal risk. Even when informed consent is implied or obtained orally, participants must be informed about all aspects of the research as outlined in the model consent. 

Continuing (Annual) Review and Final Reports 

Human subjects research is generally approved for no longer than one year. Research projects that extend beyond one year require continuing IRB review (Form B). In addition, once the project is terminated, the principal investigator must file a final report form with the IRB (Form B). 

How do I know if my project needs IRB approval? 

Answer the following questions: 

1. YES NO Is the proposed project a systematic investigation designed to develop or contribute to generalizable knowledge? Systematic investigations have specific questions or hypotheses, with the expectation that findings will be presented to the outside world. 

2. YES NO Are the human subjects in your study living individuals? If you answered NO to Question 1 or 2, stop here; no review is required, and it is not necessary to submit your project to the IRB for approval. If you answered YES to both questions, continue. 

3. YES NO Will you obtain data through intervention or interaction with these individuals? "Intervention" includes both physical procedures by which data are gathered (e.g., measurement of heart rate) and manipulations of participants’ environment that are performed for research purposes. "Interaction" includes communication or interpersonal contact between the investigator and subject (e.g., surveying or interviewing). 

4. YES NO Will you obtain identifiable private information about these individuals? "Private information" includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, or information that the individual can reasonably expect will not be made public (e.g., a medical record). "Identifiable" means that the identity of the subject may be ascertained by the investigator or associated with the information (e.g., by name, code number, pattern of answers). 

If you answered NO to Questions 3 and 4, stop here; no review is required, and it is not necessary to submit your project to IRB for approval. If you answered YES to either question, continue. 

5. YES NO Is the proposed study a student research project that is a normal part of the student's course work (e.g., a project required of all students in a research methods class), supervised by the class instructor, with the purpose of the project the development of the student's research skills? Is the project of minimal risk to participants, not dealing with issues of a sensitive nature, and not genuine research expected to result in publication or other form of public dissemination? (Note: Student research projects that are independent in nature must be submitted to the IRB for approval, e.g., projects conducted by UNCA honors students in conjunction with honors requirements; projects by students individually enrolled in an independent study or research practicum with a professor; projects by students planning to present their findings at a state, regional, or national conference.) 

If you answered YES to all questions in this section, stop here; no review is required, and it is not necessary to submit your project to the IRB for approval. If NO you must complete an IRB application and your project must be approved by the IRB prior to any data collection.