91大神

Decision Guide

The following questions are expected to help you discern if your research qualifies for an IRB exemption:

1. When does one require IRB approval?
   • If you collect research data from living individuals, both directly or indirectly, then you may have to obtain an IRB approval before you start your study. 听IRB does not regulate or review research projects that do not include human subjects. Most projects that involve deceased individuals would not require IRB approval.听听
2. How do know if I am doing human subject research?
   • If you plan to collect data from living individuals through a systematic manner to arrive at generalizable knowledge, then your activities are subject to IRB oversight
3. Can my study be EXEMPT from IRB oversight?听
   • Often researchers confuse the literal meaning of the world “exempt” with the OHR’s definition in the context of human subject research. 听If you plan to collect听data from living human beings to develop organized generalizable knowledge, then your study IS NOT EXEMPT in literal terms, but you can obtain an exemption status from completing the comprehensive IRB approval process provided all of the following conditions are met:
     1. No identifiable information is recorded or collected
     2. A signed informed consent form is obtained from the participant
     3. All participants are over 18 years of age
     4. The research participants are not protected individuals, such as children, pregnant women, mentally disabled, certain individuals with physical disability, prisoners, etc
     5. No data are collected from the participants that may pose any psychological, emotional, financial or other types of risks
     6. Other study-specific constraints may apply
4. What are the types of mechanisms under which IRB applications are reviewed?听
   • There are three types of review mechanisms. 听The review requirements and the documentation for all three mechanisms are essentially same. 听There are a few critical differences that are more attributed to the study than the researcher.
     • EXEMPT – This does not mean the research is exempt from an IRB protocol. 听It only means that the study does not require continuing annual review and the protocol can be continued beyond 3 years without renewal.听
     • EXPEDITED – This does not mean that the review is a faster. 听What it does mean is that the proposed protocol will be reviewed by a subset of IRB members rather than the entire Committee. 听
     • FULL COMMITTEE REVIEW – Those studies that pose more than minimal risk
5. What type of review mechanism should I request?听
   • Most of the time the researchers do not have the liberty to make this choice; the choice for review depends on the study. 听Not having a clear understanding on the document requirement and the review process may result in significant time delay and stress for the researchers. 听
6. Where do I start?听听
   • It may be very challenging and stressful, especially for new students, to navigate through all the rules and regulations to determine what type of application one is required to fill. 听The following is work flow has helped many researchers to submit听clear research protocols:
     1. Complete your CITI training first – visit CITI Training page for more information;
     2. Work on your informed consent – although the informed consent is a document, it is essential to note that the consent process is a conversation. 听Once the researcher determines what activities & procedures require informed consent, then it will be much more clearer what can be done and what cannot be done. 听Assess the risks and discomforts to be experienced by the paritipants and disclose that in your informed consent. 听Any additional information, such as demographics, personal behavior and other types of information you plan to collect from them needs to be disclosed up front;
     3. Determine if the data collected through the informed consent process is sufficient to answer the research question;
     4. Also determine your participant pool and how you plan to recruit/enroll them;
     5. Now determine what type of survey or research instrument you will use that would comply with the consent process and still be able to answer your research questions;
     6. Develop a research protocol – a step by step flow of various procedures and practices – to comply with all of the above;
     7. In situations where you need assistance or help, recruit or invite co-investigators to work with you – ensure they have CITI training – Social and Behavioral Research training course and supplemental modules as required by your study and participant types;
     8. If your study is conducted at the physical location of a place other than 91大神, then letters of permission on a valid verifiable format (such as letter heads) must be attached with your application. Emails and other types of correspondences will not be accepted;听
     9. If you are student, request a faculty advisor who best suits your research goal to be your mentor听– please note that the students cannot directly apply for a protocol.
        1. This is not done to prevent students from applying, but to protect them from institutional liabilties in case the protocol is non-compliant. 听
        2. If a protocol is found non-compliant, all or a portion of the data could become invalid thereby affecting the students’ academic status.
     10. Start filling out your forms;
     11. Speak to other students and faculty who have a successful human subject research program;
     12. Request for听a meeting with the compliance staff to go over specifics of your听research plan and what type of regulatory challenges you are likely to face – Tel: 615 898 2600 or by email: [email protected];听

The link provided at the end is expected to help a researcher find answers to several of the questions listed below:

• Is IRB approval required for your听study?
• Are you engaged in “research” under 91大神 Policy and Federal Regulations?
• Does your study听involve “human subjects”?
• What are different types of IRB review processes?
• What kind of IRB review should you request?
• Do you need to apply for full IRB review, expedited IRB review, or exempt IRB review?