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Ethical and Procedural Guidelines
Human participants research at Drew University is guided by the ethical principles laid out in The Belmont Report and the procedures as described in the Department of Health and Human Services Policy for the Protection of Human Research Subjects (45 CFR, Subtitle A, Part 46).
Human Participants Research Oversight
There is often confusion about what types of projects need to be reviewed by the Drew Institutional Review Board. The short answer is that all projects need to be reviewed at some level.
The first question that needs to be answered is whether you are conducting research with human participants as research and human participants are defined by the Office of Human Research Protections (OHRP). While it seems that these would be straightforward determinations, their definitions of these concepts are very specific.
Human Participant is defined in the OHRP regulations (45 CFR 46.102(f)) as follows:
Human participant means a living individual about whom an investigator obtains either data through intervention or interaction with the individual or identifiable private information.
Intervention includes both physical procedures to collect data (e.g., venipuncture) as well as manipulations of the person or the person’s environment. Interaction includes any type of communication or contact.
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 that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record). Private information must be individually identifiable (i.e., the identity of the person is or may readily be ascertained by the investigator or associated with the information).
Note that this definition of human participants excludes naturalistic observations made of individuals in public places. This type of activity involves no intervention, and reasonable people cannot assume that they will NOT be observed when they are in public places.
If you are unsure whether you are utilizing human participants as defined by OHRP in your work, please consult with the IRB Chair.
Research is defined in the OHRP regulations (45 CFR 46.102(d)) as follows:
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Regardless of whether you personally define your project as research or not, if it is systematic and is intended to contribute to knowledge that will generalize beyond your specific project, it is research as defined by OHRP and therefore needs to be reviewed by Drew’s IRB. Click here for some examples of common projects that would not be defined as research by OHRP.
How to Determine If You Are Conducting Research:
If you know that you are conducting research with human participants as these terms are defined by OHRP, you may skip to Instructions for Submitting Research for IRB Review below to proceed with the review of your work.
For everyone else who is doing anything that involves human participants as defined by OHRP (this includes both people who believe they are not doing research as defined by OHRP and people who are not sure whether they are doing research or not), please submit the Research Determination Form, which reviews the basic details of your project. This information will help the IRB chair to determine whether you are doing research as defined by OHRP or not (or confirm what you already believe to be the case).
The IRB Chair is the only person on campus who is able to make the official determination of whether you are conducting research or not. Because researchers are intimately involved with their own work, the IRB Chair can serve as an unbiased source of review.
If the IRB Chair determines that you are NOT conducting research as it is defined by the OHRP, no further contact with the IRB will be necessary. The Chair will provide you with a letter indicating that your work is defined as non-regulatory research and therefore does not meet the requirements for review set forth by OHRP. This, of course, does not remove your ethical responsibilities as a researcher, and you are encouraged to think carefully about the ethical issues associated with use of human participants before beginning your work.
If the Chair determines that you ARE conducting research as it is defined by the OHRP, your project will require some level of review by the IRB. The Chair will provide you with a letter indicating that your work is defined as research and therefore does meet the requirements for review set forth by OHRP. It will then be your responsibility to proceed with IRB review of your work. The nature of that review is outlined in Instructions for Submitting Research for IRB Review.
Instructions for Submitting Research for IRB Review: https://uknow.drew.edu/confluence/display/IRB/Institutional+Review+Board
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