1. Institutional Review Board
(IRB)
TLI – 2014
Lonnie Decker
Michele Davis

2. Agenda
Myths & Facts

3. Myth Surveys have little or no risk.
Fact: While it is quite natural to think of surveys in many cases as not having any risk, the actual risk can be very difficult to determine or justify for even the most basic of survey questions. For example, while a question as simple as, “What is your favorite color?” would seem to be completely innocent of risk, the fact is that it is impossible to determine the situation the person will be in while answering this question. Might someone be looking over their shoulder? Might they be concerned with differing perceptions that an observer might have if the answer is not kept confidential? While this might seem extreme, the questions asked on surveys are generally not this simple, and the chances for risk increase. You may not be able to envision all of the possibilities, but risk cannot be fully eliminated, and is likely more than you might anticipate. If no risk is anticipated, it is better to state this than to expect that no risk exists.

4. Myth IRB Approval and Institutional Approval both mean the same.
Fact: In order to obtain IRB Approval, researchers must first gain approval from the institution to conduct research on the premises. Institutional Approval could be described as seeking approval from the institution to use their resources, whether this is referring to their facilities, but more to the point the potential human subjects that are within that institution. IRB Approval, on the other hand, is concerned with comparing benefits and risks, to ensure that the potential risks of the research are outweighed by the expected benefits of the research (including general benefits as well as potential benefits to the participants). The institutions themselves are also interested in protecting the participants of the research, and to be informed of the types of research that is being conducted internally. Providing evidence of Institutional Approval with your application to the IRB is another area of balancing risks & benefits – in analyzing the risks to the institution(s) involved and their acknowledgement/acceptance of the research.

5. Myth IRB is a roadblock to research.
Fact: The perspective of the IRB is to help facilitate research. The mission statement includes, “The IRB achieves its primary function, protecting the rights and welfare of subjects participating in research, by educating researchers. An educated researcher makes the IRB’s job easier.” While the goal of the IRB is to ensure that “research meets Federal standards for the safety and protection of any human subjects involved in the research,” these perspectives are not contradictory. Facilitating research and working with the researchers to meet federal guidelines is the objective of the IRB.

6. Myth The IRB is scary. Myth: The IRB is scary.
Fact: While completing & submitting the paperwork may seem confusing, and in some cases daunting, the intention is not to scare researchers into not doing research. As stated, the IRB helps to ensure that the human participants research being conducted meets federal guidelines for the protection of human participants. This not only helps to ensure that all research is being conducted in a consistent manner across the university, it also helps to ensure that the researchers have met the federal guidelines. Conducting unsound research in contradiction to federal expectations – that would be scary.

7. Myth
I have easy access to information where I work, I can just use that.
Myth: I have easy access to information where I work, I can just use that.
Fact: While you may have dealings with another institution where you have simple access to data that you work with on a daily basis, you may not have permissions to do so. These permissions include that of the institution that owns the data, and (even more importantly) the privacy of the human participants that are represented by the data itself. Informed consent of the participants, privacy policies of the organizations, and state & federal privacy laws are some of the details that must be reviewed before information can be used for research. The IRB can help researchers understand & handle these issues.

8. Myth Some “research” doesn’t have to go through the IRB.
Fact: All research activities that involve human participants (even limited involvement) must be reviewed by the IRB. The federal definition of research is, ““a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge...”

9. Myth My research is exempt, so I don’t need to submit it to the IRB.
Fact: While exempt research does not need to be further reviewed by the IRB, it is the IRB that will make the determination as to whether a particular research activity is exempt. Researchers submitting an application for the IRB for review may indicate that their research meets the criteria for exempt research, however final determination for exempt research will be made by the IRB. The six categories for determining exempt research can be found at:

10. Myth IRB and IR are the same thing.
Fact: The IRB is the Institutional Review Board, whose role it is to approve and oversee all human participants research within the university. IR is Institutional Research, whose role it is to help facilitate research activities within the university. While the IRB and IR work closely, the perspectives are different, as are the relationships in working with researchers. In some cases, such as large studies involving a number of Davenport University employees or students, the researcher would work with Institutional Research (IR) to obtain permission to utilize the employees or students as human participants in their research (e.g. provide the researcher with Institutional Permission). This would entail working with IR to describe the intended research, the desired population of human participants, the timeframe involved for the research, etc. The Institutional Review Board (IRB) would then review the research proposal, evaluate the benefits and risks, ensure all necessary approvals are provided, and federal guidelines are addressed, prior to granting IRB approval.

11. Quick Fact It’s not important research, why do I need IRB approval?
Some Answers:
Federalwide Assurance (FWA)
Researcher Liability
Question: It’s not important research, why do I need IRB approval?
Answer: While the expectation of the researcher may be that very little risk is involved in their research, there is always the possibility of risk. Just like everyday life, all risk cannot be eliminated. Also, in many cases in order to perform research, there are clear expectations that some risk is involved. There are some serious ramifications that can happen in the case of adverse events occurring during the collection of research on human participants:
- The loss of ALL federal funding to the institution. While this may seem unlikely, conducting research in an organization with a Federalwide Assurance (FWA) commits to the U.S. Department of Health & Human Services (HHS) that they commit to HHS that it will comply with the requirements set forth in  the Code of Federal Regulations 45 CFR part 46, as well as the Office for Human Research Protections (OHRP) Terms of Assurance.
- Researcher liability. While some risks always exist (known or unknown), the expectation is that researchers attempt to identify possible risks and develop strategies to mitigate the risk or handle adverse events. Review by the IRB can help the researcher identify and mitigate risks, as well as to review the overall benefits of the research and determine if the research can go forward, or potentially if changes to the research can be made that might help alleviate the risks to the human participants, and ultimately the researcher.

12. Discussion – Questions?
Any Myths or Facts not yet discussed?
Questions?

13. Thank you!