According to 45 CFR 46, a human subject is "a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."
Are you conducting human subject research? Will your study contribute to generalizable (scholarly) knowledge? Have you developed research questions?
If so, reflect on the meaning of a systematic investigation, which is an activity involving a prospective plan that incorporates data collection, either quantitative or qualitative (or a combination of both), and data analysis to answer a research question. If your study includes both human subjects and systematic investigation, you will likely need to submit it to Teachers College, Institutional Review Board (IRB). For further support in determining whether your study includes human subjects, please refer to the U.S. Department of Health and Human Services' Human Subject Regulations Decision Charts.
The IRB administrator will make the final determination of whether a study requires review.
Building on Mazur and Goldfarb’s (2015) article, Sixteen Red Flags for the IRB, this post will elaborate on each red flag as it pertains to Teachers College (TC) research and may include some additional red flags to consider.
Mazur and Goldfarb’s (2015) ask “will the study’s findings matter?”
| Question # | Mazur and Goldfarb's (2015) Questions to Researchers | TC IRB Administrator's Elaboration on Questions to Researchers |
| 1 | "Assuming the investigator completes the study as planned, will it create generalizable knowledge of any significance?" Mazur and Goldfarb's (2015) |
Researchers should consider the proposed problem or study intention in the context of participant burdens. Is the pursuit of knowledge in this context or the significance justified for the burden posted on the potential study participant? |
| 2 |
“Have previous (or current) studies addressed essentially the same hypothesis?” Mazur and Goldfarb’s (2015) |
Oftentimes, researchers wish to collect new data, while there is scientific justification to do so, there are also several repositories and existing data that a researcher could tap to answer their proposed research questions. For example, a student researcher proposed to conduct a study about bullying among youth in schools. However, accessing school sites can pose several challenges. The student and their faculty member, determined that accessing existing data was a possible path forward and could commence relatively quickly, whereas site and subject recruitment, new data collection, data sorting, storage, and cleaning for analysis was a lengthy process. |
| 3 |
“Is the study designed in such a way (e.g., with an appropriate study population and adequate statistical power) that the findings will be useful?” Mazur and Goldfarb’s (2015) |
Engaging study subjects is time consuming. A researcher will recruit, schedule a meeting, administer study materials, record the data, code and secure the data, and analyze the data. That effort should be weighed against what is possible in the proposed time frame, whether the population of interest is available, and the study activities are possible at the proposed study site. |
| 4 |
“How likely is it that the study will have a material impact on medical practice?” Mazur and Goldfarb’s (2015) |
Not all studies at TC involve medical practice. However, the question can still apply to any study--what is the impact of this study? Designing a practical, accessible, and impactful study is possible, but it takes mindfulness and several revisions. Researchers should consider what is the likelihood that these efforts yield results to impact the field of study? |
| 5 |
“How likely is it that the study will help create knowledge that will support future research that eventually could have a material impact on medical practice?” Mazur and Goldfarb’s (2015) |
Not all studies at TC involve medical practice. However, the question can still apply to any study--what will your study do to build upon other studies and set the foundation for future studies? Oftentimes, researchers want to collect large amounts of data and make the next big discovery. As important is a researcher's ability to adapt what has already been tested and apply it to a new population or a new setting. Some of the most impactful studies are those that ask, “will this same finding apply in this new context?” New inventions are good, and so is replication, repetition, and experimentation. |
| 6 |
“Would negative results be useful?” Mazur and Goldfarb’s (2015) |
Sometimes a study flops--the participants did not respond as one would expect, they did not understand the study activities, or the social setting and context were not amenable to the data collection procedures. Researchers can ask, “what happened,” “what did not work,” “why did it not work,” to assess the usefulness of any negative results. Another way to view this question is does the lack of result or a negative result still yield information? After analyzing the data a researcher may not find evidence to support a hypothesis or may discover more questions than answers. In this inquiry are the negative results useful? |
Mazur and Goldfarb’s (2015) ask “do the benefits outweigh the risks?”
| Question # | Mazur and Goldfarb's (2015) Questions to Researchers | TC IRB Administrator's Elaboration on Questions to Researchers |
| 7 |
“Are the risks clearly much larger than can be justified by the potential benefits?” Mazur and Goldfarb’s (2015) |
Research compliance administrators weigh risks and benefits in every IRB protocol submission. In this review the administrator is examining the study in the context of a participant's rights, welfare, and well-being. For example, in a study involving youth removed from domestic violence situations, a researcher may wish to inquire about the youth’s readjustment routines. However, the timing of a study and the inquiry methods could distract the youth from accessing resources like mental health services. While understanding a youth’s experiences is important, the context, situation, and lived-experiences of that youth may outweigh the justification for study pursuits at a given time. |
| 8 |
“Are the risks too uncertain to even assess?” Mazur and Goldfarb’s (2015) |
Sometimes a researcher cannot provide substantial information within an IRB protocol for the research compliance administer to make an approval determination. For example, a researcher was interested in understanding sex trafficking in international waters and proposed boarding a ship to investigate these reports firsthand. The IRB Board was uncertain how the researcher could ensure their own safety, much less adequately protect the rights and welfare of their study subjects. |