08 Mar 2022: When Research Is Not Research
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When Research Is Not Research
by Tim Sensing (DMin, PhD), Associate Dean of the Graduate School of Theology at Abilene Christian University
“When is research not research?” That is an odd question for DMin programs to consider. However, since the Common Rule (45 CFR 46) was adopted in 2018, the misapplication by Institutional Review Boards (IRB) has complicated matters for many DMin students seeking approval for “human subjects research.”
Research is defined by the Department of Health and Human Services in the Common Rule or 45 CFR 46 as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Human subject is defined in 45 CFR 46 as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.”[1]
DMin programs must provide the communication mechanisms between student researchers and the IRB. Most often this connection is made during the writing of the DMin project prospectus. It is the responsibility of the investigators to become familiar with and abide by the regulations and policies about human subjects. All members of the research team should complete ethics training.[2]
Depending on the nature of the study, students will complete the exempt, expedited, or non-research application for IRB approval. The difference between these designations involves the particular intervention, methods used, sampling choices, and intended future uses of the findings. Each program’s IRB will have policies and procedures that will guide the student about which application to complete. Not all IRBs interpret 45 CFR 46 the same and it is incumbent for DMin programs to know the particularities of its home institution. In my experience, many DMin programs are familiar with exempt and expedited processes but not the non-research option.
IRBs are very familiar with research coming from the sciences, human services, and other social science fields. IRBs are also familiar with the non-research designation. However, what about DMin projects? 45 CFR 46 provides a pathway to deem non-research as a viable educational activity.[3] Theses and dissertations investigating biblical or historical topics (descriptive research) rarely come under the purview of the IRB. It is not even an afterthought for the IRB to address a student’s research about dead people. Moltmann’s use of Balthasar’s ecclesiology never crosses the threshold of 45 CFR 46. The Common Rule classifies such research as non-research.
Does the non-research designation lower the bar for the DMin degree? No! Primarily, the argument in favor of using the non-research designation is a matter of definition not rigor. 45 CFR 46 has a very narrow definition of research to capture human subjects research, not redefining what research means to academia. What is intended by 45 CFR 46 is not a watering down of meticulous precision but to increase the protections provided for persons.
How does a program proceed with using the non-research option? First, while Standard 5.4 uses the word “research,” non-research approval by the IRB requires you not to use the words “researcher” or “research” in the IRB application or prospectus.[4]Otherwise, you introduce a contradiction of terms. Appropriate synonyms include study, project, investigation, or inquiry.
Second, while the new definitions given in 45 CFR 46 do not include DMin type projects, they are covered under quality improvement and program development. There is not a single definition given by the Department for Health and Human Services for quality improvement and program development because they are discerned on a case-by-case basis (some fit the definition and some do not). Some applications are deemed non-research because the student does not seek to contribute to generalizable knowledge (i.e., apply the findings beyond the local congregation or organization).
Additionally, many DMin projects are not, by definition in the Common Rule, using human subjects in their research. Most often, the participants in DMin research are collaborators. This is especially true for Action Research, the most common choice for DMin programs. The participants design curriculum, write vision statements, plan programs, implement practices, articulate new policies or procedures, etc. They are not gathering private and personal information that puts congregants at risk. They are fulfilling tasks that are considered routine professional practice. The DMin project simply formalizes those common professional tasks in a robust and rigorous educational context for the student’s professional development. However, if a project is designed to include sensitive, personal, and confidential information from congregants or other community members, then the IRB will require and exempt or expedited review. These latter projects are human subjects research.
Even though DMin projects often employ focus groups, questionnaires, observations, and other qualitative tools of research involving living persons, the protocols are not designed to gather personal and identifiable information from the participants. Gathering historical data, oral histories, opinions about programs, policies, practices, legal information, or brainstorming possibilities are excluded from the research designation. Evaluating the DMin project’s purpose or final artifact through triangulation using qualitative measures is likewise excluded. Many DMin Action Research projects are not studying the people, but the practices of pastoral ministry.
Examples of non-research projects include community outreach, quality assurance, program evaluation, or quality improvement. Additionally, non-research projects do not involve vulnerable populations as research subjects. If a student indicates that a project’s findings or artifacts will be used for publication, curriculum for non-local use, or other public dissemination, ACU will make a case-by-case determination about the “generalizability” of the project. Generalizability restrictions for the non-research category is primarily about the risks associated with confidentiality of participants. If that risk is not applicable (for the same reasons the project is not actually human subjects) then publication or wider distribution of the project’s findings is beyond the scope of the IRB’s purview. However, if in doubt about questions of human subjects or generalizability, ACU will ask for an exempt application.
So what? According to the Common Rule, non-research is a more accurate designation for most DMin projects. While the exempt category might functionally accomplish the same result as a non-research designation, it wrongly assumes that there is a level of human subjects research occurring. Most (not all) DMin projects will not need to be submitted to IRB boards at all because the research is deemed non-research. Just like a PhD on Second Temple Judaism is not reported to the IRB, so too the DMin project designing a leadership selection process for new church plants. Advantages of using the non-research designation include: 1) a busy IRB office is saved hours of tracking, auditing, and reporting; 2) decisions are made within hours rather than days or weeks; 3) the student is released from further obligations to report back to the IRB; 4) projects begin in a timely manner; and 5) the precision of accreditation audits is more accurate.[5] This is good news!
When is research not research? While the intent to protect human subjects is a serious matter, the designation of research as non-research is an odd way of defining it. Non-research is research. DMin students should engage their projects with confidence that their work still meets the high standards of validity and reliability required by all qualitative researchers in the social sciences.
[1] 45 CFR 46 “The Common Rule” http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html.
Other countries may have different requirements. Although an international DMin student’s program resides in North America, most likely their projects will be located in their home country. Since the human subjects of those projects reside internationally, it is the responsibility of the student to comply with the local national policies.
[2] For example, CITI Programs (Collaborative Institutional Training Initiative) (https://www.citiprogram.org/index.cfm?pageID=14&languagePreference=English®ion=1). Course programs include: Responsible Conduct of Research, Conflict of Interest, Information Privacy & Security, Human Subjects Research, and Good Clinical Practice.
[3] The 2018 Common Rule revisions attempted to make clear some areas of academic research that were deemed “non-research” by the Regulations, specifying clearly things like oral history, journalism, etc. However, no revision ever seems to encapsulate all of the possibilities (like quality improvement or program development).
[4] The Commission on Accrediting. “2020 Standards of Accreditation,” 5.4.
[5] In such instances, the DMin office will want to require appropriate ethics training, file non-research applications, and store all pertinent documentation about the discernment process in order to demonstrate the programs compliance with regional and ATS accreditation standards. The DMin office will want to clearly articulate the criteria used to differentiate when the non-research application is requested versus the exempt or expedited application that is sent to the IRB. To read more about policies, procedures, and practices related to qualitative research ethics see Sensing, Qualitative Research (second edition is forthcoming from Cascade in 2022).