The beginning of a new semester brings a fresh crop of aspiring researchers to institutions each fall and spring. Students learn how to navigate post-secondary education and gain knowledge around effective research methods, both practical and intangible. Student researchers, along with early career researchers (collectively referred to here as “new researchers”), begin to experience responsible conduct of research principles firsthand. While all these foundational activities are taking root, new researchers who wish to involve people in their studies are also asked to simultaneously understand yet another layer: human subjects research (HSR) regulations. Ensuring new researchers have sufficient background as they delve into HSR can be a challenge for an institution’s human research protections program (HRPP), particularly in the realm of social, behavioral, and educational research (SBER).
Training for Reality
Basic HSR training might consist of a course occurring on the researcher’s own time, without much contemplation or discussion beyond a solo, rapidly completed learning prerequisite. This checks the initial box for HSR education but will not hold much practical meaning. Quantitative and qualitative methodology might be covered in the classroom over a semester under faculty instruction, but it can be more difficult to meaningfully inform the new researcher community on the breadth and depth of the federal regulations and nuances of exempt and expedited categories. The allowances and limitations of those categories can really impact the way the HSR is conducted, which a new researcher may not understand well yet.
For instance, adding saliva collection to a survey could be simple procedurally; however, this minor change represents a significant move from a regulatory perspective. While the survey study alone would qualify for an exemption under category 2, the addition of the saliva sample would require a review by expedited procedures and approved via category 3. This would necessitate the researcher to prepare differently for their institutional review board (IRB) submission – including building an appropriate informed consent document with the required basic elements (45 CFR 46.116(b)).
Myths and Misconceptions
An IRB administrator, manager, or HRPP staff person may have heard phrases reflecting some confusion about key HSR concepts, including:
- New researcher: I believe my study design is exempt, so I don’t have to do anything else related to the IRB.
- HRPP response: “Exempt research” doesn’t mean exempt from oversight. Rather, your research may fit into a specific bucket within defined regulatory parameters. At our institution, we handle exemptions by assessing your study design to ensure it falls into an exempt category and will issue a determination letter or other correspondence to you for your records. (This is just one path; there are many approaches to managing exemptions. The Office for Human Research Protections [OHRP] recommends an individual with regulatory knowledge make exempt determinations rather than researchers. Many institutions require some sort of submission to achieve this.)
- New researcher: I thought if I designed my survey to be anonymous, it wouldn’t count as human subjects research.
- HRPP response: Interaction with subjects via an anonymous survey still counts as HSR, even though the interaction is not occurring in person. You might utilize an anonymous method when the information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects. This is one of a few ways to fit into exempt category 2.
- New researcher: What’s the difference between exempt and expedited?
- HRPP response: “Exempt” and “expedited” research are indeed two separate groups of HSR categories. At a basic level, while both imply the research is minimal risk, expedited studies must meet the regulatory criteria for IRB approval of research. Informed consent is not required for exempt research.
- New researcher: “Expedited” reviews should be completed pretty quickly per the name, right?
- HRPP response: You’re right, expedited reviews are typically completed more quickly than full board reviews but maybe not as quickly as you expect. Here, expedited means the research is minimal risk, fits into one of the defined expedited categories, and does not require full board review. From a regulatory context, “expedited” does not mean “go fast.”
These discussions between new researcher and HRPP representatives are crucial learning points and relationship building opportunities. One-on-one interactions take time and create trust. But are they efficient, and do they occur at the right time? Innocent assumptions or misconceptions could lead to inaccurate HSR submissions, wasted time, invalid research data, or worse yet, harm to human subjects.
Getting Up To Speed
Institutional efforts to build out resources for new researchers go a long way in answering initial questions and preventing future problems. HRPP education and tools for investigators can debunk those preconceived notions and promote solutions while simultaneously showcasing the HRPP’s expertise. Take an annual approach to plan new researcher education programming. During the typically busy fall and spring seasons, document issues, frequently asked questions, or systematic frustrations as they happen. Collect metrics on pain points and recurring difficulties. Use this information to determine institutional goals for HRPP improvement. Then, spend the summer months to tackle, reorganize, and resolve the issues accumulated over the year.
An institutional goal may include HRPP efforts to solidify a new researcher’s understanding of:
- The definitions of “research” and “human subject”
- Minimal risk versus more than minimal risk
- Exempt and expedited category types and distinctions
- What is not HSR
- Quality improvement/assessment and how it differs from HSR
For institutions seeking or holding accreditation, an annual self-evaluation and goal-setting exercise can serve a secondary purpose by meeting criteria to regularly measure HRPP effectiveness.
Some HRPP strategies to educate new researchers include:
- Lay the foundation as researchers arrive. Rather than waiting for confused new researchers to come to you, plug into any existing resources allowing you to get in front of the community first. Reach out to professors who regularly incorporate student research into their curriculum and suggest best practices to both meet student objectives and fit into the HRPP’s processing capacity. Present to classes or cohorts at the beginning of the semester. Connect with the graduate school to secure a spot within scheduled new student training. Offer to speak at new faculty meetings or to faculty resource groups.
- Provide a robust toolbox. Spend time refining all outward facing materials like your website and HRPP manual. Build your own flowcharts or decision trees (or borrow already-established materials). Display or link to federal definitions and categories used for decision making. A webpage to help researchers get started could serve as the launchpad for new researcher onboarding and provide a place to break down new concepts in easy-to-understand language.
- Define a typical review timeline. Based on staffing and workload, manage new researcher expectations with a reasonable length of time they can expect to wait, especially for initial IRB review. Use a cushion to give HRPP staff flexibility when needed. Communicate the possibility of mid-semester wait times increasing when IRB submissions are heavy. This sense of timing can guide curriculum development and what type of research can practicably fit within a single semester. Particularly for student research, this might mean simplifying study design to realistically fit into the available timeframe.
- Illustrate the lifecycle of a protocol. Give new researchers a preview of possible protocol states from approval to continuing review, as applicable. Provide resources showing the differences between processing and reviewing applications for exemptions, expedited, and full board protocols.
- Create a determination form and process to help HRPP staff make not HSR (NHSR) determinations. Offer a clear explanation to researchers on the implications of receiving an NHSR determination (e.g., instruction to avoid referring to the project or outcomes as HSR down the line).
- Explore educational intake forms. Some form systems allow for help text or linking to your website where definitions or explanations can be readily accessible to submitters. Highlight terms like “anonymous,” “confidential,” and “deidentified.” Connect these concepts to your applications for easy retrieval when new researchers are in the research design and protocol drafting stages.
- Design a flexible submission process. Does your institution receive materials in a way that is guiding and allows for pivots? Consider smart forms to teach the submitter about HSR along the way and prompt appropriate regulatory requirements. For example, if certain boxes are checked, the submitter learns their study is not exempt and informed consent regulations will apply. Even better in this illustration: the submitter can retain initial input and proceed in the same flexible form without the need to start over.
- Offer deeper dive trainings. Set intentional time to demonstrate specific exempt and expedited category scenarios for the new research community with sessions allowing space for questions and answers, along with quality conversations.
It is well worth an institution’s time and effort to give special focus to educating new researchers. The investment in broad-reaching education, in multiple mediums, expands the influence of even the smallest HRPP. These tools not only assist HRPP staff in making consistent decisions but lay the groundwork for a new researcher to excel in their career towards an expert investigator. New researchers with deeper HSR comprehension submit quality IRB applications. They adhere to regulation because they better understand it. And new researchers are equipped with the foundation to provide the best possible experience for human subjects.