Demystifying the IRB: Supporting student success
By Dona Molyneaux and Tiffany J. Cresswell-Yeager
To conduct research involving human participants, graduate students must submit a proposal about their research to the Institutional Review Board (IRB) for approval. Kramer, et al. (2009) asserted the importance of the IRB in protecting human subjects because of historic abuses. The Department of Health and Human Services oversees human subject research regulations, which requires universities to have an IRB (Miser, 2005). These are federal guidelines that every institution must follow. There are three guiding principles for human subjects’ ethical treatment: respect for persons, beneficence, and justice (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Some efforts to address these principles include ensuring informed consent and voluntary participation free from coercion, protecting privacy, confidentiality, anonymity, protecting vulnerable populations, and assessing benefits and risks (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Actual or potential physical, mental, and social risks of participation must be assessed (U.S. Department of Health and Human Services, 2005). The researcher must also create a plan to minimize those risks and implement protections for the participants.
To earn the doctoral degree, students complete a research study called the dissertation. As part of conducting research, these students must comply with federal regulations related to the ethical treatment of human participants (U.S. Department of Health and Human Services, 2005). Many researchers report that submitting to an IRB is often charged with fear, confusion, and frustration (Murphy & Verden, 2011; Rickly & Cook, 2017). Because the dissertation is often doctoral students’ first experience conducting research, students often fear the IRB process (Rickly & Cook, 2017). The scholars noted that research must be narrowly focused (Rickly & Cook, 2017). Students may lack the confidence to determine how narrow the focus can and should be. Students must understand their methodology and how that might impact their participants. Murphy and Verden (2011) recommended students be very thorough with their proposals and suggested checking due dates and knowing the schedule for reviews.
To demystify the process and identify areas where additional support was needed, the authors reviewed all submitted research protocols from a three-year period at a private liberal arts university in Southeastern Pennsylvania. The IRB and the doctoral program faculty examined the challenges students face in approaching the IRB process and identified strategies for students and educators to increase the likelihood of successful proposal approvals.
A great deal of research has been conducted about the IRB, including studies about fear, dissatisfaction, communication of policy and process, and such boards’ purpose and responsibilities (Kramer & Dougherty, 2005; Kramer et al., 2009; Rickly & Cook, 2017)). Kramer et al. (2009) found that previous research often focuses on the negative or adversarial role of the IRB. Despite the fear and frustration anecdotally, Kramer, et al. (2009) found that negative and positive experiences become balanced over time when examining across boards and institutions. Kramer et al. (2009) added that faculty with negative feelings toward IRBs may influence their students to have similar negative responses.
Kramer and Dougherty (2005) found that the regulations and bureaucracy of the IRB can cause feelings of powerlessness among the researcher. Kramer et al. (2009) suggested that some of the negative feelings toward IRB may be caused by a lack of timely review, causing frustration for the researcher who is anxious to get started or who may need to meet specific deadlines. Kramer et al. (2009) also found that most researchers felt that the research had little to no risk to participants and therefore did not need the IRB’s permission to move forward.
At this institution, the first-time submission approval rate was 7% for doctoral students during the 2017-2018 academic year (Office of Institutional Research, 2018). Typically, students would take approximately four months with several resubmissions to receive approval. In an accelerated doctoral program, this added a level of dissatisfaction and difficulty in meeting timelines. Table 1 shows the number of protocols submitted by year and the numbers of not approved, decision-pending, and approved at first submission.
Results of Protocol on First Submission
|Year||Not approved on First Submission||Decision-Pending after First Submission||Approved on First Submission||Total Submitted|
Table 1 shows a large number of not approved proposals. These proposals had multiple errors and were returned to the students to be resubmitted. More than twenty proposals were decision-pending, meaning several components needed to be addressed before approval could be granted. Corrections needed to be made and sent to the IRB administrator without resubmitting it to the entire IRB. As shown in Table 1, few protocols were approved on the first submission.
The students made many common errors. The students underestimated the time it would take to complete their research study, specifically their data collection. In addition, the students often failed to identify the location of their data collection or to provide letters of support or permission to conduct their study at the stated location. A majority of the students failed to explain their data analysis plans. Finally, more than half did not provide adequate consent procedures or failed to explain their studies’ parameters on their consent documents clearly. After reviewing the submitted protocols for the three years of this study, the authors derived several patterns and themes that frequently occurred. Table 2 shows the items for review and the number of found inadequate protocols during the IRB review.
|Procedures for data analysis are not appropriate.||9|
|Consent procedures are not adequate.||7|
|Time frame is not adequate.||4|
|Other institutions are not clearly identified.||3|
|Other institutions did not provided letters of support.||3|
|Adequate protection was not ensured to participant and investigator.||3|
|Data or sample storage is not adequate.||2|
|Inadequate assessment of risk to participant and investigator.||2|
|Risk/Benefit ratio is not adequate.||2|
In examining Table 2, four proposals did not have an adequate timeframe. This may because of the accelerated nature of the program. Doctoral students may underestimate the amount of time that it may take to recruit participants and collect data. Also, participant recruitment and the data collection may not begin until IRB approval is granted, potentially delaying students’ doctoral program completion.
The study showed nine proposals did not have an appropriate plan for data analysis. This may happen because students submitted proposals without a careful plan of what to do with the data after it had been collected. To protect participants from unintended risk, the IRB must ensure that researchers – in this case doctoral students – have a clear plan to analyze the data after it is collected.
Finally, seven proposals lacked adequate procedures for consent. This is essential to protect participants in any study. Students often did not provide adequate information about how their participants could withdraw from the study. In other cases students failed to provide participants a clear understanding of the study’s procedures.
In the IRB submission process, there were several challenges for students. The students were frustrated because they did not understand what needed to be submitted or explained in greater detail in their proposals. These challenges include:
- Participant Recruitment and Consent
- Data Analysis
- Evaluation of Potential Risks to Participants and Investigators
Research site permission may be required (McDowell, 2019). Researchers may not realize that permission will be needed from the organization, school, or institution where they planned to conduct their research. Researchers may not realize how long it may take to be granted permission Cook & Hoas, 2011). There may be long processes or forms to submit depending on the policies of the organization.
Participant Recruitment and Consent
Students struggled to identify how they planned to recruit participants. Some students shared an overreliance on social media platforms as potential recruitment tools. Many also overestimated anticipated response rates. For example, students often assumed that more than 50% of those surveyed would respond. When in actuality, response rates without follow-up average from 25-30% (Fincham, 2008). Students often lacked complete and precise language in their consent documents. Despite being provided templates for use, the students struggled to articulate their procedures for obtaining consent clearly. Informed consent is an essential component of the protection of risk (Cook & Hoas, 2011).
Nine proposals had inadequate data analysis included in their proposal. Students rarely provided a clear understanding of their plan for data analysis. Many students provided information about the software tool they planned to use to conduct the analysis but not the statistical analysis techniques. Sometimes this may have occurred because students were anxious to get started collecting data because of tight timeframes in the accelerated program.
Evaluation of Potential Risk to Participants and Investigators
Because the risk is often minimal in education research, students struggle to examine the potential risks to participants’ and themselves. They often stretched the definitions or said there was no risk involved. Students often considered reputational risk, but rarely looked at emotional risk related to sensitive topics. Educators often underestimated the risk of coercion in educational surveys using their students. In addition, risks of invasion of privacy or confidentiality were often inadequately evaluated in studies. Without a clear evaluation of risk, it was difficult for the students to implement adequate protection from the risks.
The IRB process is often challenging for academic community members, specifically doctoral students who may not have much experience conducting research. This study showed that many doctoral students were unprepared for submission to the IRB. Previous research found that the IRB process is often difficult to navigate (Kramer et al., 2009; Pritchard, 2011).
We also found many common errors in student proposals. Students did not understand the necessity or the need for permission from the research site as a protection from risk. The students were not aware of the rationale for compliance and the necessary components of research protections—consent, privacy, confidentiality, and autonomy. Consent is an integral component of protecting participants (Kramer et al., 2011). Informed consent confirms the participants understand the purpose of the research, the procedures involved, and the risks associated with the study (Cook & Hoas, 2011; U.S. Department of Health and Human Services, 2005).
Murphy and Verden (2011) explain IRBs review the methods and procedures to confirm there is no danger or risk to participants. In addition, students did not include strong data analysis plans in the proposals. Students needed to more thoroughly assess the risks associated with their research. Scheppler and Kolar (2008) explain non-biomedical research can challenge researchers to determine risk. They explain some of these risks include physical or psychological harm, social or economic harm, or even inconvenience to participants (Scheppler & Kolar, 2008). In our review, some students failed to accurately consider the potential risk of data breaches, loss of confidentiality, and privacy as participants complete surveys and interviews for their studies.
Implications for Practice
To improve the IRB process for doctoral students, we recommend three strategies to increase the likelihood of approval to conduct research with human participants. IRBs should improve communication with potential student research investigators. IRBs should continually assess their practices to improve the submission process. In addition, the university community, including faculty and the IRB, should enhance support and training for doctoral students conducting research.
Improve Submission Process
The submission process is often wrought with confusion, delays, and challenges (Abbott & Grady, 2011; Jenson et al., 2003; Lopus, et al., 2007; Pritchard, 2011; Smith, 2018). Murphy and Verden (2011) suggest IRBs seek to create processes that allow for the generation of knowledge while being manageable and smooth for researchers seeking approval. Some suggestions include creating and maintaining clear deadlines and using a rubric to determine appropriate protections and risk assessment (Cook & Hoas, 2011; Kramer et al., 2009). In addition, IRBs should periodically assess their submission practices and review the forms used. Following the internal review, IRBs can use the feedback to update their forms to improve clarity and reduce confusion. Murphy and Verden (2011) recommend assessing the climate and institutional culture including attitudes and behaviors towards IRBs to improve the process for researchers. Understanding how the institution views the IRB can help understand compliance behaviors and the support needed by student researchers to be successful.
Enhance Support and Training
To improve the submissions’ quality and increase the likelihood of approval, both students and faculty advisors need better education about the research process (Abbott & Grady, 2011). Murphy and Verden (2011) found that most faculty were modeling and teaching their students to be compliant, which created an environment where students are socialized to conduct research ethically. Howard et al. (2010) argue that an effort to train and educate researchers is integral to success in developing future research. To educate students, faculty could integrate IRB case studies and exercises into their coursework. Scheppler and Kolar (2008) pose questions to be answered to increase dialogue around practice and policy. If dissertation preparation is built into coursework, faculty can create assignments to help students consider the clarity of their writing. For example, Table 3 shows an IRB assignments where students are asked to respond to the statements with increased clarity. The assignment also asks students to explain why the statement does not meet the standard for approval. This demonstrates the students can evaluate the statements and critically reflect on what is needed to improve the work.
Read the following statements and provide a response that will improve the possibility of approval. Explain why the statement does not meet the standards for approval and provide an improved response.
|Duration of research project
|from Sept. 2021 to Oct. 2021
|You must select actual dates to begin after your review and approval. In addition, it is best to select a minimum of 4 months for data collection. You can work more quickly, but you would need to apply if it takes longer than you requested. Be aware that you have one year from approval to complete your research.
|Location||I will conduct my interviews at a Starbucks near the college.||The location is the site where you will conduct research. Where are the participants from? Do you have any relationship with potential participants? How do you have access to the research participants? Why are you using this site? Best practice: Use a location other than your workplace to avoid bias and coercion.
|Data and/or Stored Samples
|I will store copies of the survey data on my password-protected computer. I am the only person with access to this computer.
|What happens if the data is stolen? How will you address a breach in confidentiality? What about the informed consent forms? What about the names and emails of participants? Did anyone provide you with this information?
|Methods||I will analyze the data using descriptive statistics.
|You need to explain your methodology, the rationale for that methodology and your data collection and data analysis plans. Use the templates to help you. Don’t just say I will analyze the data. Explain that you want to understand the relationship between test scores and teacher professional development, so you are using a correlation study. Do not overpromise. Be aware of word choice that has a statistical implication (like significance). Be very clear about what your data could show and why you are choosing the statistical test.
|Subject Recruitment and Selection
|I will conduct a survey of 75 participants from the teachers at the school. I will send them an email asking them to participate. The survey is anonymous, but everyone who participates will receive a gift card.
|If you are designing a quantitative research study, then provide the power analysis using the confidence level and confidence interval for a statistically sound sample. Best practice: minimum of 100 participants for survey research; minimum of 20 interviews for qualitative research. If the survey is anonymous, how do you know who they are to get the gift card?
Potential Risks to Subjects and Investigators
|There is no risk to the participants.
|There is always a risk to participants. The risk may be minimal. Minimal risk means that the risks of harm anticipated in the proposed research are not greater than, with respect to both probability and magnitude, the risks encountered in daily life or during the performance of routine physical or psychological examinations or tests.
|The participant will benefit emotionally by participating in the research.
|There is little personal benefit for participating in social science research. This is primarily for medical research where a procedure might benefit healing or disease progression, but you still need to provide a response. Do not overestimate the benefits of your study. For social science research, there may be benefits to society. Again, do not overestimate the benefit to society.
Communication practices emerged consistently across the data collected and analyzed. Because graduate students often are unfamiliar with the IRB process, there is fear and frustration about finding information and getting answers to questions. Miser (2005) recommends students should talk to the IRB chair about how educational research is handled. In addition, Kramer et al. (2009) argue that people react more positively when leaders communicate effectively and are more willing to listen and provide feedback. They assert that IRBs are in positions of power and therefore can demonstrate more participatory leadership practices.
To improve IRB communication between doctoral students and the IRB on a campus, the IRB staff must be clear and prompt in responding to student questions (Kramer et al., 2009). Consultations as students complete their IRB forms may be helpful and ease the workload of students and IRB staff as it will require an additional meeting at the beginning to clearly communicate about the process, but potentially fewer follow-up exchanges as students submit their materials. Kramer et al. (2009) add that open communication builds trust and is associated with increased satisfaction and commitment by researchers to comply with guidelines. These guidelines can be shared with student researchers in handbooks, materials, and other documents. One document, a checklist, can be helpful in demonstrating the exact tasks that need to be completed before submission. Table 4 shows an example of a checklist created by the IRB administrator and chair to be included in the IRB handbook to help students navigate the process.
Steps to complete:
|Review the FAQs and complete the CITI Training.|
|Prepare the Research Proposal (IRB 001).|
|Prepare the appropriate Exempt or Expedited/Full Request form IRB 004.
Please follow all directions carefully.
Determine if requesting “Exempt” or “Expedited” or “Full” review. Exempt research occurs when there is no identifying data; expedited is the most common. Full review will occur if your participants are minors.
|Include permission for all research sites and locations. If you had access to any information from the research location, plan to use the location’s name in your study, or you are recruiting participants at that location, you must have permission.|
|Confirm dates for beginning and ending data collection. Provide ample time for data collection.|
|Explain how you are recruiting your participants and how you determined your sample size. Convenience sampling does not provide the academic rigor necessary for a dissertation.|
|Review Guidelines for Consent Process. Prepare very clear consent procedures. Do not assume the IRB understands what you meant. You must explicitly explain your consent procedures.|
|Select the Appropriate Consent Forms from the templates provided. Read the templates. If the information doesn’t apply, you must delete it.|
|Explain the risk, even if minimal to participants AND researcher. Provide protections for all risk. Specifically, address privacy, confidentiality, and informed consent. Disclose your role and any connection you may have to the location or to the participants. Implement protection to eliminate or mitigate coercion or bias.|
|Explain the methods of collection and analysis in detail to show your competence with the methodology and tools for analysis. Provide the data collection instrument.|
|Attach copies of All instruments used as part of the research project, including questionnaires, surveys, tests, and interview questions (if using established instrument, provide permission to use, adapt or amend; provide reliability and validity information.) Include Letters of support or permission from research sight, school, university, or organization from someone with the authority to give permission. This is best on letterhead with signature. Provide Consent forms for all participants (if minors: participant and parent)|
|Submit proposal to Writing Specialist for approval.|
|Submit electronic copies of the Research Proposal, supporting forms, and attachments to Administrative Assistant.|
(Student & Investigator IRB Handbook, 2019)
To conduct research with human participants, students must obtain IRB approval to ensure protections and appropriate assessment of risk (Jenson et al., 2003; Kramer, et al., 2009; Murphy & Verden, 2011). Cook and Hoas (2011) found that IRB members take their responsibility very seriously. They assert that IRBs must encourage research while protecting participants. Faculty must demystify the process for students and continue to improve communication, awareness, and eliminate the fear of the process by being proactive and educated on the process and the policy. Finally, the institution and the IRB must be willing to review their policies, guidelines, and practices to ensure student and faculty research is of the highest quality and the process is fair and just to those that submit.
- What concerns do you have about submitting your research study proposal to the IRB?
- How can you communicate concern(s) to your advisor, committee, or chair?
- In examining your study, how can you better assess the risk to your participants?
- In what ways can you improve your explanation’s clarity to be sure the IRB understands the study you plan to conduct?
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Dona Molyneaux is an Associate Professor of Nursing in the Frances M. Maguire School of Nursing and Health Professions at Gwynedd Mercy University. She earned her BSN, RN, ONC, and MSN from the University of Pennsylvania and her Ph.D. from Widener University.
Tiffany Cresswell-Yeager is an Assistant Professor of Higher Education Leadership at Gwynedd Mercy University. She earned her B.A. in journalism and M.Ed. in training and development at Penn State University and her Ph.D. in sociology at Indiana University of Pennsylvania. Dr. Cresswell-Yeager’s research interests include the scholarship of teaching and learning, doctoral preparation, student engagement, and social class in higher education.