An important milestone for our dissertation assistance clients is the Institutional Review Board (IRB) application. For most graduate programs, you are eligible to submit your IRB application only after receiving approval for your dissertation proposal. Receiving approval from the IRB is so important because this is what allows you to turn your hard-wrought plans for your study into reality. In other words, IRB approval is what allows you to actually recruit participants and collect data from them. It’s an exciting step because it means you’re on the home stretch!
After investing so much time and energy into writing and editing the research proposal, our dissertation consulting clients are always eager to get through to the finish line with their studies. The methods chapter of the proposal requires that you explain your choice of research method (i.e., qualitative research method or quantitative), along with your procedures for data collection and analysis (e.g., thematic qualitative analysis, specific statistical analysis approaches).
Given the detailed description of your methods in the proposal, the IRB application can sometimes seem like a repetitive and rather frustrating exercise. Some wonder, if my committee has approved my proposal, why do I have to explain my methods and procedures all over again to the IRB to get my study approved? The answer to that question is rooted in some rather ugly history related to research, which led to the development of regulations to safeguard human research subjects from harm.
What Led to the Development of IRBs?
It may help to understand that the ethical requirements that you must satisfy to obtain IRB approval for your dissertation proposal derive from regulations put in place to protect participants from harm during research. This was the result of abuses of human subjects in research, including nonconsensual inclusion in studies and willful exposure to harm for purposes of research (Smale, 2010). Notable examples include the medical experimentation conducted on prisoners at concentration camps in Germany during World War II. This inhumane experimentation was among the issues reviewed during the Nuremberg trials, and the resulting Nuremberg Code introduced new ethical standards for research involving human subjects.
In the United States, studies such as Willowbrook and Tuskegee demonstrated the necessity of regulatory protections for research participants. In the 1950s, researchers at the Willowbrook State School in New York deliberately infected children who experienced intellectual and developmental disabilities with viral hepatitis for the purposes of examining the course of the illness (Rothman, 1982). The researchers’ rationale was that these children would likely contract the virus anyway while living in the institution.
In the Tuskegee study, which began in 1932, researchers kept 400 poor, rural Black men with syphilis enrolled in the study for 40 years to observe the course of the illness, in spite of the fact that an effective treatment for the disease was discovered during this period. The men were not offered treatment nor informed that a treatment was available. As with the Willowbrook study, the researchers rationalized the study. Their rationale was based on the assumption that these men, because of their poverty and poor access to medical care, would be unlikely to obtain the treatment anyway (Rothman, 1982). Largely as a result of the Tuskegee study coming to light in 1972, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHS) was convened in 1974, and this group released the Belmont Report in 1979.
What Is the Belmont Report?
The Belmont Report details a set of principles that help to guide the ethical inclusion of human participants in research, which likely affects the ways you will conduct your dissertation research. The Belmont Report’s guidance must be incorporated into IRB standards for all research with human subjects that is federally funded, but in fact most research institutions require such standards for all research including human participants regardless of funding source. Whether you are conducting interviews for qualitative research or collecting survey data for statistical analysis, if you plan to use human participants, you’ll need to pass your IRB application. Per the Belmont Report, there are three core dimensions of ethical principles you will need to consider: (a) respect for persons, (b) beneficence, and (c) justice.
Respect for Persons
Respect for persons is the first core ethical dimension of the Belmont Report, and in a research context, this means that you recognize and respect individuals’ autonomy (NCPHS, 1979). Autonomy refers to control and choice, and your obligation toward participants in your dissertation research is to help them attain autonomy for the duration of their participation. Another consideration related to the principle of respect for persons is that some individuals may experience limited autonomy because of factors like age, disability, or living in restrictive settings. In such cases, researchers need to take special measures to ensure that any participation in research by such individuals is fully voluntary.
Voluntariness of participation is a key concept associated with respect for persons. This means that you must help your participants understand that their participation in your dissertation research is completely voluntary, and it also means watching out for situations where coercion or undue influence might be present (NCPHS, 1979). Coercion refers to individuals’ perception that they might experience negative consequences if they decline to participate; people who are not fully autonomous are particularly susceptible to coercion. For example, if you plan to recruit prisoners or individuals who are otherwise institutionalized to collect data for your dissertation, keep in mind that because of their limited autonomy, they may experience a subtle coercive pressure to consent to participate in research.
The potential for coercion is also present when there is a power relationship between the researcher and participants. To help illustrate, imagine that your supervisor was conducting qualitative research about workplace conditions and was attempting to recruit you and other employees as participants. You might feel uncomfortable participating in interviews about job conditions with your boss, but you might also fear repercussions if you decline.
Because you and your coworkers might agree to take part in the study out of concerns of what will happen if you don’t, this participation is not truly voluntary. Note that the same concerns with power imbalance apply whether the study uses a qualitative research method or a quantitativev (i.e., using statistical analysis) approach. It’s the uneven relationship between the researcher and participants that is most concerning, although the personal nature of interviews for qualitative research may increase the risk somewhat.
As with coercion, undue influence to participate can also hamper voluntariness. This occurs when rewards to participate are excessive, and so you might consider asking your dissertation chair for help with determining an appropriate level and form of compensation if you plan to offer this to your participants. This is of particular concern when conducting research that includes participants who experience poverty, as they may find it difficult to refuse compensation.
Consider, for example, that you plan to conduct qualitative analysis of interviews with low-income adults about food insecurity, and you offer $100 cash in compensation. It is possible that some individuals who do not truly wish to talk with you about your dissertation topic will do so anyway to obtain the payment; this would be considered undue influence. Reducing compensation amounts and/or offering gift cards rather than cash may help to reduce the risk of undue influence.
Beneficence
The second major ethical principle of the Belmont Report is beneficence. This refers to the researcher’s obligation to (a) avoid harming participants and (b) maximize the benefits of participation while minimizing any potential harm (NCPHS, 1979). Harm due to research may be obvious, such as infection with hepatitis in the Willowbrook study, but it may also be more subtle, especially in the social sciences research many of our dissertation assistance clients conduct. Researchers need to consider the potential for harms such as psychological distress, which participants may experience when interviewed about sensitive topics. Another set of harms may arise from being identified as a research participant; for example, social stigma or employer retaliation are risks of being identified as a research participant.
Justice
The third major ethical principle under the Belmont Report is justice. This refers to the equal and fair distribution of burdens and benefits of research (NCPHS, 1979). It will help to keep this principle in mind when deciding on the research population for your dissertation. For example, it is unfair to specifically select disadvantaged persons for participation in risky research. According the principle of justice, it is also unethical to target specific groups for inclusion in risky research simply because they are easy to enroll (i.e., convenience samples).
Our statistical consultants often work with our dissertation assistance clients to develop quantitative methodologies, and use of a convenience sample in and of itself is not ethically problematic. If the sample is convenient specifically because of the population’s vulnerability, however, this is problematic. For example, people living in poverty or prisoners may be convenient to enroll in studies; however, this does not mean that they should bear a disproportionate share of the burdens of research. This is not just on a societal level. Similarly, it is unfair to specifically select comparatively advantaged persons for inclusion in research that offers direct benefits to participants.
What to Expect When Submitting Your IRB Application
Understanding the principles that underlie the IRB application should give you an appreciation for the importance of this step, and it can also help you to plan ahead for a smoother application process. When we assist with topic development for our dissertation consulting clients, we always suggest thinking through–at the very beginning of the study–any potential ethical issues that might later hold up IRB approval. Discussing any potential pitfalls with your dissertation chair can also help to ensure that you are planning wisely. The worst case scenario is that you submit a methodological plan that the IRB will not approve—this may require rewriting large segments of your dissertation proposal to create a more ethically acceptable plan. That is definitely something to avoid!
To help with planning ahead, we’ll review some common areas of the IRB application with tips on how to handle these. First, though, let’s go over the three different levels of review: (a) exempt, (b) expedited review, and (c) full review. Dissertations are considered exempt from IRB review when they do not include human participants or when they use data that were previously collected. If you were planning a qualitative analysis of existing policy documents or statistical analysis of data from the National Center for Education Statistics, for example, your study would receive exempt status.
Studies are permitted to go through an expedited review when they do include human participants but nothing more than minimal risk is anticipated. Many of our dissertation assistance clients are conducting research in education, and obtaining original quantitative or qualitative research data from teachers about classroom practices is generally considered to pose minimal risk; therefore, an expedited review would be likely. Finally, a study will require full IRB review if participation creates greater than minimal risk of harm for participants. IRBs are required to have at least five members, but only a subset of members must approve exempt or expedited reviews. The entire IRB must review and approve study protocols for full reviews, which makes this process lengthier than exempt or expedited reviews.
Regardless of your dissertation’s level of review, our dissertation consultants can help out with preparation for your IRB process, starting with mindful planning. If you’re hoping for an expedited or exempt review, it definitely helps to plan for this from the very beginning of topic and methods development. Here are some key areas of the IRB application to think over as you begin your dissertation.
Gaining Access to Research Site
In order to collect data for research purposes on the grounds of institutions or organizations, you must first obtain and document permission. If this is what you envision for your dissertation, it will help to plan ahead so that your site permission letter is signed and ready to submit with your IRB application. Many of our dissertation consulting clients are drawn to qualitative research, and if your plan is to, say, interview participants at your university or their work locations, you’ll need to obtain permission from these sites.
Note that this rule does not only apply to conducting in-person interviews for qualitative research purposes. If you will be distributing surveys to a group of people at a particular location, such as their church or fitness club, a site authorization letter is needed for the location. You do not need to have plans to be physically present at the site to collect data for the site permission requirement to apply. If you plan to recruit participants from a particular location and collect data using remote means (e.g., email, phone), you are still required to obtain site permission.
Participant Sampling and Recruitment
Because ethical treatment of others throughout your dissertation is essential, your IRB application will require detailed explanations of your procedures related to recruitment and sampling. Again, it helps enormously to plan ahead mindfully to avoid major ethical hiccups related to participants, and our dissertation coaches and statistics consultants offer this assistance to clients routinely. To demonstrate adherence to the principle of justice, it is important that your population of interest aligns logically with the aims of your study.
Due to limited resources, dissertation candidates needing large datasets for their statistical analysis often find that it helps to use convenience samples. As noted previously, use of a convenience sample can be ethically problematic. But, it is not in itself grounds for disapproval by the IRB unless an underlying vulnerability or source of disadvantage is the reason for this convenience. For example, use of prisoners, pregnant women, people living in institutions, people living in poverty, or children as convenience samples is ethically problematic because it may not be fair on a group level (Smale, 2010).
Even before you collect data, your interactions or contacts with others can create ethical issues. For this reason, our dissertation consultants often assist our clients with detailed planning related to gaining access to potential participants. The IRB will also need to know how you plan to screen individuals for suitability to participate in your study. Finally, the IRB will need to know if you intend to compensate participants, and if so, the nature and amount of that compensation.
Data Collection Procedures
The IRB will also want to learn the specifics of your data collection plans, including the procedures you will use to collect your data and instruments you intend to use for this purpose. Whether you plan to use qualitative analysis or statistical analysis, be prepared to attach any instruments you plan to use. The IRB will want to verify that these are appropriate given your research topic.
Reviewing your planned data collection procedures and instruments allows the IRB to evaluate whether the amount and types of information you are seeking from participants is appropriate given the scope and aims of your study. For example, if you are planning to conduct qualitative analysis of combat veterans’ experiences of post-traumatic growth, and your qualitative research protocol delves deeply into childhood abuse events, the IRB might question why digging into such a sensitive area is necessary given its tenuous association with your topic. Our dissertation consultants can assist with spotting these types of issues before you ever submit your application, which will speed up the process considerably.
Assessment of Risks and Benefits
Talking over potential risks and benefits of your study with a dissertation coach can also help to smooth the pathway to IRB approval. Although IRB members will assess the level of risk based on their own review of your research plan, you should be prepared to provide your own description of what you perceive as the risks and benefits of participation in your dissertation. To make sure you give thorough consideration to all forms of risk, it will help to discuss possible legal, psychological, physical, economic, and social risks with your chair or dissertation consultant (Smale, 2010).
For any risks you identify, you should also be prepared to offer additional protections to participants. In many cases, this will simply be a reminder that participation is voluntary and that they can withdraw at any time. For more severe risks, however, you should be prepared to offer additional support. For example, if you will be doing qualitative research on traumatic experiences, it is possible for participants to become very distressed psychologically during interviews. In such cases, being prepared to offer resources for counseling may be appropriate. Note that there should be a balance of risks versus benefits, and where risks are high to the participant with low potential for direct benefit, these should be balanced by clear potential for benefit of others (Smale, 2010). Using the previous example of qualitative analysis of interviews about traumatic experiences, more effective preventive practices may be a benefit to others of this research.
Obtaining and Documenting Informed Consent
A key aspect of the IRB application that our dissertation consultants assist with is the informed consent process. Because autonomous, fully voluntary participation in research is required per the principle of respect for persons, the IRB will need to verify that you have an adequate informed consent process planned. Planning ahead will help to speed up the application process, as you will need to submit your informed consent form along with your IRB application.
Per the Belmont Report, you must explain your study’s purpose, procedures, risks and benefits, and right to withdraw (i.e., voluntariness) to participants before collecting any data. Editing the language to support comprehension is essential per the Belmont Report, and our dissertation consultants can assist with developing language for your informed consent form that is easy to understand. You should provide enough information for participants to make a fully informed decision (Smale, 2010), and you should also allow time for questions and answers to ensure participants understand the study.
Although providing full information about the study’s purpose and procedures is typically required, in some cases, full disclosure before you collect data may impact the validity of the findings. For example, our statistical consultants often assist with developing psychological experiments in which participants must be unaware of the condition to which they are assigned, as such awareness might bias their responses on data collection measures. In such cases, you may request a waiver related to full disclosure (Smale, 2010). Note that you should plan to fully debrief participants following any study that uses deception in this way.
It’s highly recommended that you talk with your chair or a dissertation coach about special accommodations if you plan to include children or persons with intellectual disabilities in your dissertation sample. Persons with intellectual disabilities are often assumed to be incapable of consent, but this is not necessarily the case. For such individuals, providing informed consent materials in accessible language and/or visual formats can help to promote understanding. Minors may only provide assent to participate, and a parent or legal guardian must also give informed consent for their child to participate. Check with your university if you plan to include minors in your sample, as some of our dissertation assistance clients’ IRBs will not approve any research with minors.
Managing Data After Collection
Finally, our dissertation consultants can also help with logistics related to participant privacy. Your IRB application will need to explain how you will protect your participants’ privacy both during and after data collection. This includes ensuring that others cannot overhear data collection processes such as interviews for qualitative research. As for the data, you will need to explain how you will deidentify it for dissemination and secure it for storage.
Although the IRB application isn’t required until you’re three chapters into your dissertation, it definitely helps to plan ahead to ensure that there are no major holdups once you get to that stage. Our dissertation consultants have extensive experience with planning for IRB considerations during initial topic and research plan development—we can also assist with navigating the actual IRB application! Getting the green light from your IRB is an exciting step in your dissertation journey, and we’d be happy to support your success as you take this step!
References
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects research. U.S. Department of Health & Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
Rothman, D. J. (1982). Were Tuskegee & Willowbrook ‘studies in nature’? The Hastings Center Report, 12(2), 5-7. https://doi.org/10.2307/3561798
Smale, M. A. (2010). Demystifying the IRB: Human subjects research in academic libraries. Libraries and the Academy, 10(3), 309-321. https://doi.org/10.1353/pla.0.0114