Chapter 8 Institutional Review Boards and IRB Applications/Approval

Emily Coombs, (she/they) & Meredith R. Maroney\(^{1}\) (she/her), University of Calgary

We respectfully acknowledge that the University of Calgary is located on the traditional territories of the people of the Treaty 7 region in Southern Alberta, which includes the Blackfoot Confederacy (comprising the Siksika, Piikani, and Kainai First Nations), the Tsuut’ina First Nation, and the Stoney Nakoda (including the Chiniki, Bearspaw, and Wesley First Nations). The City of Calgary is also home to the Métis Nation of Alberta, Region III.

\(^{1}\) Meredith R. Maroney is now at the University of Massachusetts Boston, Department of Counseling and School Psychology


IS THIS FORTHCOMING? IF IT IS DELAYED, SHOULD I DELETE THIS LINE? Supplementary podcast: [link will be inserted here]

The supplementary podcast will provide a collection of narratives from academics at various points in their career. They will discuss their experiences working alongside the Institutional Review Board (IRB). As well as how their areas of research influence their IRB experience. This podcast aims to provide the listener with a comprehensive chronology of how one navigates IRBs throughout their career.

The focus of this lesson is to provide an overview of the foundational elements of the Institutional Review Board (IRB). We discuss the Belmont Report, the role of OHRP, what it means to have Federal Wide Assurance, and essential elements of informed consent. We conclude with a summary and recommendations for conducting research with understudied populations, along with considerations for researchers throughout the IRB application process.

8.1 Learning Objectives

Learning objectives for this chapter include the following:

  • Explain the importance of ethical principles in research, including protecting participants from harm, ensuring confidentiality, and maintaining integrity.
  • Evaluate potential ethical considerations that may arise during the IRB application process and identify ways to address this with populations of interest.
  • Reflect on how personal values and implicit biases (at both the individual and systemic level) may impact research design and participant experiences
  • Articulate how IRB requirements arose from researcher harms

8.3 Institutional Review Boards

Institutional review boards (IRBs), also known as research ethics committees or research ethics boards (REBS), protect human subjects involved in research. To conduct research with human participants, researchers must seek approval from a review board comprising members with varying backgrounds and areas of expertise THESE REFS MISSING (Grady, 2015; FDA, 2019). Before collecting data, researchers must submit a detailed proposal of the research plan, emphasizing possible risks and benefits to research and what will be explicitly communicated to and asked of participants. The IRB reviews the research proposal, which includes recruitment materials, informed consent documents, interview protocols, measures, and study design MISSING REF (FDA, 2019). After reviewing materials, researchers may be asked to modify or revise aspects of the proposed research, particularly if additional detail is needed or there is concern about the welfare or rights of the participants. If researchers do not satisfy the review board that the benefits of the proposed research outweigh the risks, the research project may not be approved. Researchers must keep the IRB updated if challenges arise, if they choose to modify their study design, and provide periodic updates before the agreed-upon expiry date (e.g., once a year). It is also the responsibility of researchers to communicate with IRBs once a study has concluded and is closed to new participants.

8.4 The Belmont Report

The Belmont Report was published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, prompted by the signing of the National Research Act in 1974 (Protection of Human Subjects of Biomedical and Behavioral Research, 1979). The committee was tasked with outlining specific guidelines and principles that should inform research with human subjects to prevent ethical violations and ensure the protection of human research subjects. The Belmont Report discusses the boundaries between ethics and research and reviews three ethical principles and applications of informed consent, participant selection, and assessing benefits and risks. Several key events led to the creation of the National Research Act and the subsequent development of The Belmont Report, which are detailed below.

8.4.1 Key Events

The Tuskegee Syphilis Study began in 1932 as the United States Public Health Service set out to “determine the natural course of untreated, latent syphilis in black males,” (Brandt, 1978, p. 21). This research study was conducted in Macon County, Alabama, and the participants were Black men with syphilis (N = 399) and control participants (N = 201). Although initially proposed to last between six and nine months, the experiment continued for 40 years. A series of papers were published between the 1930s and 1960s, but the study did not receive public attention until it was written about in the public media in 1972. After a yearlong review process, there were several ethical concerns with the proposed research, which was found to be “ethically unjustified” by the Department of Health, Education, and Welfare. The real purpose of the study was concealed, and researchers coerced a vulnerable population with the promise of resources (Equal Justice Initiative, 2020). Essentially, participants who were infected with syphilis were not educated or treated by researchers and were prevented from accessing treatment, even when it was widely accessible, so researchers could continue to observe how the disease would progress. This resulted in the death of 128 participants from syphilis or related complications and the infection of partners and children (Institute, 2020).

The Nuremberg Code consists of 10 ethical research principles developed in 1947 as part of the Nuremberg Medical Trials and has informed current research principles (Shuster, 1997). The Nuremberg Medical Trials were carried out following unethical medical experimentation in Germany during World Word II. Human rights were violated, even when participants protested harmful experiments (see Weindling, 2022, for a detailed discussion) A major point emerging from the Nuremberg Code is the importance of voluntary consent to research by human participants. In addition, the Nuremberg Code details when medical experimentation is justified and what conditions must be met (Shuster, 1997).

8.4.2 Basic Principles of The Belmont Report

The three principles outlined in The Belmont Report are: respect for persons, beneficence, and justice (Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Respect for persons details that “individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection”). Beneficence is understood through two main principles: “(1) do not harm and (2) maximize possible benefits and minimize possible harms.” Finally, justice refers to the potential benefits of research and is guided by these formulations “(1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit.”

8.5 The Role of the Office for Human Research Protections

The Office for Human Research Protections (OHRP) is part of the Department of Health and Human Services (HHS) and “provide[s] leadership for all federal agencies that conduct or support human subjects research” (Human Research Protections, 2016). This includes developing educational programs and publications, advising and consulting on research, and overseeing research out of U.S.-based and worldwide institutions (Human Research Protections, 2020). All institutions registered or approved to conduct research under OHRP’s purview can be found at this link.

8.6 Federalwide Assurance

In order to be recognized by OHRP as engaged in research, institutions must submit an assurance of compliance noting the commitment to following the regulations that are required to protect human participants. The written document approved by OHRP is known as a federalwide assurance (FWA), and must be updated by each institution every five years (Human Research Protections, 2017).

8.10 Voluntary Participation

At no point during the informed consent, research study, or analysis should a participant feel that their participation is not voluntary (American Psychological Association, 2017, sec. 8.03; Protection of Human Subjects of Biomedical and Behavioral Research, 1979, pt. C). Ensuring that participants understand this sentiment is an integral element of informed consent. Through explicit statements, participants must know that they may withdraw at any time without penalty. Any language limiting the participant’s ability to decline participation directly conflicts with APA’s general principles. Additionally, it is essential that when working with vulnerable populations, the researcher takes care to ensure that there is no pressure to participate. Practically, this exists as straightforward statements made throughout the informed consent. Moreover, a statement related to the expected dissemination of results is encouraged as it will help inform the participant if they wish to continue.

8.11 What May Be Holding Up The IRB Application

Navigating the IRB review process can sometimes feel like a journey filled with twists and turns. In the quest for a successful application, understanding the avoidable stumbling blocks that can lead to delays and resubmissions becomes crucial. This discussion delves into the first category of these hurdles, shedding light on the often-overlooked issue of application incompleteness.

8.11.1 Incomplete Applications

Missing Supporting Document. Typically researchers are asked to upload supporting documents as part of their IRB application. Determining what documents to include can be overwhelming, particularly for new investigators. As research has become more integrated with the online world, a whole host of supporting documents, which should be listed in the institution’s IRB manual or instructions, must follow (Rothwell et al., 2021; Salmons, 2016). For instance, when advertising a study on social media, submitting a specific ad and the expected caption is wise. To ensure they have all the supporting documents, one must reflect on how much participant contact they will have, where they will connect with participants, and the specific messaging they will use.

Vague Description of Objectives and Processes. Ensuring that the statement of objectives clearly describes the research is vital. Thai includes comprehensive descriptions of the study outcomes and the importance of this specific research. Additionally, giving clear and explicit detail about the processes of recruiting and every interaction researchers may have with participants will ensure the IRB reviewers are not left guessing about the breadth of the studies’ impact on the public.

Even though the study might be “minimal risk,” participants have the right to know how and why the contribution of their time is important. When the objectives and purpose of the study are clearly and comprehensively described, the IRB reviewers will have greater confidence in their own assessment of the viability of the proposed project.

Generic Informed Consent Letter. There is a perception that informed consent letters are “legalistic,” “formulaic,” and that “no one reads them anyways” (Drolet et al., 2023, p. 19). However, this is not the case; the informed consent process is a conversation between the participant and the researcher. This open dialogue will ensure that participants are informed about how their participation contributes to further knowledge. The objective should be to ensure that the informed consent document makes the research as understandable as possible. Pictures, diagrams, accessible language (Try to write them at a grade 8 level), white space, and bullet points will ensure ease of understanding. If the research is using equipment, for instance, an electroencephalogram (EEG), take the opportunity to show the participant photographs. This may demystify the research process and make participants more inclined to engage and clearly show what is being asked of them.

Often research processes are filled with a lot of jargon and acronyms. Such language is likely easily understandable by those who know the research; however, the average participant is not usually “in the know” regarding technical or method-specific knowledge. Avoid the use of complex and technical language. Endeavor to write the informed consent using lay language. When in doubt, try explaining the study to someone who lacks knowledge about the research. Consider how they might explain the study to their grandmother or their cousin. If they can understand it, then the informed consent is on the right track.

Term Confusion. Defining and clarifying the terms used in one’s application is essential. This is achieved by providing precise and concise definitions for uncommonly used terms. For instance, explain what it means for the study to be “exploratory.” For qualitative researchers, this is relatively straightforward and commonplace. However, looking at “exploratory” through a quantitative lens may lead to confusion—additionally, endeavor to use consistent terminology throughout the application. It is crucial to keep in mind the audience of the IRB application, which may include individuals who need to become more familiar with the specific terminology used in the field.

Anonymous and anonymized data are terms that often spark confusion for students or researchers who are new to the IRB process. These terms are often used interchangeably, which is not in accordance with their definitions. Anonymous implies that the researcher will never know who the participant is, whereas anonymized data is the process of de-identifying data for analysis or dissemination purposes. When submitting the application, it is important to explain all research-specific terms and clearly understand the distinguishing features of closely associated terms.

Inconsistent and Inaccurate Information. At some point within a budding academic career, students and/or researchers may be asked to complete an IRB application for a faculty member. While this can be an exciting prospect, such delegation may be given to someone who does not know the research intimately or at all. Lack of familiarity with the research may contribute to reasonable errors in defining inclusion and exclusion criteria, forgetting to include the time commitments required of participants, or needing more clarity concerning remuneration. In these cases, there are a few steps that might be helpful: Firstly, it is integral to place one’s self in the participant’s position, what they would wish to know about the study, what would be essential information, and how it would impact the researcher willingness to participate. Secondly, it may also be helpful to inquire into institution-specific IRB manuals and guidelines; for instance, the University of Massachusetts Boston has a series of investigator manuals to guide researchers through the IRB process (Boston, 2022). Thirdly, one should ask established researchers at their institution for hints and examples of past IRB applications. Lastly, knowing the Office for Human Research Protections (OHRP) guidelines and resource books is invaluable as it provides the knowledge necessary to make strong arguments to IRBs when necessary. Secondly, it may also be helpful to inquire into institution specific IRB manuals and guidelines, for instance the University of Massachusetts Boston has a series of investigator manuals aimed at guiding researchers through IRB process (Boston (2022)]. Thirdly, one should ask established researchers at thier institution for hints and examples of past IRB applications. Lastly, knowing the Office for Human Research Protections (OHRP) guidelines and resource books is an invaluable tool as it provides the knowledge necessary to make strong arguments to IRB’s when necessary.

Having addressed potential issues in the IRB application process, the focus now shifts to challenges that may arise during the IRB review stage. Navigating through the intricate landscape of IRB review feedback poses its own obstacles, necessitating a careful examination of potential problems and effective strategies for resolution.

8.11.2 IRB Review Feedback Problems

Failure to Disclose Magnitude of Risks and the Impacts of Research. Minimal risk does not imply that the participant risk is zero. Further, just because the perception that risks have a low magnitude of harm does not ensure they do not have a probability of occurring. the researcher must ensure that they appropriately assess the balance between risks and benefits, that all risks are adequately described, and that the occurrence and probability of harm are fully described. For example, a risk may have a significant magnitude if it occurs but a small chance of occurring. If only the magnitude is described, the benefits may not be perceived to outweigh the risks. Comparatively, ensure that the researcher has not overstated the risks, as this may negatively impact recruitment or cause IRB reviewers to question the accuracy of the statement.

No person is always vulnerable or invulnerable. With this in mind, consider risks and vulnerability from the participants’ perspective by reading the application, information, and consent letter as though the researcher are a participant. This will ensure that they understand that vulnerability is assessed related to the research question.

Failure to Consider Undue Influence. It is prudent to ensure that recruitment happens in a neutral environment free of undue influence. Research may be initiated by academics who have a personal connection with their study population. Though this is not unethical, recruiting from personal connections can lead to unique challenges. Take steps to mitigate potential conflicts of interest by employing neutral recruiting methods. Practically this could appear as a standardized recruitment email that explicitly states, “ it will not negatively affect our relationship should you not advertise this study.” The researcher could also limit recruitment to being purely online, which may reduce the risk of influencing any potential participants.

Additionally, taking deliberate steps to mitigate coercion is an integral role of any researcher. For instance, asking a community agency to share a flyer so that people can opt-in can reduces a perceived sense of pressure experienced by potential participants. In contrast, directly contacting people the researcher knows who would meet study criteria may help increase the sample size, but may result in IRB concerns about coercive recruitment methods (Klitzman, 2013).

The Reviewer is Unfamiliar with Proposed Research Methodology. A key source of delay is that most submissions must respond to at least one request for further information or clarification from the Human Research Ethics Committee (Brandenburg et al., 2021). This may be due in part to a disconnect in understanding between the IRB reviewer and the researcher. Researchers may sometimes be asked to clarify terms related to their proposed methodology or analytic plan. For example, an expert in qualitative research methods may understand specific qualitative research terms. Additionally, reviewers may express hesitance for approving a study if they have not worked with patient data, while a IRB reviewer with a health research background may be able to give feedback on the best way to safely transfer clinical data. However, it is essential to remember that the IRB reviewers will come with differing areas of expertise.

It is likewise important not to assume that the reviewer understands the study method. In some cases, it helps to operationally define key terms, provide more information and explain the data collection and study procedures extensively. Providing ample citations of sources related to the chosen research design and methodology may increase reviewers’ confidence in the proposed methods.

8.12 Summary, Conclusions, and/or Recommendations: Ethical Considerations for Emerging Challenges

We began this chapter with an overview of the history of policies and procedures related to IRBs. In our second section, we identified common challenges new researchers may encounter when completing the IRB application process. To conclude our chapter we detail a few considerations for navigating IRB applications based on our research interests and positionalities. In the first section, MM describes her process of navigating IRB applications in a manner that centers the experiences of autistic participants. In the second section, we share considerations for conducting research with online communities. Finally, we conclude with a research method that has been increasingly discussed in supervisory settings: autoethnographies. Although the examples we provide are specific to our shared research interests at the intersection of autism and LGBTQ identities, we hope the considerations and suggestions that we offer can be adapted to additional specific populations of interest.

8.12.1 Destigmatizing the area of study

Autism is a stigmatized area of study. This bias can manifest through stereotypes and misconceptions about autistic people particularly subgroups not immediately thought of when hearing the term autism (e.g., White, heterosexual, cisgender boys). These perceptions may also be held by IRB reviewers responsible for making decisions for research studying autism. When conducting research focused on the experiences of intersectional autistic participants, I (MM) have found that part of my job as a researcher is to provide education and justification for my research decisions. In these examples, I am not talking about a particular institution but sharing examples across multiple institutions informed by my experiences and conversations with colleagues. For instance, reviewers’ biases about how autism manifests can inform the sort of feedback they provide about the study design, such as asking about the presence of a legal guardian for autistic adults over the age of 18, or expressing worry about asking about sexual and gender identity among an autistic sample. Although we want to ensure all participants have the capacity to consent to participation in research, only when conducting a study with autistic adults have I been required to state this at the outset and as participation criteria. In a discussion among a group of autistic autism researchers navigating the IRB was mentioned several times, particularly concerning this tension between centering autistic voices versus protecting a “vulnerable population” (Dwyer et al., 2021, p. 215). As stated by Dr. Sandra Jones, “We need to make sure autistic people are able to actively participate in research: that we are not protected by IRBs so much that we are actually silenced” (Dwyer et al., 2021, p. 215)

As a neurotypical, queer researcher who conducts research at the intersection of autism, sexuality, and gender, I have found it necessary to frame my area of study in anticipation of possible critiques, particularly starting from a space of naming that there are many biases about autistic people and that yes, autistic people are also LGBTQ+ and can talk about experiences related to identity development and self-awareness.

The way autism presents itself can vary significantly across individuals, making exploring how to best support individual participation needs and preferences in each study design essential. For example, revising an informed consent form to use bullet points and white space may make it easier for participants to review key information but may be presented in a different format than reviewers are used to. By stating this upfront, researchers can educate reviewers and demonstrate how they communicate risks and participation criteria while attending to participants’ differences.

There is a history of excluding people with disabilities from research because it is assumed that they cannot provide consent, which is inaccurate (Marshall et al., 2012). Marshall and colleagues (2012) explored ethical concerns related to research with LGBTQ individuals with intellectual disabilities, highlighting the importance of managing the risk of coercion, consenting to participating in the study, and navigating issues of confidentiality and disclosure. Increasingly, researchers are partnering with communities in meaningful ways; this is a positive shift. By collaborating with community partners or co-researchers early in the research process, researchers can better ensure that what we are studying is meaningful and that study materials are presented to meet populations’ needs. Unfortunately, academic systems are often inflexible, and many barriers in place reflect ableism on both interpersonal and structural levels. For instance, there are a number of challenges that emerge when conducting community based participatory action research (see McCracken, 2020 for an overview). As stated by Dr. Dora Raymaker, “even the things that we have to do with the IRB (institutional review board) to include autistic collaborators butt up against ableist systems—the fact that we exist and that we have these needs is going to make the rest of the field change to accommodate us and make room for us for what we are doing” (Dwyer et al., 2021, p. 214).

This example can be applied to research with understudied populations or populations who may be labeled as vulnerable. We encourage researchers-in-training to consider the populations with whom they are most interested in working and what aspects of the research design will likely require advocacy. For instance, in this textbook’s Community Based Participatory Research chapter , one will find an interview that MM conducted with Dr. Roberto Abreu. He details how he advocates throughout the IRB process to reduce barriers to participation with Latinx transgender individuals. When considering a study with LGBTQ youth, researchers may wish to ask for a waiver of parental consent to ensure that students are not outed if they wish to participate in their research (see Flores et al., 2018). Such practices require researchers to share more detail about their rationale; in support of their advocacy efforts, researchers may find it helpful to consult and reference previously completed studies.

8.12.3 Approaching autoethnography

Autoethnography is a qualitative method in which an academic researcher draws on and analyzes their lived experience to provide insights into self-identity, cultural norms, communication practices, traditions, symbols, societal rules, felt sense, meaning-making, emotions, values and larger social, cultural, and political issues (Adams et al., 2014, p. 2). In recent years, institutional research boards have shifted towards requiring IRB approval for some autoethnographic studies, often determined on a case-by-case basis, which has led to new considerations and challenges in the IRB application process. Writing an autoethnography is not as easy as putting “pen to paper.” Since autoethnography involves studying oneself, it may raise ethical considerations requiring an ethics committee’s approval. Like any research involving human subjects, autoethnography must adhere to ethical principles and obtain ethical approval from the relevant institutional review board (IRB) before conducting the research. The IRB review process can lead to delays, challenges, or tensions, particularly regarding protecting the individual when they wish to share their story openly MISSING REFERENCE (Maxwell, 2019). One primary concern that IRBs may have is the need to obtain consent from others who are mentioned in the study. To ensure that personal information is kept confidential and maintain objectivity while interpreting their experiences. To illustrate such a need, we turn to Edwards’ (2021) autoethnography, wherein they reflect on an experience in which they were identified in a colleague’s published autoethnographic report. The publication gave rise to feelings of hurt and disdain as it was circulated around campus. This example depicts the need for autoethnographic researchers to be cognizant of their plans for publication as they may need to consider issues related to privacy, anonymity, and potential harm to themselves or others. Though some institutions may not require IRB approval for all autoethnogaphic studies, others may require it for autoethnographic doctoral dissertations MISSING REFERENCE (see Muscente & Lucero, 2021) when researchers are still learning best practices; seeking consultation before conducting autoethnographic research is vital.

8.12.4 In closing

As we conclude this chapter on ethical applications, it’s evident that the landscape of research ethics is both intricate and essential. Successfully navigating the terrain of IRB applications requires not only a comprehensive understanding of the guidelines and regulations but also a commitment to upholding the principles that underpin them. The ethical application process is not merely a bureaucratic requirement but a testament to our dedication to producing knowledge that benefits society at large while minimizing harm. By embracing ethical considerations as the cornerstone of our research endeavors, we ensure the integrity, validity, and societal impact of our work. As they continue their academic and professional journey, may the insights shared in this chapter serve as a compass, guiding them towards ethically sound and socially responsible research practices.

8.13 Suggestions for Practice, Further Learning, and/or Conversation (Formatted “Heading 1” on Home/Styles)

8.13.1 Checking Understanding and Reflection Exercise

Purpose: This activity gives students critical insight into the multiple considerations and roles while completing an IRB application. By engaging students in the ethics applicant and investigator role, they may gain perspicuity into the multidimensionality of the IRB application process. Overall, the students’ perceived insight determines success in this activity. They will gain a practical understanding of navigating ethical issues that may arise in their research or when serving on an IRB. Moreover, they will be able to engage in thoughtful, ethical analysis and discussion, preparing them to conduct research with the highest level of integrity.

  • Have students read a brief overview of institutional review boards (IRBs) and their role in research, such as this chapter, which would function well as an overview.
    • Provide examples of key areas IRBs typically review, such as informed consent, confidentiality, and risks and benefits to participants.
  • Next, ask students to reflect on their own research experiences or interests.
    • Have they ever conducted research that required IRB approval, or do they plan to in the future?
    • What populations do they hope to study? What ethical considerations have they addressed or will they need to address in their research?
  • After reflecting on their experiences, have students read a case study [see supplementary materials] involving ethical considerations and IRB approval. Ask students to work in small groups to discuss the case study and the ethical considerations involved.
    • What are the potential risks and benefits of the study?
    • What might be alternative approaches taken to address the ethical concerns?
  • Finally, bring the class together and have each group share their thoughts and insights. Discuss the perspectives and ethical considerations involved, and explore how IRBs might approach the case study.

8.14 Supplementary Materials

8.14.1 Case Study: Investigating Life Satisfaction in Autistic Elders

Research Question: What factors contribute to life satisfaction in autistic elders?

Research Design: A qualitative study involving interviews with autistic individuals aged 55 to 99+.

Background: Autistic elders, like other aging adults, experience a range of life stratification, which refers to the unique experiences of systematic differences in life ventures, opportunities, and outcomes based on age, gender, race, ethnicity, socioeconomic status, and other social and cultural factors (Bishop-Fitzpatrick et al., 2019; Gothelf, 2019; Munnell & Orlova, 2017). However, autistic elders may face additional challenges and complexities due to their autism diagnosis, affecting their health, social connectedness, and quality of life (Bishop-Fitzpatrick et al., 2019, p. 8).

Some research suggests that autistic adults may experience greater social isolation, difficulties with daily living skills, and higher rates of comorbid medical and mental health conditions as they age (Bishop-Fitzpatrick, 2019, p. 8). Autistic elders may also face challenges in accessing appropriate healthcare and support services and navigating social and communication barriers in their communities (Munnell & Orlova, 2017).

In addition, autistic elders may face discrimination and stigma based on their age, disability status, and other factors, which may impact their social and economic opportunities and overall well-being (Munnell & Orlova, 2017). However, it is essential to note that a range of experiences exists; thus, there is potential that not all autistic elders experience adverse outcomes or challenges, and some may exhibit resilience and positive adaptation in later life. Presently a limited body of literature exists; more research is needed to better understand the life stratification experiences of autistic elders and to develop effective interventions and support services to promote their health, well-being, and social inclusion in later life.

Methodology: We aim to recruit 16 to 18 participants to partake in semi-structured interviews expected to take anywhere from 45 minutes to an hour. Interviews will take place over Zoom and will be recorded and transcribed. Interviews will be coded and transcribed using password-protected software (e.g., Nvivo, Otter.ti). Notes, memos, and interview transcripts will be stored in a password-protected folder with data encryption (electronic) or in locked file cabinets in the PI’s office (physical). Participant names and emails will only be used to share the results with individual participants and invite individual participants to future research-related events. Names and emails will not be linked to specific data after the complete research. The identity of participants will be stored in a password-protected drive that is only accessible to the researchers. Interviews will be conducted by the PI, graduate student research assistant and undergraduate research assistant, all trained in qualitative research methods. Semi-structured questions and probes will be used for clarification purposes or further exploration in a non-leading manner.

Interviews will only be offered in English.

Participants will be informed of the interviewer’s positionality as this may increase the comfortability of participants. During the interview portion of the study, semi-structured questions will be focused on three different yet interrelated categories. Firstly, participants will describe their lived experiences with their autism diagnosis. This aims to build rapport with the participant and get them talking about themselves. Secondly, they will be asked questions about how they define life satisfaction within their own lives, describe their overall well-being and quality of life, and highlight where disparities and inequalities arise in their life.

Risks and discomforts associated with the research: The present research study has minimal risks and discomforts. Participants may feel uncomfortable reflecting on challenges and negative experiences

Describe the potential, direct benefits: We anticipate no potential benefits.

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