Resources & Guidance

Towson University pledged to become a more inclusive and equitable institution in its Diversity Strategic Plan 2020-2025. One way that the IRB supports this goal is by making suggestions on the language used in research documents to refer to the identities of human subjects’ research participants. Many professional organizations, such as the American Psychological Association (APA) and the National Institutes of Health (NIH), have published guidelines for inclusive and destigmatizing language.  I will begin by defining inclusive language terms. I will then discuss the relevance of language related to identity as an ethical issue. Finally, I will provide some suggestions for appropriate language use.  Resources to support the use of inclusive and destigmatizing language will also be provided.

Definitions of inclusive language terminology
The APA and NIH encourage the use of person-first or identity-first language depending on the preferences of the community to which one is referring. In person-first language, the individual’s personhood is emphasized over their disability, characteristic, or condition. For example, we would use the term “a person with an addiction” to emphasize that addiction is only one aspect of the person, as opposed to “an addict” which suggests that “addict” is the person’s whole identity. To the contrary, in identity-first language, the disability, characteristic, or condition is emphasized such as when referring to older adults or addicted persons. People may prefer identity-first language because it is a way that the individual can “own” the disability, characteristic, or condition as a point of pride, because it is a way of emphasizing their connection with a specific community, or for other reasons.  For example, in Alcoholics or Narcotics Anonymous, using the moniker, “addict” is an important part of the recovery process. Referring to oneself as an addict is a way of acknowledging that being addicted to substances is a central part of who the person is and that recovery from addiction is a lifelong process. In inclusive language, the goal is to avoid use of terms that would exclude groups of people such as when using “mankind” to refer to all people; in this case, individuals who identify as women or non-binary may feel excluded.

Why the language we use is an ethical issue
The main goal of research with human subjects is to understand and/or solve the real-world problems of specific populations. As such, good research depends on our ability to recruit samples of participants that represent the population to which we want to generalize our findings. The language we use in our research documents, especially our recruitment materials and informed consent forms, is therefore critical for ensuring that we attract and enroll all segments of our target population.  Factors that may impact a researcher’s ability to recruit a representative sample are using language that excludes or invalidates a specific segment of the target population and/or failing to provide clear inclusion/exclusion criteria. Failing to recruit a representative sample may mean that the study is not capable of meeting its stated aims. As noted in the PI manual, a study that cannot meet its aims has only risks and no benefits.

In addition to impacting the external validity of a study, use of language that excludes, invalidates, or ignores specific segments of a population might be seen as a microaggression. Microaggressions are everyday slights, insults, or invalidations of individuals from minoritized identities that can negatively impact mental health. Thus, using exclusive language is inconsistent with the Belmont Report Principle of Non-Malfeasance or “Do No Harm.” For example, asking individuals whether they identify as male or female in demographics questionnaires may make individuals who do not identify with the gender binary feel excluded from or invalidated by the research.

Recommendations for appropriate language use in research documents
As suggested above, different communities may have different preferences for the terms used to describe them and their community. As such, researchers should be careful to educate themselves about the ways in which different communities refer to themselves when developing research documents such as recruitment materials and informed consent forms. The APA’s Inclusive Language Guideline suggests that if a community’s preferences are unknown, it is best to use person-first language. Moreover, PI’s should be thoughtful about who their target population is and be sure that their protocols and recruitment materials are clear about the inclusion and exclusion criteria for the study.  For example, if the study is examining biological differences between males and females, then recruitment materials should be clear that the target population is individuals who were assigned male or female at birth or whose gender identity matches their sex assigned at birth. Finally, demographics questions assessing identities should be exhaustive or permit participants to write in their identity. For example, researchers may use two questions to assess gender identity. The first question would ask whether the individual identifies with the trans community.  The second question, “I identify as” would give participants the following options to choose from: (a) a man, (b) a woman, (c) non-binary, (d) I prefer to write in my gender identity.  If (d) is chosen, then participants should be given the option to write in their gender identity.  The same approach can be used when assessing race and ethnicity. Note that use of the option “other” may make participants who do not identify with one of the given categories feel invalidated and therefore should not be used.

Resources for inclusive language
Researchers who want more information about inclusive language should visit the APA’s Inclusive Language Guidelines, or the National Institutes of Health’s NIH Style Guide: Person-first and Destigmatizing Language.

Many of us learned how easy and convenient online data collection can be during the pandemic. The internet provides easy access to diverse study populations and is a quick and convenient way to obtain large samples. Using online surveys that are set to remove IP addresses is one way to ensure that participants, and their data, are anonymous, especially when there is no compensation being provided. It is important for researchers to remember, however, that recruitment materials represent the first contact with potential research participants. Thus, recruitment is the point at which the informed consent process begins and must be guided by the principles of Autonomy, Justice, and Non-malfeasance, which are explained below.  This month, I want to talk about how those principles affect online recruitment as well as IRB policies that researchers must follow when recruiting participants online. 

Autonomy and Online Recruitment 
The principle of Autonomy requires that researchers respect research participants’ rights to privacy and to make the decision voluntarily whether to take part in a study. The internet may seem to be a public forum. As such, researchers may believe that individuals’ identities and the information they share online is public. This belief is problematic for two main reasons. First, closed, or private (e.g., online AA or NA meetings; organizational Listservs; online support groups) sites have rules of conduct that indicate who may post to the site, who has access to the membership list, and what types of information may be posted to the site. As such, members of closed groups can reasonably expect that their identities and the information they share will be kept private, at least within the group. Second, members of private online groups or Listserv subscribers may view information that is shared as having been endorsed or approved by owners or moderators. Moreover, researchers may be members of the groups from which they want to recruit (e.g., if the PI is in recovery and wants to recruit other recovering individuals through an online AA meeting that the PI regularly attends). In both instances, there is the concern that members may feel undue influence to participate in the research when they would otherwise choose not to.

Justice and Online Recruitment 
The principle of Justice requires that the risks and burdens must be shared equally among all segments of a population that stands to benefit from the research. Thus, for example, if a study is expected to benefit the general population, then the PI may not limit their recruitment to a specific segment of the population (e.g., prisoners) that is easily accessible. This is also true for online recruitment.

Non-Malfeasance and Online Recruitment
Finally, researchers are obligated by the principle of Non-malfeasance either to “do no harm” or to minimize harm to the extent possible.  When conducting studies on sensitive topics such as substance use, bereavement, gender- or sexual-minorities, researchers may want to recruit participants through sites or listservs that cater to these populations. However, researchers must not do anything that would violate members’ sense of trust in the sites or give the impression that the group does not respect members’ privacy. If participants lose trust in a site, they may lose access to an important support system such as a bereavement or mutual help group. It may also make participants reluctant to trust other comparable sites.

Policies for Online Recruitment 
There are many ways in which researchers can use the internet to recruit participants. For example, researchers may send emails through listservs. They may pay Social Media Influencers to make announcements about the study or for banner advertisements. Researchers may post material about the study on their personal social media site or to open or closed social media groups that cater to specific populations. When using such methods, researchers must provide the following information in their IRB applications:

1. Researchers must provide a list of all online venues where they intend to post study information, which would include:
   1. All websites (i.e., URLs);
   2. All social media groups, threads, or forums;
   3. Names of all Social Media Influencers who will make announcements about the study;
   4. All sites that will be paid to post advertisements; and/or
   5. All organizational listservs that will share study information.
2. Researchers must indicate whether each online venue they plan to use is private (closed) or public (open). For private sites, the researcher must read and agree to abide by their rules. Researchers may also share links to the rules for posting in their application.  If permission from moderators is required to post research recruitment materials, then the researcher must state that they will obtain permission from the moderator before they post their recruitment notices.
3. Researchers must provide the language that will be used in emails or social media posts as well as attach to the application all fliers that will be posted. If Social Media Influencers will be paid to recruit participants, then the PI must include the script that will be used by the Influencer when making announcements about the study.
4. Spamming is prohibited. Therefore, researchers must indicate that if their study is taken down, they will not post the link or advertisement to that site again. Moreover, while they may post to the same site more than once, if permitted by the site moderators and/or rules, researchers should keep the number of posts to the same site reasonable (e.g., no more than once per week).

College students, especially those enrolled in a faculty member’s course, are an easily accessible sample making them highly attractive as potential research subjects. This is especially true when the research question focuses on instructional techniques.  This article discusses why college students, especially students in your classes, should be considered vulnerable populations. Content will focus on the necessary protections that PI’s must have in place should they want to use their own students as research subjects. 

Why College Students are Considered Vulnerable Populations 
The National Bioethics Advisory Commission (NBAC, 2001) defines a vulnerable population as “a person or persons whose capacity to provide voluntary informed consent is limited due to one or more of the following intrinsic characteristics: (a) cognitive or communicative limitations, (b) institutional vulnerability, (c) deferential vulnerability, (d) medical vulnerability, (e) economic vulnerability and/or (f) social vulnerability”. College students possess one or more of these characteristics making them a vulnerable population.  Specifically, some college students are minors and are therefore unable to legally provide informed consent.  As such, college students may be susceptible to undue influence or coercion because of deferential or institutional vulnerability. For example, if the Principal Investigator (PI) is their course instructor, students may not believe they have the right to refuse participation. Alternatively, they may believe that participation will give them benefits such as lenience on the part of the instructor when grading assignments or the opportunity to have their grades raised.  This is especially true for students who are doing poorly in a class.  Finally, students may come from minoritized or marginalized groups (e.g., DACA; sexual/gender minorities) for whom the potential risks and burdens of research may be greater than for non-minoritized students.

Special Protections Needed when using Students in your Classes as Research Participants
It is important to note that some universities do not permit professors to use students in their own classes as research subjects.  Towson University does permit this if the research is relevant to college students (Principle of Justice, Belmont Report) and the PI puts some or all of the following protections in place.  

• Protection Option 1: Faculty should consider recruiting a Co-Investigator (Co-I) who has no relationship to the students. This Co-I should be fully responsible for obtaining informed consent and implementing the study procedures. The Co-I can be a graduate student. However, the Co-I should not be the course Teaching Assistant because the issue of undue influence or coercion is the same for anyone who has access to or control over course grades.
• Protection Option 2: The research should be conducted fully online with the survey set to anonymize the data (i.e., to not collect IP addresses). In this way, no additional personnel are required to conduct the study procedures.  

Both options ensure that the Instructor/PI will not know who has chosen to participate in the study and will not be able to link specific students to their data.

Additional Protections Required when Students will be Compensated for their Participation:
To reduce the risk of coercion, the PI should not know who has chosen to participate. This is not possible when compensation in the form of extra credit will be provided. If a PI wants to offer extra credit as an incentive, the following procedures must be followed. First, the Instructor should not know who has participated in the study until after the final exam has been graded. If Option 1 is used, the Co-I can maintain the list of students eligible to earn extra credit and provide this list to the course instructor at the appropriate time. If Option 2 is used, then the instructor should provide a link to a separate survey where students can enter their names to be eligible for extra credit. The PI must indicate in both the protocol and the consent form that they, the instructor, will not access this list until after the Final Exam has been graded. In all instances where extra credit will be offered for study participation, the faculty instructor MUST offer alternative ways for students to earn extra credit other than study participation.

Language to be Included in the Informed Consent Form

• Voluntary Nature of Participation: Although all consent forms must make clear the voluntary nature of research, this is particularly important when the PI is the course instructor for potential research subjects.  In addition to stating that the decision whether to participate is entirely up to the subject, the consent form should also state that the decision whether to participate will in no way affect the student’s grade in the class, the student’s relationship with the faculty member, or the student’s relationship with Towson University.
• Whether Participation and Data are Anonymous: The consent form should explain whether the course instructor will know who participated.  If no compensation is being offered, then the study can be considered anonymous (i.e., the instructor will not know who participated and will be unable to link specific students to their responses). If extra credit or other form of compensation is being offered, students must be informed when the instructor will know who participated and how the security of the list of participants will be ensured until such time as extra credit is being awarded (e.g., the list is being maintained by an outside investigator and will not be shared with the instructor until after the Final Exam has been graded).
• Alternatives to Participation: If extra credit is being offered, the consent form needs to make clear what students need to do to earn extra credit (e.g., sign a sign-in sheet; provide their contact information in a separate survey). In addition, the consent form should make clear alternative methods for earning extra credit other than study participation.

Other Considerations
When engaged in the Scholarship of Teaching and Learning (SOTL), there may be instances in which the PI is trying out a new instructional technique that may, or may not, be beneficial.  In this case, the data being collected are classroom assignments that all students are required to complete. Moreover, students are only being asked to complete surveys or to participate in procedures that are a routine part of the course. Finally, because it is a new instructional technique, the PI may not know whether they plan to publish or present the data collected.  In this instance alone, the PI may implement the new instructional technique without IRB approval. If the data proves to be interesting, the PI may then submit a protocol requesting permission to publish or present data that were previously collected for non-research purposes (i.e., Exempt Category 4).  It is recommended, however, that PI’s contact a member of the IRB or someone in the Research Office before making the decision about whether an IRB application is needed.

References:

• Ethical and policy issues in research involving human participants: report and recommendations of the National Bioethics Advisory Commission. National Bioethics Advisory Commission. 
• Belmont Report.

One of the keys to successfully navigating the IRB review process is to understand what reviewers are looking for in an application.  This month, I offer this information to help applicants better understand how to reduce the number of revisions that may be required, thereby speeding up the review process.  

Make Sure the Risk/Benefit Ratio is Clear and Favorable

The primary responsibility of the IRB is to ensure that the risks of research are either outweighed or justified by the anticipated benefits.  When approaching your IRB application, be sure to clearly state the potential benefits of the research. Moreover, anticipate, and list, any risks to participants and clearly describe how they will be mitigated.

Provide a Brief, but Meaningful, Rationale

The IRB requests one to two paragraphs, with citations, that support the importance of the research and its anticipated benefits.  At the end of the rationale, clearly describe the aims of the research. The IRB needs to know your study aims so that they can evaluate whether the design is sufficient to meet those aims. One of the mottos that reviewers keep in mind during the review process is that “a study that is not sufficiently well-designed to meet its aims has only risks and no benefits”. This is because a study that cannot meet its aims will waste participants’ time which, while arguably minor, is in fact a research risk.  Because the risk/benefit ratio would not be favorable, the study would not be approvable.

Provide a Detailed Description of Your Methodology

Please provide a detailed description of your study methodology from the first to the last contact with participants.  Remember that informed consent begins when the participant is first introduced to the study, whether this is through an email, flier, social media post, or other means, and ends after the last study procedure has concluded. As such, you need to describe your recruitment methods; how, and by whom, informed consent will be obtained; where the study will take place; what the participant will be expected to do as part of their participation; and how/where the data will be stored. At each step, be clear about any risks (such as the potential for loss of confidentiality) and how those risks will be managed or mitigated. If you are requesting a waiver or alteration to the process of informed consent, a justification must be provided.

Include All Supporting Documents

The IRB will require you to submit final copies of all recruitment materials, stimuli, and measures.  Moreover, the IRB requests that you submit the Consent Forms, Surveys, and/or Interview Questions, in the format in which they will be presented to participants.  If data collection is occurring online, submit both a pdf copy of the survey and a link.  For studies involving qualitative interviews or focus groups, submit the script you will use to introduce the interview followed by the questions you plan to ask (it is not necessary to include all follow-up prompts, however). Finally, if the interview is to be recorded you must make that clear to participants as soon as recording starts. Inform participants that you plan to document their acknowledgement to agree to be recorded, and that they have read the consent form, understand what is expected, and have had their questions answered.  Finally, if the study involves more than minimal risk, the specific risks to participants should be reiterated on tape before the interview begins.

Make Sure Your Informed Consent Document/Information Sheet Includes All Required Information

This part of the application gets the most attention and often requires the most revisions.  To ensure that you are including all required information, please refer to the Consent Form Template above. Be sure that the information in the consent document is consistent with the information presented in the application.

Respond to ALL Reviewer’s Comments and Make Revisions Clear to the Reviewer

If you are asked to revise your application, it is helpful to provide a written response that summarizes what changes have been made. You MUST respond to every comment, regardless of whether you agree or not. If you disagree with, or can’t make, a requested revision, justify why you are not making the change.  If your justification is sound, and the procedure does not result in an unfavorable risk/benefit ratio for participants, the reviewer may accept the justification.  However, please note that the IRB reviewer may not find the justification compelling or may require other revisions to ensure that all potential risks are mitigated to the extent possible. 
Please make your revisions apparent to the reviewer. The Kuali system will make the revisions in the on-line forms visible to the reviewer, but it is important for you to make the changes in the attachments apparent. This can be done by highlighting the changes, using track changes, or using a different colored font. Submitting attachments without doing this will elongate the review process.

Conclusion

Please note that this is not an exhaustive list but does cover the main concerns that prolong the review process.  If you have questions, please feel to reach out to me or any other member of the IRB. 

Committee Membership and Work

Towson University’s IRB is comprised of 13 members, appointed by the Provost. In accordance with Federal regulations, the IRB contains at least one non-scientist and a community member. The IRB also seeks a gender, racial, and ethnically diverse Committee with varied expertise (e.g., qualitative researchers; child and adolescent researchers; etc.). The IRB includes representation from each of the Colleges, and this year four new members were named.  

Participation on the IRB is a 12-month commitment, with members usually reviewing 1 or more exempt or expedited applications each week. Between July 5th and August 26th 2022, for example, the committee reviewed 51 applications including one full board application, 25 new, 8 renewals, and 16 amended protocols in addition to a number of revised resubmissions.

Mission of the Committee
While the IRB’s main responsibility is the protection of participants in Human Subjects research, TU’s IRB also strives to educate and support the Human Subjects Research Community. To that end, the Committee develops guidance based on the Federal Regulations. For example, because the consent form is the document that receives the most revisions, the IRB provided a consent form template for investigators to use that will ensure their document contains all required language. Updated guidance, the consent form template, and a comprehensive “PI” manual can all be found by following the Resources & Guidance link on the IRB section of the OSPR website. In addition, I, the Vice Chairperson, Bethany Willis-Hepp, Assistant Director for Research Compliance, Jenn Ippolito, as well as any member of the Committee are available to come and speak to your colleges, departments, classes, etc. about the IRB process and to answer questions.  We are also available for one-on-one consultation.

Some Future Plans
The IRB is charged with ensuring that research is being conducted in accordance with the approved protocol. To that end, the IRB may contact Investigators to schedule a time to review the forms being used and the study procedures to ensure that they comply with the IRB approved protocol. In the future, I plan to offer columns on other topics such as what the IRB is looking for in the Kuali protocol application; assessing demographics to ensure inclusivity; etc. Please feel free to reach out to me directly should you have a topic you would like to see addressed in a future article.  
It is my sincere privilege to serve as your IRB chair and I look forward to working with all of you to ensure that we continue to conduct high quality and ethically responsible research.