Vulnerable Populations

An institutional vulnerability is when persons are within a system where they are subordinate to a formal authority, which could influence the decision to participate in research.

Deferential vulnerability is like institutional vulnerability, except the coercion from subordination does not come from a formal hierarchy. Subordination is based on informal relationships where there is a differential in power dynamics, putting the individual at a higher risk of exploitation due to the subordinate status. This situation could occur when recruiting one’s own patients for research.

General strategies:

• Do not use persons with a difference in power dynamics simply because they are convenient and assessable to the study team.
• Initiate contact outside the environment where the source of subordination occurs. For example, a flyer about the possibility of participating in a research study posted in common areas, such as the cafeteria or student community center, is better than the professor/investigator asking for participation in the classroom and inviting interested students to approach the professor/investigator after class.
• Design recruitment strategies so that the participant who is interested may approach the researcher and initiate enrollment. For example, provide flyers that provide the study team’s contact information that allows interested participants to reach out on their own to participate.
• Have the enrollment and consent process conducted by someone on the research team who is at “arm’s length” to the potential research participant. For example, employees should not be recruited or consented with their present supervisor. Patients of the study doctor could be recruited by the study coordinator and not their own doctor.
• Voluntary participation should be emphasized at all points of the recruitment and informed consent process.

Students recruited as research participants are vulnerable to coercion because of the possibility that they may perceive grades or other benefits as dependent upon their participation in research. A student may not be compelled to participate in research as part of a course requirement.

When recruiting students as subjects here are some things to consider:

1. Justification for Targeting Students: Researchers who plan to enroll only students must be able to provide a rationale, other than convenience, limiting enrollment to only students.
2. Investigators or instructors may not impose penalties on students who fail to participate in research or show up for scheduled research-related appointments.
3. Recruitment
   1. Indirect Recruitment Option
      1. This is a preferred method because it avoids using class time to recruit or engage in the research and allows for the enrollment decision to occur outside the presence of the researcher-instructor and classmates.
      2. Examples on how to do this:
         1. IRB-approved recruitment materials may be posted anywhere on campus with the appropriate departmental permission (e.g. unit or office sign-off if necessary).
         2. Mass email from Registrar: Investigators seeking approval from the Registrar’s Office to email recruitment materials or study announcements to students must explain this recruitment method in the IRB submission and protocol. The Registrar must be provided a copy of the IRB approval letter before such an email can be sent. The Registrar may or may not grant such a request, regardless of IRB approval.
   2. Direct Recruitment
      1. Investigators may make study-related announcements (such as study title and investigator contact information) or provide recruitment materials (such as flyers) to students in classrooms or online courses.
      2. However, be mindful of the potential for coercion/undue influence when the investigator is also the class instructor or recruitment is performed with the instructor in the room.
      3. Recruitment methods should permit students to self-identify outside of the classroom to maintain confidentiality and minimize the potential for peer pressure. For example, students should be provided with contact information for a study team member who they may contact for more information after class, rather than be asked to express interest at the time of the announcement.
4. Consent
   • The consenting process must emphasize that students may choose not to participate in the research and that their decision will not affect their grade, class standing, or relationship with any instructor. (Template language: Your decision to take part or not take part in this study will not affect your grades, your relationship with your professors, or standing in the University.)
5. Course Credit or Extra Credit for Participating
   1. If course credit or extra credit is offered in exchange for participation, an alternate means of earning equivalent course credit or extra credit must be made available for those who cannot, or choose not to participate in a study.
   2. The alternative to participate should be comparable in terms of effort, time commitment and credit given.
   3. Use of extra credit should be reasonable (i.e., it should not significantly increase a student’s overall grade).
   4. This alternative assignment must be articulated in the research protocol and consent document.
6. Use of Class Time to Participate in Research
   1. Submissions proposing the use of class time for research should include an explanation of the benefit of the research to the students.
   2. An alternative activity should be provided to those students who choose not to participate.
7. Use of Educational Records for Research Purposes
   • Educational Records are regulated by Family Educational Rights and Privacy Act (FERPA). Education Record is defined by FERPA as any record directly related to a student which contains personally identifiable information and is maintained by the university or a party acting on behalf of the university (e.g. class assignments, grades, A/V recordings, and non-directory level information).
   • See policy 700.05 Education Research: FERPA and PPRA Compliance.

Employees recruited as research participants are vulnerable to coercion because of the possibility that they may perceive employment or other benefits as dependent upon their participation in research. An employee may not be required to participate in employer-initiated research as a condition of employment.

Investigators recruiting employees should consider:

1. Justification for Targeting Employees: Researchers who limit enrollment to only employees must be able to provide a rationale, other than convenience, for restricting the study population to employees.
2. An employee cannot be required to participate in research as a condition of employment.
3. Compliance with Human Resources Policies: Researchers should review the organization’s policy about employees participating in research on “company time”. Often employers have restrictions about when and how employees can participate in research. When recruiting employees, Investigators should ensure they are following human resources policies.
4. Consent: Ensure participants know that they may choose not to participate in the research and that their decision will not affect their employment or performance evaluation.
   1. Recruitment
      1. Indirect Recruitment: IRB-approved recruitment materials may be posted in general areas on campus with the appropriate departmental permission (e.g. unit or office sign-off if necessary).
      2. Direct Recruitment: Investigators may make study-related announcements or provide recruitment materials to employees at regular meetings. However, recruitment methods should permit employees to self-identify as interested in participation in a way that maintains confidentiality. For example, employees should be provided with contact information for a study team member who they may contact for more information.
      3. When possible, engage in recruitment and consent activities outside of the presence of the employee’s supervisors.
      4. Take steps to avoid identifying employees who decline participation. Whenever possible the research procedures should be conducted out of sight of other employees. For example, surveys or questionnaires could be given to the employee participants to complete at home and be mailed back to the Investigators instead of asking all employee-participants to convene in a room.
5. Employee Data in Research
   • Researchers should not use employee data for research purposes without the prior written consent of the employees and documented permission from Human Resources.

Investigators must provide appropriate safeguards if planning to recruit economically disadvantaged subjects.

The compensation plan must be reviewed to ensure that economically disadvantaged subjects are not vulnerable to coercion or undue influence by the value of the compensation.

Economically disadvantaged persons may face additional burdens to participating in the research. Things that we might take for granted, such as access to transportation or computers, may not be as readily available.

For example, if the study requires filling out online surveys, can persons without access to a computer equally participate as those with a computer in their homes? One answer is to use publicly available libraries to access the internet. However, if these computers are only available during normal business hours, and most subjects will have to work during that time, is this really a viable option?

Researchers will need to be cognizant of these hurdles and be realistic, and perhaps creative, in finding ways to overcome real-life barriers a potential research participant may face when enrolling in research.