1. Equitable selection. Federal regulations (both DHHS and FDA) require that IRBs make sure that the selection of participants for a study is equitable. An effort must be made to ensure diversity of participants. Also, the number of participants must be appropriate to conduct meaningful research. Recruitment methods and strategies must be suitable for the study.
2. Undue Influence. Undue influence is created when a person is induced to act otherwise than by their own free will or without adequate attention to the consequences. Recruitment activities should be designed to avoid the appearance of undue influence.
   1. Timing of the request.  The study should be introduced to potential participants in a way that allow them ample time to consider whether or not they want to enroll in a study, with no undue pressure.
   2. Individual making the request. The individual recruiting participants should not be in a position of power over potential participants. It should be clear the decision to participate in a study is voluntary and will not affect a person’s grades, education or employment.
   3. How the request is made. Language included in the recruitment materials needs to be clear, truthful, balanced, and easy to understand. There should not be any promise of personal gain or offer of excessive inducements. Compensation should not be emphasized or highlighted.
3. Respect. The recruitment plan must include procedures appropriate for the intended study population, especially if the population requires specific safeguards (children, prisoners, low socioeconomic individuals or those lacking decision-making abilities). Other populations, such as employees / students may be considered a vulnerable population depending on their circumstances in relation to the research.
4. Privacy. Recruitment plans should respect an individual’s reasonable expectations for privacy. If an individual’s private information is used for recruitment purposes, appropriate approvals should be obtained. When contact information for potential participants is found online or in the public domain the original purpose or intent of the posting must be evaluated. For example, students’ email addresses are available by searching the UTD directory. However, this does not constitute consent by the Institution nor the individual that this information be used for recruitment purposes.

The IRB considers UTD students to be a vulnerable population. This is particularly true when UTD faculty and staff are engaged in the research activities. Students should always be aware that their decision to participate in a research study is voluntary and that their education, grades, or employment will not be affected in any way. Investigators should be aware of the following considerations.

1. Voluntary participation. Instructors cannot mandate or require student participation in research as part of a course requirement. Measures must be built into the research to assure students that their participation is strictly voluntary and that they may withdraw their participation at any time without penalty.
2. Investigator led classes. Investigators who propose enrolling their own students in research should carefully consider the appropriateness of enrolling individuals they directly supervise or instruct and will require explicit justification. The risk of undue influence or coercion must be addressed and mitigated appropriately.
   1. Various procedures may be used to minimize the possibility of unintended undue influence or coercion while still permitting students to participate in research. These include:
      1. Avoid recruitment methods involving direct contact with potential participants.
      2. Use recruitment methods such as postings, flyers, information sheets, etc. that allow potential participants to initiate contact.
      3. Provide a number of research projects and equal alternative assignments from which students can choose for meeting course credit (or extra credit) requirements.
3. Classroom Recruitment. The IRB will not approve recruitment of potential participants during class time. The instructor and all others associated with the conduct of the class (e.g., teaching assistants, etc.) must not be present during announcement of the research opportunity or any recruitment activity. Rather an announcement should be made in advance indicating that class will either start later than usual or end earlier than usual so the recruitment activity can occur. It should be emphasized that attendance at the announcement and recruitment are voluntary and students’ attendance and enrollment decision will not be known by those administering the course.
4. Recruitment for convenience. Recruitment of students cannot be based on convenience. When such activities are limited to the student population, investigators must provide appropriate justification in the IRB application. Justifications such as “students are easy to access” or “there are a lot of students on campus” will not be accepted.
5. Sona System. Student recruitment cannot be limited to the Sona system. Additional methods must be used to include a more diverse sample than those with access to Sona or in need of Sona research credits. Alternate methods could include flyers, social media, lab websites, etc.

All recruitment materials require IRB review and approval. Any and all changes to approved recruitment materials must be submitted to the IRB through a Modification request.

Materials should include the following:

• The word “research” – must be represented that this is a research study
• “UTD” – it must be clear this is a study affiliated with the university
• PI’s name (and/or Faculty Sponsor if appropriate)
• Name of contact person (with contact information).  Emails must be UTD (xxx@utdallas.edu)
• Eligibility criteria, if applicable (e.g.., Women only)
• Whether or not participants will be paid
• Purpose of the study, in summary form
• Text appropriate for the intended audience – language clear, concise, and easy to understand
• Location of research – on campus, Callier, community, etc.
• Time commitment involved
• When lotteries, raffles, and/or drawings are used to recruit or retain participants, they include:
  • That winning a prize is not guaranteed, and
  • The approximate chance of winning (e.g., no less than 1 in 1000)

• Misleading or coercive language
• Exculpatory language
• Language that would lead a participant to believe (or explicitly states) a research study is proven safe or effective treatment or is better or equal to other treatments or therapies
• Stressing payment
  • No bolded text, different color text, italics, larger text, bold graphics surrounding payment
• Promises of “free treatment” when the intent is only to state that subjects will not be charged for taking part in the study
• Compensation for participation to include a coupon good for a discount on the purchase price of the product being tested once it has been approved for marketing
• Claims, either explicitly or implicitly, about the biologic or device under investigation that are inconsistent with FDA labeling