IOWA STATE UNIVERSITY

Institutional Review Board

Recruitment of Research Participants

Recruitment of research participants takes many forms that involve presenting potential participants
with information about the study, prior to their enrollment, to help establish interest and willingness
to serve as a research subjects. It is often the first information participants see about a study, and is
considered by federal regulations and the IRB to be the beginning of the informed consent process.
Thus, it is imperative that the information clearly and accurately represents the research. It is also
important that the recruitment process be handled in an ethical manner.

Toward these ends, all recruitment plans and materials must receive IRB approval before any
potential participants are invited to take part in any non-exempt research project. Only those
materials approved by the IRB may be used for participant recruitment; any changes to the processes
or materials must receive IRB approval prior to implementation.

The IRB does not review recruitment materials for exempt research. However, researchers are
responsible for conducting recruitment in a manner consistent with the ethical considerations
outlined in this document (i.e., promoting voluntariness, protecting privacy, accurately informing
potential participants, etc.).

Ethical Considerations
The IRB reviews recruitment materials and processes to ensure they are handled in a manner that
addresses the following ethical considerations:

Respect for privacy – In some cases, simply being invited into a study may involve privacy
concerns. For example, sending an email or leaving a voice message inviting an individual to
take part in a study of individuals with a specific disease or stigmatizing condition may “out”
them to others. Recruitment methods must take into account privacy concerns.

Lack of pressure or undue influence – Participation in research must be voluntary. Thus, the
study should be introduced in a manner that allows participants adequate time and ability to
freely consider whether or not they wish to take part. Undue pressure because of the timing
of the request, who makes the request (e.g., a participant’s teacher, boss, physician, etc.),
method of request or the offering of undue inducements should be avoided.

Accurate and clear description of the study – Information shared with participants should be
accurate and clearly presented. Number of visits, expected time commitment, any eligibility
criteria, etc., should fully align with the proposed research plan. Information must be clear
and understandable, and free from technical or scientific jargon.

Unbiased presentation of the study – Information should be balanced and free of misleading
emphasis that makes the study excessively attractive (e.g., avoid wording such as “free

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 medical treatment,” “guaranteed weight loss,” “new and improved,” etc.). Anticipated
benefits should not be overstated.

Avoiding the therapeutic misconception – Patients often think that taking part in a clinical
trial—or any research proposed by a health care provider—will benefit them. The
recruitment methods and materials should avoid contributing to this misconception. Careful
wording, such as using “research subject” instead of “patient,” avoiding the term “treatment,”
etc., can help.

Who May Recruit?

Individuals initiating contact to recruit participants must have basic knowledge about the study (so
they can answer questions) and training on ethical human subjects research. In nearly all cases, these
individuals must be included as study personnel on IRB applications.

In most cases, individuals whose role is limited to the following situations do not need to be included
as study personnel:

 Forwarding IRB-approved recruitment materials to potential participants;

 Securing permission from potential participants to share their contact information with the
research team;
 Providing contact information to the research team, if it is otherwise allowable (e.g., a staff
person in the ISU Registrar’s Office who provides Directory Information to a researcher).

IRB Submission Requirements

Researchers should describe in the IRB application how potential participants will be identified and
invited to take part in the study. This description should include the following information with
enough detail that the recruitment plans can be fully understood by the IRB. Recruitment processes
and materials vary greatly, and may involve formal letters, posting flyers, sending emails,
announcements in classes or other settings, postings to online bulletin boards or social media sites,
or informal personal conversations.

As a general rule, any recruitment materials that will be seen by research subjects require IRB review
and approval. Thus, with the IRB application (or modification application), researchers must send
final copies of any and all recruitment materials. Materials should be personalized as needed for
each study phase or participant group; in some cases, multiple versions may be needed.

At the end of this document there are tables summarizing the information to include in the IRB
application to describe recruitment plans.

Guidance on Content of Recruitment Materials

Content of recruitment materials varies with the nature of the study. In general, it should be limited
to information that helps potential participants assess their interest and eligibility. Information
should be presented clearly, concisely, and using lay person’s language; technical or scientific jargon
should be avoided.

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The IRB recommends that recruitment materials include:
 A clear statement that this is RESEARCH (use the word RESEARCH, rather than “treatment,”
“program,” or “project”), particularly if the study involves an intervention
 A general description of the purpose of the research
 When applicable, the regulatory status of a drug or device (investigational, approved)
 In summary form, the criteria that can be used by the subject to determine his/her own
eligibility (e.g., age range, any medical restrictions in lay person’s terminology, etc.)
 Time or other commitment required of the participants (e.g., total number of visits, expected
duration, etc.)
 Contact information for interested individuals
 Location of the research

When appropriately worded, the following items may also be included:

 Potential direct or societal benefits (must be truthful and reasonable; benefits must not be
overstated)
 Compensation plans, provided they are stated simply and not overly emphasized

The following items are not appropriate for inclusion in recruitment materials
 Overly emphasized payment amounts
 Claims that the research will improve a participant’s medical condition
 Any promise of free treatment or care
 Language that overstates or overpromises the expected benefits of participation
 Any exculpatory language (where rights are waived)
For FDA regulated studies, recruitment materials should not include:
 Claims, either explicitly or implicitly, that the drug, biologic, or device is safe or effective for
the purposes under investigation.
 Claims, either explicitly or implicitly, that the test article is known to be equivalent or superior
to any other drug, biologic, or device.
 Terms, such as new treatment, new medication, or new drug without explaining that the test
article is investigational.
 Promise of a coupon good for a discount on the purchase price of the product once it has
been approved for marketing.

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Special Issues in Recruitment
Use of Social Media
Social media use is increasingly common, but there continues to be varying levels of knowledge and
awareness about issues surrounding privacy, public availability, interaction norms, etc. Individuals
may believe their comments in response to a recruitment advertisement are private, when in fact,
the information they share (which may be private) is available to all users or the public. Individuals
may also make comments about the perceived validity of the study, efficacy of the intervention, or
other issues that can adversely affect willingness to enroll. The NIH recommends that researchers
consider the following before social media as a recruitment venue:
1. Have I considered the full implications of privacy in this new and less-controlled environment?
2. I need to carefully consider how my materials will be used.
3. Have I controlled my informational data in a locked format?
4. Have I made the contact for further information site protected for the privacy of interested
individuals?
5. Do I clearly understand that the interactive nature of social media escalates the speed of
interaction, allowing for greater opportunities for errors in protecting private information?
Have I planned to obviate those errors?
6. Have I accounted for problems related to the portability and secure handling of information,
including the encryption of all government laptops, the encryption of sensitive information
during transport, including but not limited to transport across the network or on portable
media, and the reporting of unintended breaches of sensitive personal information in the
government’s possession?
7. Have I included my complete strategy for use of the social media and my strategies for
protection of privacy and strategies for informed consent explicitly in my proposal to the IRB?
8. Have my team and I clearly understood the invasive nature of joining groups (i.e., support
groups, disease groups, advocacy groups, etc.) for the purpose of recruitment? This can
undermine the trust of government research and your IC.
More detail about each of these questions is available in the NIH Guidance Regarding Social
Media Tools.

Recruitment of Vulnerable Populations

Researchers’ students and staff
Except in unusual circumstances, researchers should not directly ask their students or staff to be
research subjects, as it may be hard to refuse such a request. Instead, students or staff may be
recruited indirectly (e.g., through flyers, large-group emails in which all students in a department
are included, etc.) and allow volunteering students or staff to initiate contact. Students or staff
should never be pressured.

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 In cases where very personal or private information is collected during the study, researchers
must have compelling scientific justification for including their students or staff due to privacy
concerns.
Recruitment in classrooms
Participation in research must be presented as a voluntary option. In cases where course credit
or extra credit is offered, students must be informed of non-research alternative methods of
earning the same amount of credit; those alternatives must be genuinely comparable in terms of
time and effort.

Recruitment incentives (“Finder’s fees”, bonus payments)

Finder’s fees, where payment or other compensation is provided in exchange for referring or
enrolling subjects in research studies, are not allowed.

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 Information to Include With IRB Applications
When applicable, describe how participants’ contact information will be obtained for recruitment purposes. The following is a list of common
sources of contact information, along with information that the IRB will need to know to assess these plans.

Item Information to Describe in IRB Application

Review of Public Records (e.g., voter lists, utilities lists, phone Specify the source(s) of the records.
directories, ISU directory, etc.)

Review of Private Records (e.g., medical records, student Identify the specific records to be reviewed, along with a description of
records, employment records, etc.) how the research team will be granted permission to access the private
records.

Purchased Mailing Lists Specify the source(s) of the lists.

Personal Contacts/Knowledge Provide a description of how potential subjects are known to the
researcher.

“Snowball” sampling Provide a description of what information about participants will be

provided as part of the snowball sampling.

Referrals (e.g., from medical care providers, colleagues, Describe the process for obtaining referrals, and how any privacy
teachers, etc.) concerns will be addressed.

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Describe the method for contacting and inviting participants. The following is a list of common methods of contact, along with a description of
the information to be included in the IRB application and corresponding materials that should be submitted for approval.

Recruitment Method Describe in IRB Application Submit with IRB Application Materials

Directly Contacting
Participant

Written communication, Describe the specific plans, including Final text of letter(s), email(s), or other written
such as letter or email sent frequency, timing, how any privacy communication.
to potential subjects concerns will be addressed, etc.

Verbal communication , such Describe the specific plans, including Phone script(s), script(s) for announcement(s) and/or list(s) of
as via phone call, personal frequency, timing, how any privacy talking points to be covered
announcement, or word-of- concerns will be addressed, how undue
mouth influence or coercion will be minimized,
etc.

Indirect Contact Methods

Flyers Indicate where flyers will be placed Final copy of all flyer(s)

Website announcements, Indicate where announcement(s) will be Final text of website announcements, or text to be
including SONA, online placed, specific Listserves to be used, distributed.
bulletin boards, Listserve etc.
distribution, etc.

Personal or verbal Indicate where announcements will be Script(s) for announcement or list(s) of talking points to be
announcements made, who the intended audience is, covered
etc.

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 Informal personal Describe expected setting(s) and targets Script(s) or list(s) of talking points to be covered
communication of the communication

Television or radio Indicate where advertisements will be Final content of the advertisements.
advertisements placed

Social media postings Indicate social media sites to be used Final text of social media posting(s)
and describe procedures to address
privacy concerns inherent with social
media use (see below)

Referrals (researcher asks Describe these plans, including the Final text of information to be shared with potential
colleague to provide study relationship between the colleague and participant.
information to potential potential subjects, and how any
participants) concerns related to privacy or undue
influence will be addressed.

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