Last Revised: 10.2015
Prior Version: 7.2007
Recruitment of Subjects
Introduction
Recruitment of participants is one of the most challenging aspects of research involving human
subjects. It is an essential part of the research protocol and must be presented in sufficient detail
to allow the IRB to fully assess the investigator’s plan. Recruitment of participants must be
equitable and include racial, ethnic, educational, socioeconomic, and gender diversity
appropriate to the research study. Exclusion of any specific group (e.g., women of child-bearing
potential) must be justified in the protocol. Both the benefits and risks of research participation
must be equitably distributed. All recruitment efforts must respect personal rights to privacy and
confidentiality and be compliant with HIPAA regulations, when applicable.
Definitions
Finders’ Fees are money paid for recruiting/referring participants on a per-participant basis.
Bonus Payments are payments to investigators, research staff or the institution as an incentive to
accelerate the enrollment of participants.
Cold Calling is when a researcher initiates contact with an unknown potential research
participant.
Advertisement is any form of communication aimed directly to potential research participants to
promote and announce an investigator’s study and request for participants.
Secondary Recruitment refers to asking a study participant for identifying information about
friends, family members or others with the intent to contact that secondary person as potential
research participants.
Policy
Recruitment procedures must be designed so that informed consent, parent/guardian permission,
and assent are given freely, and there is no coercion or undue influence. In order to evaluate this,
the IRB must know who the study participants will be, what incentive(s) is being offered, and the
conditions under which a payment is issued. Financial payment, academic credit, gifts, gift
cards, or raffles should be reasonable for the time, expenses, discomfort, or inconvenience of
participating. The IRB must review all of the research documents and activities that bear directly
on the rights and welfare of the participants of proposed research, including the methods and
material that investigators propose to use to recruit study participants. Potential participants may
not be contacted for a different research study unless documented permission was granted in a
previous IRB-approved study.
Page 1 of 5
CWRU SBER IRB Policies and Procedures
Last Revised: 10.2015
Prior Version: 7.2007
Contacting Potential Participants by Phone
Prospective participants may have their first contact over the phone with a member of the
research staff or third-party person who follows a script to discuss the study and to determine
basic eligibility for the specific study. Scripts read by the researcher or other individuals
assisting in the recruitment of participants must be submitted to the IRB for review and approval.
The IRB must review these procedures and documents to assure that they adequately protect the
rights and welfare of prospective participants. Examples of when scripts are needed include
phone screeners who will be interacting with potential subjects; any phone conversation that
communicates standard research study information.
The IRB must have assurance that any information collected about prospective participants will
be appropriately handled including the destruction of identifying information if the potential
participant is not interested or eligible for participation. A recruitment/cover letter giving brief
information about the study and informing the potential participant that he or she will be
receiving a call from the study staff is recommended.
Contacting Potential Participants in Person
A researcher or his or her staff may approach prospective study participants about participation
in any IRB-approved protocol. The researcher may approach the potential participant about
participation in his or her own protocol or on behalf of another investigator.
Engaging prospective study participants is usually allowed but the method of obtaining names
and contact information, who will contact the potential participants, how permission will be
obtained from the treating physician, and how data confidentiality will be protected, must be
presented in detail in the protocol. Investigators must obtain permission from a study site (e.g.,
school, factory or business) before approaching prospective study participants. The IRB will
want copies of letters of cooperation or IRB approvals from each study site prior to approval.
Advertisements
Advertising materials are part of the recruitment process and should be submitted as part of the
initial IRB electronic application. Investigators must obtain IRB approval for all television,
radio, videotape or print advertisements, posters, flyers, handouts, e-mail solicitations, websites,
and other recruitment methods and materials intended for the recruitment of prospective
participants to a research protocol.
Advertisements are directly related to the informed consent process and must be consistent and
guard against coercion and undue influence. The IRB must ensure that appropriate safeguards
exist to protect the rights and welfare of research participants. Advertising or soliciting for study
participants is the start of the informed consent and participant selection processes. In order to
evaluate advertisements, the protocol must state who the participants will be and what
compensation, if any, is being offered; and describe how the material will be used, distributed,
Page 2 of 5
CWRU SBER IRB Policies and Procedures
Last Revised: 10.2015
Prior Version: 7.2007
and/or posted. This is especially critical when a study may involve participants from a
vulnerable population (i.e., university students, children, cognitively impaired).
The IRB pays particular attention to risk and potential benefit information to ensure it is
presented in a balanced and fair manner. The information presented should not mislead, for
example, by promising benefits or implying a benefit beyond that potentially provided by the
research. If advertising materials become available after initial approval or have been modified,
the materials in questions must be submitted to the IRB via an Amendment Form. The materials
may not be used until the IRB approves them.
What May be Included in Advertisements
Any advertisement to recruit participants should be limited to the information the prospective
participant needs to determine eligibility and interest. When appropriately worded, the following
items may be included in advertisements:

The condition and/or the purpose of the research in summary form.

Statement that the study is research.

The criteria that will be used to determine eligibility for the study in summary form.

A brief list of participation benefits, if any (e.g., a no-cost health examination).

The time or other commitment required of participants.

The location of the research and the person or office to contact for further information.

Compensation may be mentioned, but not as a specified amount or as a benefit.
What Not to Include in Advertisements

A statement or implication of certainty of a favorable outcome or other benefits beyond
what is outlined in the consent document and the protocol.

Claims, either explicitly or implicitly, that the research procedures are safe or effective,
or that the research procedures are known to be equivalent or superior to any other
procedure, method, technique, etc.

Promise of a free service or item when the intent is only to say participants will not be
charged for taking part in the research and/or when investigator cannot provide or arrange
a free service or item.

Emphasize the compensation, by such means as larger or bold type.

The specified amount to be paid.

Include any exculpatory language.
IRB Approval Stamp on Advertisements
The IRB stamps all advisements indicating their approval and date approved via iRIS. There may
be instances where these approval stamps automatically inserted through iRIS are placed in
inappropriate locations on the advertisement. In these cases, investigators can use a clean
unstamped copy of your advertisement as long as it represents the IRB-stamped document and
contains the IRB approval date.
Page 3 of 5
CWRU SBER IRB Policies and Procedures
Last Revised: 10.2015
Prior Version: 7.2007
Contacting Potential Participants Using Electronic Media (including email)
All Internet recruitment materials directed at potential participants are considered advertisements
and the same rules apply. This includes information posted on social media websites (e.g.,
Twitter, Facebook, YouTube, etc.), community boards, recruitment registries, (e.g.,
ResearchMatch), chat rooms, or other websites. Investigators are required to provide the IRB
copies of letters or emails of cooperation for electronic study sites. In the event that the site is
open to the public, including researchers, investigators must provide verification that the site is
public.
Web forms may ask visitors to answer questions regarding eligibility for a specific study. If
identifiable private information is collected via the website, the IRB will review plans for
protecting the confidentiality of that information and ensure that the website clearly explains
how identifiable private information might be used. The IRB must have written assurance that
any information collected about prospective participants will be appropriately handled.
Secondary Recruitment
Secondary recruitment refers to asking a study participant for identifying information about
friends, family members or others with the intent to contact them as potential research
participants. While there are important research reasons that secondary recruitment is needed, it
must be approached in a manner that respects the privacy of the potential participants. Failure to
hear from primary or secondary participants cannot imply consent to further contact.
Exception to the Standard Method for Contact
The IRB allows investigators to obtain information about potential participants from enrolled
study participants if ALL the following criteria are met:

The person is not called without sending an IRB-approved letter in advance.

The rationale for this approach, including how the contact information will be kept
confidential, is justified in the protocol.
It is the IRB policy that investigators may ask enrolled participants in an approved IRB study for
the names, addresses, and/or e-mail of relatives or other persons who may be contacted by the
investigator to participate in the study or an aspect of the study (e.g., genetic screening).
Telephone numbers and other health related information maybe NOT be solicited by the
investigator or provided by the study participant to the investigator. Health information is
excluded by implication (e.g., requesting identifying information to contact the subject’s
relatives who have diabetes). The enrolled participant should be asked to inform the person that
their name, address, and/or e-mail have been provided to an investigator.
Payment for Recruitment
Payments to investigators, research staff and the institution as an incentive to accelerate the
enrollment of participants (i.e., bonus payments) are prohibited. The IRB requires full disclosure
of any financial arrangements that may encourage investigator to recruit participants for research
participation that may not be in the subject’s best interests. In some special circumstances,
Page 4 of 5
CWRU SBER IRB Policies and Procedures
Last Revised: 10.2015
Prior Version: 7.2007
individuals who are not formally listed on the protocol may be performing specific researchrelated activities (such as a receptionist participating in the recruitment process), but solely in the
role of service provider.
The IRB prohibits the use of finders’ fees for recruitment or identification of potential study
participants. If payments for recruitment are proposed, they must be justified in detail in the
protocol including defining the work that is done by the recruiters. The protocol must also
explain what measures are taken to ensure that payments will not lead to undue influence or
coercion of study participants.
References or Regulatory Citations
45 CFR 46.111(a)(3)
45 CFR 46.116
OHRP Guidance on Written IRB Procedures, July 1, 2011
OHRP Guidance on Clinical Trial Websites
Page 5 of 5
CWRU SBER IRB Policies and Procedures