Recruitment for Human Research Subjects

The Institutional Review Board-Health Sciences Research (IRB-HSR) must approve all materials for human subject recruitment before the recruitment efforts begin.  Federal Regulations [21 CFR 50.20, 21 CFR 50.25, and 21 CFR 56.111(a)(3)] require that the IRB-HSR review and approve all advertisements seeking participants for enrollment in research. The Food and Drug Administration (FDA) considers advertising the first step in the informed consent process.

Recruitment is the dialogue that takes place between an investigator and a potential subject prior to the initiation of the consent process. In some ways, recruitment is the introduction to the consent process. Recruitment may take the form of a flyer, a newspaper advertisement, etc., or a verbal exchange between an investigator and a potential subject. Investigators who are responsible for both the primary care of a subject/client and wish to consider enrolling the subject/client in a research project should carefully differentiate for the subject/client the alternatives and options of participation in the research without undue prejudice or pressure. Respect for potential subjects begins with recruitment procedures that ensure the voluntary participation of the subject. Potential subjects should not feel coerced into participating in research, nor must they fear the loss of some benefit to which they are otherwise entitled if they choose not to participate. A person in authority, such as a teacher recruiting students or a physician recruiting subjects, should take special precautions to ensure that a potential subject's decision to participate in research is not based on subtle pressures such as grades, monetary reward, or fear of loss of benefits, such as medical treatment. Investigators proposing to recruit their own students, employees or patients as research subjects should justify in the protocol the necessity for the inclusion of the dependent subject. In addition, the IRB will closely scrutinize the precautions in place to prevent the appearance of coercion in the recruitment of subjects. The investigator may contact the IRB for strategies for indirect recruitment.

The IRB-HSR reviews recruitment material for informational content as well as the mode of its communication (i.e., TV, radio, newspaper, bulletin board, email, letters etc.…). Generally, the any material to recruit participants should be limited to the information the prospective subjects need to determine their eligibility and interest. 

Additional review and approval from UVA Marketing Communications and/or Public Relations may be required depending on the type of advertisement.

If the study has an outside sponsor, the advertisement may also need to be approved by the sponsor.

What is recruitment material?

Any material whose purpose is to inform and invite potential subjects to participate in a research study and provides contact information for the potential subject to initiate study related communication is considered recruitment material. Study materials that are given to the potential subject PRIOR to consent, that might influence a potential subject’s decision to participate, may also be considered recruitment material and should be submitted for IRB-HSR approval. This includes items such as study information sheets or informational videos, etc.

Typical recruitment materials includes both indirect and direct modes:

Indirect methods

  • bulletin boards, flyers and handouts, posters
  • classified ads (print and online)
  • general media (radio, television, online videos)
  • journal or magazine articles (print and online) soliciting participation
  • listserv emails
  • newspaper ads (print and online)
  • online ads
  • press releases that contain recruitment elements
  • social media posts
  • websites and website postings
  • presentations to the public with the focus on recruitment may also be included.

Examples of the above include Daily Progress, Craigslist, Cville Weekly, Facebook, Google Adwords, StudyKIK, Vimeo, Youtube, UVA Health Clinical Trials website posts.

Direct contact

  • letters
  • e-mails
  • telephone calls
  • verbal consent scripts

What is NOT an advertisement for subject recruitment? 

  • Communications focused on health professionals, such as "Dear Doctor" letters and doctor-to-doctor letters (even when asking the physicians to refer potential subjects)
  • News stories and press releases that DO NOT contain recruitment information 
  • Publicity intended for audiences other than potential subjects, such as financial-page advertisements directed toward prospective investors 
  • Patient Education Materials to be distributed after the consent is signed. 

How to develop material for recruitment of human subjects:

Recruitment materials should contain the following key elements:

  • Name of the enrolling facility. - "UVA Health " is the preferred location of reference.  This can be waived if UVA Health is already present in a logo, banner, or as part of a website. For ads where space is an issue, "UVA" is an acceptable abbreviation. 
  • Location of the study or research group such as "Department or Division of..."
  • Name of condition/disease under study
  • Purpose of the research. Use lay language and aim for a sixth grade reading level. Write in short, complete sentences. Make sure you are clear that you are recruiting for research as opposed to providing treatment. 
  • Major inclusion/exclusion criteria such as age/gender requirements. Do not copy this list from the protocol because this is too much information and too soon in the process.
  • BRIEF list of procedures required. For example: blood tests, X-rays, MRI, etc. that will be performed as part of the study. Of particular interest is information that may influence a potential subject's decision to participate such as use of placebos 
  • Time commitment for participation. For example: number of visits, length of each visit and total length of study participation. 
  • Contact Information. Primary contact name and info. This should be UVA contact information, personal email or phone is not permitted. 
  • Name of Principal Investigator (PI). This is only necessary if it is not the primary contact. 
  • IRB-HSR number/UVA Study Tracking number. This information is required for almost every ad. 
  • Compensation (optional). Compensation may be mentioned but not emphasized (e.g., bold or larger font). Make clear if the amount mentioned is per visit or at study completion
  • Voluntariness of participation

Recruitment materials should NOT include the following: 

  • Promise or imply treatment, cure, or benefits. 
  • "Catchy" words like "free" and "exciting." Avoid all appearance of undue influence. 
  • Offer free care or free items provided as part of research procedures. For example: free exam, free medical supplies, free pedometer, etc. The statement that "Study-related medications, exams, tests, etc. are provided at no cost" is preferred. 

Creation of Templates and Information:

Recruitment materials for health system research MUST be created using UVA Health Brand templates with the goal of creating professional print materials. Templates are available at www.uvahealthbrand.com. If the marketing department creates only a logo for a study, brand templates are not required.

In addition, UVA Health Strategic Relations and Marketing provides an excellent service to assist study teams in the development of recruitment materials and social media promotion. Please visit https://www.uvahealthbrand.com/our-brands/uva-health for more information.

Social Media Information: 

IRB-HSR templates REQUIRED for use in the following cases

NOTE:  A UVA Health website ad is recommended for all studies engaging in recruitment. Social media ads created by UVA Health Marketing require a link to a web ad.

To submit UVA HS Clinical Trials Website Advertising, go to: www.uvahealth.com/clinicaltrials 

 

Other types of recruitment, IRB templates are provided but their use is not mandatory. Even if not used, the templates should still be referred to as a guideline for content

Recruitment materials for health system research should be created using UVA Health brand template. Templates are available at www.uvahealthbrand.com.

When can I submit subject recruitment materials?

With the exception of UVA Health Clinical trials website ads, ALL recruitment material must be submitted with the INITIAL prereview submission to the IRB HSR.  This is relevant for full board, expedited and exempt applications. 

After review and approval by the UVA IRB HSR, all revisions to recruitment material are to be submitted to the IRB via IRB PRO-SUBMIT DOCUMENTS-Modifications.  You will be required to include a Modification request form with your submission. 

To submit a UVA Health Clinical Trials Website ad: 

  1. Complete the UVA HS Clinical Trials Website template
  2. Go to www.uvahealth.com/clinicaltrials and submit using the Submit a Trial for Advertisement link
  3. Be sure to choose the keywords and categories and upload the completed web ad.

A note about sponsor produced recruitment materials: Review all documents provided by the sponsor before submitting to the IRB-HSR. Sponsor produced ads are often missing locally required elements such as HIPAA language and UVA site contact information. If the site will be using these materials, insert this information before submitting to the IRB-HSR.

For print material that is not editable, contact information can be included by affixing a sticker label (“stickie” template above) to the document at the time of distribution. 

All ads are approved with no expiration date.

How to submit advertising if the UVA IRB-HSR is not the IRB of record for your study

The IRB-HSR does not review or approve recruitment material for protocols that are reviewed and approved by a Non-UVA IRB. Follow the IRB of record’s procedures to obtain approval of the recruitment material.

To request an ad to be posted on the UVA Health Clinical Trials website:

The UVA IRB-HSR will post the submitted ad and will provide documentation of receipt.

UVA Health Strategic Relations and Marketing (Marketing) Review

The use of UVA Health brand templates and downloadable materials (available at www.uvahealthbrand.com) is recommended to ensure the appropriate use of the UVA logo and related branding guidelines. Marketing staff also aid in creating custom documents.

Marketing approval is required in addition to IRB-HSR approval for all print ads*, some online postings, radio and television ads, social media ads, and videos that use the name of UVA, UVA Health, and/or logo. This includes the use in contact information. Recruitment materials that require professional printing or result in a cost to the study team in order to produce the materials require Marketing approval.

*Ads printed in a publication, i.e. magazine, newspaper. Excludes Cville Weekly ads.

Radio/Television/Video

Radio, television and video scripts and actual recordings require approval by the IRB-HSR and Marketing. Scripts should be submitted for approval PRIOR to recording.

Final versions of recordings should be submitted for approval PRIOR to going live.

Social Media (Facebook, Twitter)

All social media postings must be approved by IRB-HSR.

Social media ads created by Marketing should be submitted to the IRB-HSR for approval. Additional Marketing approval is not required.

Social media accounts created for studies or research centers must be approved by the IRB-HSR and Marketing. Study teams should contact Marketing for assistance in developing the account. Once created, the study team should submit a Management Plan to the IRB-HSR for approval prior to going live (see template section). 

Non-Monetary Gifts and Retention Incentives

Non-Monetary Gifts and Incentives require IRB-HSR approval.

Submit the list of items to IRB PRO-Submit Documents- Choose, Modification. The list of items should contain a picture and/or description of the retention items (see template section). Include with your submission a completed Modification request form.

The IRB-HSR will review the items to verify if the use of these items appears to be exert undue influence. The convened board may be asked to review the retention incentives to make this determination. Full Board review will always be requested for any item valued over $25.00 for items given to children and over $50.00 for items given to adults.  If the board deems any item is inappropriate for use at UVA, the study team will be notified in writing of the board’s determination.

Recruitment of Children

The ethical requirement of respect for persons, as outlined in the Belmont Report, applies to children as well as adults. Children, however, are in a dependent relationship to adults and easily manipulated in an academic or clinical setting. A child's dependent relationship entitles them to extra protections and are thus considered a "vulnerable subject population". Investigators should take every precaution to ensure that a child's decision to participate in research is both voluntary and free from coercion. A child's refusal to participate should not be met with a negative response or punishment. The IRB strongly recommends that investigators address the following when submitting applications that include the recruitment of children: 

  • Investigators should acknowledge and create a mechanism for addressing and minimizing the coercion implicit in requests to participate from parents, teachers, or other adult authorities. 
  • Investigators should make provisions to minimize the fear of ridicule, social pressure, or peer pressure to participate. 
  • Incentives or rewards for participation may be used but should not be so valuable, within the value system of the parent or the child, as to sway the child's legitimate reluctance to participate. 

Permission of the School 

School officials and/or teachers do not have the authority to give consent for the participation of children in research. Only a parent or guardian may allow a child, with the child's assent, to participate in research. The IRB requires submission of proof of approval of the school district prior to allowing investigators to contact, recruit, or enroll children into a study. Investigators should contact school district officials regarding the appropriate procedures for obtaining permission to conduct the research in individual schools. 
The No Child Left Behind Act of 2001(Public Law 107-110) amended the Protection of Pupil Rights Amendment (PPRA), which concerns surveys of students, in two ways: 

  • First, it added an eighth category to the categories of protected information in surveys of children that were already covered by PPRA. 
  • Second, it gave parents new rights with regard to the surveying of students who are children, the collection, disclosure, or use of information from students for marketing purposes, and certain non-emergency medical examinations. 

PPRA, as amended, has two sets of requirements for surveys: 

  • Requirements that apply to "protected information" surveys that are funded in whole or in part by the U.S. Department of Education. 
  • Requirements that apply to "protected information" surveys that are funded by sources other than the U.S. Department of Education and that are administered or distributed by education institutions that receive funds from any Department of Education program (i.e. public elementary and secondary schools and some private schools). 

PPRA lists 8 categories of protected information for survey responses: 

  • political affiliations of student or student's parent; 
  • mental or psychological problems of student or student's family; 
  • sex behavior or attitudes; 
  • illegal, anti-social, self-incriminating or demeaning behavior; 
  • critical appraisals of others with whom students have close family relationships; 
  • legally recognized privileged or analogous relationships; 
  • religious practices, affiliations or beliefs of student or student's parent; 
  • income. 

PPRA has implications for IRBs in applying the Common Rule criteria for waiving informed consent (in section 116(d) of the Common Rule). Specifically the second IRB criterion: "research does not adversely affect the rights and welfare of subjects" is impacted because of the "rights" that PPRA gives parents. 


Practical Implications in Applying the Common Rule Waiver Requirement pertaining to rights and welfare: 
First Set of Requirements: US Department of Education Funded Protected Information Surveys 

  • Does the research involve "protected information" surveys? 
  • Are the surveys U.S. Department of Education- funded in whole or part? 
  • Are the surveys "required"? 

If the answer is yes to the three questions, PPRA affords parents the right to provide written informed consent.

Payment for Recruitment

Finder's fees and other financial incentives paid by a sponsor or by an investigator to others related to the recruitment of research subjects are prohibited. No one may receive any incentive for the purpose of encouraging individuals to participate in research.
All payments by sponsors for research conducted under the auspices of the University of Virginia must be made directly to the University of Virginia and will be managed by the University. Payments should never go directly to investigators, key personnel, or subjects without first going through the University.