[D7.0000] Principal Investigators (PI) Guide for Recruitment (Identification and Recruitment of Human Subjects for Research)

Access: 

• Access to review medical records for review of protected health information (PHI) for the purpose of designing a research study or identifying potential subjects is limited to individuals in the covered entity. Researchers outside the covered entity must request access from the UK Healthcare Privacy Officer.
• In the IRB application, submit a request for a Waiver of HIPAA authorization in order to directly access or obtain PHI from the covered entity, including from the Center for Clinical and Translational Science (CCTS) Data Trust, Bioinformatics, or other healthcare entity.

Contact where a treatment relationship exists: 

• A healthcare provider who has a treatment relationship with a prospective research subject may contact or approach patients about participation in an IRB-approved protocol. The provider may approach the potential subject about participation in their own protocol or on behalf of another investigator. If the protocol is by another investigator, the permission of a potential subject is required before identifying information is given to the study investigator.
• In research projects where prospective subjects are identified through review of private records, initial telephone contact, or mail/internet questionnaire to invite participation in a research study by an unknown investigator (cold call) or direct mailings is not acceptable unless specifically approved by the IRB. There is a potential for coercion or undue influence, and potential subjects may be offended, especially in research on sensitive topics, by the investigator's having direct access to their name, address, and phone number. 

Contact where no treatment relationship exists: 

• For a hospital-based study, a potential subject's provider must give approval before the patient is contacted by an investigator. The electronic health record may alert providers that a patient is a potential candidate for a research study. The provider may choose to inform the patient about a particular study and indicate in the record that the patient is interested in being contacted to learn more about the study. If the subject is in the hospital, someone on the hospital staff involved in the subject’s care must inform the patient that their is going to be invited to participate in a study.   
• For post-hospitalization follow-up studies (either prior to discharge or at a follow-up visit), researchers must inform prospective participants that they may be contacted. For example, a flyer could be included in discharge materials, indicating the patient may be called and invited to take part in a voluntary research survey for which they are free to decline.
• Contacting outpatients for recruitment to research studies requires the potential subject's primary provider or applicable specialist related to the study condition to approve before the subject is contacted. The prospective subject’s provider or specialist may correspond with a potential subject about a study and invite them to participate by contacting the investigator in charge of the study. The communication should not contain any information that may be perceived as undue influence or coercive to potential participants and must be approved by the IRB prior to sending.
• If an investigator wants access to a potential subject’s contact information and/or records to invite them to participate in a study, and the potential subject’s provider is no longer employed by the University of Kentucky, the Chairperson of the Department, in which the provider was employed, should be contacted for permission to access the records. The Chairperson should then send a letter to potential subjects informing them of the study.

An investigator may contact potential subjects by mail and enclose a card to be returned, indicating the desire to be contacted to participate in a study. Potential subjects may be sent two to three letters, but if the person does not respond, the investigator must remove that person from the contact list. Failure to respond cannot imply consent to contact. Letters must be approved by the IRB prior to sending the letter.

• Secondary recruitment relies on an existing subject, sharing solicitation materials (letter, study brochures, return postcard, etc.) with other potential recruits. For example, an investigator may employ this chain-referral method to recruit family members of a subject for a genetic study. To respect privacy, investigators generally should allow the potential recruits to decide whether to respond to the recruitment material, rather than make direct “cold” contact with the potential recruits. Name or contact information should not be shared with the investigator without permission from the potential subject.
• Response Driven Sampling (RDS) is a type of secondary recruitment.  Sometimes referred to as “snowball” recruitment, this method may be used to reach specific socially disadvantaged “hidden populations” that need representation in health research. The difficult-to-reach populations may include drug users, sexual and gender minority participants, and individuals with HIV. The method may involve providing remuneration to current research subjects who refer individuals to the research project. The practice is not considered the same as “finder’s fees,” which is the prohibited practice of compensating healthcare professionals for referrals. 
  
  While not prohibited, there are ethical issues to consider with snowball recruitment. The IRB may approve under certain circumstances. Investigators should provide the IRB with materials used, a detailed description of the procedures involved, and justification for using this method in the context of the research, study population, and other attempted recruitment strategies. Current subjects should not feel obligated to provide referrals, and they should be advised not to pressure potential recruits. The IRBs will make a case-by-case decision on such requests based on study context, study population, other attempted methods of recruitment, potential subject-level or long-term health benefit, and other applicable considerations.

Generally, the IRB is not required to review clinical trial website postings (e.g., clinicaltrials.gov), unless the information goes beyond directory listings of basic descriptive information. The following federal guidance documents provide a rational and interpretation of “basic descriptive information”: 

• FDA Recruiting Study Subjects - Information Sheet
• Office for Human Research Protections (OHRP) Guidance ON IRB Review of Clinical Trial Websites

• Using social media and online techniques must be approached with caution and regard for applicable policies and guidance, such as the UK Social Media Policies and Guidelines (AR 10:4) and the online platform’s Terms of Use (TOU) and Conditions or established policies and procedures (e.g., Craigslist FAQ).
• IRB review and approval prior to implementation of social media or online advertising is required. Describe specific media intended for use.  Provide a copy or screenshot of the ad or post, including text, images, tags, etc. Indicate hashtags that will be associated with the post if applicable.  Indicate where the ad will be posted (e.g., University site/page, Clinical Trial page, Paid Online Advertising)
• Posting ads directly on others' personal pages (e.g., personal Facebook page) or linking ads to individuals is discouraged as it may be considered an invasion of privacy.
• Provide a process for handling user-generated content, including frequency of monitoring and the individual who will review comments or public postings. The user comment function may be disabled on some social media platforms.  This option may be useful for pages that have the potential to elicit comments that could bias study results or inadvertently disclose private or confidential information (e.g., un-blind treatment, effectiveness claims).
• If making or responding to comments, identify your views as your own. If you identify yourself as a UK faculty or staff employee online, it should be clear that the views expressed are not necessarily those of the institution.
• If posting in Online Classified Ads or Job Posting Websites (e.g., Craigslist or LinkedIn), limit posting to one appropriate category, such as miscellaneous or health/medical. Posting in multiple categories may be perceived as a nuisance or harassment by the venue’s users.  In addition, identify and comply with the TOU, including privacy policies, prohibited content, posting location, and frequency.
• Seek permission to access or interact with closed groups or online forums.  As a rule, do not engage online in a manner that would be improper in an equivalent live setting.  For instance, it would be inappropriate to show up unannounced at a private support group meeting to recruit research participants. Obtain approval and request an introduction from the administrator or moderator before engaging in a similar activity online.
• Recruiting on TikTok: In June 2023, the federal government issued an interim rule that prohibits the use of the social media app TikTok on any device being used in furtherance of a contract or project funded by federal monies. That includes UK-owned devices, as well as devices that are the employee’s own but used for work as part of a bring-your-own-device (“BYOD”) program. There are still some questions as to the scope of this rule, and the UK Office of Legal Counsel is working to provide more general guidance to the university community. Until further university-wide advice is given, Legal Counsel advises that UK employees should not have TikTok on any devices being used for work or use TikTok for research study recruitment purposes.
• See "Advertising Strategies" for preventing online survey fraud on the ORI Survey Research webpage.

An investigator may not invite participation of potential subjects by a letter that requires the subject to send back a postcard (or to telephone) only if he or she does not wish to participate. Subjects may become unwitting participants if, for example, they never receive the letter, do not read English, or are simply confused by the instructions. This approach also raises privacy concerns for certain types of research (e.g., research involving sexually transmitted diseases or psychiatric illness, or drug or alcohol abuse). IRB only approves “passive” procedures if the federal criteria for waiving informed consent are met.

Consistent with state law, the UK IRB does not approve finder’s fees in research studies. Finder’s fees are any payments to physicians or other professionals for referring individuals to research studies.

A recruitment bonus is an additional payment from a sponsor to a researcher or UK based on the rate or timing of recruitment, is prohibited (e.g., additional payment beyond a fixed negotiated fee to accelerate recruitment). This may place potential subjects at risk of coercion or undue influence or cause inequitable subject selection.

Public-facing advertising with the intent of subject recruitment is subject to UK public relations review. For instructions and optional recruitment services, see the Participant Recruitment Advertising website. 

Direct advertising for study subjects is the start of the informed consent and subject selection process, and IRB review is required for direct recruitment materials that are intended to be seen or heard by prospective subjects to solicit their participation in a research study. The IRB reviews the final copy of printed advertisements to evaluate the relative size of type used and other visual effects. The IRB assures that the advertisements do not state or imply a favorable outcome or other benefits beyond what is outlined in the consent document and the protocol or include exculpatory language. Advertisements to recruit participants are limited to the information the prospective participants need to determine their eligibility and interest. Examples of direct advertisement include newspaper, radio, and television advertisements, bulletin board announcements, recruitment posters, flyers, dear doctor letters, video recruitment tapes, and Internet postings.

Obtain approval for placement of advertising in facilities or common areas. Follow instructions under FAQ #14 on the Participant Recruitment Advertising website. Some communities have anti-litter ordinances that prohibit placing flyers in areas such as on utility poles or parked cars.

• Advertising must:
  • State clearly that the program of study is research
  • Show affiliation with the University of Kentucky
  • Provide contact information, and
  • Be respectful and appropriate
• Claims should not be made in recruitment materials, either explicitly or implicitly, that the drug, biologic, or device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other drug, biologic, or device that is inconsistent with Food and Drug Administration (FDA) labeling.
• Recruitment materials for investigational drug, biologic, or device studies should not use terms such as "new treatment," "new medication," or "new drug" without explaining that the test article is investigational. A phrase such as "receive new treatments" leads prospective study subjects to believe they will be receiving newly improved products of proven worth, and is inappropriate.
• Recruitment materials should not promise “free medical treatment” when the intent is only to inform subjects that they will not be charged for taking part in the investigation.
• Noting that the study is IRB approved may be misconstrued by potential participants as an endorsement or approval of an investigational product or intervention.
• When appropriately worded, the following items may be included in recruitment materials:
  • the name and address of the investigator and/or research facility;
  • the condition under study and/or the purpose of the research;
  • in summary form, the criteria that will be used to determine eligibility for the study;
  • a brief list of participation benefits, if any (e.g., a no-cost health examination);
  • the time or other commitment required of the subjects;
  • *that subjects will be compensated (see restrictions below); and
  • the location of the research and the person or office to contact for further information.
• *Recruitment materials may state that subjects will be paid to compensate for their time and/or travel. For Phase I-III clinical trials and other significant risk research, it is not permissible to state the amount to be paid to potential subjects. For all other research protocols, the IRB will make the decision of whether the amount to be paid may be posted in the recruitment materials on an individual protocol basis. Payment should not be emphasized in the recruitment materials. Generally, the use of the word “paid” or an equivalent term in an advertisement headline would be emphasized and not permitted for greater than minimal risk research. UK does not allow a company name to be included for gift cards on public advertising, as it may be misconstrued as an endorsement. For recruitment where a limited number of respondents will be entered to receive a gift card or incentive, the term “drawing” is preferred over “raffle” in public ads.
• When recruitment materials are to be taped for broadcast, the IRB reviews the final audio/video tape or may review and approve the wording of the recruitment materials prior to taping to preclude re-taping because of inappropriate wording. The review of the final taped message prepared from IRB-approved text may be reviewed through expedited procedures. 

PRE-SCREENING POTENTIAL SUBJECTS TO DETERMINE ELIGIBILITY (REDCap Instructions) [D125.0000]

Pre-screening of potential subjects to determine initial eligibility and interest in a study is considered part of the recruitment process and therefore requires IRB review. The IRB should ensure that the procedures followed adequately protect the rights and welfare of prospective subjects. 

Pre-screening may be done over the phone with interested candidates, in person, or online. Only information directly related to the potential participant’s eligibility and suitability for the study should be collected (e.g., basic enrollment criteria, ability to travel to the site for research visits). The investigator must protect the privacy of the potential subject and the confidentiality of information collected. If prescreening information provided by the potential subject will be retained, additional requirements may apply. 

Using REDCap to administer a pre-screening questionnaire (survey) can be efficient for the investigator and convenient for the potential participant.  Links to the survey may be added to recruitment material or placed in ResearchMatch communications. 

To use REDCap to administer a pre-screening survey, follow these steps: 

1. Include a copy of the survey in your IRB application.
2. Describe the recruitment method in the IRB Research Description. See sample description.
3. Since pre-screening collects self-disclosed information from potential study participants before informed consent for study participation. Since the information is retained in REDCap, begin the survey with informed consent from the potential participant. See sample consent language.
4. Since the online consent process does not involve obtaining the potential participant’s signature, submit an IRB Request for Waiver of Signatures on Informed Consent. The IRB may waive the requirement for obtaining a signed consent (documentation) if the research activity presents no more than minimal risk and involves no procedure for which written consent is normally required.
5. Obtain permission to contact the potential participant if eligible for the study, and if applicable, obtain permission to contact them with future study opportunities. See sample questions.

SAMPLE Research Description if using REDCap for pre-screening eligibility survey: 

The study will employ a pre-screening eligibility survey to determine if a volunteer meets basic enrollment criteria (see Appendix X). We built and will administer the eligibility survey on UK’s REDCap, which provides HIPAA-compliant storage on UK servers and encrypted transmission of survey responses. The portable devices do not download the data; it is directly stored in the secure web-based connection (https) behind the firewall. All files are password-protected once entered into the system. All project data is stored and hosted locally. A link to the eligibility survey will be provided in recruitment materials. The link will also be included in the study information sent to ResearchMatch participants who have indicated interest in the study. Before redirecting the volunteer outside of ResearchMatch and to the REDCap survey, the volunteer is once again asked to confirm their interest in completing the pre-screening survey. 

The REDCap survey includes an online consent process, with consent indicated by selecting the “submit” button. Since no signature is obtained, we are requesting a waiver of documentation for the pre-screening survey. The volunteer may skip questions or discontinue the survey at any time. All respondents will be asked permission for the investigator to retain information and contact the individual with future study opportunities 

Sample REDCap Eligibility Survey Consent: 

You are invited to complete this pre-screening survey to see if you might be a good fit for the ____________research study.  ____________(principal investigator) is conducting the ___________ research study at the University of Kentucky. The pre-screening survey will ask general information and health questions. Your answers give us an idea of whether or not you meet some of the basic criteria for the study. Completing this screening survey does NOT obligate you to participate in the _________ research study. If your answers show that you might qualify, we will (contact you/meet with you) to explain the ________ research study further. There may be no direct benefit to you for completing the screening survey.

Only complete the pre-screening survey if you choose to do so. You may also skip any questions or quit the survey at any time. 

Your response to the survey will be kept confidential to the extent allowed by law. This survey is on the University of Kentucky's web-based tool called REDCap. REDCap has features to help keep your information secure. However, as with anything involving the Internet, we can never guarantee the complete confidentiality of the information.

If you have questions about this pre-screening survey or the _________ research study, please feel free to ask. You may contact the study team at_________________.  If you have complaints, suggestions, or questions about your rights as a research volunteer, contact the University of Kentucky Office of Research Integrity at 859-257-9428 or toll-free at 1-866-400-9428.

The survey will take about ___ minutes to complete. By clicking the [submit] button below, you are indicating that you understand the information and agree to begin the pre-screening survey.

Permission to contact survey questions: 

• Agreement to be contacted: 

  If you appear to meet the criteria for the ________ study and you wish for a member of ____________ (principle investigator)’s study team to contact you, include your name and preferred contact information below: 

                                Name: ________________  ______________  _______________

                                                   (first)                                  (middle)                 (last)
                                Daytime phone: (    )      -               .    Email address: __________________.

• Permission for investigator to retain information and contact individual with future study opportunities (include if applicable): 

  Do you give your permission for ___________(insert investigator or staff) to keep your answers on file and contact you regarding your willingness to participate in future research studies about _______________(insert name of disease, condition, or topic area)?  

                                   Yes, ______ may keep my answers and contact information and contact me with future study opportunities.
                                   No.  I would like my answers and contact information destroyed when the ____ research study is over.                

 

• The proposed method and timing of disbursement should not be coercive or present undue influence.
• Payment should not be contingent upon completion of the entire study.  Any credit for payment should accrue as the study progresses.
• Payment to participants who withdraw from the study should be made at the time they would have completed the study (or completed a phase of the study) had they not withdrawn, unless it creates inconvenience or a coercive practice.
• Payment of a small portion as an incentive may be allowed upon completion of a study when such an incentive is not coercive.
• Payment to research participants for participation in studies should not be included as a benefit in the analysis of risks and benefits. For select studies, the IRB may permit including payment in the key information section of the informed consent.
• Any amount paid as a bonus for completion should be reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn.
• All information concerning payment, including the amount and schedule of payments, should be set forth in the informed consent document.
• Compensation for participation in a trial offered by the sponsor should not include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.
• Payments to the organization or research staff designed to accelerate recruitment and are tied to the rate or timing of enrollment are prohibited.

If you plan to provide outreach communications to enrolled participants via newsletters, study-specific social media, or webpages, indicate plans in the Research Description portion of the IRB application. If the IRB has reviewed and approved the outreach plan, the individual participant-facing materials or communications do not require additional IRB review, as long as they do NOT involve recruitment, compliance, or retention messages. Participant communications that include recruitment referrals or encourage retention/compliance must be reviewed by the IRB.