1.0 Policy Purpose
This policy describes the expectations and responsibilities of Research Personnel regarding the Recruitment process of Human Subjects for research studies. In accordance with The Belmont Report, Research Personnel must respect an individual’s reasonable expectation for Privacy and Confidentiality when gathering information about a potential participant and determining who will invite an individual to participate in research. This policy ensures the equitable Recruitment of potential research participants by providing information regarding appropriate methods and mechanisms for recruiting research volunteers.
2.0 To Whom the Policy Applies
This policy applies to any individual who conducts Recruitment of Human Subjects for research studies approved by the Brown Institutional Review Board (IRB) or Human Research Protection Program (HRPP).
3.0 Policy Statement
Methods and materials used to Recruit Human Subjects for research must
- be equitable and free of bias;
- not exert Undue Influence or induce Coercion;
- not imply or guarantee any benefits beyond the scope of the research; and
- respect Privacy and Confidentiality of potential participants.
The IRB/HRPP are charged with reviewing and Approving the Recruitment Materials, methods, procedures, and tools used to Recruit potential research participants before any recruitment strategies are implemented.
The IRB/HRPP will evaluate all Recruitment methods and materials to ensure compliance with the Federal Policy for the Protection of Human Subjects (45 CFR 46). All print, electronic, video, and audio Advertisements; Third-Party Recruitment methods; Brown-specific recruitment tools; and Subject Pools, recruitment lists, databases, and registries used to solicit potential research participants must be reviewed and Approved by the IRB/HRPP prior to use, and must adhere to the approval criteria in this policy.
3.1 Recruitment Plans
3.1.1 Recruitment Time Frames and Settings
Recruitment activities must be designed and conducted in a manner that permits potential participants sufficient time, determined by the nature and risks of the research, to consider if they wish to participate. In Approving a recruitment plan, the IRB/HRPP will consider the length of time between Recruitment, the informed consent process, and the first research procedure in order to ensure potential participants have time to consider the research activities, and to avoid undue pressure or excessive inducements.
Recruitment activities must be carried out in a setting that provides the potential participant Privacy and that is free of situational or environmental influences or intimidations.
3.1.2 Considerations for Vulnerable Populations
The Principal Investigator (PI) must give particular consideration when recruiting Vulnerable Populations described in the federal regulations (e.g., pregnant women, human fetuses, and neonates; prisoners; and children), and when recruiting populations who may be more susceptible to Undue Influence or Coercion due to the nature of the research, their situation, or their condition. Researchers must recognize these vulnerabilities and make special provisions when recruiting these potential participants to ensure they have the ability to act with autonomy and understand the expectations of the research
3.1.2.1 Brown University Students and Staff
PIs intending to recruit Brown University students or staff to participate in a research study must ensure that the recruitment plan minimizes any perception of Undue Influence or Coercion, as these populations are vulnerable to perceived pressures to appear to professors, supervisors, and/or colleagues as cooperative and supportive of the PI, the research, and/or Brown.
Such pressure may manifest itself with respect to both the initial decision to participate in the research, and any subsequent decisions to continue or discontinue participation once enrolled in a study. The recruitment plan must assure potential participants that their relationship with Brown and their grade, standing, employment, status, etc. are not dependent on and will not be otherwise affected by their decision to participate in a study.
In conducting recruitment procedures, a PI may not use the Confidential or Private information of Brown faculty, students, or staff to which the PI has access as a result of the PI’s appointment or employment at Brown.
PIs and any other individual of influence or power within the University (e.g., a Dean, Department Chair, etc.) must not require that students participate in a specific research study as part of a class or for a grade. By federal regulation, research participation must be voluntary. When research participation is a course expectation, when extra credit or course credits are offered for participation, or when recruitment occurs in a classroom, students must be informed of non-research alternatives involving comparable time and effort to fulfill the course requirements or to obtain the credit in order for the possibility of Undue Influence to be minimized. Students cannot be penalized for refusing to participate in research.
Recruitment of students must adhere to The Family Educational Rights and Privacy Act (FERPA) and must be conducted in accordance with the Brown University Student Data Release Policy and Guidelines.
3.2 Recruitment Methods
All Recruitment methods must be thoroughly described in the IRB/HRPP Application. The PI should carefully consider the study aim(s), targeted research population(s), participant Privacy, and potential for bias and Undue Influence when designing recruitment activities.
PIs must not assume passive agreement by the potential participant if they do not respond to the Recruitment Material, or otherwise use an “opt out” method requiring the potential participant to respond if they do not want to participate.
Potential participants who receive multiple unsolicited requests for participation may feel harassed. Therefore, PIs may not contact potential participants more than three times in total per research study to solicit their participation.
Recruitment Material may not be used prior to IRB/HRPP Approval. After Approval, if a PI intends to change or add new Recruitment Material, it must be reviewed and Approved by the IRB/HRPP prior to implementation using the Amendment or Exempt Modification process.
3.2.1 Advertisements
All Recruitment Materials used to solicit volunteers must be included with the IRB/HRPP Application for review. The IRB/HRPP must review and Approve the final version of all Advertisements, which may include, but are not limited to, the following:
- Printed material;
- Newsletters used for recruitment purposes;
- Electronic advertisements;
- Email; and
- Video and/or audio scripts
Advertisements should generally be limited to the information that potential participants reasonably need in order to determine their eligibility and interest in the research.
3.2.2 Electronic Recruitment
Electronic Recruitment Materials must be clearly identified as recruitment for a voluntary research study. This Material may not be located or posted in such a way that it could be easily mistaken for, or confused with, employment or paid work.
Subject lines or teaser ads are not required to include all of the criteria for IRB/HRPP Approval (as described in Section 3.3 below) and may only include limited information to entice prospective participants. Electronic Recruitment Material must transfer prospective participants to a second Advertisement that contains the information that was required to receive IRB/HRPP Approval. Subject lines or teaser ads may not directly transfer prospective participants to a consent document, as a consent document does not meet the definition of Recruitment Material.
Electronic sites that may not be Publicly Available (e.g., mailing lists, private message boards, or closed discussion groups) may be used for recruitment only with the written permission of the site owner. PIs are not required to submit a copy of the owner’s permission with the IRB/HRPP Application, but must keep a copy of that permission on file with the study’s research records and make it available to the IRB/HRPP upon request.
When recruiting through electronic communities, researchers must conduct their activities in accordance with that site’s policies or with the permission of the community’s site owner, moderator, or administrator, and be respectful of the user community’s culture, standards, and expectations. It is the responsibility of the PI to ensure that submitted Recruitment Materials comply with electronic communities’ requirements.
3.2.3 Third-Party Recruitment
Third-Party recruitment occurs when a PI asks a personal contact, organization, or commercial entity outside of the research team, to recruit on behalf of the research team.
Recruitment Material from a Third-Party recruiter must clearly reflect that the Third-Party is not involved in the research study and instruct potential participants to indicate their interest in the study by contacting the research team directly.
Third-Party recruiters may not
- Collect any research-related information from potential participants used to determine eligibility; and/or
- Provide to a PI information about potential participants that would breach the potential participants’ Confidentiality or Privacy; and/or
- Receive compensation for Recruitment, unless they are a commercial entity hired to recruit as a service and have no relationship with the potential participants.
3.2.4 “Snowball Sampling”
PIs may ask enrolled participants to recruit prospective participants (referred to as “snowball sampling”) provided certain conditions are met. The IRB/HRPP generally agrees that enrolled participants who do not receive rewards or compensation for referrals are unlikely to induce bias, or feel Undue Influence or Coercion. Appropriate measures must be taken by the PI and enrolled participants to ensure that the Confidentiality of prospective participants is not violated during this process.
3.2.5 Brown-Specific Recruitment Tools
3.2.5.1 Today@Brown
Solicitations through Today@Brown to Recruit Human Subjects for research are permitted for Brown research faculty if the study is supported by sponsored funding (including Brown internal sponsored funding, e.g., Office of the Vice President for Research Seed and Salomon awards) and has Brown IRB/HRPP approval to use this Recruitment procedure.
Student research and research under an IRB Authorization Agreement in which Brown relinquishes IRB oversight cannot use Today@Brown for recruitment
3.2.5.2 Sites.brown.edu
Sites.brown.edu is a self-service platform for Brown faculty and staff who wish to host individual, lab, conference, or other non-departmental or non-administrative organization websites on the brown.edu domain.
PIs may use Sites.brown.edu to collect screening and/or research data about participants for Level 1 Risk research studies only. At this time, it is not permissible to use this platform to collect Level 2 and/or Level 3 Risk research data. For Level 2 and Level 3 Risk studies, PIs may only use Sites.brown.edu to create a website for prospective or active study participants to learn more about a study Approved by the Brown IRB/HRPP.
3.2.6 Subject Pools, Recruitment Lists, Databases, and Registries
PIs may create and maintain a list of research volunteers who previously were screened for or who took part in a research study, or expressed interest in being contacted for future research opportunities by meeting the following conditions:
- Receiving permission from volunteers to retain their name and pertinent information for future research; and
- Providing volunteers the opportunity and instructions on how to remove their names and pertinent identifiable information from the list at any time.
IRB/HRPP review and Approval is required for the use of this Recruitment procedure and must be obtained before the Research Personnel discuss this option with potential volunteers. The IRB/HRPP will evaluate how permission is sought, the appropriateness of the data being requested, and the Confidentiality and security measures in place to secure the data.
3.2.7 Publicly Available Information
PIs may use information that is Publicly Available to contact potential participants. PIs do not need prior permission from potential participants to collect or use Publicly Available contact information, as long as such contact information does not explicitly identify the directory or list as not to be used for solicitation purposes.
3.3 Approval Criteria
Unless specifically waived or granted exception by the IRB/HRPP, all Recruitment Materials must meet the following criteria for IRB/HRPP Approval:
- Describe the study as a “Brown University research study”;
- Include the name and contact information of the PI or Research Personnel knowledgeable about the research and research procedures;
- Include the study protocol number;
- Do not state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the IRB/HRPP Application or consent process;
- Do not state or imply that research procedures are known to be equivalent or superior to practices available to potential participants outside of the research context;
- Do not describe research procedures as “new,” “safe,” or “effective” for the purpose under investigation; and
- Do not include exculpatory language through which a participant or their Legally Authorized Representative waives the participant’s legal rights or releases the PI, the sponsor, or Brown from liability or negligence.
In addition, Recruitment Materials may include compensation if participants will be paid, but cannot emphasize compensation by font or design enhancements.
3.4 Recruitment Incentives and Bonuses
Payment arrangements between or among sponsors, organizations, PIs, enrolled participants, and individuals referring research participants may place prospective and enrolled participants at risk of Coercion or Undue Influence, or cause inequitable selection of participants. As such, payment, compensation, reward, or bonuses in exchange for referrals of potential participants from others (known as “finder’s fees”) is not permitted unless the recruiter is a commercial entity hired to recruit as a service and has no relationship with the potential participants. Payments designed to accelerate recruitment that is tied to the rate or timing of enrollment (known as “bonus payments”) are also not permitted.
3.5 Non-Recruitment Communication
There are forms of communication involved in research that are not intended for Recruitment purposes and therefore do not need IRB/HRPP review.
3.5.1 Communication with Key Informants or Third-Party Recruiters
Key Informants providing information about topics other than themselves and Third-Party recruiters do not meet the definition of Human Subjects, nor are they Research Personnel. Therefore, communication with these groups and their activities does not require IRB/HRPP review.
Recruitment Materials used by Third-Party recruiters to recruit on behalf of the research team do require IRB/HRPP review and approval.
3.5.2 Press Releases
Press releases (e.g., news stories, bulletins, announcements, etc.) about an active research study are generally not considered Recruitment Material and may be submitted for publication without IRB/HRPP Approval as long as the information disseminated is not intended to recruit participants.
If the press release includes eligibility criteria and/or a description of how potential participants may contact the PI or access more information about the study, this press release meets the definition of Recruitment Material and IRB/HRPP review is required prior to publication.
3.5.3 Clinical Trials Directories
Use of electronic directories of Clinical Trials is not considered Recruitment when the format of the directory limits the information provided to only the basic trial information (e.g., study title, eligibility criteria, investigator’s contact information, etc.).
Examples of Clinical Trial directories that do not need IRB/HRPP review include National Institutes of Health (NIH) ClinicalTrials.gov, the NIH National Cancer Institute’s cancer clinical trials listing, FDA Clinical Trials, and the government-sponsored AIDS Clinical Trials Information Service (ACTIS).
When information posted on a Clinical Trials website goes beyond directory listings, such information meets the definition of Recruitment Material and IRB/HRPP review is required prior to posting.
4.0 Definitions
For the purpose of this policy, the terms below have the following definitions:
- Advertisements:
-
A public announcement that is intended to be seen or heard by a prospective participant to solicit that person’s enrollment in a research study.
- Amendment:
-
An Amendment is a change to an approved research study (Expedited or Full Board) that is subject to IRB review and approval before implementation, unless the immediate change is necessary to eliminate an apparent hazard to participants. Currently enrolled and active participants must be informed of the change if it could affect their willingness to continue participation in the study. The Amendment review process is required by federal regulations.
- Approve:
-
An IRB action taken when the required determinations are made that allow research involving human subjects to proceed consistent with federal regulations, state and local laws, and University policy.
- Clinical Trial:
-
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
- Coercion:
-
Overt or implicit threat of harm intentionally presented by one person to another in order to obtain compliance.
- Confidentiality:
-
Refers to how a researcher has agreed to handle, manage, and disseminate the information disclosed by or data regarding a participant. There is a relationship of trust between these parties and the expectation that confidential information or data will not be divulged to others by the researcher without the participant’s permission in ways that are inconsistent with the agreement regarding disclosure of the information or data.
- Exempt Modification:
-
A change to an Exempt research study that is subject to HRPP review and approval before implementation, unless the immediate change is necessary to eliminate an apparent hazard to participants. Currently enrolled and active participants must be informed of the change if it could affect their willingness to continue participation in the study. The Exempt Modification review process is required by Brown policy.
- Federal Policy for the Protection of Human Subjects (45 CFR 46):
-
The basic Department of Health and Human Services policy on the protection of human participants in research. This policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research.
- Human Research Protection Program:
-
The Human Research Protection Program (HRPP) exists to promote high quality, ethical research. It does this by serving as the advocate for the rights and welfare of persons who participate in research programs conducted by faculty, staff, students, and researchers at Brown University. The HRPP has responsibility for review of research involving human subjects conducted at Brown University, and assists researchers in complying with federal, state and Brown policies regarding experimentation involving human subjects.
- Human Subject:
-
A living individual about whom an investigator (whether professional or student) conducting research (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
- Institutional Review Board:
-
A specially constituted review body established to protect the rights and welfare of human subjects recruited to participate in biomedical or social/behavioral research conducted under the auspices of its affiliated institution.
- IRB Authorization Agreement:
-
A written agreement between two or more institutions that is used to document the delegation of IRB review responsibilities. This agreement may also be referred to as a reliance agreement or cede review agreement.
- Key Informant:
-
Any individual who provides information on topics other than themselves with respect to a specific research study.
- Legally Authorized Representative:
-
An individual, judicial, or other body authorized under applicable law to consent to research participation on behalf of a designated person.
- Principal Investigator:
-
An individual with the appropriate scientific and/or scholarly training and expertise to assume direct responsibility for the ethical conduct of a study involving human subjects, providing technical and administrative oversight of the research and making important study-related decisions. For purposes of HRPP policy, only one individual is designated as the principal investigator of a human research study.
- Privacy:
-
Refers to a participant’s right to control who has access to them, their location, and their space. It is the recognition that a participant has the right to determine the extent, timing, and circumstances of sharing themselves (physically, behaviorally, or intellectually) with researchers.
- Publicly Available:
-
Refers to data and/or biospecimens when used for human subjects research that are accessible to anyone in the general public, without the need for special permissions or privileges.
- Recruitment:
-
The process of identifying and reaching potential participants to enroll in a research study. It is considered the beginning of the participant selection and informed consent/assent processes.
- Recruitment Materials:
-
May include (but are not limited to) printed materials, newsletters, recruitment lists, phone scripts, e-mails, electronic advertisements, and video/audio scripts. Recruitment materials must contain enough information to provide potential participants a sense of the study and the ability to decide if they may be eligible to participate.
- Research Personnel:
-
Persons, including the Principal Investigator, who have direct contact with participants, contribute to the research in a substantive way, have contact with a participant's identifiable data or biological samples (e.g., tissue, blood, urine, plasma, saliva), or use a participant's personal information for research purposes.
- Subject Pools:
-
A group of individuals who identified themselves as being willing to participate in research. Signing up to join a subject pool does not enroll a person in a research study or make that person a research participant.
- Third-Party:
-
In terms of Recruitment, any person or vendor (outside of the research team) who recruits on behalf of that team.
- Undue Influence:
-
Excessive or inappropriate reward or other overture in order to persuade a person to act against that person’s own interests or without adequate consideration of the consequences in order to obtain compliance.
- Vulnerable Population:
-
A group of participants that may have insufficient power or resources to protect their own interests, which may make them susceptible to Undue Influence and/or Coercion depending on the situation, their condition, or the research. A population’s vulnerability may change depending on the nature of the research and may fluctuate over time. Investigators must take special care and consideration when recruiting, consenting, and conducting research activities with these populations.
5.0 Responsibilities
All individuals to whom this policy applies are responsible for becoming familiar with and following this policy. University supervisors are responsible for promoting the understanding of this policy and for taking appropriate steps to help ensure compliance with it.
6.0 Consequences for Violating this Policy
Failure to comply with this and related policies is subject to disciplinary action, up to and including suspension without pay, or termination of employment or association with the University, in accordance with applicable (e.g., staff, faculty, student) disciplinary procedures.
7.0 Related Information
Brown University is a community in which employees are encouraged to share workplace concerns with University leadership. Additionally, Brown’s Anonymous Reporting Hotline allows anonymous and confidential reporting on matters of concern online or by phone (877-318-9184).
The following information complements and supplements this document. The information is intended to help explain this policy and is not an all-inclusive list of policies, procedures, laws and requirements.
7.1 Related Policies:
7.2 Related Procedures:
7.3 Related Forms:
N/A
7.4 Frequently Asked Questions:
N/A
7.5 Other Related Information:
Policy Owner and Contact(s)
Policy Owner: Vice President for Research
Policy Approved by: Vice President for Research
Contact Information:
Policy History
Policy Issue Date:
Policy Effective Date:
Policy Update/Review Summary:
This Policy is not new; it was converted to the University’s new policy template and re-reviewed by the IRB at its convened meeting on October 15, 2020. Prior approved policy version had a Policy Effective Date of July 4, 2020.