1.0 Policy Purpose
The purpose of this policy is to describe the expectations and responsibilities of Research Personnel when conducting human subjects research targeting individuals with whom they have a known Interpersonal Relationship (e.g., students, employees, colleagues, friends, family members, Principal Investigators (PIs) and other Research Personnel, and/or patients). This policy is not intended to supersede the established ethical principles or mandates of any discipline, organization, or association.
2.0 To Whom the Policy Applies
This policy applies to all Research Personnel at Brown University who conduct human subjects research approved by the Brown Institutional Review Board (IRB) or determined to be Exempt by the Brown Human Research Protection Program (HRPP).
3.0 Policy Statement
The Belmont Report includes the basic ethical principle of respect for persons, which requires that participants enter into research studies voluntarily and with adequate information. It also describes the Informed Consent process, including the essential elements of disclosure of information, comprehension by the prospective participant, and voluntariness of participation. Voluntary participation in a research study necessitates that the Recruitment and Informed Consent processes are free of Coercion and Undue Influence.
The Recruitment, enrollment, and conduct of research activities with Human Subjects who have an Interpersonal Relationship with Research Personnel involve unique ethical concerns. A Power Differential may exist when Research Personnel have authority to make decisions that could impact the prospective participant outside the context of the research. For example, if the participant is a student, the Research Personnel’s authority may affect the participant’s grades, academic progress, or recommendations; if an employee, it may impact the employee’s work environment, the hiring process, performance evaluations, or salary; if a colleague, friend, or family member, it may generate for the participant a fear of ruining a friendship or a hope to help a relative professionally; and if a patient, it may create for the patient anxiety of losing access to healthcare or a wish to appease the clinician.
The existence of a Power Differential between Research Personnel and prospective participants with whom the Research Personnel have an Interpersonal Relationship may result in a Recruitment or an Informed Consent process that is not voluntary and free of Coercion or Undue Influence. Individuals may feel they cannot decline participation in a research study if they believe it may lead to negative consequences for their Interpersonal Relationships. Prospective participants may even feel compelled to enroll in a study to maintain a good relationship with the Research Personnel involved. Moreover, the enrollment of participants already known to Research Personnel may heighten the potential for a loss of Confidentiality for those participants.
It is permissible for Research Personnel to conduct targeted human subjects research activities with participants with whom they have an Interpersonal Relationship only when using the additional safeguards outlined in this policy. Such participants must not be exposed to research-related risks based on access or as a matter of convenience, but instead must be considered in the context of the study’s eligibility criteria and scientific objectives.
3.1 HRPP Application Procedures
In the HRPP Application, the PI must:
- Identify any Interpersonal Relationship(s) and Power Differential(s) between the Research Personnel and targeted participants;
- Provide a scientific justification for the inclusion of the targeted participants in the study;
- Address any potential Power Differential(s), Coercion, and Undue Influence; and
- Indicate how the PI and other Research Personnel will mitigate these issues.
This policy outlines important points to consider when addressing potential Power Differential(s), Coercion, and Undue Influence, and ways to mitigate their associated risks.
Unless specifically waived by the IRB/HRPP, the Recruitment and Informed Consent processes must be conducted by someone other than the Research Personnel with the Interpersonal Relationship, so that these Research Personnel are unable to identify if a prospective participant enrolls in the study. This may be achieved by:
- Recruiting prospective participants through indirect methods, rather than direct, individual, or personal communication;
- Having Research Personnel without the Interpersonal Relationship conduct the Informed Consent process; and/or
- Requesting a Waiver of Documentation of Informed Consent or using a Code to track participants to prevent identification of individuals by Research Personnel.
When an Interpersonal Relationship exists, PIs should minimize the information collected that will identify participants. This can be achieved by:
- Collecting or receiving anonymous data from participants;
- Collecting or receiving data indirectly from participants (e.g., through a survey or questionnaire);
- Ensuring that Research Personnel with an Interpersonal Relationship do not have access to Personally Identifiable Information (PII) for any participants and are not responsible for removing PII from participant data; or
- If the Interpersonal Relationship is temporary and will end while the study is active, delaying analysis of PII until after the Interpersonal Relationship has concluded (e.g., course grades or performance evaluations have been submitted).
3.1.1 Unintentional Enrollment of Participants with a Known Interpersonal Relationship
If Research Personnel learn that participants with whom they have an Interpersonal Relationship have been recruited and enrolled in their research study, the Research Personnel should refer to the applicable sections in this policy for important points to consider regarding their Interpersonal Relationship.
The PI should pause the research activities with participants with whom Research Personnel have an Interpersonal Relationship, and:
- Assess the probability that these participants will experience possible harm, and
- Assess the magnitude of harm if any is likely to occur, and
- Assess any anticipated benefits from continued enrollment; or
- Consider withdrawing the affected participants.
There is no need to contact the IRB/HRPP unless the PI determines that the probability and magnitude of possible harm outweigh any anticipated benefits of the participants’ continued enrollment.
3.2 Students as Participants
The inclusion of students from any public or private educational institution as part of the general population of participants in research, or the recommendation that students from any public or private educational institution volunteer as research participants is permitted and common.
However, unless specific to the scientific design of a study, when another population of participants is equally suited to answer the research question, Research Personnel who are also teachers, faculty, or other instructors of courses (e.g., teaching assistants) should avoid targeting recruitment and/or enrollment of their current students, students in their respective departments, and/or students they supervise.
Research Personnel interested in targeting their own students for research participation should consider:
- Using indirect Recruitment processes (e.g., flyers, information/sign-up forms);
- Designing the Recruitment process for current students to be conducted by another faculty member or qualified personnel not associated with the research study; and
- Using Blinding or Coded Information collected by someone other than the respective Research Personnel so participants are not identifiable to Research Personnel.
In addition to the procedures set forth in this policy, the inclusion of Brown University students as participants must adhere to and be conducted in accordance with the applicable related policies in Section 7.1 below.
3.3 Employees and Unpaid Workers as Participants
Depending on the nature of the study or the research activities involved, Research Personnel should consider conducting research activities in a physical space outside a participant’s workplace or outside of a participant’s regular work hours, if possible, to maintain the Confidentiality of the individual’s participation in the study. Workplace and work hours apply to participants who are employees, contractors, and unpaid workers of an organization or entity, and includes, but is not limited to, individuals who have full-time, part-time, temporary, or visiting status, as well as students, interns, volunteers, and apprentices.
When Research Personnel intend to conduct research activities with a participant at the participant’s workplace (e.g., Participant Observation, in-person data collection), documentation of permission from an Authorized Signatory is required before any research activities may begin at that location, unless waived by the IRB/HRPP. This documentation of permission must:
- Acknowledge that Research Personnel will be present at the workplace in order to conduct activities for a Brown University research study;
- Grant Research Personnel access to the workplace;
- Describe the research activities that will occur at the workplace; and
- Release the employee or unpaid worker from work obligations that may be impacted by participating in study activities in their workplace.
Research Personnel and study materials must not:
- Indicate that participation will give the employee or unpaid worker any competitive occupational advantage over other individuals who choose not to enroll in the study;
- Impose any occupational penalty, direct or implied, on employees or unpaid workers who choose not to enroll; and
- Involve anyone in the Recruitment process who may supervise employees or unpaid workers who are prospective participants.
In addition to the procedures set forth in this policy, the inclusion of Brown University employees or unpaid workers as participants must adhere to and be conducted in accordance with the applicable related policies in Section 7.1 below.
3.4 Colleagues, Friends, Family Members, and PIs/Research Personnel as Participants
Colleagues, friends, and family members of Research Personnel asked to volunteer in that Research Personnel’s study, as well as PIs/Research Personnel participating in their own studies, may be more willing to ignore or accept the risks of a research study.
3.4.1 Colleagues, Friends, and Family Members as Participants
Research Personnel who intend to enroll their colleagues, friends, and/or family members should consider:
- How the enrollment of these participants may affect their relationships (present and future) if a colleague, friend, or family member:
- Is harmed or injured by a research-related activity;
- Withdraws their consent to participate;
- Must be withdrawn due to noncompliance with study requirements or eligibility criteria;
- Shares sensitive and/or Confidential information as part of data collection;
- Experiences a reportable event; and/or
- Has an incidental finding discovered during the course of the study.
- If Research Personnel are able to provide Compensation to these participants for research activities according to the Brown Conflict of Interest and Commitment Policy and the Conflict of Interest in Research Policy. If these Policies do not permit Compensation to colleagues, friends, and/or family members in the context of research, then such individuals cannot be included in the study.
3.4.2 PIs and Other Research Personnel as Participants
PIs and other Research Personnel may be willing to take unnecessary risks in their goal of creating new knowledge and/or personal interest in the success of their research. Study-related risks that may be addressed and mitigated for non-Research Personnel may be minimized or overlooked when the study participants are the researchers themselves.
PIs and other Research Personnel who wish to volunteer as participants in their own studies or PIs who wish to enroll other Research Personnel as participants should consider:
- How the enrollment of these participants for self-experimentation, who may be responsible for the design, conduct, and/or reporting of study results, could potentially bias or misrepresent the data;
- Whether the study is truly generalizable and can meet the federal definition of research if the PI or other Research Personnel are the only participants; and
3.5 Patients as Participants
When Research Personnel are clinicians and intend to enroll patients for whom they provide direct care, they must consider the patient’s conflict with refusing their clinician and how Therapeutic Misconception may affect the Recruitment and Informed Consent processes.
Research Personnel who provide direct care for patients must justify in the HRPP Application the Research Personnel’s involvement in the Recruitment and/or Informed Consent processes. If their involvement is not justified, they may request that a clinician or clinic staff who is not affiliated with the research study approach patients about participation.
A clinician or clinic staff unaffiliated with the research study may:
- Ask a patient’s permission to share the patient’s contact information with Research Personnel;
- Give patients the name and contact information of Research Personnel to enable the patient to make contact themselves; and/or
- Send IRB/HRPP-approved Recruitment Material to patients on behalf of Research Personnel.
For the purpose of this policy, the terms below have the following definitions:
- Authorized Signatory:
An individual who is authorized by an institution or organization to use their signature to (i) bind the institution or organization or (ii) approve a specific action for or on behalf of the institution or organization.
The process by which investigators and/or participants do not know to which study group the participants are assigned. There are single blind studies (in which the participant is blind) and double blind studies (in which both the participant and the investigator are blind).
- Coded Information/Biospecimens:
Identifying information (such as name or social security number) or biospecimens that would enable the investigator to readily ascertain the identity of the individual to whom the private information or biospecimens pertain that has been replaced with a number, letter, symbol, or combination thereof (i.e. the code); and for which a key to decipher the code exists that enables linkage of the identifying information or biospecimens to the private information or biospecimens.
Overt or implicit threat of harm intentionally presented by one person to another in order to obtain compliance.
Payment, merchandise, class credit, or other gifts or services provided to research participants or their legally authorized representatives for their time and effort associated with research participation. Compensation should be appropriate to the population, the cultural norms of the research location, and research activities.
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.
Category of review of human subjects research that is minimal risk, and not subject to review and approval by an IRB. Categories of Exempt research activities are defined by federal regulations.
- 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 Subjects:
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.
- Informed Consent:
Prospective agreement to participate in research expressed by an individual (or their legally authorized representative) giving them the opportunity to choose what may or may not happen to them during the research study based on the elements of information, comprehension, and voluntariness.
- 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.
- Interpersonal Relationship:
Involves social associations, connections, or affiliations between two or more people that may vary in their degree of intimacy, duration, reciprocity, and power distribution. These relationships may be intimate, familial, professional, or informal. Relationships may, but need not, be regulated by law, custom, or mutual agreement, and form the basis of many other social groups or organizations.
- Participant Observation:
A research methodology involving participation, observation, and analysis of the daily life of the people being studied.
- Personally Identifiable Information:
Information that can be used to distinguish or trace an individual’s identity, such as name, social security number, and biometric records, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual, such as date and place of birth or mother’s maiden name.
- Power Differential:
Relationship in which one or more individuals has a role that is perceived to have or actually has more authority, agency, or knowledge over another.
- 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, and who provides technical and administrative oversight of the research and makes important study-related decisions. For purposes of HRPP policy, only one individual is designated as the Principal Investigator of a human research study.
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 Material:
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 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.
- Therapeutic Misconception:
An ethical problem in human subjects research when a participant mistakenly believes that the primary purpose of the study in which they are enrolled is to directly benefit the individual participants, rather than to produce generalizable knowledge.
- 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.
- Waiver of Documentation of Informed Consent:
An allowance in the Federal Policy for the Protection of Human Research Subjects (45 CFR 46) for an IRB to waive the requirement for the investigator to obtain a signed consent document from participants when specific conditions are met.
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
- Brown University Student Data Release Policy and Guidelines
- Conflict of Interest and Commitment Policy
- Conflict of Interest in Research Policy
- Policy on the Recruitment of Human Subjects Research Participants
- Sexual and Gender-Based Harassment, Sexual Assault, Interpersonal Violence, and Stalking Policy
7.2 Related Procedures
7.3 Related Forms
7.4 Frequently Asked Questions (FAQs)