Contact the Tufts Health Sciences IRB at IRBoffice@tuftsmedicine.org or (617) 636-7512 with any questions about this policy.

Introduction

For the purposes of this policy, Employees/Students includes employees (faculty/staff/contractors, etc.), volunteers, students, residents, interns, and fellows.

Workplace/School refers to the institution at which the Employee/Student holds their Employee/Student position.

These populations may be vulnerable to real or perceived undue influence (excessive or inappropriate rewards for participating) or coercion (threat of harm for not participating) when recruited through their workplace or school. For example, Employees/Students may believe that their decision of whether to participate in the research will affect their relationship with peers or supervisors/instructors, and therefore their performance evaluations, career advancement, grades, recommendations, etc.

Note: This policy does NOT address FERPA and PPRA requirements for inclusion of students at schools that receive funds from the US Department of Education. Contact the IRB office with questions about FERPA and PPRA.

Note: Refer to the Policy on Enrollment of Minors if enrolling Employees/Students under the age of 18.

Targeted Recruitment Through the Workplace/School

Justification

If Employees/Students are to be directly targeted for recruitment through their Workplace/School, a justification for this recruitment other than mere convenience must be included in the Protocol or Site-Specific Appendix.

Recruitment Practices

These requirements apply to all projects reviewed by the IRB (i.e. all Human Subjects Research whether Exempt or non-Exempt, as well as all Not Human Subjects Research projects subject to IRB review).

If Employees/Students are to be directly targeted for recruitment through their Workplace/School, the following safeguards should be used to mitigate the risk of real or perceived undue influence or coercion:

• When possible, Employees/Students should not be recruited by a person with authority over them.
  • If such an authority figure will be asked to disseminate IRB-approved recruitment materials, they should be instructed not to deviate from the IRB-approved messaging. Research participation should be presented as completely voluntary, not as an assignment.
• When possible, recruitment methods should permit Employees/Students to self-identify as interested in participation in a way that maintains confidentiality. In particular, authority figures should not be made aware of any Employee/Student’s decision of whether or not to participate in the research, or of whether or not to withdraw from the research.
  • If authority figures will be aware of these decisions, they must not factor these decisions into performance evaluations, grades, advancement opportunities, recommendations, or any other assessment of the Employee/Student.
• Employees/Students should be made aware of these safeguards. For example, a statement may be included in recruitment/consent materials such as: “You can decide to participate or not to participate, and this will not affect your standing as a student at [Institution]. Your professor will not know whether you decide to participate.”

Attestation

This requirement applies to all projects reviewed by the IRB (i.e. all Human Subjects Research whether Exempt or non-Exempt, as well as all Not Human Subjects Research projects subject to IRB review). This requirement also applies to research reviewed by an External IRB.

If Employees/Students are to be directly targeted for recruitment through their Workplace/School, the IRB requires an attestation from the head of the applicable department/division/program/institution who has authority over the targeted group of Employees/Students.

• This attestation is to confirm the following points:
  1. The authority figure agrees to the targeted recruitment of Employees/Students.
  2. An Employee/Student’s decision of whether or not to participate in this study, or of whether or not to withdraw from this study, should NOT affect their standing as an Employee/Student. This will be communicated to any authority figures (e.g. managers, instructors) who will be aware of Employees’/Students’ participation.
  3. The recruitment plan minimizes the potential for (real and perceived) undue influence and coercion.
      
• The IRB has posted a Letter of Support Form – Permission to Recruit Employees or Students to serve as this attestation. A signed letter on institutional letterhead confirming points 1-3 may also be accepted.
• The attestation must not come from a research team member. If a research team member has authority over the targeted group of Employees/Students, the attestation should come from somebody with a higher level of authority over the group.
• If Employees/Students from multiple departments/divisions/programs within an institution are to be targeted for recruitment, attestations can either be obtained from the head of each department/division/program, or from one person with authority over all included departments/divisions/programs.
• If Employees/Students from multiple institutions are to be targeted for recruitment, the IRB may approve the protocol before all attestations are received. In this case, each attestation must be submitted to the IRB in a Modification before recruitment can begin at the respective institution.

Other Recruitment Scenarios

Non-Targeted Recruitment at the Workplace/School

Employees/Students may respond to recruitment materials disseminated through their workplace/school even if those materials are not specifically targeted at Employees/Students. (For example, a flyer may be posted for the patient population or general public, but an Employee/Student may see the flyer and enroll in the study.) Employees/Students are not considered vulnerable to undue influence or coercion in this scenario, and no attestation is required in order to permit them to enroll.

Note that indirect or passive recruitment may still be considered to be Targeted at Employees/Students if it will primarily reach Employees/Students (for example, posting a flyer in a staff break room or student center).

Recruitment Not Through the Workplace/School

If the Workplace/School is not involved in recruitment, then its Employees/Students are not considered vulnerable to undue influence or coercion. (For example, a researcher may obtain a list of contact information for Employees/Students at various institutions from a professional society that maintains the list. The researcher may then directly contact the Employees/Students using that list, with no involvement of anyone at the Workplace/School.)

In general, no attestation is needed in this case under Tufts HS IRB policy. Please note that institutions may have their own policies regarding participation of their Employees/Students in research. It is the researcher’s responsibility to comply with institutional policies.

Inclusion of Employees/Students in Research Without Recruitment

Some studies do not involve recruitment or enrollment of subjects. (These studies typically consist of secondary analysis of existing data, and may qualify for a waiver of informed consent and/or waiver of HIPAA authorization, and/or may be Exempt from informed consent requirements, etc.) There is generally no opportunity for undue influence or coercion in this case, so no attestation is required. Permission may be required from the institution to use its records.

FERPA and PPRA requirements may apply at schools that receive funds from the US Department of Education. Contact the IRB office with questions about FERPA and PPRA.