Section XII:

Safeguarding Confidentiality and Records

WPP #: XII-4

Title 4:

Identification and Recruitment of Research Participants

Effective Date:

05-14-14

Revision History:

4-1-09

Policy Statement

VCU investigators and research staff should be vigilant in facilitating research participants’ trust in VCU and the research enterprise. Investigators and research sites (whether within or outside of VCU) are to work together to ensure that the privacy rights of prospective participants are protected with appropriate safeguards for identification and recruitment of eligible research subjects. Investigators and research sites are responsible for complying with their respective HIPAA requirements.

Virginia Commonwealth University (VCU) encourages research activities both within and outside VCU in many varied types of settings ranging from clinical settings to educational settings. Within this policy, VCU provides specific guidelines for using private identifiable information (including, but not limited to Protected Health Information) for the identification and recruitment of potential research participants. For additional policies regarding advertising and other recruitment matters, see:

What This Policy Covers: This policy addresses investigator plans to identify, notify, and ultimately recruit research participants where:

Private identifiable information is collected or otherwise recorded by the investigator/research staff for the purpose of initiating future contact with prospective research participants and the investigator has no prior permission from a prospective research participant to access his/her private identifiable information. (Note: From an IRB perspective, acknowledgement of having read the HIPAA Notice of Privacy Practices does not constitute permission).

What Is Not Covered: This policy does not apply to or limit research activities involving the identification or recruitment of prospective research participants from public lists or other non-confidential data sources.

This policy does not restrict feasibility determinations for research involving Protected Health Information (PHI). However, feasibility determination practices should not involve removing any private information from the premises of the organization that is responsible for protecting the information.

Description and Procedures

This policy includes the following sections:

A) Selected Ethical Considerations in Developing Recruitment Strategies
B) Guidelines for Assessing Study Feasibility
C) Non-VCU Sites: Guidelines for Identification and Recruitment
D) VCU Sites: Guidelines for Identification and Recruitment
E) Guidance for Reviewers

The identification and recruitment strategies outlined in this policy are not intended to limit investigators, but to provide a framework for typical practices that have been approved by the VCU IRB. Alternative approaches are anticipated; however, the VCU IRB recommends pre-review of proposed procedures that greatly deviate from the spirit of these guidelines (contact the Office of Research Subjects Protection, the IRB Panel Chairperson, or the reviewer to discuss alternative recruitment plans).

  1. Important Reminders and Ethical Considerations for ALL Recruitment Sites:
    1. For recruitment practices covered by this policy, the VCU IRB strongly discourages ‘cold calls/contacts.’ A ‘cold call’ is any contact with specified research participants where neither the investigator (nor his or her representative) has prior permission (a) from the subject to access their private identifiable information (e.g., signed consent document or (b) the IRB has not waived consent for the purpose of recruitment.
    2. HIPAA Applicability: The use of identifiable health information for identification and recruitment is also subject to HIPAA regulations which may be more restrictive than this IRB policy. The VCU IRB is designated as a Privacy Board to ensure regulatory compliance requirements are met in the conduct of human participant research. All research activities involving Protected Health Information (PHI) must implement an appropriate pathway for the use or access as directed in the federal Privacy Rule (45 CFR 160 and 164)
    3. Respect the Privacy of Individuals – The recruitment strategy should be responsive to an individual’s reasonable expectations for privacy. When VCU is the recruitment site, both the investigator and the service provider represent the same institution (with a shared organizational identity). In this way, concerns regarding confidentiality are not as sensitive as when recruiting from Non-VCU sites. However, if the research also involves information that could be stigmatizing (e.g., HIV status, illicit drug use, etc.) additional considerations for privacy may still be needed. Conversely, when a Non-VCU site is the recruitment site, a prospective research subject has an assumed expectation of privacy that would not include VCU research activities. Investigators should consider the sensitivity of the private, identifiable information needed to prepare for recruitment, the target population, eligibility windows, and plan accordingly.
    4. Avoid Coercion – Recruitment strategies should be developed in such as way as to limit the impression of coercion. Some individuals may find it difficult to refuse participation if someone in whom they trust (e.g., physician) is making the request. However, these same individuals may prefer to have someone known to them tell them about the study first. These are conflicting concerns and can result in differing recruitment strategies for otherwise similar research protocols.
  2. Guidelines for Assessing Study Feasibility at ALL Recruitment Sites:

    This process includes steps undertaken to determine whether there are sufficient numbers of potentially eligible subjects. Private identifiable information is NOT recorded at this stage. The following guidelines apply:

    1. IRB review and approval is not required.
    2. In cases involving Protected Health Information at VCU recruitment sites, IRB review and approval is required.
    3. If using Non-VCU recruitment sites, VCU investigators must follow the Non-VCU institution’s procedures regarding HIPAA requirements.
  3. Non-VCU Sites: Guidelines for Identification and Recruitment:
    1. General Tips:
      1. Consider what complications might impact enrollment, including recruitment timelines and eligibility windows as you plan strategies to contact research participants.
      2. The degree of involvement by the Non-VCU site has implications for ‘engagement’ in the research (see WPP #XVII-6 Involving Non-VCU Institutions in VCU Human Subjects Research).
      3. The Non-VCU recruitment site should be fully aware of applicable rules and regulations governing their release of private identifiable information (e.g., HIPAA, FERPA).
    2. Identification for Recruitment Purposes (Involving Non-VCU Sites):
      1. Obtain permission from an authorized official at the Non-VCU recruitment site for the purpose of gaining access to private identifiable information in order to initiate recruitment contact.
      2. Describe your overall recruitment strategy, including what role the Non-VCU site will play in making the initial contact with the prospective research participants.
      3. Private identifiable information recorded for the purpose of recruitment should be limited to the minimum data elements necessary to effectively carry out the recruitment plans.
      4. Obtain VCU IRB approval, including a waiver of informed consent for recruitment, which will allow for the private identifiable information to be used without permission of the individuals. This waiver of informed consent for recruitment is commonly approved by the IRB for these purposes and is reviewed based upon the risks related to confidentiality and privacy concerns related to recruitment procedures, not the research risk in toto. (WPP XI-1 Consent Process, Elements, Waiver of Consent).
      5. If obtaining and recording Protected Health Information (PHI) from a Non-VCU recruitment site, follow HIPAA compliance procedures identified by the Non-VCU Site.
    3. Planning Your Recruitment Strategy and IRB Submission (Involving Non-VCU Sites):
      1. Developing Your Recruitment Approach (Involving Non-VCU Sites): Within your IRB submission, describe the overall recruitment strategy, which may include a single approach or a combination of approaches, depending upon the study. The following are two standard approaches to consider along with the overall design of your recruitment strategy:
        • “OPT IN” – prospective subjects receive information (in person or by letter, phone, email, etc.) which prompts the individual to take some action if they DO want further contact or information about the research opportunity. Note that in this approach, prospective subjects may only be contacted if they have initiated the process.
        • “OPT OUT” – prospective subjects receive information (in person or by letter, phone, email, etc.) prompting them to only take action only if they DO NOT want further contact or information about the research.  Note: To approve an “opt out” approach, the VCU IRB must approve a waiver of consent (refer to WPP XI-1 Consent Process, Elements, Waiver of Consent). IRBs routinely approve this type of waiver, considering the typically very low risk of investigators accessing the prospective subject’s personally identifiable information.
      2. Introducing the Research Opportunity (Involving Non-VCU Sites): The prospective research participant may be introduced to the research opportunity in person, via phone, email, letter, or a mixed approach, as appropriate. The following standard approaches do not represent an exhaustive list:
        1. Standard Written Introductions:
          1. The VCU IRB must review and approve the written correspondence including content, format, choice of letterhead, and planned signatures. Although a mailed letter is most frequently employed, electronic communication may be appropriate in some situations.
          2. Letters may be signed by a Non-VCU site authorized official (e.g., research officer, administrator, department head, clinician, etc.) or may be co-signed with the investigator. The Non-VCU site will typically indicate how they prefer to have the initial introduction carried out. If private, identifiable information is to be removed from the Non-VCU site for the purpose of generating the introductory letters:
            • The VCU IRB must first review and approve a waiver of informed consent for recruitment.
            • The Non-VCU site may have additional required procedures prior to removing any private identifiable information from their premises.
          3. Letters should, at a minimum, contain contact information for the prospective subject (i) to obtain more information about the research and the study team and (ii) to express a lack of interest in study participation and request that no further research contact occur.
          4. In the case of an “OPT-OUT” strategy, investigators should typically allow a reasonable amount of time (usually is 10 business days) for a prospective subject to receive a written recruitment letter and respond. Certain studies may have more stringent time constraints, such as very brief eligibility windows, which may justify a shorter response period. Justification for shorter response periods must be included in the research plan and reviewed and approved by the VCU IRB.
        2. Standard Verbal Introductions: If an authorized official at the Non-VCU recruitment site informs the prospective participant about the study verbally (as part of an office visit, via phone, or other) and the participant does not expressly object, the investigator may proceed with contacting the prospective participant. The service provider is to record and communicate prospective participant refusals to be contacted.
      3. Preparing for Questions, Objections, and Complaints about Recruitment Procedures (Involving Non-VCU Sites): Despite careful planning of recruitment strategy, a certain number of questions, objections/refusals to hear about the study, and complaints may be expected by the investigator, the Non-VCU site, and the IRB. Questions, objections, and complaints related to the recruitment procedures may be made by subjects at any time during the recruitment or active study phase. In anticipation of such, investigators should describe, within the research plan, how the research team will:
        1. Answer questions (e.g., “How did you get my name?”). Responses should be clear and concise, explaining permissions obtained as appropriate.
        2. Uphold “no contact” requests. What steps will be taken to ensure no further contact with prospective subjects who have previously voiced a desire not to be contacted? How will these requests for no further contact be reported to the Non-VCU site?
        3. Respond to and monitor all complaints (including unresolved concerns) expressed regarding the recruitment process. Complaints go beyond questions and extend into specific areas of privacy, confidentiality, or trust. How will the investigator and the Non-VCU site work together to respond to complaints and what individual will be responsible for monitoring all complaints?
        4. Inform the IRB of complaints received at the time of continuing review (or sooner if the nature or number of complaints escalates beyond what is anticipated for that given protocol). A simple complaint log is suggested.

      Examples:

      • When using an opt-out strategy, extenuating circumstances may result in the prospective subject not having received an introductory letter. In such cases, the investigator or research staff contacting the individual should offer to re-start the recruitment procedures (beginning with the introduction) or offer to explain the study over the phone at the time of contact. An individual’s refusal to hear about the study or receive a (second attempt) introductory letter is the final word. The investigator should record the event but would use his/her judgment in determining if this is an actual complaint.
      • In the above case, if the refusal is combined with a complaint regarding the recruitment procedures, privacy, and other concerns which cannot be resolved, the investigator should record the event on a complaint log and report to the IRB at the time of Continuing Review.
      • In the rare case of a prospective subject complaint including a claim that they have been treated unfairly or placed at increased risk, the matter should be reported to the VCU IRB (using the UP Prompt Reporting Form) and also to the Non-VCU site.
  4. VCU SITES: Guidelines for Identification and Recruitment:

    When VCU is the recruitment site, both the investigator and the service provider represent the same institution. In light of a shared VCU identity and a general public knowledge of VCU as a research institution, privacy concerns can typically be approached with more flexibility within VCU than when recruiting from Non-VCU sites.

    The following general guidelines should be followed:

    1. General Tips: If obtaining and recording Protected Health Information (PHI) within VCU, contact the IRB for guidance regarding IRB submission requirements.
    2. Identification for Recruitment Purposes (at VCU):
      1. Inform an authorized official at the VCU recruitment site (clinic, department, or other) about the purpose of the research and recruitment strategy planned.
      2. Obtain VCU IRB approval. A waiver of informed consent for recruitment (which will allow for the private identifiable information to be used without permission of the individuals), may be appropriate in cases where private identifiable information involves sensitive information (e.g., sensitive diagnoses, matters that my affect public reputation or cause potential embarrassment). This waiver of informed consent for recruitment is commonly approved by the IRB for these purposes and is reviewed based upon the risks related to confidentiality and privacy concerns related to recruitment procedures, not the research risk in toto. (Ref: WPP XI-1 Consent Process, Elements, Waiver of Consent).
      3. Follow additional applicable HIPAA compliance procedures (see WPP XII-3 Health Insurance Portability and Accountability Act (HIPAA) Information and the Conduct of Research).
    3. Planning Your Recruitment Strategy and IRB Submission (Involving VCU Sites):
      1. Developing Your Recruitment Approach (Involving VCU Sites): Within your IRB submission, describe the overall recruitment strategy, which may include a single approach or a combination of approaches, depending upon the study. The following are two standard approaches to consider along with the overall design of your recruitment strategy:
        • “OPT IN” – prospective subjects receive information (in person or by letter, phone, email, etc.) which prompts the individual to take some action if they DO want further contact or information about the research opportunity. Note that in this approach, prospective subjects may only be contacted if they have initiated the process.
        • "OPT OUT” – prospective subjects receive information (in person or by letter, phone, email, etc.) prompting them to only take action if they DO NOT want further contact or information about the research. Note: When appropriate, to approve an “opt out” approach, the VCU IRB must approve a waiver of consent (refer to WPP XI-1 Consent Process, Elements, Waiver of Consent). IRBs routinely approve this type of waiver, considering the typically very low risk of investigators accessing the prospective subject’s personally identifiable information.
      2. Introducing the Research Opportunity (Involving VCU Sites): The prospective research participant may be introduced to the research opportunity in person, via phone, email, letter, or a mixed approach, as appropriate. Within the VCU system more flexibility is afforded to investigators (e.g., recruiting directly within given location or with a specific population). Regardless of the given approach, the prospective subject should clearly understand that s/he is being asked to be part of a VCU research project and that participation is voluntary.
    4. Preparing for Questions, Requests, and Complaints about Recruitment Procedures (Involving VCU Sites): Despite careful planning of recruitment strategy, even within VCU, a minimal number of complaints may be anticipated. Questions, requests, or complaints related to the recruitment procedures may be made by subjects at any time during the recruitment or active study phase. In anticipation of such, investigators should describe, within the research plan, how the research team will:
      1. Answer questions (e.g., “How did you get my name?”). Responses should be clear and concise, explaining permissions obtained if appropriate.
      2. Uphold “no contact” requests. What steps will be taken to ensure no further contact with prospective subjects who have previously voiced a desire not to be contacted? How will these requests for no further contact be reported to the Non-VCU site?
      3. Respond to and monitor all complaints (including unresolved concerns) expressed regarding the recruitment process. Complaints go beyond questions and extend into specific areas of privacy, confidentiality, or trust. How will the investigator respond to complaints and what individual will be responsible for monitoring all complaints?
      4. Inform the IRB of complaints received at the time of continuing review (or sooner if the nature or number of complaints escalates beyond what is anticipated for that given protocol). A simple complaint log is suggested.

      Examples:

      • When using an opt-out strategy, extenuating circumstances may result in the prospective subject not having received an introductory letter. In such cases, the investigator or research staff contacting the individual should offer to re-start the recruitment procedures (beginning with the introduction) or offer to explain the study over the phone at the time of contact. An individual’s refusal to hear about the study or receive a (second attempt) introductory letter is the final word. This event is not necessarily a complaint, but does represent a potential problem, should a trend develop. The investigator should record the event but would use his/her judgment in determining if this is an actual complaint.
      • In the above case, if the refusal is combined with an unresolved complaint regarding the recruitment procedures, privacy, and other concerns which cannot be resolved, the investigator would want to record the event on a complaint log and report to the IRB at the time of Continuing Review.
      • In the rare case of a prospective subject complaint includes a claim that he/she has been treated unfairly or placed at increased risk, the matter should be reported to the VCU IRB (using the UP Prompt Reporting Form) and also to the Non-VCU site.
  5. Reviewer Guidance: While the issues related to the recruitment from Non-VCU sites differ in fundamental ways from the issues related to recruitment at VCU, reviewer responsibilities are similar:
    • Evaluate the Adequacy of the Plan: Evaluate the proposed steps and ensure that the recruitment strategy proposed is appropriate and respectful of the privacy of the prospective recruits, yet is also not coercive.
    • Consider the Sensitivity of the Research and the Overall Recruitment Plan: It is the responsibility of the VCU IRB reviewer to review the risk that the given recruitment strategy imposes in a way that effectively weighs the sensitivity of the private identifiable information as well as the target population, themselves (e.g., vulnerable subjects, subjects largely unfamiliar with research).
    • Evaluate Reports of Complaints: If actual or perceived harm is assessed (beyond inconvenience or disinterest) and/or the level or frequency of complaint by subjects is inordinately high, the reviewer should consider if a change to the strategy is needed.
    • Consider the Need for a Waiver of Informed Consent for Recruitment: To approve an “opt out” approach, the VCU IRB must approve a waiver of consent for recruitment purposes (refer to WPP XI-1 Consent Process, Elements, Waiver of Consent). A waiver of informed consent for recruitment should be considered as a default action depending on the circumstances of the research. IRBs routinely approve this type of waiver, considering the typically very low risk to subjects of investigators accessing personally identifiable information.

References

VCU IRB WPP XII-3 HIPAA Information and the Conduct of Research
VCU IRB WPP XVII-2: Subject Recruitment and Compensation
VCU IRB WPP XVII-9: Use of the Internet for Recruitment and/or Research Data Collection
Family Educational Rights and Privacy Act (FERPA)