Recruiting Study Subjects and Reasonable Payment (Remuneration)
February 2006

I. RECRUITMENT

What does the JHM IRB need to know about recruitment of study subjects?

Federal regulations (both DHHS and FDA) require that IRBs make sure that the selection of subjects for a study is equitable.  Each protocol submitted to the JHM IRB for review must explain how subjects will be identified and recruited for the study.  Once the pool of potential subjects is identified, the IRB must consider how the investigator proposes to approach those individuals.  Any approach to subjects must be non-coercive and the potential subjects must voluntarily participate in the recruitment process.  The IRB and the investigator must respect and protect subject privacy.  By privacy, we mean the subject’s right to control access to him or herself.  In order to assure that these principles are met, the JHM IRB will review the study recruitment plan and all recruitment materials to determine how the materials will be used, whether the plan will reach the target audience, and how communication between the investigator and the potential subjects will occur. 

Note:  The JHM IRB will also review a recruiting plan to make sure that it complies with HIPAA and institutional requirements.  Certain populations, such as students and employees, receive added protections from the JHM IRB because their decision to participate in a study may not be truly voluntary; the decision may be vulnerable to coercion or undue influence exerted by the teacher/supervisor.  Patients also receive added protection.  Please see http://irb.jhmi.edu/Guidelines/Patientrecruitment.html for information about recruiting patients into research studies.  Under HIPAA, the use of a person’s protected health information or “PHI” in research generally is not permitted without an authorization from the subject or an IRB waiver of authorization.  Therefore, HIPAA requires either an authorization from the subject or a full or partial IRB waiver of HIPAA authorization for recruitment.

What types of recruiting tools may be used to inform potential subjects about a study?

Advertising and other recruiting tools may be used to inform potential subjects and/or other clinicians about a study.  All proposed printed advertisements or brochures, web postings, or audio/video advertising, and all communications with primary care physicians, other investigators, or potential subjects informing them about a study must be submitted for IRB review and approval prior to use. The JHM IRB will consider the text of the recruitment material and its placement.  These tools are considered to be part of the subject selection and the informed consent process for the study.   The type of recruiting tool should be specified (e.g., posted flier, web site notice, newspaper ad, radio, newsletter from support groups, etc.) Also, the specific location (e.g., name of the newspapers, radio stations, etc.) of the tool must be provided.  All proposed recruiting tools associated with a recruitment plan must be reviewed and approved by the JHM IRB prior to use.  This includes any recruitment plans, tools, or campaigns that will be undertaken by the sponsor or any contract research organization involved in the research.

Any proposed changes (including where the tool will be used) to previously approved recruiting tools must be submitted to the JHM IRB for review and approval before they may be used to recruit subjects for a study.

When Is IRB Review of Clinical Trial Websites Not Required?

Clinical trial websites that provide only directory listings with basic descriptive information about clinical trials in general do not need to be reviewed by an IRB. Basic descriptive information includes:

• Study Title
• purpose of the study
• protocol summary
• basic eligibility criteria
• study site location(s), and
• how to contact the study site for further information

Clinical trial websites that include more than this basic descriptive information must be reviewed and approved by the IRB prior to posting. Examples of clinical trial listing services that do not need IRB review and approval include the National Institutes of Health (NIH) ClinicalTrials.gov website, the NIH National Cancer Institute's cancer clinical trials listing (Physician Data Query [PDQ]), and the government-sponsored AIDS Clinical Trials Information Service (ACTIS). See http://www.hhs.gov/ohrp/policy/clinicaltrials.html

The JHM IRB generally will require informed consent and HIPAA privacy authorization for recruitment unless it is impracticable to obtain consent/authorization for the recruitment process.  If the JHM IRB determines that it is impracticable to obtain consent/authorization, the JHM IRB may grant a partial waiver of privacy authorization.  (Please note that waiver of consent generally is not available for FDA studies.)  Again, the investigator should describe the exact plan for the recruitment process in the protocol and request a partial waiver of informed consent/privacy authorization if the investigator believes it is needed for the protocol.

What privacy issues arise in the context of subject recruitment? 

The DHHS and FDA regulations require that investigators protect the privacy of study subjects.  The regulations do not, however, define what privacy means.  Invasion of personal privacy is a subjective matter and it is difficult to assess what each individual subject will consider to be an invasion of privacy.  The subject has the right to control access to him/herself, and that right extends to the entire subject selection, recruitment, and enrollment process.  Any recruitment plan proposed for a research study must address privacy issues.

If the JHM IRB approves a partial waiver of consent and HIPAA privacy authorization for recruitment purposes, should an investigator inform the potential subject as to how the investigator obtained the subject’s protected health information?

When the JHM IRB approves a partial waiver of consent and HIPAA privacy authorization for the purpose of recruiting subjects for a study, the individual being recruited will not know how the investigator obtained his/her protected health information.  If a recruiting letter is used, even if signed by the individual’s referring physician, it is advisable to include the following language (or something similar):

“The researchers have been given permission to contact you by a Johns Hopkins committee established under federal law to review uses of patient information.”

Remember: Even when the IRB partially waives informed consent/HIPAA authorization for recruitment purposes, in most cases the investigators must still obtain subject informed consent and a HIPAA privacy authorization in a Hopkins-approved form for the use of subject information in the study itself.

What information must be included in recruiting tools?  What other information may be included?

The content of the recruiting tool must be informative to the potential subject. The information must be accurate and delivered without “overselling” the concept to the reader.   The recruiting tool may not unduly influence the participant’s decision to participate in the study.  The tool may not state or imply a certainty of favorable outcome or other benefits beyond those that are outlined in the consent document and protocol.  The following information must be included in any proposed printed recruiting tool:

Audio and video recruitment tools do not need to include the JHM IRB protocol number. In addition, recruiting tools may include the following additional information:

What are restrictions on recruitment ads?

II. REASONABLE PAYMENT OR REMUNERATION

The JHM IRB is responsible for ensuring that any payment or remuneration offered to participants in human subject research is fair and not an undue inducement to participate. The following guidelines are provided to help investigators develop payment or remuneration plans. 

 1. Definitions:  

• Compensation: Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research.
• Remuneration: Payment for participation in research. Not compensation.
  http://www.hhs.gov/ohrp/irb/irb_glossary.htm

 2. Reasonable Remuneration:
Remuneration for participation in research should be reasonable and the amount paid should be comparable to other research projects involving similar time, effort, and inconvenience. Payment amounts should not be large enough to constitute an undue inducement to participate in a risky or uncomfortable procedure. For studies in which financial remuneration is a major reason for participation, and which represent minimum risk to the participants, remuneration may be sufficient to engage participants.

• Short research studies involving one visit: It is acceptable to provide participant payment contingent upon completion of the study. The plan for remuneration should provide that subjects disqualified through no fault of their own are paid for the time and effort they expended prior to their termination from the study.
• Research studies involving multiple visits or lengthy or repeated participation: Partial payment should be provided to participants who withdraw, are discharged early from the study by the investigator, or otherwise fail to complete the study as agreed. The amount of partial payment should relate to the amount of time, effort, or discomfort involved. Payment schedules may be designed on a per-day, per-visit, or per-procedure rate, or some combination thereof. The terms for partial payment must be described in the application and in the consent form.
• End-loaded incentives, such as completion bonuses: Such remuneration may be acceptable to encourage the completion of a research project. The amount of such incentives should depend on the risk and duration of the study interventions. In general, the range for a completion bonus should not exceed 50% of the total remuneration for the study. However, studies that involve increased risks or discomfort to the participant or which require a long-term commitment by the subject should not include a large bonus.
• Prompt payment: The consent document should describe the remuneration amount and the timing of payment. It is acceptable to withhold some or all of the payment until the end of the study, however, once participation is complete, withdrawn, or discharged, payment must be provided promptly unless the application and consent form provide otherwise.
• Peer or network (“snowball”) recruiting: The IRBs have been asked to consider a recruitment method that is referred to as “snowball recruiting”, “respondent-driven sampling” or “peer or network recruitment.”  The method involves providing remuneration in the form of gift certificates or cash to individuals who participated in a research project if they refer others (friend/associate/partner) for enrollment into a research project. The JHU/JHHS General Counsels have determined that the practice is not illegal in the State of Maryland and that the practice does not meet the definition of a “finder’s” fee.  Therefore, an investigator may request approval of this type of recruitment activity.  The IRBs will make a case-by-case decision on such requests.  They will evaluate the protocol to determine that the proposed amount of compensation is reasonable and reflective of the work involved, that there are proposed limits to the amount that may be provided to those who refer others, and make an assessment of the risk of undue influence or coercion that may be exerted by an individual who refers others for study participation.

What about bonus payments to the research team or the organization designed to enhance recruitment?

Research sponsored by commercial sponsors must include as part of the contract budget terms for conduct of the project.  It is the policy of the Organization that a budget for commercially funded research may not include direct payments to personnel who will conduct the project.  In addition, a budget may not include a proposed financial bonus or proposed financial penalty specifically targeted at participant recruitment efforts. 

Investigators who are approached by sponsors with an offer to provide a payment contingent on a particular rate or timing of enrollment (for example, an extra payment if five participants are recruited in one week, or extra payment to the site with the highest enrollment for the month), should ask the sponsor to renegotiate the per capita rate with the Office of Research Administration (ORA) so that additional resources may be put towards recruitment.