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Information for Research Participants
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Institutional Review Boards
UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
UChart Forms & Guidance
HSRO Forms & Documents
University Fees
Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
HIPAA
Translations
Western IRB (WIRB)
About the HSRO


Basic Folder Information

22.2 IRB Approval Guidelines


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

August 6, 2008



Policy

IRB review and approval requires that the privacy of potential participants is protected, that subjects are not under pressure or coercion to participate in the study and that information presented to subjects is accurate and balanced. To accomplish these goals, IRB review and approval of participant recruitment methods, advertising materials and recruitment-relevant payment arrangements shall include consideration of the study purpose and goals, the research setting(s), the special problems of vulnerable populations (c.f. policy SECTION 23) and the adequacy of safeguards to ensure that the identification and recruitment of all participants is confidential and free of coercion, undue influence or invasion of privacy.   Specific criteria for IRB review and approval include: 

22.2(A):  Recruitment methods and advertising materials:  

Recruitment methods and advertising materials should contain:

  1. a clear statement that the activity is for research purposes
  2. a simple and concise description of the purpose of the research
  3. general eligibility criteria for participation
  4. a brief description of the significant risks and possible benefits (if any)
  5. the time or other commitments required of participants
  6. contact information (including the name and address of a contact person)for use by potential participants seeking further information or to enroll
  7. clear indication that the recruitment is for a “[University of Miami and/or affiliated institution] research study
  8. (if applicable) a statement that the experimental drug/agent or device involved in   the study is “investigation” and without FDA approval for the given indication
  9. (if applicable) they should describe the possibility of receiving placebo
  10. information consistent among all other study-related materials including consent forms, introductory letters to subjects, recruitment scripts and web postings

Recruitment methods and advertising materials should not:

  1. be coercive or include any exculpatory language appearing to waive any potential subjects’ rights or any liability for negligence
  2. imply certainty of a favorable outcome or benefit beyond what is defined in the protocol and consent forms
  3. They must not be misleading or imply other benefits beyond what is indicated in the approved consent form
  4. claim, either explicitly or implicitly, that:
    1. any research procedure is superior to any current practice
    2. (if applicable) any experimental drug/agent or device is known to be safe or effective
    3. (if applicable)  the use of any experimental drug/agent or device is equivalent or  superior to the use of any currently available drug/agent  or device
    4. (if applicable) participants will receive “free medical treatment” when the intent is only that subjects will not be charged for research-related, protocol-defined  treatment
  5. emphasize compensation to participants or the amount of such compensation by such means as larger or bold type
  6. For FDA-regulated research, recruitment methods and advertising materials should not:
    1. make claims, either explicitly or implicitly, about the drug, biologic or device under investigation that are inconsistent with FDA labeling
    2. use terms such as “new treatment”, “new medication” or “new drug” without explaining that the test article is investigational

An individual's decision to participate in research must be free from coercion or undue influence. The Principal Investigator (PI) must ensure, and the IRB shall require, that all recruitment methods provide subjects with sufficient time to consider the decision to enroll in a research study.

For initial studies, the IRB Chair or designee may provide expedited review of recruitment methods and materials if he/she is conducting expedited review of the study. The IRB Chair or designee shall use discretion as to whether the proposed recruitment method and/or materials fulfill the requirements stated above and/or must be submitted to the convened IRB for review and decision. The IRB Chair or designee may make recommendations for changes in recruitment methods or materials to the Principal Investigator.  If the IRB Chair or designee does not approve a recruitment method or materials, the Principal Investigator may appeal to the convened IRB. 

22.2(B):  Compensation, Incentives or Other Inducements to Participants:

Study participants may (but not necessarily) be compensated monetarily or provided other incentives or inducements as symbolic recognition for their enrollment and/or continuing contributions to research.  When given, such compensation, incentives or other inducements must be limited in extent and manner so they are not perceived to be coercive or providing undue influence or duress; and they should be provided without regard to a subject’s economic status. Incentives, compensation and/or other inducements to subjects should reflect the risk, discomfort or inconvenience associated with study participation; and they should not be so large as to result in any one group of individuals (such as the economically disadvantaged) bearing an unduly large share of the risks and burdens of research participation. 

For FDA-regulated research, compensation to subjects’ participation in a study may not include an offer from a sponsor of a coupon good for a discount on the purchase price of the product (drug/agent/device) once it has been approved for marketing.

Incentives, compensation or inducements must not be such that a subject’s participation in research is other than voluntary.  IRB study approval requires that the promise or expectation of a reward for study participation should not influence a subject’s willingness to participate in the research. Nor should rewards influence a subject’s decision-making process such that the subject acts without due consideration of the risks of participation.  

Incentives, compensation or other inducements to subjects for enrollment or continued participation in a study must be accurately explained in informed consent documents and must be fair and reasonable. This description shall include the amount and/or item and the schedule of its provision.  If total compensation to a subject exceeds $600, the following IRS concept should be conveyed in the informed consent:

“The compensation you receive may be taxable. When the total compensation paid to someone participating in one or more studies is $600 or more in one calendar year, the [University or other affiliated institution paying the compensation] is required by the IRS to treat this compensation as any other payment for compensation/salary and to report the amount to the IRS.  You will also be responsible for reporting this compensation when you file your tax return” 

In IRB deliberations, incentives/compensation or other inducements must not be considered a “benefit” off-setting (in whole or part)  “risk” to subjects.  Rather, the IRB must be assured that these are not influencing subjects to participate in research that they would not otherwise choose to participate in. 

Research subjects may withdraw from a study at any time and for any reason.  Incentives, compensation and/or other inducements may not be provided on a schedule that may coerce or unduly influence a subject’s decision to continue participation.  Incentives, compensation or inducements for the continuing participation of a subject in a study should be given on a prorated basis as the study progresses to reflect the time and inconvenience of a subject’s participation throughout a study and may not be fully withdrawn or withheld pending the subject’s completion of the study.  Unless otherwise justified and IRB-approved, this proration shall be “temporal”  (i.e. the amount after two study interventions and/or visits should be twice that for one study intervention/visit etc ). 

Additional incentives, compensation or other inducements may be provided to subjects for completing a study. Unless justified and IRB-approved, these may be no more than 10% of the fair market value of the total among all incentives, compensation or other inducements being offered to subjects at the time of their enrollment in the study. 
Incentives, compensation and/or other inducements for study participation may not be provided to a group of subjects as a whole (i.e. pizza to a class of students if all participate, etc). 

22.2(C):  Recruitment Incentives/Compensation, Bonuses, Referral Fees or other Inducements to Investigators or to those Referring Subjects: 

Financial or other arrangements to investigators or to those referring subjects are not permitted if these could influence,  or be reasonably perceived as influencing , participant recruitment or the interactions with participants.  The definition of “financial or other arrangements” includes but is not limited to incentives, compensation, bonuses, referral fees or other inducements such as stock options, travel opportunities, educational stipends, merchandise, vouchers, gift certificates, medical care or other services, discount coupons, extra vacation time, academic rewards such as class credit or anything else of value. 

Physicians and others including the University or affiliated institutions, clinics, laboratories, hospitals or other health care facilities or professionals may not receive “finder’s fees” for referring subjects to a research study.

Study investigators (and/or their research programs), the University or affiliated institutions may receive funds to defray the reasonable expenses of a research study.  Such expenses may include (but are not limited to) the percentage of effort of personnel directly engaged in the research, costs for infrastructure, hospital fees, pharmacy charges, laboratory fees, research equipment costs, rent, recruitment advertising and compensation or incentives to subjects. If received, such expenses must be noted (on a generalized basis)  in informed consent documents.  Such proposed expense reimbursements must be reported by investigators to the IRB and considered for approval by the IRB based on their fair market value. 

Expenses of a research study defrayed on a per-subject payment schedule should be fixed for each subject and may not increase as a result of subject enrollment meeting specific thresholds (i.e. $100 per subject for the first 10 subjects then $150 per subject for the next 10 subjects etc) unless the increase is based on a documented increase in direct expenses and approved by the IRB.



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