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Recruitment Oversight

COMIRB Recruitment Guidelines


Potential subjects cannot be specifically identified or contacted until COMIRB approval for the
research has been obtained. It is possible to obtain general data relating to the availability of a
specific population to ascertain the feasibility of the study.
 
There are a number of ways to recruit subjects:
 
  • Existing Research Relationship
  • Clinical or Professional Relationship
  • Recruitment Database
  • HIPAA A Authorization
  • Advertisements
  • ResearchMatch
 

 

Students as Subjects
 
When UCD students and/or employees are being recruited as potential subjects, researchers
must ensure that there are additional safeguards for these subjects. The voluntary nature of
their participation must be primary and without undue influence on their decision. Researchers
must emphasize to subjects that neither their academic status nor grades or their employment
will be affected by their participation decision.
To minimize coercion, investigators should avoid, whenever possible, the use of their students
and employees in procedures which are neither therapeutic nor diagnostic. In these latter
situations, investigators should solicit subjects through means such as bulletin board notices,
flyers, advertisements in newspapers, and announcements in classes other than their own.
When entering a classroom to recruit students and conduct research, e.g. administer a survey,
investigators must do so at the end of the class period to allow non-participating students the
option of leaving the classroom, thereby alleviating pressure to participate.
 
Finders Fees and Incentives
Finder’s fees include any payment or gift to an individual who identifies a prospective subject.
Principal Investigators and research personnel may not individually receive incentive payments
or finder’s fees on a per participant basis. PIs may accept monetary rewards that are offered by
the sponsor only after the research is closed to enrollment and only if the reward is directed to
the research team as a whole (e.g. funds allocated for purchasing educational materials or to
support attendance at educational conferences).
 
 
Note: For Faculty and staff employed by the Denver VA: Questions regarding finder's fees and incentives involving VA studies should be directed to the Denver VA Research office or VA regional counsel.
 
Advertisements
The investigator will provide the COMIRB with all recruiting materials to be used in identifying
participants including: the information contained in the advertisement, the mode of its
communication; the final copy of printed advertisements or the COMIRB Advertising
Components Submission Form (CF-260); the final audio/video taped advertisements .
 
The COMIRB must approve any and all advertisements prior to posting and/or distribution. The
COMIRB may review:
  • The information contained in the advertisement
  • The mode of its communication
  • The final copy of printed advertisements
  • The final audio/video taped advertisements
 
This informatiion should be submitted to the COMIRB with the initial application or as an addendum to the Protocol.
 
The COMIRB reviews the material to assure that the material is accurate and is not coercive or unduly optimistic, creating undue influence to the subject to participate which includes but is not limited to:
 
  • Statements implying a certainty of favorable outcome or other benefits
  • Claims, either explicitly or implicitly, that the drug, biologic or device was safe or effective for the purposes under investigation
  • Claims, either explicitly or implicitly, that the test article was known to be equivalent or superior to any other drug, biologic or device
  • Using terms like "new treatment," "new medication", or "new drug" without explaining that the test article was investigational
  • Promising "free medical treatment" when the intent was only to say particpants will not be charged for taking part in the investigation"
  • Emphasis on payemnt or the amount to be paid, such as bold type or larger font on printed media
  • Does not include exculpatory language
  • Offers by the sponsor to include a coupon good for a discount on the purchase price for the product once it has been approved for marketing
 
Any advertisement to recruit subjects should be limited to the infomration the prospective subjects need to determine their eligibility and interest.
 
Payment to Subjects
Payment to research subjects is a way to reimburse a subject for travel and other experiences
incurred due to participation. However, payment for participation is not considered a research
benefit. Regardless of the form of remuneration, investigators must take care to avoid coercion
of subjects. Payments should reflect the degree of risk, inconvenience, or discomfort associated
with participation. The amount of compensation must be proportional to the risks and
inconveniences posed by participation in the study.
 
The panel must review both the amount of payment and the proposed method of disbursement
to assure that neither entails problems of coercion or undue influence.
 
Credit for payment should accrue and not be contingent upon the participant completing the
entire study. Any amount paid as bonus for completion of the entire study should not be so great that it becomes coercive.
 
COMIRB Application
You will need to indicate the methods of recruitment to be used in the study such as:
  • In-person or face-to-face
  • Direct mailings to potential subjects (Letters/Postcards, etc)
  • Electronic correspondence (E-mails)
  • Telephone
  • Advertisements
  • Other Methods
 
All recruitment materials must be approved by the COMIRB before use. All recruitment materials must include the COMIRB number and the PI's name.  All advertisements must include the word "Research".
 
Selection of Subjects is Equitable
The COMIRB will review the recruitment methods and inclusion/exclusion criteria for the research to ensure equitable selection of subjects.  In making this assessment the COMIRB takes into Account the purposes of the research and the setting in which the research will be conducted, and is particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, fetuses, pregnant women, human in vitro fertililzation, persons who are decisionally challenged, or persons who are economically or educationally disadvantaged.
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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