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Guidelines for Human Subjects Recruitment Material

Federal Guidelines


FDA Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators 1998 Update

     
●  Ads must state clearly that the program of study is Research.
●  Ads must provide contact information:
          
o Investigator's name
          
o Person to contact
          
o Contact's phone and/or e-mail. If research site has a web site address,   
              please include the URL. Example: Browse UKCMC Research Areas and Centers  
              http://www.mc.uky.edu/research/clinicaltrials.htm
●  Ads must list purpose of study.
●  Ads must not make claims or promises of safety, efficacy, or superiority.
●  Ads must not include coercive language.
●  Ads may list benefits and may state that subjects will be paid, but must not include dollar
    amounts to be paid.
●  Ads may summarize criteria that will be used to determine eligibility.
●  Ads may list time or other commitment required.
●  Ads may list location of research.

UK Guidelines

Sponsor's National Advertising Campaigns
Please note: human subjects recruitment material and related research information supplied to multi-site study locations does require IRB approval, but does not need review by UK. This applies to recruitment material that does not identify the University of Kentucky, informational brochures about drugs/devices, educational materials about the disease, dietary guideline booklets or other study-related information.

University of Kentucky Official Graphics Standards Manual
Guidelines for using the official University of Kentucky institutional signature.

University of Kentucky Style Guide
Style rules and usages followed by UK writers and editors targeting the general public.

Photos and Clip Art

●  Photos of the investigator are permitted on the flyer. The UK photo release form (pdf) and 
    HIPAA form must be signed.
●  Commercial photographs may be used if publishing rights have been obtained.
●  Clip art is not allowed on flyers as outlined in the UK Official Graphics Standards Manual.

Recruitment Letters

●  Require IRB approval, but do not require UK review.
●  Mailing labels for physicians at UK and throughout Kentucky are available. Request at
    www.ukhealthcare.uky.edu/labelrequest.htm

Questionnaires
To add a study screening questionnaire form to your Web site, have your web developer start here with pre-designed templates.

          ●  webdev.mccs.uky.edu/ukhealthcare/clinicalform.asp – dynamically generates the 
              code
          ●  webdev.mccs.uky.edu/ukhealthcare/clinicaltrialsform.htm – requires editing; 
              instructions are at the bottom of the page

Veterans Affairs Medical Center
Contact Veterans Affairs Public Affairs for review, approval of flyers and ads and ad placement: Joanna Hawthorn, Joanna.Hawthorne@med.va.gov or Candice Hulle, candace.hull@med.va.gov, 859/281-4814.

CenterWatch
CenterWatch is a directory providing detailed profiles of approximately 875 clinical research centers. UK researchers can list their IRB-approved trials on UK's CenterWatch page by simply answering yes on the Human Subjects Recruitment Request Form or by contacting Tamar Skowronski at tamar.skowronski@thomson.com or by fax: 617/856-5901. Approved PDF flyers can be e-mailed to Adrian at CenterWatch for recruitment of study volunteers, a faxed IRB approval letter will need to accompany flyer.

If you register online using the Clinical Trials Patient Recruitment Service New Trial Submission Form, all wording submitted must have prior IRB approval. All trial listings will be posted within two business days if flyer is e-mailed and 5 five days if flyer is faxed; CenterWatch will notify you the day your trial is posted.
 

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  Comments to Roxane Poskin, Last Modified: June 12, 2006
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