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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
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● 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.
I
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Comments
to Roxane
Poskin, Last Modified:
June 12, 2006
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