Prepare trial-specific materials

Prepare participant-friendly informed consent document

  • Try to see your material as a participant would. Avoid technical or legal jargon. Use active voice and personal pronouns. (Instead of “The patient may contact his or her physician at any time….,” say “You may call me any time….”). Use white space and diagrams, calendars, and simple outlines to make your document easier to read and understand.

Create trial-specific materials for participants

  • Items like brochures and fact sheets help participants understand the trial and talk about it with family and friends. Other materials like newsletters and buttons can be tangible tokens that show participants they are part of something meaningful. Always keep trial-specific materials participant friendly and balanced when describing the costs, benefits, and goals of the trial.

Ensure that materials are culturally appropriate

  • The racial and ethnic backgrounds of potential participants play an important role in the feelings, viewpoints, and communication needs they bring to their conversations with you about trials. For example, ethnically diverse populations may have issues related to trust, language barriers, and feelings about medical professionals that will impact their thinking about a trial.

Literature and Tools (94)

Image Representing Resource Type (Journal Article)
A randomized recruitment intervention trial in Parkinson's disease to increase participant diversity: early stopping for lack of efficacy.
Posted: Feb 22, 2013.
Tilley BC,Mainous AG 3rd,Elm JJ,Pickelsimer E,Soderstrom LH,Ford ME,Diaz VA,Siminoff LA,Burau K,Smith DW. Clin Trials. 2012 Apr. 9. 2. 188-97.
KEYWORDS: Knowledge/Attitudes/Beliefs, Logistics/Transportation, Underserved, Level of Clinical Trials Knowledge or Awareness, Staff Experience Level, Physician Champions, Provider-Patient Relationship, Attitudes, Minority Groups, Verbal Communications, Brochure or Flyer, Non-Cancer
Image Representing Resource Type (Journal Article)
A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials.
Posted: Feb 13, 2013.
Hutchison C,Cowan C,McMahon T,Paul J. Br J Cancer. 2007 Sep 11. 97. 6. 705-11.
KEYWORDS: Knowledge/Attitudes/Beliefs, International, Consent, Brochure or Flyer, Cancer, Treatment
Image Representing Resource Type (Journal Article)
The process of developing audiovisual patient information: challenges and opportunities.
Posted: Feb 13, 2013.
Hutchison C,McCreaddie M. J Clin Nurs. 2007 Nov. 16. 11. 2047-55.
KEYWORDS: Knowledge/Attitudes/Beliefs, Staff Experience Level, International, Cancer, Treatment
Image Representing Resource Type (Journal Article)
IRB Review of the Use of Social Media in Research.
Posted: Feb 13, 2013.
Gearhart C. Monitor. 2012 Dec. 26. 5. 39-42.
KEYWORDS: Institutional Issues, Regulatory Issues, Web, Social Media
Image Representing Resource Type (Journal Article)
Practical guidance: the use of social media in oncology practice.
Posted: Feb 13, 2013.
Dizon DS,Graham D,Thompson MA,Johnson LJ,Johnston C,Fisch MJ,Miller R. J Oncol Pract. 2012 Sep. 8. 5. e114-24.
KEYWORDS: Institutional Issues, Regulatory Issues, Web, Social Media, Cancer

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