Revising the consent document: NCI style


by Jackie Tekiela, MS, CIP, Institutional Review Board (IRB) Administrator at Wheaton Franciscan Healthcare

The National Cancer Institute (NCI) recently completed a two-year effort to revise the NCI informed consent template, resulting in shorter and more concise informed consent documents. In session A18, titled Rewriting the National Cancer Institute (NCI) Informed Consent Template, Jeanne M. Adler, RN, MPH, CCRP, presented the background, method, and rationale behind the changes. Throughout the presentation Jeanne offered specific examples of language and excerpts from the draft template.

In preparing the template, working groups started with a “blank page and the regulations” and developed a concise consent template. The groups consisted of patient advocates, institutional review board (IRB) chairs, central IRB (CIRB) chairs and members, clinical research associates (CRAs), investigators, nurses, and cooperative group regulatory and protocol development staff, and consulted with individuals from the U.S. Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP).

Applying this consent template to three closed studies, they reduced the length of the consent documents from 16 to seven pages each.

New template features included:

  • Description of how a study differs from standard treatment 
  • Risk section formatted as tables for each drug or regimen/arm 
  • Clearer definition of risk frequency (“x out of one hundred,” rather than percentage) 
  • Risks described from study participant perspective 
  • Brief description of standard care to place research in context 
  • Section length limits • Doctor’s contact information in one single place 
  • Two study titles – both a lay title and technical title 
  • More text examples, covering different types and phases of studies, mandatory specimen collection, optional research biopsy, future studies consent, and optional specimen collection 

Other interesting points:

  • Suggested limiting word or page count, or the estimated reading time 
  • Emphasized the role of the informed consent document (ICD): to summarize and document the process, not provide detailed descriptions that should be part of the process 
  • Attachments should be informative and optional 
  • Forms should include risks of procedures only if part of research question, not if part of usual care 
  • Correlative trials should be embedded into ICD and concisely worded

Handouts for the session are available on the Conference Passport (your code to access the site was emailed to you and is on the back of your conference name badge).

The finalized template is expected to be released in January 2013 (effective date for new trials will be 6-8 weeks after that). It will be distributed to everyone in the Cancer Therapy Evaluation Program (CTEP) database, cancer centers, and partners. Once posted, anyone will be able to access it on the Investigator Resources page of CTEP’s website.