Questions About Cancer? 1-800-4-CANCER

Conducting Clinical Trials

  • Updated: 06/03/2013

Appendices 3 - 7

Appendix 3: Checklist for Easy-to-Read Informed Consent Documents
Appendix 4: Communications Methods
Appendix 5: Supplemental Materials
Appendix 6: Comprehensive Working Group on Informed Consent in Cancer Clinical Trials
Appendix 7: Informed Consent Template Update Working Group

Appendix 3: Checklist for Easy-to-Read Informed Consent Documents

Text

  • Words are familiar to the reader. Any scientific, medical, or legal words are defined clearly.
  • Words and terminology are consistent throughout the document.
  • Sentences are short, simple, and direct.
  • Line length is limited to 30-50 characters and spaces.
  • Paragraphs are short. Convey one idea per paragraph.
  • Verbs are in active voice (i.e., the subject is the doer of the act).
  • Personal pronouns are used to increase personal identification.
  • Each idea is clear and logically sequenced (according to audience logic).
  • Important points are highlighted.
  • Study purpose is presented early in the text.
  • Titles, subtitles, and other headers help to clarify organization of text.
  • Headers are simple and close to text.
  • Underline, bold, or boxes (rather than all caps or italics) give emphasis.
  • Layout balances white space with words and graphics.
  • Left margins are justified. Right margins are ragged.
  • Upper and lower case letters are used.
  • Style of print is easy to read.
  • Type size is at least 12 point.
  • Readability analysis is done to determine reading level (should be eighth grade or lower).
  • Avoid:
    • Abbreviations and acronyms.
    • Large blocks of print.
    • Words containing more than three syllables (where possible).

Graphics

Graphics are:
  • Helpful in explaining the text.
  • Easy to understand.
  • Meaningful to the audience.
  • Appropriately located. Text and graphics go together.
  • Simple and uncluttered.
  • Images reflect cultural context.
  • Visuals have captions.
  • Each visual is directly related to one message.
  • Cues, such as circles or arrows, point out key information.
  • Colors, when used, are appealing to the audience.
  • Avoid graphics that won't reproduce well.

6National Cancer Institute, Clear and Simple,23.
7National Cancer Institute, Making Health Communications Programs Work, 37.
8 C. Doak et al., Teaching Patients With Low Literacy Skills 2nd ed. (New York: Lippincott, 1996): 3.
9 C. Meade, Consent forms, 1527.

Appendix 4: Communications Methods

  • Time to Read and Discuss the Form

    Researchers should encourage the potential research participant to thoroughly read and re-read the consent form and supplemental materials, if provided, and to discuss the proposed research with others before signing the consent form. This may require a delay between the describing of the study and the signing of the consent document.

  • Assess Understanding

    It may be helpful for the researcher to ask the potential research participant short questions, after the research has been described and the consent form read, in order to assess that the potential research participant has at least a basic understanding of what the research involves.10 Example questions include:

    • Tell me in your own words what this study is all about.
    • Tell me what you think will happen to you in this study.
    • What do you expect to gain by taking part in this research?
    • What risks might you experience by participating in the research?
    • What are your alternatives (other choices or options to participating in this research)?

  • Communication Techniques

    Videos, audiotapes, interactive computer programs, and discussions with qualified lay individuals may assist in educating the potential research participant about the clinical trial.

10S. Titus et al., "Do you understand? An ethical assessment of researchers' description of the consenting process," J Clin Ethics 7 (1996): 60-8.

Appendix 5: Supplemental Materials

Information needs vary from person to person and it may be important to supplement the informed consent document with additional material that will increase the participant's understanding of the proposed study. The following list is intended to provide the clinical trial participant, as well as the clinical researcher, with an awareness of the cancer-related information that is available. It may be helpful to talk with local oncology professionals to learn of other resources, including published materials, videos, and Web-based documents.

Types of Information:

Clinical trial/disease information from national organizations

  • therapeutic alternatives
  • clinical trial information
  • disease-specific booklets
  • drug information
  • nutrition booklets
  • questions to ask your doctor
  • symptom management

Information from local organizations

  • clinical trials programs
  • insurance programs/coverage
  • Institutional Review Boards
  • procedure information; e.g., bone marrow biopsy, insertion of a central line, etc.
  • advocate/support programs

Appendix 6: Comprehensive Working Group on Informed Consent in Cancer Clinical Trials

Co-Chairs - August, 1998

Stephen Crawford, M.D.
IRB Chairman
Fred Hutchinson Cancer Research Center
Seattle, WA
Janice Dutcher, M.D.
Professor of Medicine
Montefiore Medical Center
Bronx, NY
 
Nancy Kass, Sc.D.
Associate Professor
Program in Law, Ethics, and Health
Johns Hopkins University
Baltimore, MD

Members

Robert Chapman, M.D.
Division Head of Hematology/Oncology
Henry Ford Hospital
Detroit, MI
 
Deborah Collyar
Patient Advocates in Research
Danville, CA
 
Patricia Flynn, M.D.
Chair, Clinical Trials Committee
St. Jude Children's Hospital
Memphis, TN
 
Marge Good, B.S.N., O.C.N.
Manager
Wichita Community Clinical Oncology Program
Wichita, KS
 
Lawrence Gostin, J.D., L.L.D.
Professor of Law
Georgetown University Law Center
Washington, DC
 
Stuart Grossman, M.D.
Associate Professor of Oncology
Johns Hopkins Oncology Center
Baltimore, MD
 
James E. Krook, M.D.
Principal Investigator
Duluth Clinic
Duluth, MN
 
Charles McCarthy, Ph.D.
Senior Research Fellow
Kennedy Institute of Ethics
Washington, DC
 
Cathy Meade, R.N., Ph.D.
Director, Education Program
Lee Moffitt Cancer Research Institute
Tampa, FL
Wendy Mettger, M.A.
President, Mettger Communications
Tacoma Park, MD
 
Joyce Mull, M.P.M.
Director of Regulatory Affairs
National Surgical Adjuvant Breast and Bowel Project
Pittsburgh, PA
 
Penny Pierce, Ph.D.
Assistant Professor
University of Michigan School of Nursing
Ann Arbor, MI
 
Jane Reese-Coulbourne, M.S.Ch.E., M.B.A.
Executive Vice President
National Breast Cancer Coalition
Washington, DC
 
Karen Rothenberg, J.D., M.P.A.
Marjory Cook Professor of Law
University of Maryland
College Park, MD
 
Mace Rothenberg, M.D.
Executive Officer
Southwest Oncology Group
San Antonio, TX
 
David Smith, Ph.D.
Director, Poynter Center
Indiana University
Bloomington, IN
 
Willard Smith
Chairman, IRB
Toledo Community Hospital Oncology Program
Toledo, OH
 
Ellen Stovall
Executive Director
National Coalition for Cancer Survivorship
Washington, DC

Federal Representatives

Jeff Abrams, M. D.
Senior Investigator
National Cancer Institute
Bethesda, MD
 
Diane Aiken, M.A.
Assurance Coordinator
Office for Protection from Research Risks
Rockville, MD
 
Marianne Bentz, M.S.N.
Compliance Oversight Coordinator
Office for Protection from Research Risks
Rockville, MD
 
Gary Chadwick, Pharm. D., M.P.H.
Associate Director
Human Subject Protection
Food and Drug Administration
Rockville, MD
 
Evan Derenzo, Ph.D.
Senior Staff Bioethicist
National Institutes of Health
Bethesda, MD
 
Jennifer Flach*
Community Cancer Control Specialist
National Cancer Institute
Bethesda, MD
 
Leslie G. Ford, M.D.
Associate Director
Early Detection and Community Oncology Program
Division of Cancer Prevention
National Cancer Institute
Bethesda, MD
 
Paul W. Goebel
Associate Director for Human Subject Protection
Food and Drug Administration
Rockville, MD
 
Richard Kaplan, M.D.
Senior Investigator
National Cancer Institute
Bethesda, MD

*Coordinators

Joan K. Mauer, M.T.
Senior Quality Assurance Coordinator
National Cancer Institute
Bethesda, MD
 
Mary S. McCabe, R.N.*
Director, Office of Clinical Trial Promotion
National Cancer Institute
Bethesda, MD
 
Richard Mowery, Ph.D.
Chief, Clinical Trials Monitoring Branch
National Cancer Institute
Bethesda, MD
 
Rose Mary Padberg, R.N., M.A., O.C.N.*
Clinical Trials Nurse Specialist
National Cancer Institute
Bethesda, MD
 
Joan P. Porter, D.P.A., M.P.H.
Office for Protection from Research Risks
Rockville, MD
 
Gary L. Smith
Quality Assurance Coordinator
National Cancer Institute
Bethesda, MD
 
Richard S. Ungerleider, M.D.
Chief, Clinical Investigations Branch
National Cancer Institute
Bethesda, MD
 
Paula Squire Waterman, M.S.
Human Subject Protection Specialist
Food and Drug Administration
Rockville, MD
 
Robert E. Wittes, M.D.
Director
Division of Cancer Treatment, Diagnosis and Centers
National Cancer Institute
Bethesda, MD

Appendix 7: Informed Consent Template Update Working Group

Members - March, 2004

Jeff Abrams, MD
Associate Chief - Clinical Investigations Branch
Coordinator, CTEP Pilot Projects
National Cancer Institute
Bethesda, Maryland
Jeanne Adler, RN
Nurse Consultant - Clinical Investigations Branch
National Cancer Institute
Bethesda, Maryland
Sandra Batte
Patient Advocate
Cancer And Leukemia Group B
Chesterfield, Missouri
Deborah Collyar
Patient Advocate
Patient Advocates In Research
Blackhawk, California
Andrea Denicoff, RN, MS, CANP
Nurse Specialist, Clinical Trials, Palliative Care
Office of Education and Special Initiatives
Office of the Deputy Director for Extramural Science
National Cancer Institute
Bethesda, Maryland
Leslie Ford, MD
Associate Director of Clinical Research
Division of Cancer Prevention
National Cancer Institute
Bethesda, Maryland
Jacquelyn Goldberg, JD
Administrator - Central Institutional Review Board
National Cancer Institute
Bethesda, Maryland
Wilma Hoffman, RN, BSN, CCRC, RAC
Director, Protocol Development & Regulatory Compliance
American College of Radiology
Radiation Therapy Oncology Group
Philadelphia, Pennsylvania
Linda Krebs, RN, PhD, AOCN
Central Institutional Review Board Informed Consent Sub-committee
Associate Professor
University of Colorado School of Nursing
Denver, Colorado
Barbara LeStage, MHP
Central Institutional Review Board Informed Consent Sub-committee
Patient Advocate
Chair - Directors Consumer Liaison Group
Wrentham, Massachusetts
Wendy Mettger, MA
President - Mettger Communications
Takoma Park, Maryland
Dan Moore
Attorney at Law
Central Institutional Review Board Informed Consent Sub-committee
Decatur, Illinois
Joyce Mull, MPM
Director of Regulatory Affairs
National Surgical Adjuvant Breast and Bowel Project
Pittsburgh, Pennsylvania
Rose Mary Padberg, RN, MA
Nurse Consultant - Division of Cancer Prevention
National Cancer Institute
Bethesda, Maryland
John R. Taylor
Protocol Editor
Cancer And Leukemia Group B Central Office
Chicago, Illinois
D. Lawrence Wickerham, MD
Associate Chairman/Director of Operations
National Surgical Adjuvant Breast and Bowel Project
Pittsburgh, Pennsylvania
Brenda Young
Director, Clinical Trials Informatics
American College of Radiology
Radiation Therapy Oncology Group
Philadelphia, Pennsylvania