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
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.
-
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.
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
Co-Chairs
- 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
-
|
- 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
-
|
*Coordinators
Members
- Jeff Abrams, MD
- Associate Chief - Clinical Investigations Branch
- Coordinator, CTEP Pilot Projects
- National Cancer Institute
- Bethesda, Maryland
|
- Barbara LeStage, MHP
- Central Institutional Review Board Informed Consent Sub-committee
- Patient Advocate
- Chair - Director=s Consumer Liaison Group
- Wrentham, Massachusetts
|
- Jeanne Adler, RN
- Nurse Consultant - Clinical Investigations Branch
- National Cancer Institute
- Bethesda, Maryland
|
- Wendy Mettger, MA
- President - Mettger Communications
- Takoma Park, Maryland
|
- Sandra Batte
- Patient Advocate
- Cancer And Leukemia Group B
- Chesterfield, Missouri
|
- Dan Moore
- Attorney at Law
- Central Institutional Review Board Informed Consent Sub-committee
- Decatur, Illinois
|
- Deborah Collyar
- Patient Advocate
- Patient Advocates In Research
- Blackhawk, California
|
- Joyce Mull, MPM
- Director of Regulatory Affairs
- National Surgical Adjuvant Breast and Bowel Project
- Pittsburgh, Pennsylvania
|
- 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
|
- Rose Mary Padberg, RN, MA
- Nurse Consultant - Division of Cancer Prevention
- National Cancer Institute
- Bethesda, Maryland
|
- Leslie Ford, MD
- Associate Director of Clinical Research
- Division of Cancer Prevention
- National Cancer Institute
- Bethesda, Maryland
|
- John R. Taylor
- Protocol Editor
- Cancer And Leukemia Group B Central Office
- Chicago, Illinois
|
- Jacquelyn Goldberg, JD
- Administrator - Central Institutional Review Board
- National Cancer Institute
- Bethesda, Maryland
|
- D. Lawrence Wickerham, MD
- Associate Chairman/Director of Operations
- National Surgical Adjuvant Breast and Bowel Project
- Pittsburgh, Pennsylvania
|
- Wilma Hoffman, RN, BSN, CCRC, RAC
- Director, Protocol Development & Regulatory Compliance
- American College of Radiology
- Radiation Therapy Oncology Group
- Philadelphia, Pennsylvania
|
- Brenda Young
- Director, Clinical Trials Informatics
- 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
|
|
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