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Conducting Clinical Trials

  • Updated: 06/03/2013

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Simplification of Informed Consent Documents

After both research participants and investigators voiced concerns that informed consent documents for clinical trials were becoming too long, complicated, and difficult to understand, the National Cancer Institute (NCI), along with the Office for Protection from Research Risks (now the Office of Human Research Protections) and the U.S. Food and Drug Administration, formed an Informed Consent Working Group to propose solutions.

The Working Group included a diverse group of experts: physicians, nurses, patient advocates, Institutional Review Board (IRB) members, ethicists, legal experts, communication experts, and representatives of the pharmaceutical industry.

In 1998, the group issued its "Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials." The recommendations are used by investigators writing consent documents and by IRBs reviewing such documents. In addition, a consent form template was created that includes all of the federally required elements for the document, including the explanation of the research procedures, related risks and possible benefits, alternatives to participation, and the rights of research participants.

Recommendations

These "Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials" were prepared by the Comprehensive Working Group on Informed Consent in Cancer Clinical Trials for the National Cancer Institute in October 1998.

The Problem

Many informed consent documents have become too long and complex, and do not provide a sound basis for informed decision-making. 1,2,3

Purpose

These recommendations are intended to provide a clear template for informed consent documents and supplemental materials used in clinical research. The goals of the recommendations and accompanying template are to increase potential research participants'* understanding of proposed studies and better enable them to make decisions about participation.

The recommendations are intended to assist: (1) sponsors and/or investigators who write consent forms and (2) local Institutional Review Boards (IRB) which oversee research projects and consent documents at their institutions (45 CFR 46.109 and 21 CFR 56.1096).

Although the recommendations are focused on treatment studies, they may also apply to prevention, early detection, diagnosis, and other types of trials. The recommendations are relevant to all phases of clinical research; however, each phase may generate additional specific considerations to be addressed in the informed consent document. (The template highlights some of these considerations and the sample consents serve as examples of specific study considerations.)

The recommendations are not intended to address issues for genetic testing and tissue banking. These are being addressed in other forums.


* This document uses the term "research participant" to mean "research subject," the term used in the Federal regulations. Please see Appendix 1 for additional definitions of terms.


Background of the Issues

The goal of the informed consent process is to provide people with sufficient information so they can make informed choices about whether to begin or continue participation in clinical research. The process involves a dynamic and continuing exchange of information between the research team and the participant throughout the research experience. It includes discussion of the study's purpose, research procedures, risks and potential benefits, and the voluntary nature of participation.

The informed consent document provides a summary of the clinical study and the individual's rights as a research participant. The document acts as a starting point for the necessary exchange of information between the investigator and potential research participant. Also, research participants and their families may use the consent document as an information resource and reference throughout participation in the trial.

The informed consent document is often considered the foundation of the informed consent process; it does not, however, represent the entirety of the process. Nor is the informed consent document a risk-management tool for the investigator and/or institution.

Development of a consent document that provides useful and understandable information has become more challenging due to the increased complexity of medical research and care. Such challenges require careful consideration of what information is useful to participants and how to provide it in clear and simple language.

Recommendations

The Comprehensive Working Group on Informed Consent in Cancer Clinical Trials* has developed: (1) recommendations related to specific Federally-required elements in the consent form,** and (2) general recommendations to enhance the research participant's understanding of the consent form.

In addition, the Working Group recommends that relevant agencies such as the National Institutes of Health and the Food and Drug Administration facilitate the development of methods to enhance the informed consent document and process in clinical research.


*Appendix 6 lists the participants in the Comprehensive Working Group on Informed Consent in Cancer Clinical Trials.


** Federal regulations require that the informed consent document include certain basic elements and provide for inclusion of additional elements when appropriate (45 CFR 46.116, 21 CFR 50.20, and 21 CFR 50.25). Please refer to the Code of Federal Regulations and Appendix 2 for the list of Federally-required elements of informed consent.


Recommendations for Specific Federally-Required Consent Elements

The following recommendations provide guidance in the interpretation of the Federal regulations related to specific elements of the informed consent document and are outlined in the accompanying template. Although the Comprehensive Working Group considered all of the Federally-required consent elements, it chose only to develop recommendations for the following elements. The template, however, does address all of the Federally-required elements for informed consent. See Appendix 2 for the complete list of Federally-required elements.

Purpose of the Study

The consent form should clearly and simply explain the purpose of the research study and state why the potential research participant is eligible to enroll. The main objective of the proposed study should be placed in the context of standard care. For example:

The purpose of this research study is to find out whether adding the drug Taxol to a commonly-used chemotherapy is better at preventing your cancer from coming back than the commonly-used chemotherapy by itself. The study will also see what side effects there are from adding Taxol to the commonly-used chemotherapy. Taxol has been found to be effective in treating patients with advanced breast cancer. In this study, we want to see whether Taxol will be a useful addition to the treatment of patients with early-stage breast cancer and to see if the side effects seem to be worth the possible benefit.

Research Regimens

Research participants should be able to: (1) understand what is going to happen to them in the research study, (2) distinguish what is standard care from what is investigational care, and (3) understand what additional standard care, that otherwise would not be given, is provided because they are in the research study.

The consent document should include a simple schema, clearly list and describe the research regimens of the protocol, and explain how it will be determined which regimen the research participant will receive. If the study involves randomization, the chance of a participant being placed in a particular group should be stated clearly.

When the comparison between procedures or therapies is the primary objective of the study, the consent form should describe both approaches, even if one is considered standard. If comparison is not the objective of the study, standard therapies should be listed but need not be described in the research consent form.

Risks

Physical risks of participation should be described. Nonphysical risks should be included when they could affect the patient's decision about participation. Examples of relevant nonphysical risks of participation may include: increased time commitments and travel considerations, financial implications, risks related to insurability and employment, and psychological effects.

The risks associated with the trial should be described and compared to risks of common standard therapeutic alternatives (if available) and to the option of no treatment. Specifically, the consent form should describe risks that are:

  1. very likely, regardless of severity, and
  2. less likely but serious, or rare but relatively severe as compared to the severity of the disease and/or risks of alternative options.

Interpretation of these terms is subjective and should be determined by the investigators and IRBs.

The risks associated with standard medical therapy that would be delivered regardless of participation in the clinical trial (such as placement of a central venous catheter) should not be included in the research consent document. Information about the risks of standard medical procedures should continue to be provided in separate informed consent documents as part of usual (nonresearch) medical care. Investigators and IRBs, however, may choose to include risks of standard medical practice in the research consent document if such inclusion would clarify: (1) the distinction between the standard and investigational therapies and/or (2) the cumulative or additive risks associated with the research trial.

Risks should be presented for the entire regimen rather than listing the risks for each specific drug or procedure that comprise the intervention. This will provide a more accurate and comprehensive summary of the research risks and reduce the repetition of side effects common to different agents or modalities in the trial.

Benefits

Potential benefits to the research participant and to others should not be overstated in the consent form. Because positive outcomes cannot be guaranteed, any statements regarding potential therapeutic benefit should be based on available data. No investigational approach should be identified as the only chance for cure, or contrasted with standard approaches that offer no chance of cure. When relevant, the consent form should state that the investigational therapy may be no better than or may even be inferior to standard therapy or have no therapeutic effect. This issue is of particular relevance to early phase trials where there are limited human data.

Alternatives

The informed consent document should list the alternatives to participation in the clinical trial, including the option of no anticancer treatment at the current time, or treatment with standard therapy, when appropriate.

Confidentiality

The confidentiality section of the informed consent document should state that although measures will be taken to protect the privacy and security of personally-identifiable data, absolute confidentiality cannot be guaranteed. The consent document should list the organizations that will have access to personally-identifiable data and that personally-identifiable information may be disclosed as required by law. When listing organizations that will have access to research records, describe for what purposes the information will be disclosed to these organizations.

Other Information

Information not required by the Federal regulations should not be included in the informed consent document unless it is necessary for the potential participant's understanding of the proposed research.

Drug information sheets and information explaining access devices and supportive care should be provided separately (as supplemental materials), and not in the research consent forms. Information that is not required for the basic understanding of the research purpose, procedures, risks, or possible benefits by the potential participant, but is intended for the benefit or legal protection of those conducting the research, should be presented in a separate document.

General Recommendations

Readability

Informed consent documents should be understandable to the patient population at the local facility. Documents should be written at an eighth grade or lower reading level. Investigators are also encouraged to use computer software applications or other techniques that assess reading level. Technical and legal jargon should be avoided.

Use of active voice, short sentences, personal pronouns, clear page layout with "white space" borders, and large fonts make documents easier to read. 4,5 The use of simple outlines, flow charts, diagrams, study schemas, calendars, and other graphics are encouraged. Consent forms should use the second person because it reflects the conversation between the investigator and potential research participant. (See Appendix 3 for suggestions for developing easy-to-read informed consent documents.)

Supplemental Information

The research participant should be informed about and provided access to supplemental information during the initial decision-making process and throughout the research trial. This approach should minimize the length and complexity of the informed consent document and allow the essential elements of consent to be better highlighted in the consent document. Supplemental materials may enable the potential research participant to more effectively read the consent form and ask questions of the investigator at the initial informed consent discussion or during participation in the trial. Supplemental materials that can be used with consent forms for a variety of protocols may need only a single IRB review, depending upon local IRB review procedures.

Supplemental materials may include: information sheets developed by investigators and IRBs; Web-based information such as the NCI clinical trials Web site (http://cancertrials.nci.gov) and Physician Data Query (PDQ); booklets, videos, and other materials provided by NCI's Office of Cancer Communications; pharmaceutical information materials written for the lay public; and copies of the complete research protocol.

Investigators should consider the use of a variety of communication techniques that complement the informed consent document to enhance the potential research participant's understanding. (See Appendix 4 for some suggested communication methods.)

Consent Comprehension in Diverse Populations

It is essential to include diverse populations in cancer research. This important and complex issue requires cultural sensitivity in developing the informed consent document and communicating with the potential research participant and family members. The standards for valid consent should not be compromised in the face of language, cultural, or physical challenges.

Oral and written translations are only part of the process of presenting informed consent information to non-English-speaking persons. Culturally-appropriate consent documents and supplemental materials such as videos, audiotapes, and interactive computer programs may be especially helpful in communicating information to individuals from diverse populations, whether or not English is their primary language. Consent documents should also be adapted to the needs of individuals with limited literacy skills and those who are vision impaired. A single research trial may require several versions of the informed consent document to tailor the information to a variety of populations.

Notification of New Information

When new knowledge emerges that is likely to affect a research participant's willingness to continue participation in the trial or might have affected the decision to enter the trial in the first place, the participant should be informed and written consent may need to be documented again. The urgency of notifying the research participant of new toxicity data, for example, depends on the likelihood and severity of the risk. New information regarding relatively minor risk or low severity may be presented orally at the next routine visit. In any case, the IRB should be notified and consulted as soon as possible to assist the investigator in determining the appropriate form of notification.

When a Phase III study includes review by a Data Safety and Monitoring Board, potential research participants should be informed of its existence in the consent document. For example:

A Data Safety and Monitoring Board, an independent group of experts, will be reviewing the data from this research throughout the study. We will tell you about new information from this board or other studies that may affect your health, welfare, or willingness to stay on this study.

Conclusion

The informed consent document is only one part of the larger process of informed consent that occurs between the potential research participant and members of the research team. The informed consent document should be understandable to the research participants involved.

The informed consent process should involve an ongoing dialogue between investigators and research participants. Investigators should address the research participants' concerns and questions and should confirm that research participants understand the basic purpose and conduct of the study. Only in this way can researchers ensure that the rights of research participants are protected and that the integrity of the informed consent process is maintained.

Endnotes

1 S. Grossman et al., "Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families?" J Clin Oncology 12 (1994): 2211-5.

2 R. Joseph, "Viewpoints and concerns of a clinical trial participant," Cancer 74 (1994): 2692-3.

3 C. Meade et al., "Consent forms: How to determine and improve their readability," Onc Nursing Forum 19 (1992): 1523-8.

4 National Cancer Institute, Clear and Simple: Developing Effective Print Materials for Low-Literate Readers NIH Pub. No. 95-3594 (December 1994): 22-37.

5 National Cancer Institute, Making Health Communications Programs Work: A Planner's Guide NIH Pub. No. 95-3594 (April 1992): 37-8.

Templates

NCI Consent Form Template for Adult Cancer Trials -- May 12, 2013

The template may be downloaded and modified, as needed.

Appendices 1 - 2

Appendix 1: Definition of Terms

Research means a systematic investigation designed to develop or contribute to generalizable knowledge; e.g., to discover new information or to revise conventional wisdom. Such investigations may include development of new therapeutic interventions, their evaluation, and subsequent application.

Human Subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:

  1. Data through intervention or interaction with the individual, or
  2. Identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

Clinical Trial, for the purpose of these recommendations, is a research activity that involves administration of a test intervention (e.g., a drug, surgical procedure, diagnostic test, or medical device) to humans in order to evaluate the intervention. In some cases it may refer to the first use of a new intervention in humans without any control treatment. In other cases it may refer to a rigorously designed and executed experiment involving a test and control intervention and randomization.

Appendix 2: Code of Federal Regulations for the Protection of Human Subjects in Research

DEPARTMENT OF HEALTH AND HUMAN SERVICES (45 CFR 46. 116)

General Requirements for Informed Consent

Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:*

  1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
  2. A description of any reasonably foreseeable risks or discomforts to the subject;
  3. A description of any benefits to the subject or to others which may reasonably be expected from the research;
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
  8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

  1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
  2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
  3. Any additional costs to the subject that may result from participation in the research;
  4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
  6. The approximate number of subjects involved in the study.

* Paragraphs (c) and (d) refer to Informed Consent waivers and have not been included in this document.

FDA CONSENT REQUIREMENTS (21 CFR 50. 20-27)

Basic Elements of Informed Consent

(a) In seeking informed consent the following information shall be provided to each subject:

  1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which arexperimental.
  2. A description of any reasonably foreseeable risks or discomforts to the subject.
  3. A description of any benefits to the subject or to others which may reasonably be expected from the research.
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.
  6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
  7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
  8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

  1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
  2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
  3. Any additional costs to the subject that may result from participation in the research.
  4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
  5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
  6. The approximate number of subjects involved in the study.

(c) The informed consent requirements in these regulations are not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed for informed consent to be legally effective.

(d) Nothing in these regulations is intended to limit the authority of a physician to provide emergency medical care to the extent the physician is permitted to do so under applicable Federal, State, or local law.

Sec. 50. 27 Documentation of Informed Consent

(a) Except as provided in Sec. 56. 109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of the consent. A copy shall be given to the person signing the form.

(b) Except as provided in Sec. 56. 109(c), the consent form may be either of the following:

  1. A written consent document that embodies the elements of informed consent required by Sec. 50. 25. This form may be read to the subject or the subject's legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed.
  2. A short form written consent document stating that the elements of informed consent required by Sec. 50. 25 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.

Appendices 3 - 7

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

Appendices 8 - 10

Appendix 8: Cover Letter from Dr. Jeff Abrams, February 15, 2012

Appendix 9: Planning Committee and Government Advisors to the Committee NCI Concise Informed Consent Template Project - February 2013

CCR/NIH
Christine Grady, RN, PhD, Deputy and Acting Chief, Department of Bioethics, Clinical Center
Caryn Steakley, RN, MSW, Deputy Clinical Director, Center for Cancer Research (CCR)

CDP/ DCTD/NCI
Tracy Lively, PhD, Associate Chief, Diagnostics Evaluation Branch, Cancer Diagnosis Program (CDP)

CIP/ DCTD/NCI
Barbara Galen, MSN, CRNP, CNMT, Program Director, Cancer Imaging Program (CIP)
Frank Lin, MD, Medical Officer, Clinical Trials Branch, CIP

CTEP/ DCTD/NCI
Jeff Abrams, MD, Associate Director, Cancer Therapy Evaluation Program (CTEP)
Jeanne Adler, RN, MPH, CCRP, Nurse Consultant, Clinical Investigations Branch, CTEP
Meg Mooney, MD, Branch Chief, Clinical Investigations Branch, CTEP

DCCPS/NCI
Sandra Mitchell, PhD, CRNP, Research Scientist and Program Director, Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (DCCPS)
Wendy Nelson, PhD, MPH, Program Director, Basic and Behavioral Research Branch, Behavioral Research Program, DCCPS

DCP/NCI
Leslie Ford, MD, Associate Director, Clinical Research & Acting Deputy Director, Division of Cancer Prevention (DCP)
Kathleen Foster, RN, BA, Nurse Specialist, Clinical Trials, DCP
Marge Good, RN, BSN, MPH, OCN, Nurse Consultant, Community Oncology and Prevention Trials Research Group, DCP
Lori Minasian, MD, FACP, Acting Director, DCP
Diane St. Germain, RN, MS, CRPNP, Nurse Consultant, Community Oncology and Prevention Trials Research Group, DCP
Judy Smith, RN, MSN, AOCN, Nurse Consultant, Lung and Upper Aerodigestive Cancer Research Group, DCP

Office of the NCI Director
Shannon Bell, MSW, Former Director, Office of Advocacy Relations
Steven Krosnick, MD, Program Director, Coordinating Center for Clinical Trials (CCCT)
Jean Lynn, RN, MPH, OCN, Program Director, CCCT
Kelli Marciel, MA, Director, Office of Advocacy Relations
Rose Mary Padberg, RN, MA, Public Health Advisor for Clinical Trials, Office of Communications and Education (OCE)
Geriann Piazza, MA, Technical Writer/Editor, OCE

NCI Support Contractor (EMMES)
Rebecca Enos, RN, MPH

Government Advisors to the Planning Committee

FDA
Sandra Casak, MD, Staff Fellow, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)
Ruthann Giusti, MD, Medical Officer, CDER, FDA
Shan Pradhan, MD, Medical Officer, CDER, FDA

OHRP
Jerry Menikoff, JD, MPP, MD, Director, Office for Human Research Protections (OHRP)
Julie Kaneshiro, Team Leader, Policy, OHRP
Lisa Rooney, Compliance Oversight, OHRP
Lisa Buchanan, Compliance Oversight, OHRP

Appendix 10: Working Group Rosters: NCI Concise Informed Consent Template Project - February 2013

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