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Conducting Clinical Trials

  • Updated: 08/18/2011

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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.

Related Resources

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

Informed Consent Template for Cancer Treatment Trials
(English Language)

Template Date: August 12, 2011

*** Download this template as a Word document and modifiy as needed.

_______________________________________________________________

(Text of template)

*NOTES FOR INFORMED CONSENT AUTHORS:

  • Model text suggested for use in the informed consent form is in bold. It is recommended that the bold text be retained when adapting the template to a specific protocol.
  • Instructions and examples for informed consent authors are in [italics].
  • A blank line, __________, indicates that the local investigator should provide the appropriate information before the document is reviewed with the prospective research participant.
  • The term 'study doctor' has been used throughout the template because the Principal Investigator of a cancer treatment trial is a physician. If this template is used for a trial where the Principal Investigator is not a physician, another appropriate term should be used instead of 'study doctor'.
  • The template date in the header is for reference to this template only and should not be included in the informed consent form given to the prospective research participant.

*NOTES FOR LOCAL INVESTIGATORS:

  • The goal of the informed consent process is to provide people with sufficient information for making informed choices. The informed consent form provides a summary of the clinical study and the individual's rights as a research participant. It serves as a starting point for the necessary exchange of information between the investigator and potential research participant. This template for the informed consent form is only one part of the larger process of informed consent. For more information about informed consent, review the "Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials" prepared by the Comprehensive Working Group on Informed Consent in Cancer Clinical Trials for the National Cancer Institute. The Web site address for this document is http://www.cancer.gov/clinicaltrials/understanding/simplification-of-informed-consent-docs/
  • A blank line, __________, indicates that the local investigator should provide the appropriate information before the document is reviewed with the prospective research participant.
  • Suggestion for Local Investigators: An NCI pamphlet explaining clinical trials is available for your patients. The pamphlet is entitled: "Taking Part in Cancer Treatment Research Studies". This pamphlet may be ordered on the NCI Web site at https://pubs.cancer.gov/ncipl or call 1-800-4- CANCER (1-800-422-6237) to request a free copy.
  • Optional feature for Local Investigators: Reference and attach drug sheets, pharmaceutical information for the public, or other material on risks. Check with your local IRB regarding review of additional materials.

*These notes for authors and investigators are instructional and should not be included in the informed consent form given to the prospective research participant.

Study Title

This is a clinical trial, a type of research study. Your study doctor will explain the clinical trial to you. Clinical trials include only people who choose to take part. Please take your time to make your decision about taking part. You may discuss your decision with your friends and family. You can also discuss it with your health care team. If you have any questions, you can ask your study doctor for more explanation.

You are being asked to take part in this study because you have [Type/stage/presentation of cancer being studied is briefly described here. For example: "Colon cancer that has spread and has not responded to one treatment".]

Why is this study being done?

The purpose of this study is to…. [Limit explanation to why study is being done. Explain in 1-2 sentences. Some examples are provided.]

[Example: Phase 1 study]

Test the safety of [drug/intervention] at different dose levels. We want to find out what effects, good and/or bad, it has on you and your [specify type/stage/presentation of] cancer.

[Example: Phase 2 study]

Find out what effects, good and/or bad, [drug/intervention] has on you and your [specify type/stage/presentation of] cancer.

[Example: Phase 3 study]

Compare the effects, good and/or bad, of [drug/intervention] with [commonly-used drug/intervention] on you and your [specify type/stage/presentation of] cancer to find out which is better. In this study, you will get either the [drug/intervention] or the [commonly-used drug/intervention]. You will not get both.

How many people will take part in the study?

About [state total accrual goal here] people will take part in this study. [If appropriate, a short description about cohorts can be given here. For example: "At the beginning of the study, (enter number of first cohort) patients will be treated with a low dose of the drug. If this dose does not cause bad side effects, it will slowly be made higher as new patients take part in the study. A total of (enter maximum number) patients are the most that would be able to enter the study".

What will happen if I take part in this research study?

[List tests and procedures and their frequency under the categories below. Include whether a patient will be at home, in the hospital, or in an outpatient setting.]

Before you begin the study …

You will need to have the following exams, tests or procedures to find out if you can be in the study. These exams, tests or procedures are part of regular cancer care and may be done even if you do not join the study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.

  • [List tests and procedures as appropriate. Use bulleted format.]

During the study …

If the exams, tests and procedures show that you can be in the study, and you choose to take part, then you will need the following tests and procedures. They are part of regular cancer care.

  • [List tests and procedures as appropriate. Use bulleted format.]

You will need these tests and procedures that are part of regular cancer care. They are being done more often because you are in this study.

  • [List tests and procedures as appropriate. Use bulleted format. Omit this section if no tests or procedures are being done more often than usual.]

You will need these tests and procedures that are either being tested in this study or being done to see how the study is affecting your body.

  • [List tests and procedures as appropriate. Use bulleted format. Omit this section if no tests or procedures are being tested in this study or required for safety monitoring.]

[For randomized studies:] You will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your doctor can choose the group you will be in. You will have an [equal/one in three/etc.] chance of being placed in any group.

If you are in group 1 (often called "Arm A") [Explain what will happen for this group with clear indication of which interventions depart from routine care.]

If you are in group 2 (often called "Arm B")… [Explain what will happen for this group with clear indication of which interventions depart from routine care.]

[For studies with more than two groups, an explanatory paragraph containing the same type of information should be included for each group.]

When I am finished taking [drugs or intervention]…[Explain the follow-up tests, procedures, exams, etc. required, including the timing of each and whether they are part of standard cancer care or part of standard care but being performed more often than usual or being tested in this study. Define the length of follow-up.]

[Optional Feature: In addition to the mandatory narrative explanation found in the preceding text, a simplified calendar (study chart) or schema (study plan) may be inserted here. The schema from the protocol should not be used as it is too complex, however a simplified version of the schema is encouraged. Instructions for reading the calendar or schema should be included. See examples.]

Study Chart [Example]

You will receive [drug(s) or intervention]every [insert appropriate number of days or weeks] in this study. This [insert appropriate number of days or weeks] period of time is called a cycle. The cycle will be repeated [insert appropriate number] times. Each cycle is numbered in order. The chart below shows what will happen to you during Cycle 1 and future treatment cycles as explained previously. The left-hand column shows the day in the cycle and the right-hand column tells you what to do on that day.

Cycle 1

DayWhat you do
Two days before starting study
  • Get routine blood tests.
Day before starting study
  • Check-in to _____________ the evening before starting study.
Day 1
  • Begin taking ______ once a day. Keep taking _____ until the end of study, unless told to stop by your health care team.
Day 2
  • Leave _______________ and go to where you are staying.
Day 8
  • Get routine blood tests.
Day 15
  • Get routine blood tests.
Day 22
  • Get routine blood tests.
Day 28
  • Get routine blood tests and exams.
  • Get 2nd chest x-ray for research purposes.
Day 29
  • Return to your doctor's office at _______[insert appointment time] for your next exam and to begin the next cycle.

Future cycles

DayWhat you do
Days 1-28
  • Keep taking _____ once a day if you have no bad side effects and cancer is not getting worse. Call the doctor at _____________ [insert phone number] if you do not know what to do.
  • Get routine blood tests each week (more if your doctor tells you to).
  • Get routine blood tests and exams every cycle (more if your doctor tells you to).
  • Get routine X-rays, CT scans, or MRIs every other cycle (more if your doctor tells you to).
Day 29
  • Return to your doctor's office at _______[insert appointment time] for your next exam and to begin the next cycle.

Study Plan [Example]

Another way to find out what will happen to you during the study is to read the chart below. Start reading at the top and read down the list, following the lines and arrows.

How long will I be in the study?

You will be asked to take [drugs or intervention] for (months, weeks/until a certain event). After you are finished taking [drugs or intervention], the study doctor will ask you to visit the office for follow-up exams for at least [indicate time frames and requirements of follow-up. When appropriate, state that the study will involve long-term follow-up and specify time frames and requirements of long-term follow-up. For example, "We would like to keep track of your medical condition for the rest of your life. We would like to do this by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and checking on your condition every year helps us look at the long-term effects of the study."]

Can I stop being in the study?

Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely.

It is important to tell the study doctor if you are thinking about stopping so any risks from the [drugs or intervention] can be evaluated by your doctor. Another reason to tell your doctor that you are thinking about stopping is to discuss what followup care and testing could be most helpful for you.

The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest; if you do not follow the study rules; or if the study is stopped.

What side effects or risks can I expect from being in the study?

You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. However, doctors don't know all the side effects that may happen. Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects. Many side effects go away soon after you stop taking the [drug(s) or intervention]. In some cases, side effects can be serious, long lasting, or may never go away. [The next sentence should be included if appropriate. There also is a risk of death.]

You should talk to your study doctor about any side effects that you have while taking part in the study.

Risks and side effects related to the [procedures, drugs, interventions, devices]include those which are:

Likely

Less Likely

Rare but serious

[Notes for consent form authors regarding the presentation of risks and side effects:

  • Using a bulleted format, list risks and side effects related to the investigational aspects of the trial. Side effects of supportive medications should not be listed unless they are mandated by the study.
  • List by regimen the physical and nonphysical risks and side effects of participating in the study in three categories: 1." likely"; 2. "less likely"; 3. "rare but serious".
  • There is no standard definition of "likely" and "less likely". As a guideline, "likely" can be viewed as occurring in greater than 20% of patients and "less likely" in less than or equal to 20% of patients. However, this categorization should be adapted to specific study agents by the principal investigator.
  • In the "likely" and "less likely" categories, identify those side effects that may be 'serious'. 'Serious' is defined as side effects that may require hospitalization or may be irreversible, long-term, life threatening or fatal.
  • Side effects that occur in less than 2-3% of patients do not have to be listed unless they are serious, and should then appear in the "rare but serious" category.
  • Physical and nonphysical risks and side effects should include such things as the inability to work. Whenever possible, describe side effects by how they make a patient feel, for example, "Loss of red blood cells, also called anemia, can cause tiredness, weakness and shortness of breath."
  • For some investigational drugs/interventions/devices there may be side effects that have been noted during treatment however not enough data is available to determine if the side effect is related to the drug/intervention/device. Because some local IRBs request to be informed of these possible side effects, this information, when available, is provided to the study chair. Inclusion of this information in the informed consent document is not mandatory. However, if included, these side effects should be listed under a separate category titled "Side effects reported by patients, but not proven to be caused by (drug/intervention/device)". Side effects in this category do not have to be labeled as "likely", "less likely" or "rare but serious" and should not be repeated here if they appear in a previous category. Similar to the other categories, these side effects should be listed in a bulleted format.]

Reproductive risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. [Include a statement about possible sterility when appropriate. For example, "Some of the drugs used in the study may make you unable to have children in the future." If appropriate include a statement that pregnancy testing may be required.]

For more information about risks and side effects, ask your study doctor.

Are there benefits to taking part in the study?

Taking part in this study may or may not make your health better. While doctors hope [procedures, drugs, interventions, devices] will be more useful against cancer compared to the usual treatment, there is no proof of this yet. We do know that the information from this study will help doctors learn more about [procedures, drugs, interventions, devices] as a treatment for cancer. This information could help future cancer patients.

What other choices do I have if I do not take part in this study?

Your other choices may include:

  • Getting treatment or care for your cancer without being in a study
  • Taking part in another study
  • Getting no treatment

[Additional bullets should include, when appropriate, alternative specific procedures or treatments.]

  • [For studies involving end-stage cancer, add the following paragraph as an additional bullet.] Getting comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly, but instead tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.

Talk to your doctor about your choices before you decide if you will take part in this study.

Will my medical information be kept private?

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:

  • [List relevant organizations like study sponsor(s), pharmaceutical company collaborators, local IRB, etc.]
  • The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), involved in keeping research safe for people

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

[Note to Informed Consent Authors: the above paragraph complies with the new FDA regulation found at 21 CFR 50.25(c) and must be included verbatim in all informed consent documents. The text in this paragraph cannot be revised.]

[Note to Local Investigators: The NCI has recommended that HIPAA regulations be addressed by the local institution. The regulations may or may not be included in the informed consent form depending on local institutional policy.]

What are the costs of taking part in this study?

You and/or your health plan/ insurance company will need to pay for some or all of the costs of treating your cancer in this study. Some health plans will not pay these costs for people taking part in studies. Check with your health plan or insurance company to find out what they will pay for. Taking part in this study may or may not cost your insurance company more than the cost of getting regular cancer treatment.

(If applicable, inform the patient of any tests or procedures for which there is no charge. Indicate if the patient and/or health plan is likely to be billed for any charges associated with these 'free' tests or procedures.)

(Include the following section if a study agent is manufactured by a drug company and provided at no charge)

The (identify study agent supplier here using the most appropriate choice of the following options: NCI, Cooperative Group, or another NCI-supported Clinical Trials Network) will supply the [study agent(s)] at no charge while you take part in this study. The (insert name of study agent supplier identified in first sentence) does not cover the cost of getting the [study agent(s)] ready and giving it to you, so you or your insurance company may have to pay for this.

Even though it probably won't happen, it is possible that the manufacturer may not continue to provide the [study agent(s)] to the (insert name of study agent supplier identified in first sentence) for some reason. If this would occur, other possible options are:

  • You might be able to get the [study agent(s)] from the manufacturer or your pharmacy but you or your insurance company may have to pay for it.
  • If there is no [study agent(s)] available at all, no one will be able to get more and the study would close.

If a problem with getting [study agent(s)] occurs, your study doctor will talk to you about these options. (End of section)

(Include the following section if a study agent is manufactured by the NCI and provided at no charge)

The NCI will provide the [study agent(s)] at no charge while you take part in this study. The NCI does not cover the cost of getting the [study agent(s)] ready and giving it to you, so you or your insurance company may have to pay for this.

Even though it probably won't happen, it is possible that the NCI may not be able to continue to provide the [study agent(s)] for some reason. If this would happen, the study may have to close. Your study doctor will talk with you about this, if it happens. (End of section)

You will not be paid for taking part in this study.

For more information on clinical trials and insurance coverage, you can visit the National Cancer Institute's Web site at http://www.cancer.gov/clinicaltrials/understanding/insurance-coverage . You can print a copy of the "Clinical Trials and Insurance Coverage" information from this Web site.

Another way to get the information is to call 1-800-4-CANCER (1-800-422-6237) and ask them to send you a free copy.

What happens if I am injured because I took part in this study?

It is important that you tell your study doctor, __________________ [investigator's name(s)],if you feel that you have been injured because of taking part in this study. You can tell the doctor in person or call him/her at __________________ [telephone number].

You will get medical treatment if you are injured as a result of taking part in this study. You and/or your health plan will be charged for this treatment. The study will not pay for medical treatment.

What are my rights if I take part in this study?

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your medical care. You can still get your medical care from our institution.

We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study.

In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.

Who can answer my questions about the study?

You can talk to your study doctor about any questions or concerns you have about this study. Contact your study doctor __________________ [name(s)] at __________________ [telephone number].

For questions about your rights while taking part in this study, call the ________________________ [name of center] Institutional Review Board (a group of people who review the research to protect your rights) at __________________ (telephone number). [Note to Local Investigator: Contact information for patient representatives or other individuals in a local institution who are not on the IRB or research team but take calls regarding clinical trial questions can be listed here.]

*You may also call the Operations Office of the NCI Central Institutional Review Board (CIRB) at 888-657-3711 (from the continental US only). [*Only applies to sites using the CIRB.]

Please note: This section of the informed consent form is about additional research studies that are being done with people who are taking part in the main study. You may take part in these additional studies if you want to. You can still be a part of the main study even if you say 'no' to taking part in any of these additional studies.

You can say "yes" or "no" to each of the following studies. Please mark your choice for each study.

[Insert information about companion studies here. Provide yes/no options at each decision point. The following studies are included as examples therefore are written with italicized font. Any text provided for patients should use the same non-italicized font as used for the rest of the informed consent document.]

[Example: Quality of Life study]

Quality of Life Study

We want to know your view of how your life has been affected by cancer and its treatment. This "Quality of life" study looks at how you are feeling physically and emotionally during your cancer treatment. It also looks at how you are able to carry out your day-to-day activities.

This information will help doctors better understand how patients feel during treatments and what effects the medicines are having. In the future, this information may help patients and doctors as they decide which medicines to use to treat cancer.

You will be asked to complete 3 questionnaires: one on your first visit, one 6 months later, and the last one 12 months after your first visit. It takes about 15 minutes to fill out each questionnaire.

If any questions make you feel uncomfortable, you may skip those questions and not give an answer.

If you decide to take part in this study, the only thing you will be asked to do is fill out the three questionnaires. You may change your mind about completing the questionnaires at any time.

Just like in the main study, we will do our best to make sure that your personal information will be kept private.

Please circle your answer.

I choose to take part in the Quality of Life Study. I agree to fill out the three Quality of Life Questionnaires.

YES NO

[Example: Use of Tissue for Research]

[The following example of tissue consent has been taken from the NCI Cancer Diagnosis Program's model tissue consent form found at the following URL

http://www.cancerdiagnosis.nci.nih.gov/specimens/model.pdf]

Consent Form for Use of Tissue for Research

About Using Tissue for Research

You are going to have a biopsy (or surgery) to see if you have cancer. Your doctor will remove some body tissue to do some tests. The results of these tests will be given to you by your doctor and will be used to plan your care.

We would like to keep some of the tissue that is left over for future research. If you agree, this tissue will be kept and may be used in research to learn more about cancer and other diseases. Please read the information sheet called "How is Tissue Used for Research" to learn more about tissue research.

Your tissue may be helpful for research whether you do or do not have cancer. The research that may be done with your tissue is not designed specifically to help you. It might help people who have cancer and other diseases in the future.

Reports about research done with your tissue will not be given to you or your doctor. These reports will not be put in your health record. The research will not have an effect on your care.

Things to Think About

The choice to let us keep the left over tissue for future research is up to you. No matter what you decide to do, it will not affect your care.

If you decide now that your tissue can be kept for research, you can change your mind at any time. Just contact us and let us know that you do not want us to use your tissue. Then any tissue that remains will no longer be used for research.

In the future, people who do research may need to know more about your health. While the xyz may give them reports about your health, it will not give them your name, address, phone number, or any other information that will let the researchers know who you are.

Sometimes tissue is used for genetic research (about diseases that are passed on in families). Even if your tissue is used for this kind of research, the results will not be put in your health records.

Your tissue will be used only for research and will not be sold. The research done with your tissue may help to develop new products in the future.

Benefits 

The benefits of research using tissue include learning more about what causes cancer and other diseases, how to prevent them, and how to treat them.

Risks

The greatest risk to you is the release of information from your health records. We will do our best to make sure that your personal information will be kept private. The chance that this information will be given to someone else is very small.

Making Your Choice

Please read each sentence below and think about your choice. After reading each sentence, circle "Yes" or "No". If you have any questions, please talk to your doctor or nurse, or call our research review board at IRB's phone number.

No matter what you decide to do, it will not affect your care.

1. My tissue may be kept for use in research to learn about, prevent, or treat cancer.

YesNo

2. My tissue may be kept for use in research to learn about, prevent or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease).

YesNo

3. Someone may contact me in the future to ask me to take part in more research.

YesNo

Where can I get more information?

You may call the National Cancer Institute's Cancer Information Service at:

1-800-4-CANCER (1-800-422-6237)

You may also visit the NCI Web site at http://www.cancer.gov/

You will get a copy of this form. If you want more information about this study, ask your study doctor.

Signature

I have been given a copy of all _____ [insert total of number of pages] pages of this form. I have read it or it has been read to me. I understand the information and have had my questions answered. I agree to take part in this study.

Participant ________________________________

Date _____________________________________

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 Documents6,7,8,9

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 (Initial Membership, August, 1998)

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

Appendix 7: Informed Consent Template Update Working Group (Current Membership, March, 2004)

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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