text:
Appendices 1 - 2
Appendices 3 - 7
Appendices 8 - 10
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.
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.
Many informed consent documents have become too long and complex, and do not provide a sound basis for informed decision-making. 1,2,3
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.
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.
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.
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.
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:
- very likely, regardless of severity, and
- 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.
- 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.
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.
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
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.
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.
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.
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:
- Data through intervention or interaction with the individual, or
- 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
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:*
- 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;
- A description of any reasonably foreseeable risks or discomforts to the subject;
- A description of any benefits to the subject or to others which may reasonably be expected from the research;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
- 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;
- 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
- 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:
- 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;
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
- Any additional costs to the subject that may result from participation in the research;
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
- 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
- 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.
Basic Elements of Informed Consent
(a) In seeking informed consent the following information shall be provided to each subject:
- 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.
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others which may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- 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.
- 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.
- 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.
- 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:
- 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.
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
- Any additional costs to the subject that may result from participation in the research.
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
- 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.
- 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:
- 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.
- 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
- 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).
- 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
- 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
- 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
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
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)
Tracy Lively, PhD, Associate Chief, Diagnostics Evaluation Branch, Cancer Diagnosis Program (CDP)
Barbara Galen, MSN, CRNP, CNMT, Program Director, Cancer Imaging Program (CIP)
Frank Lin, MD, Medical Officer, Clinical Trials Branch, CIP
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
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
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
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
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
Selected Bibliography
Advisory Committee on Human Radiation Experiments. The Human Radiation Experiments. New York: Oxford University Press, Inc., 1996.
Beauchamp T, Childress J. Principles of Biomedical Ethics. Third Edition. New York: Oxford University Press, Inc., 1989.
Buchanan A, Brock D. Deciding for Others: The Ethics of Surrogate Decision Making. New York and Cambridge: Cambridge University Free Press, 1995.
Bursztajn H, Feinbloom R, Hamm R, et al. Medical Choices, Medical Chances: How Patients, Families, and Physicians Can Cope with Uncertainty. New York: Free Press, 1984.
Davis T, Holcombe R, Berkel H, et al. Informed consent for clinical trials: A comparative study of standard versus simplified forms. JNCI 1998;90:66874.
Doak C, Doak L, Root J. Teaching Patients with Low Literacy Skills. Second Edition. New York: Lippincott, 1996.
Doak L, Doak C, Meade C. Strategies to improve cancer education materials. Onc Nursing Forum, 1996;23:130512.
Doak C, Doak L, Friedell G, et al. Improving comprehension for cancer patients with low literacy skills: Strategies for clinicians. CA-A Can J for Clinicians 1998;48:15162.
Dworkin G. Autonomy and informed consent. The Theory and Practice of Autonomy. New York: Cambridge University Press, 1988.
Engelhardt T. The Foundations of Bioethics. Oxford: Oxford University Press, Inc., 1996.
Faden R, Beauchamp T. A History and Theory of Informed Consent. New York: Oxford University Press, Inc., 1986.
Federal Policy For The Protection Of Human Subjects. (Common rule). Federal Register 1991;56:28002.
Freeman W. Making research consent forms informative and understandable: The experience of the Indian Health Service. Camb Q Healthc Ethics 1994;3:51221.
Gostin L. Informed consent, cultural sensitivity and respect for persons. JAMA 1995;274:8445.
Grossman S, Piantadosi S, Covahey C. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncology 1994;12:22115.
Hochhauser M. Some overlooked aspects of consent form readability.IRB: A Review Of Human Subjects Research 1997;19:59.
Joseph R. Viewpoints and concerns of a clinical trial participant. Cancer 1994;74:26923.
Katz J. Experimentation with Human Beings. New York: Russell Sage Foundation, 1972.
Katz J. The Silent World of Doctor and Patient. New York: Free Press, Macmillan Inc., 1984.
Levine R. Ethics and Regulation of Clinical Research. New Haven and London: Yale University Press, 1998.
Meade C, Howser D. Consent forms: How to determine and improve their readability. Onc Nursing Forum 1992;19:15238.
Miller S. Monitoring versus blunting styles of coping with cancer influence the information patients want and need about their disease. Cancer 1995;76:17797.
Olver I, Buchanan L, Laidlaw C, et al. The adequacy of consent forms for informing patients entering oncological clinical trials. Ann Onc 1995;6:86770.
Office for Protection from Research Risks, Protecting Human Research Subjects, Institutional Review Board Guidebook, 1993.
Prentice E, Gordan B, Gwenn, O, et al. Informed consent in oncology clinical trials. Can Mgmt July/August 1997;611.
Porter J. Basic considerations in informed consent in research. Clinical Research and Regulatory Affairs 1995;12:95109.
Savulescu J, Momeyer R. Should informed consent be based on rational beliefs? J Med Ethics 1997;23:2828.
Schafer A. The ethics of the randomized clinical trial. N Engl J Med 1982;307:71924.
Sulmasy D, Lehmann, L, Levine, D, et al. Patients' perceptions of the quality of informed consent for common medical procedures. J Clin Ethics1994;5:18994.
Tabak N. Decision making in consenting to experimental therapy. Cancer Nursing1995;18:8996.
Titus S, Keane M. Do you understand? An ethical assessment of researchers' description of the consenting process. J Clin Ethics 1996;7:608.
Vanderpool H, ed. The Ethics Of Research Involving Human Subjects: Facing the 21st Century. Frederick, MD: University Publishing Group, 1996.
Veatch R. The Patient as Partner: A Theory of Human Experimentation Ethics. Bloomington and Indianapolis: Indiana University Free Press, 1987.
Veatch R, ed. Medical Ethics. Second Edition. Sudbury, MA: Jones and Bartlett Publishers, 1997.
Department of Health and Human Services, Federal Register 56. June 18, 1991;CFR46:10146, 124.
Food and Drug Administration, Department of Health and Human Services, Federal Register 45. May 30, 1980;21CFR50:2050,27;56:109.


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"Good game ball. Never had a problem with them." (E4560)
"Great soccer ball, aired it up and used it in a game right away with zero problems!!!!" (E1623)
"Great service. Received my product within days of ordering. I will definetly purchase from you again. Thanks!:)" (E7671)
Neoprene Ankle Supports/Brace-Closeout [E12871]

subset: commoncrawl


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As your dedicated partner for Brocade training, ExitCertified offers certified SAN, IP Layer, and Ethernet Fabric training across North America. Our Education Specialists can help you find the right Brocade course and modality to suit your training needs, including instructor-led private, public and virtual training environments
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Designer Baby Bedding
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Size:Please Choose2 x 3 feet5 x 7.6 feet $(+714.00)7.9 x 10.6 feet $(+1712.00)
Gray Web Counterfeit Rug by Chandra Rugs
The Counterfeit Rug Collection from Chandra Rugs is sure to make a statement in your child's room! This stunning, hand-crafted area rug features quality craftsmanship and a stylish design.
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- Antique Jewelry
- The Ages
- Engagement Rings
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- Diamond Jewelry
- So Much More
Art Deco Wonder of a Diamond Platinum Ring
The horizontal profile employed during the later years of the Art Deco period is demonstrated in this wonder of a platinum ring. Towering "above" is an old European cut diamond with an actual weight of .92 carats with a near colorless grade of G and VS1 clarity. Descending down the stair-step mount are ten (10) additional old European cut diamonds with a total diamond weight of .40 carats which bring the rapturous Art Deco wonder to a grand total of 1.32 carats of brilliance. Please note the linear open work architectural design of the gallery.
Accompanied by gemological lab certificate (see "Measurements & More").
Date: Circa 1935.
Measurements: Just shy of 1/4 of an inch (0.6 cm) in width and ¾ of an inches (1.9 cm) in length of diamond area. Weight of 4.0 grams (2.6 dwt).
Ring Size: US 6 3/4 (UK N 1/2; Int. Dia. 53.5; Euro 17.1 mm; Japan just under a 14) and can be easily sized to fit most. Ring sizing information.
Hallmarks: 10% Irid Plat; number "40228".
Condition: Excellent.
Origin: American.
Note: This ring comes with an EGL USA certificate for the main diamond only with a replacement value of $10,620.
Forms of Payment
- VISA and MasterCard, Discover and American Express credit & debit cards.
- Personal checks drawn on U.S. banks only - Please allow 7 business days for clearance.
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When buying a corset be sure to look around and why not make it as a serious shopping experience. Whether it may be your first or hundredth time there are so many things to consider in choosing the right one. The reason behind your purchase and where you are buying the corset play a big role. Keeping also in mind your body and size which are key to picking out the proper corset.
There are many things you should ask yourself, are you buying this corset for fashion, medical or for slimming purposes. Is this more of a last minute buy or something you have been thinking about for quite some time. Knowing the reasons why you are buying the corset will be so helpful In determining what you buy is exactly what you set out for.
Knowing your body is the next thing you will need to know besides the reasoning behind your purchase. The purpose of a corset is to slim up to your torso. Their main purpose is to sit tight against your body pushing up your upper chest area. So knowing your measurements starting from your hips, waist chest size will be key getting a proper fitting corset. Also you need to figure out if what you are interested in purchasing is either an overbust or under bust corset. The difference being that overbust corsets sit atop your breasts and underbust sit underneath. Some use the underbust as a slimming corset that can be worn underneath garments. Both can be worn casually or intimate.
Another thing to keep in mind when purchasing a corset is the boning. There are two methods used which are very popular those are steel and plastic. They are the most commonly used inside of corsets to stabilize and stiffen the corset against your body. Boning in corsets is what gives the ability to flatten your stomach. Plastic boning is more often used then steel boning primary because it is less expensive. Steel tends to be pricier but are way more durable. Steel boning is more commonly used in lacing.
If you are looking to purchase a corset simply as a shopping experience then plastic boning will do. They will still get the job done as the fabrics and material are very flexible. Typically a couple of good stores to buy corsets are http://www.corsets-au.com/ (my first choice) and www.secretcorset.com, both provide good shipping and fair prices.
There is a variety of places that you may find your perfect match. Searching the internet or visiting your local lingerie store will carry a selection. When buying online make sure to read the sizing chart and understand where your measurements fit so that you may pick the right one for you. You may also inquire and ask questions if you unsure of sizing and how it will fit you. Majority of stores are happy to help and have general knowledge of their inventory. You may also call or live chat sales representatives who may be able to help you on the spot. All in all corset shopping can be fun and an experience especially if you're a first time buyer.


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Bristol Upholstered Armchair
Please Select Fabric: Brushed Canvas
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Please Select Color: Brushed Canvas, Natural
Special Order (8-10 Week Delivery)
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Crafted with the gracious lines of a British easy chair, this armchair is cozy and welcoming. The curve of its pleated English roll arms is echoed in the scrolled back, and the turned front legs are set on casters.
- 29" wide x 38" deep x 35" high
- Curved back with thick padding and English roll arms.
- Extra-thick foam-core seat is wrapped with lofty padding.
- Turned front hardwood legs with an Espresso finish.
- Casters on front legs provide easy mobility.
- Kiln-dried hardwood frame.
- Crafted by master upholsterers in the USA.
- For successful delivery: Furniture Delivery Video.
- Dimensions & Care
- Generously padded with a thick layer of cushioning on the tight back for extra comfort.
- Frame is constructed using kiln-dried solid and engineered hardwood, and is reinforced with mortise-and-tenon joinery, double dowels, and corner blocking for structural integrity.
- Heavy-gauge sinuous steel springs provide exceptional support.
- Expertly built by master craftsmen in America.
- Overall: 29" wide x 38" deep x 35" high
- Frame Back Height: 35"
- Seat: 29" wide x 21" deep x 17" high
- Inner Arm to Arm Seat Width: 17"
- Diagonal Depth: 28"
- Arms: 5" wide x 22" high
- Front Legs (nonremovable): 3.5" diameter, 8.75" high including casters
- Back Legs (nonremovable): 3" wide x 1.5" deep x 7.75" high
- Weight: 37 pounds
- Wipe with a soft dry cloth only.
Care & Composition
View complete Care & Cleaning Instructions
View the composition of each of our fabrics
Assembly & Installation
View complete Slipcover Installation Instructions
Replacement Cushions & Slipcovers
When you choose Pottery Barn furniture, you're not just getting exceptional quality; you're also choosing exceptional customer service. Should you ever need to purchase a replacement cushion or slipcover, our associates can place that order for you at any time. For assistance, please call 1.888.779.5176.
- Shipping Info
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At Pottery Barn, we take great pride in the quality and craftsmanship of our products. Attention to design, materials, safety and construction is our priority. We carefully inspect your order prior to shipment. Upon receipt, please inspect your purchase and notify us of any damage; we will arrange for a prompt replacement. If, within 7 days for Quick Ship upholstery and 30 days for all other products, you are dissatisfied for any reason, you may return your purchase for a refund of the merchandise value.
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You may return merchandise through the mail for a refund or replacement. For detailed procedures for returning items through the mail, please contact Customer Service at 1.888.779.5176, 7 days a week, 5:00am - 9:00pm (PT).


text: Stars come out for Prostate Cancer Awareness Month23 Mar 2012 Stars from the world of TV and politics have come together to show their support of this year's Prostate Cancer Awareness Month. Amongst the celebrities is Ricky Gervais, who, after teasing his co-worker Karl Pilkington to have a direct rectal examination he did. Read more


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Found 1 Item Tagged "Akhenaten (probably)"
The starting point for this lively patterned abstraction was an earlier canvas by Stuart Davis entitled House and Street, 1931. Treating eac...
Hiroshige's One Hundred Famous Views of Edo
Hiroshige's 118 woodblock landscape and genre scenes of mid-nineteenth-century Tokyo, is one of the greatest achievements of Japanese art.
On View: Base of Mummy Case with Painting
After Osiris's murder by Seth, Isis and her sister Nephthys mourned the death of the benevolent god-king. Their grieving may be seen as prep...
200 Eastern Parkway
Brooklyn, New York 11238-6052
Eastern Parkway/Brooklyn Museum
Wednesday: 11 a.m.–6 p.m.
Thursday: 11 a.m.–10 p.m.
Friday–Sunday: 11 a.m.–6 p.m.


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'Got this for my 3 month old boy. He loves the music and the wings that make fun sounds are easy to grip...'
momma bear - Newcastle
It's amazing how long rattlers can amuse your little one for! At Kiddicare, we've got a fantastic range of rattlers from Playgro, Lamaze and Little Bird. Why not take a look?
©Kiddicare 2014


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Hi there
Just like to say Hi to all you guys out there in ARCHERYLAND, (aint it a great place to be:D ). A special Hi to all the other SKIPPS that are part of this forum.
These things are a great way to meet a lot of interesting people (I mean that in the loosest form) and learn a great deal about this sport that we love ARCHERY wether it be Field, Hunting or even just shootin a bail of straw in the back yard its the greatest sport in the world.
The bow that I will be shooting in the very near future will be the Martin SABER (scorchin bow:eek: ). And will be looking at venturing to Thialand in 2007 for the World Transplant Games. If there is anybody at all that is interested in shooting at the Transplant games all you have to do is get in contact with your states Transplant Assossiation and they will fill you in on the rest. Also please contact me at firstname.lastname@example.com or on this forum so I know how many people woud like to see this great sport added to the program;) . But it will all depend on the numbers and the interest from the world over for them to have it as part of the program.
Anyway heres to straight arrows for everyone. and remember live your dreams and go at them FullBoar:cool:


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Health Care Security & Privacy in 2013 and Beyond Webinar Series
A strategic perspective
Learn how health reform transformation is changing security and privacy in health care and how it may impact your organization's approach today and tomorrow. Hear from Deloitte's top thought leaders Harry Greenspun, M.D., Senior Advisor, Health Care Transformation & Technology, Deloitte Center for Health Solutions and Mark Ford, Principal, Deloitte & Touche LLP on how the transformation of health care has significant implications for an organization's security and privacy.
Watch the three-part series now:
Insights into future security and privacy issues in health care
Topics covered: Aggregation of data and new technologies/big data
Webinar duration: 30 minutes
New care models, value-based health care and considerations for mitigating security and privacy risks
Topics covered: Data flow across stakeholders and value-based care (VBC)/ population health/ accountable care organizations (ACOs)
Webinar duration: 30 minutes
Are your security & privacy functions prepared to fully leverage mHealth and connect data with your consumers?
Topics covered: Connecting data with the consumer and security and privacy in an mHealth and consumer-driven market
Webinar duration: 30 minutes


text:
Saturday, November 01, 2014
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Saratoga County
KINGSTON, N.Y. -- FEMA is opening another one of its Disaster Recovery Centers in the Hudson Valley this week to assist residents and small business owners with assistance following Sandy.
Unlike the registration centers in Kingston and Saugerties, this Disaster Recovery Center will provide residents and business owners with an opportunity to talk to FEMA and Small Business Administration representatives about their specific situations.
Ulster County was recently declared a disaster area by FEMA because of damage caused by Sandy. State Assemblyman Kevin Cahill says Ulster County individuals who initially were denied disaster assistance should reapply because of the declaration.
The center will be open at the Hudson River Maritime Museum from noon to 5 p.m. Monday and 10 a.m. to 5 p.m. Tuesday through Friday.
Residents can also apply for assistance by calling FEMA at (800) 621-3362, or by registering online at disasterassistance.gov.
Reproduction in whole or in part without permission is prohibited.
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text: Danze is one of the fastest growing plumbing companies in America. It is no surprise that they offer an extensive line of the highest quality faucets available on the market today. Their faucets come in a range of great styles and are made with extremely durable materials. They offer a surprisingly good value with premium components such as drip-free ceramic valves and solid brass waterways. Each faucet comes with a limited lifetime warranty from manufacturing defects, and all our faucets ship free!


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With teammates Philippe Gilbert and Steve Morabito riding beside him, BMC Racing Team's Cadel Evans crossed the finish line at the summit of Mont Ventoux Sunday after a battle to the top on the Tour de France's longest stage.
Difficult Before The Climb
Evans conceded 8:46 to solo stage winner Chris Froome (Sky Procycling), who increased his overall lead to 4:14 over Bauke Mollema (Belkin Pro Cycling). After losing contact with 11 kilometers to go in the 20.8 km climb at the end of the 242.5-km stage, Evans slipped to 16th overall, 15:40 behind. "What can I say? I was nowhere near where I wanted to be and had a lot of difficulties," the 2011 Tour de France winner said. "I was feeling fine to start, a bit tired after the start and exhausted even before we started the climb. It's hard to go in with big expectations when you're exhausted before the climb even starts. As the climb went on, (I felt) worse and worse. When you're popped out of the group, it doesn't do much for your motivation."
Fast All Day Long
For the second straight day, BMC Racing Team's Marcus Burghardt was seen near the front as he tried to make the day's breakaway. "We wanted to have one guy in the break to be support for Cadel later in the race when it started to blow," teammate Brent Bookwalter said. "He was a little ways off in the counter but it was still a good effort." Bookwalter and Amaël Moinard said the team did its best to protect Evans before the punishing climb to the finish that averages 7.5 percent. "It was very, very fast at the beginning and all day long," Moinard said. "Then, we all had to struggle to be in a good position at the bottom of the Ventoux. It was very hard. I think that everybody had to make great efforts to be in a good position at the bottom and then (from the bottom), it was very fast."
Listen to complete comments from Bookwalter, Evans and Moinard on the BMC Racing Team Tour de France Audio Line.


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Mollyanna's Q & A
Who's your favorite sports team, and why?
Oohh, atheletes and musicians-two titles men wear that are so sexy ;) Basketball: Grizzlies for sure ! (because Memphis is close to me and I can go to the games and have hot friends on the dance team) and then of course the Lakers (just because they are fun to watch and twitter blows up when they play-everyone gets into their games) Football: 49ers! Just because I like them. And of course my Saints! who doesn't love them-especially if your from the south;) Baseball: Braves. end of story.
What's your favorite movie quote?
Those change - right now it is probably from the movie The Perks of being a Wallflower: "We accept the love we think we deserve" But favorite movie- hands down SMOKEY AND THE BANDIT. Forever and always :)
What's your favorite video game, and could you kick our butts at it?
Oh no! I'm not a video game girl :( I never really have time. I bet if I was though.. I would totally kick butt at it-duh.
Piercings/Tattoos (How many? Where?)
LOVE GUYS WITH TATTOOS! I am way too scared to commit- so NO tattoos. And just one piercing, each ear.
What's the most embarrassing song on your iPod?
I may or may not have Spice Girls
What's your best party trick?
Where there's a party there's music, right? Well mix me and music and there you'll find a little mama who won't stop dancing until the music stops...and prob not even then if you're lucky ;) Yeah I can shake it.
What's the most memorable pick-up line you've ever heard?
OMG. I seriously think theres some guy code book that they buy that has these lines in them! Via Facebook guys have no shame and seriously no game. Bless their Hearts! :(
What's the worst job you've ever had?
Bar waitress at Buffalo Wild Wings. I had a love/hate relationship with it. I always found myself getting in trouble for overserving my guests (how do I know their limit?) Loved it when the hotties came in but then you had to treat those intoxicated "not-so-hot" ones with the same love, and that well ... yeah. Haha stalker status.
What's the most dangerous thing you've ever done?
Being that I hang with the boys a lot, they tend to have no fear factor as opposed to girls. Haha. At my old high school some of the baseball boys, another of my best guy friends, and I was all riding around in some winter weather and for some reason decided to ride over an iced bridge while hanging onto the doors with them open and our feet on the bridge like we were skating on the ice. It was very fun but looking back I think wow - that was dumb.
It's 4AM after a crazy night out – what are we eating?
I am probably going for some cheap Mexican corn chips, guacamole, and salsa. Yeah I'm pretty cheap when it comes to food.
What's the strangest thing in your fridge right now?
I am a gluten-free vegan. My fridge and cabinet are full of "strange" foods compared to most!
What's the naughtiest thing you've ever done in public?
I am big on dares. If someone dares me to do something I have no shame I am so in! I say, what do you have to lose? You only have one life so be spontaneous and make it a FUN ONE!!! -Soo by that I would say maybe not the most (bc that I'll keep to myself), but one I will share was in high school me and a few new friends all went streaking on my old high schools baseball field! ...And only later did we find out they had cameras...because my dad found out...because he was still on the school board there. Fail.
What do you feel sexiest wearing?
A classic rock tee and cheeky undies. Two of my favs. and two of my usuals ;)
Tell us a joke.
You're kidding me, right? Everyone knows you can never tell one on the spot. Most aren't even funny when you do! Real comedians make you crack up in person... guess you'll have to meet me to hear your jokes ;)


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There have been several inquiries about this event lately. Many are by people who may be climbing Mount Washington for the first time. I will try to cover as much in this thread as I think is pertinent to a newcomer.
For the first timer I would suggest:
Where do I stay?
The nearest big towns on the east side of Mount Washington (The Mount Washington Valley Area) are North Conway to the south and Gorham to the north. There are many motels to suit any pocketbook in the North Conway Area. Also to the south are the towns Bartlett and Jackson which also have many places to stay. Try this link:
In the Gorham area my personal favorite is:
Also here is the Gorham Chamber of Commerce:
There is also a lot of camping in the area. Two of my favorite campgounds are:
Although you can register in advance, we generally meet at the Pinkham Notch Visitor Center on Rte. 16 in Pinkham Notch on the morning of the hike/fundraiser. This year it is 7/28/07. Here you can turn in your paper work and receive the goody bag which always contains a map of Mount Washington. If you are in the North Conway area on Friday night 7/27/07, there is also a registration at Horsefeathers in downtown North Conway.
What trail is best?
One does not have to hike to the summit to participate in this event. There are many good destinations on the east side of the mountain which do not require hiking to the summit.
For a beginner who is interested in going to the summit I would suggest the Tuckerman Ravine Trail. This leaves from Pinkham Notch and climbs through Tuckerman Ravine to the summit of Mount Washington. It rises 4250' over 4.2 miles. Many use a combination of this trail and Lion's Head Trail either on the ascent or descent. This trail is easy to follow unless the summit is completely fogged in, in which case one should probably turn around anyway. There will be many people on this trail on a summer weekend who will be glad to assist in the event of an emergency or to give directions. There are several other trail options which start at or near Pinkham Notch, if one would like to take a lesser travelled route. There will be knowledgeable people at the registration desk who can suggest a route for all skill levels.
What should I bring?
You should bring a daypack which has at least:
A sandwich and some snacks. High energy food is best. Peanut butter sandwiches are good for this. Raisins, apples, bananas, oranges. GORP (Granola, oatmeal, raisins and peanuts) is always good and can be bought in premixed bags or you can make your own. Many supermarkets have sections where you can choose what you like. Chocolate is always good to have along. Many people fuel up with protein the night before. Pasta like the marathoners, or a nice steak or burger.
Drinks: A minimum of 2 litres per person of water or something like Gatorade. More if it's a hot day. Take a short break and a few sips every half hour. Stay hydrated. It is a good idea to have plenty to drink in the morning before a hike. Stay away from drinking a lot of coffee or tea as this will dehydrate you.
Clothing: No cotton! The saying is "Cotton kills!" Wear polypropylene clothing. It will dry quickly in the event of a downpour. Many people have died as a result of hypothermia even in the summer months. Bring a fleece pullover. It is July 3rd and the temp on Mount Washington right now is 43 degrees.
A wicking shirt for climbing. This will keep the sweat away from your body and keep you from cooling down in the wind. Pull the fleece on when you stop to retain heat.
A windbreaker/ rain jacket. There is almost always wind, and a rain shower can come up at any time. More than likely you'll be walking in the clouds. Wind/rain pants are a good idea, too.
An extra shirt, to put on at the summit as the one you start out in will probably be soaked in sweat when you arrive. There are changing rooms (and rest rooms) in the Sherman Adams Building on the summit if needed.
Gloves or mittens and a wool hat. There has been snow recorded on Mount Washington in every month of the year. Even if there is no snow, the temp may feel like there is. Wind chill can be a big factor even in summer.
Footwear: I highly suggest a good, hightop hiking boot. Sides up over the ankle. Many people hike in sneakers and I think they are just asking for trouble. It's a long way out on a sprained ankle. The rocks can be extremely slippery when they're wet, even after a brief shower. The unevenness of the ground can be very dangerous to exhausted limbs and cause slips and trips that would not otherwise happen. I've hiked many miles and taken many tumbles and my boots have saved my ankles on many occassions. Goretex is best, it keeps your feet dry. Wear good comfortable polypro socks to wick moisture away from your feet. Bring an extra pair in your pack.
A trekking pole (hiking stick): I personally find this an indipensable tool. It helps with balance on the way up and helps take the strain off the knees on the way down.
My other tips would be: In a group, stay together. Hike to the ability of the slowest in the group. No one should be allowed to continue on, or to return alone. If you must split up, then split up in groups. If someone is hurt or too tired to continue, then return to the base with them. Do not push on for the summit in the hopes of finding help or shelter. Getting down is the best way. In the event of a real emergency look for an experienced person along the trail who knows the mountain. This person will know where to get help. Do not rely on a cell phone as service is spotty at best.
In the event of the weather turning bad, head down. There may be more experienced people pushing on to the summit, but why risk it? The mountain will be there the next time you want to try.
If you're exhausted, turn around. Remember, even if you reach the summit, you still have to get down. This can be harder than the climb, because now your limbs are tired and you start to stumble.
Only you can judge yor ability and comfort level out there. Be honest with yourself.
If you're in charge of a group, you must be acutely aware of your fellow hikers. Watch for fatigue and dehydration as well as hypothermia, as stated before, hike to the weakest members ability.
Pretend the summit building is not there. Hike as though there is no warm, comfortable place to reach on the summit. The thought of pushing on to the safety of the summit buildings when many should have turned around has gotten many hikers in trouble.
Lastly, if you bring your dog: Remember, it can be just as dangerous out there for your dog as it is for you. Keep them on the trail by leash or voice command. Make sure they have enough food and water, treat them as you would any member of your hiking group. Old dogs who don't get out much probably shouldn't make this climb. People will not appreciate rescuing your dog. Dogs can pull muscles and sprain ankles just like people. A young, fit, healthy dog who is under control and not running all over the place should have little trouble making this climb. Of chief concern should be the pads of their feet. The rough quartzite mica-schist make up of the rock on Mount Washington can tear the pads up. A good product to use is Mushers Secret to protect their paws. Check them often and watch for signs the dog is favoring a paw or leg. Turn around if need be. Your dog trusts you and if it is like mine it will follow you to the end of the earth. Respect this trust and treat the dog similarly.
Last of all, please don't let any of this scare you off. Thousands of people hike Mount Washington each year and a very small percentage get in trouble. Common sense goes a long way out there. Go out and have a good time, but stay within your limits. We all hope to see you on the trail having a good time! I hope this info helps you to have a safe, memorable experience on Mount Washington!


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Wine & Cheese Pairing @ CIA at Greystone
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Technology and Social Change
Recorded at the Mises Institute on 20 November 2009. Sponsored by Jeremy S. Davis. [30:51]
Technology and Social Change Various Artists Economics for High School Students
From: Economics for High School Students , Friday, November 20, 2009 by Jeffrey A. Tucker
Available for download as Wmv , Mp4 or watch this video on YouTube .
Available for download as Mp3 .


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The dairy industry has been working to develop a "smarter" chocolate milk. We've done this because leading health and nutrition organizations such as the American Dietetic Association, the American Academy of Family Physicians and the American Academy of Pediatrics recognize the valuable role of flavored milk in the diets of American children.
The "smarter" chocolate milk I refer to is sweetened with stevia, a 100% natural zero calorie sweetener. I've tasted a version of this chocolate milk and it's great. Each serving has 71% less added sugar, 50 fewer calories, 13 grams fewer carbohydrates and 10 grams fewer total sugars than traditional chocolate milk while providing the same amount of calcium, vitamin D and protein.
There's a precedent for the success of such a program. According to the Centers for Disease Control and Prevention, by switching chocolate milk in New York schools from whole milk to low-fat milk, 5,960 fewer calories and 619 fewer grams of fat were served to children in 2009 versus 2004. In addition, milk sales actually increased, showing that the students found the change acceptable.
Dairy farmers understand the problem with traditional chocolate milk and we've been trying for years to encourage processors to produce lower sugar chocolate milk. Now that solutions are available, it's time to move.
Let's get serious about working together to help our children. I implore Jamie Oliver and John Deasy to sit down with me to talk about this exciting new option in chocolate milk. I believe we have a solution where everyone can be happy.
Thanks for your consideration,
Dino Giacomazzi
Giacomazzi Dairy
1. Murphy M, Douglass J, Latulippe M, Barr S, Johnson R, Frye C.
Beverages as a source of energy and nutrients in diets of children and
adolescents. The FASEB Journal 2005; A434,275.4.
Source: Dino Giacomazzi