We would like to hear from donors about the following informed consent form sample whether or not they believe that we have adhered to the FDA's guidelines (provided below our sample here also) for creating same. This is also to give donors further information about some of the preliminary details of the structure of our study and a chance to help us shape it.
Informed Consent Form (Sample)
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.
This study involves research, to try to discover the efficacy of Essiac on Stage 4 breast and/or colon cancer that has been diagnosed as not further treatable by conventional methods of chemotherapy, radiation, and other conventional treatment methods to see if Essiac will ameliorate or cure those diseases. The subjects are expected to participate over a five-year period with the researchers to follow up with the subjects once per year during that five year interval as long as the subjects are able to.
The subjects will agree to pay $2,500 one time to participate in the study to cover administrative costs and costs of the Essiac.
DO NOT FREEZE OR MICROWAVE Essiac! DO NOT take with food or mix with anything else but water, preferably spring water. Refrigerate after opening. There is an expiration date on each bottle. Essiac has a pleasant herbal flavor and is a light amber/brownish colored liquid.
For our study, participants will need to take one ounce (1 oz.) of Essiac mixed with an ounce (1 oz.) of cold spring water that participants are then to sip slowly over at least ten (10) minutes, once per day ONLY, soon after you wake up for the day, whatever time you wake up, and at least 30 minutes before you eat anything. You MUST take the above Essiac mixture on an empty stomach or it may cause nausea or stomach cramps. You may also drink up to sixteen ounces (16 oz.) of spring water right after taking it. Do this once per day for at least 60 days. This procedure is experimental. (Please see
possible side effects and what to do to stop them in the paragraph below).
You may experience cramping or nausea or hormonal changes which may cause mood changes and some breast tenderness or milk leakage from breasts. If you experience any of these, stop taking one ounce (1 oz.) doses of Essiac once every day and take one tablespoon EVERY OTHER DAY on the same schedule originally mentioned with the without mixing it with spring water but drinking up to 16 oz. of water afterwards until the symptoms stop. If you continue to experience discomfort, stop altogether for about a week or even two until you feel better. Then if you have not finished the whole 60-day course then you can go back to the original dosage until the end of the 60-day course. Whenever you need to, you can reduce the dosage as described above and then go back as your body’s reactions suggest.
After participants have finished the two 32 oz. bottles of Essiac as a criteria for this study over whatever time period it takes, participants must go to their oncologists for further testing to see if their condition has improved and get copies of their medical records and forward those records to us.
Participants may reasonably expect to feel much better physically with more energy and a general greater feeling of physical well-being and to possibly ameliorate the effects of or see their cancers cured even though those cancers will have been far advanced and to prolong their lives longer than expected under the circumstances. Since we are only accepting participants in this trial whose oncologists have determined that no further conventional treatments,
e.g., chemotherapy, radiation, or surgery, etc., would be beneficial to said participants, we would not at this time recommend any other more conventional alternative treatments for the participants of this trial, but we would recommend that they research their conditions as
thoroughly as they can, asking questions of their oncologists, and seek any other alternatives that seem suitable to them either while participating in this trial or after.
The Food and Drug Administration may possibly inspect the records of participants’ of this trial. We will not disclose, except as is required by law, your personal identifying information to anyone unless you sign a HIPAA form permitting us to do so. We shall disclose the results of our study but without your personal identifying information.
Contact, Donna Lee, at firstname.lastname@example.org for answers to any pertinent questions about this trial, trial participants’ rights and or any suspected research-related injury.
Participation is voluntary. Refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
This particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) which are currently unforeseeable.
If you would like to withdraw from the study, please contact us and let us know at email@example.com. There will be no refunds of the $2,500 paid for administrative costs and for the Essiac that we supply for any reason.
If significant new findings develop during the course of the research which may relate to the participants’ willingness to continue participation we will provide those findings to the participants. We will accept no more than 2500 subjects for this trial who must be
American citizens or legal resident aliens of the U.S. and must provide photo ID to that effect.
This informed consent form is 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.
Nothing in this informed consent form 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.
I have read and understand the contents of this form, have paid the $2,500 for administrative fees and my supply of Essiac and consent to participate in this trial as outlined above and as I attest below and have had notarized (Please sign, have notarized and scan and attach this form to an e-mail and return it to us at firstname.lastname@example.org; If you have any trouble with this, please contact us at email@example.com).
_______________________________________ Over 18 years of age
Subject First and Last Name (Print) (Circle) Yes or No
Legal Guardian First and Last Name if Subject is under 18 years of age (Print)
____________________________________________________________________________Permanent/Mailing Street Address (No P.O. Boxes Please!)
City, State and Zip Code
Signature of Subject or Legal Guardian if Subject is under 18 years of age and date signed (to be witnessed by a Notary Public)
Subpart B--Informed Consent of Human Subjects
Sec. 50.25 Elements of informed consent.
(a) Basic elements of informed consent. 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 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) When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes. This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act. The statement is: "A description of this clinical trial will be available onhttp://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."
(d) 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.
(e) 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.
[46 FR 8951, Jan. 27, 1981, as amended at 76 FR 270, Jan. 4, 2011]