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Consent to participate in biomedical research


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CONSENT TO PARTICIPATE IN

BIOMEDICAL RESEARCH

[Insert the lay title of the study.]


[If the study involves using different consent forms for different populations,
identify the population group as the subtitle of the study.
]

You are asked to participate in a research study conducted by [insert names and degrees of all investigators], from the [insert department affiliation] at the Massachusetts Institute of Technology (M.I.T.) (if applicable, insert the name of any collaborating institution). You have been asked to participate in this study because [explain succinctly and simply why the prospective subject is eligible to participate]. [If appropriate, state the approximate number of subjects involved in the study. If subjects must be patients with a specific disease/condition, and if they must have tried standard treatments without good results, say so in clear terms.] You should read the information below, and ask questions about anything you do not understand, before deciding whether or not to participate.


PARTICIPATION AND WITHDRAWAL


Your participation in this research is completely VOLUNTARY. If you choose to participate you may subsequently withdraw from the study at any time without penalty or consequences of any kind. If you choose not to participate, that will not affect your relationship with M.I.T. (if applicable, insert the name of any collaborating institution) or your right to health care or other services to which you are otherwise entitled.

PURPOSE OF THE STUDY


[State what the study is designed to discover or establish.]

PROCEDURES


If you volunteer to participate in this study, we would ask you to do the following things:


  1. Describe the procedures chronologically using lay language, short sentences, and short paragraphs. Use subheadings to organize this section and increase readability. Distinguish which procedures are experimental and which are standard treatments.

  1. Define and explain medical and scientific terms in ordinary language (for example: the term placebo, the amount of blood to be drawn should be defined in terms of teaspoons or tablespoons).

  1. Specify the subject's assignment to study groups, length of time for participation in each procedure, the total length of time for participation, frequency of procedures, location of the procedures to be done, etc.

  1. For research involving randomization of subjects into different arms of studies, specify the randomization procedures.

POTENTIAL RISKS AND DISCOMFORTS




  1. Identify each intervention with a subheading and then describe any reasonable foreseeable risks, discomforts, inconveniences, and how these will be managed.

  1. In addition to physiological risks/discomforts, describe any psychological, social, legal, or financial risks that might result from participating in the research.

  1. If there are significant risks to participation that might cause the researcher to terminate the study, please describe them.

  1. Include the following statement:

The treatment or procedure may involve risks that are currently unforeseeable.

ANTICIPATED BENEFITS TO SUBJECTS


Based on experience with this [drug, procedure, device, etc.] in [animals, patients with similar disorders], researchers believe it may be of benefit to subjects with your condition [or, it may be as good as standard therapy but with fewer side effects]. Of course, because individuals respond differently to therapy, no one can know in advance if it will be helpful in your particular case. The potential benefits may include:

[Describe the anticipated benefits to subjects resulting from their participation in the research.]




  1. If there is NO likelihood that participants will benefit directly from their participation in the research, state as much in clear terms. For example: “You should not expect your condition to improve as a result of participating in this research” Do not include financial rewards for participating in this section; that will be addressed later.

ANTICIPATED BENEFITS TO SOCIETY


[State the anticipated benefits, if any, to science or society expected from the research.]

ALTERNATIVES TO PARTICIPATION




  1. Describe any appropriate alternative therapeutic, diagnostic, or preventive procedures that should be considered before the subjects decide whether or not to participate in the study. If applicable, explain why these procedures are being withheld. If there are no efficacious alternatives, state that an alternative is not to participate in the study.

  1. If the prospective subjects are suffering from a terminal illness, and there are no alternative treatments available, you should say so; but avoid suggesting that participation in the research is the only way to obtain medical care and attention.

PAYMENT FOR PARTICIPATION




  1. State whether the subject will be paid or offered other benefits. If not, state so.

  1. If the subject will receive payment, describe remuneration amount, when payment is scheduled, and proration schedule should the subject decide to withdraw or is withdrawn by the investigator.

  1. If the subject will be reimbursed for expenses such as parking, bus/taxi, baby-sitter, travel companion/assistant, etc., list payment rates.

  1. Subjects should not lose payment if they develop side effects or illness.

POSSIBLE COMMERCIAL PRODUCTS


(Note: If this does not apply to your research, please omit)


  1. If any human materials (tumor tissue, bone marrow, blood, etc.) are used for establishing a cell line which may be shared with other researchers and which may in the future be of commercial value, the subject must be informed of the fact in the consent form.

FINANCIAL OBLIGATION


(Note: If there is no financial obligation of the subject, please say so.)
It is possible that your insurance will not pay for all of the treatments and tests you will receive if you participate in the research. That is because many insurance companies, HMOs, and health benefits plans do not cover experimental treatments. If that happens, the charges you will have to pay will be as follows: [Provide an itemized list.]
Suggested alternative text:
Neither you nor your insurance company will be billed for your participation in this research.


  1. If it is likely or even possible that procedures or tests the subjects will undergo will not be covered by their insurance, health benefits plan, or other third party payers, you should make this clear.

  1. Bills should not be submitted to third party payers without the written consent of the subject.

PRIVACY AND CONFIDENTIALITY


The only people who will know that you are a research subject are members of the research team and, if appropriate, your physicians and nurses. No information about you, or provided by you during the research will be disclosed to others without your written permission, except: if necessary to protect your rights or welfare, or if required by law.
When the results of the research are published or discussed in conferences, no information will be included that would reveal your identity. If photographs, videos, or audio-tape recordings of you will be used for educational purposes, your identity will be protected or disguised. [If subjects are to be audio-taped or video-taped specific consent for this must be obtained in the Procedures section. Also describe the subject's right to review/edit the tapes, who will have access to them, and when they will be erased. Describe how personal identities will be shielded, disguised, etc.]
[When the research records may be subject to inspection by FDA, a funding agency, or an industrial sponsor, you must add:]
Authorized representatives of the Food and Drug Administration (FDA) [or a funding agency, such as the National Institutes of Health] and the manufacturer of the drug [or device] being tested [insert name of company] may need to review records of individual subjects. As a result, they may see your name; but they are bound by rules of confidentiality not to reveal your identity to others.


  1. Give a brief description of how personal information, research data, and related records will be coded, stored, etc. to prevent access by unauthorized personnel. State if and when individual data will be destroyed following analysis, and the format in which data will be reported.

  1. Explain how specific consent will be solicited, if any other uses are contemplated.

CONSEQUENCES OF WITHDRAWAL


(Note: If this does not apply to your research, please omit) [Explain the consequences of a subject's decision to withdraw from the research and state whether withdrawal must be gradual, for reasons of safety.]



  1. WITHDRAWAL OF PARTICIPATION BY THE INVESTIGATOR

The investigator may withdraw you from participating in this research if circumstances arise which warrant doing so. If you experience any of the following side effects [list and describe] or if you become ill during the research, you may have to drop out, even if you would like to continue. The investigator, [insert name], will make the decision and let you know if it is not possible for you to continue. The decision may be made either to protect your health and safety, or because it is part of the research plan that people who develop certain conditions may not continue to participate.


If you must drop out because the investigator asks you to or because you have decided on your own to withdraw, you will be paid [insert amount of payment or other remuneration].

NEW FINDINGS


During the course of the study, you will be informed of any significant new findings (either good or bad), such as changes in the risks or benefits resulting from participation in the research or new alternatives to participation, that might cause you to change your mind about continuing in the study. If new information is provided to you, your consent to continue participating in this study will be re-obtained.

EMERGENCY CARE AND COMPENSATION FOR INJURY


If you feel you have suffered an injury, which may include emotional trauma, as a result of participating in this study, please contact the person in charge of the study as soon as possible.
In the event you suffer such an injury, M.I.T. may provide itself, or arrange for the provision of, emergency transport or medical treatment, including emergency treatment and follow-up care, as needed, or reimbursement for such medical services. M.I.T. does not provide any other form of compensation for injury. In any case, neither the offer to provide medical assistance, nor the actual provision of medical services shall be considered an admission of fault or acceptance of liability. Questions regarding this policy may be directed to MIT’s Insurance Office, (617) 253-2823. Your insurance carrier may be billed for the cost of emergency transport or medical treatment, if such services are determined not to be directly related to your participation in this study. If the study is sponsored by a private drug or device manufacturer, delete the previous sentence.

IDENTIFICATION OF INVESTIGATORS


In the event of a research related injury or if you experience an adverse reaction, please immediately contact one of the investigators listed below. If you have any questions about the research, please feel free to contact [identify all personnel involved in the research as listed in the COUHES Application under the following subheadings: Principal Investigator, Faculty Advisor (if student is the P.I.), Co-Investigator(s). Include the daytime telephone numbers and addresses for all listed individuals. For greater than minimal risk studies, include night/emergency telephone numbers.]

RIGHTS OF RESEARCH SUBJECTS


You are not waiving any legal claims, rights or remedies because of your participation in this research study. If you feel you have been treated unfairly, or you have questions regarding your rights as a research subject, you may contact the Chairman of the Committee on the Use of Humans as Experimental Subjects, M.I.T., Room E25-143B, 77 Massachusetts Ave, Cambridge, MA 02139, phone 1-617-253 6787.


SIGNATURE OF RESEARCH SUBJECT OR LEGAL REPRESENTATIVE

I have read (or someone has read to me) the information provided above. I have been given an opportunity to ask questions and all of my questions have been answered to my satisfaction. I have been given a copy of this form.
BY SIGNING THIS FORM, I WILLINGLY AGREE TO PARTICIPATE IN THE RESEARCH IT DESCRIBES.
________________________________________

Name of Subject


________________________________________

Name of Legal Representative (if applicable)


________________________________________ ______________

Signature of Subject or Legal Representative Date




SIGNATURE OF INVESTIGATOR

I have explained the research to the subject or his/her legal representative, and answered all of his/her questions. I believe that he/she understands the information described in this document and freely consents to participate.
________________________________________

Name of Investigator


________________________________________ _____________________________

Signature of Investigator Date (must be the same as subject’s)




SIGNATURE OF WITNESS (If required by COUHES)

My signature as witness certified that the subject or his/her legal representative signed this consent form in my presence as his/her voluntary act and deed.
________________________________________

Name of Witness


________________________________________ _____________________________


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