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Informed Consent


 

All research requires informed consent.  Voluntary participation and informed consent is at the very core of the need for IRB oversight.  How that consent is achieved varies based on the research design and the level of review.  Informed consent is a process, not just a form. Information must be presented to enable people to voluntarily decide whether or not to participate as research subjects.  It ensures respect for people by providing the opportunity for thoughtful consent to ensure that participation is voluntary.  The procedures used to obtain informed consent should be designed to educate the subject population in terms that they can understand to ensure that research participants understand the consent they have provided.  As a result, the IRB will seek to ensure that the following general requirements of informed consent are satisfied in all studies:

  • Informed consent must be prospectively obtained from the participants or their legally authorized representatives;

  • Information must be conveyed in understandable language;

  • Subjects must be given sufficient opportunity to consider whether they want to participate;

  • Consent must be given without coercion or undue influence; and

  • Subjects must not be made to give up legal rights or be given the impression that they are being asked to do so.

 

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How do you document informed consent?

Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

The consent form may be either of the following:

  • a written consent document that embodies the elements of informed consent (see checklist).   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; or

  • a written form stating that the elements of informed consent required by this policy 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 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.

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Are there exceptions or situations where a signed, informed consent form is not acceptable?

Yes.  The IRB Committee may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds that:

  • the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

  • the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

For most anonymous surveys and other exempt applications, no informed consent form is required.  In fact, an application that requires a signed consent form in this situation may be rejected since it compromises the anonymity of the research subjects.  In this case, however, researchers still have an ethical responsibility to ensure that informed consent occurs.  In cases where the documentation requirement is waived, the IRB will normally require the investigator to provide subjects with a written statement regarding the research.  The IRB is likely to require use of such a written statement, in the form of an information sheet or cover letter, which includes most or all of the same elements as a consent form, but does not require the signature of the subject.

There also are a few other instances where the IRB may grant an application without a signed, informed consent form.  These are outlined in the IRB Policy.

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What should be put in a cover letter or document to ensure informed consent when a signed, consent form is not used?

Investigators who are requesting exempt status normally will not need to use a signed informed consent form when the identities of subjects will be completely anonymous if the consent form is not signed and there is minimal risk involved in the study.  Investigators in these instances, however, should be conscious of the ethical principles guiding the process of informed consent and ensure that they have provided sufficient information to satisfy the basic elements of informed consent.  At a minimum, they should either provide a cover letter or introductory remarks (e.g., at the beginning of a survey)  that provide:  a reference to UTC and the title of the research project; the identity of the principal investigator(s) and their contact information; an introduction to the study; the aims of the study; a brief summary of the background or reason for the project; a summary of why the individual has been asked to participate in the study; a description of the type of participation requested and any procedures; an outline of any risks; an overview of how confidentiality will be maintained; an discussion of any benefits; a description of any alternatives to participation; a discussion of any costs and/or benefits;  and a method of securing additional information or asking questions.

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What are the standard elements of informed consent?

Consent forms should be simple and straightforward so that all subjects will have an easily understood form that outlines the proposed research.  For most studies, it is recommended that the consent forms be written at an eighth grade reading level.  Unless the subjects are themselves medical professionals, scientific or technical terms should either be replaced with or defined in lay language.  Legalistic sounding language should not be used.  These phrases interfere with a subject's comprehension of the consent form and lend the appearance of a legal document to the consent form. (Examples include: "You hereby agree," "You certify that," "You, the undersigned, do acknowledge that," "You understand that," "You realize that," "You have been told that," or "It has been explained to you that." )

When constructing a consent from, the investigator should review the following elements and include them when appropriate to ensure they are in compliance with federal law and UTC Policy.  Research participants must be told about the purpose, procedures, risks and benefits of a particular study, the subject's rights in participating in research, the freedom to decline to participate without any jeopardy.  If applicable, the alternative treatments available will be explained.  The individual will also be given the opportunity to obtain further information and answers to questions related to the study.  Sample consent forms are available.  These elements are outlined in more detail in the UTC IRB Policy.  Briefly they include:

 

A. Heading and Title:

Reference to the University of Tennessee at Chattanooga and notification that a research project is being discussed should be included in the heading of all consent forms. The study title also should be included in the heading of the form. For example:

UNIVERSITY OF TENNESSEE AT CHATTANOOGA INFORMED CONSENT FORM Attitudes toward Cartoon Violence and its Real or Perceived Impact Upon Children

 

B. Identify Principal Investigator(s):

This section should indicate who is conducting the research. The first and last names of the principal investigator(s) should be used and the investigators identified with titles and department and other pertinent contact information at the beginning of the form, so that it is clear who is carrying out the study.

 

C. Purpose and Background:

This section should introduce the study, state the aim of the study, give a brief summary of the background or reason for the project, discuss the number of subjects expected to participate in the study, and explain why the individual has been asked to participate. The reason a person has been asked to participate should be simply but specifically stated (e.g., "because you have tried to quit smoking in the past but have not been successful," "because you are undergoing surgery and will be given a general anesthetic," "because you are a healthy person").  If the study is sponsored research, the sponsor should be named.

 

D. Procedures:

To emphasize the voluntary nature of participation in research, this section should begin with a phrase like, "If you agree to be in this study, the following will happen." For social and behavioral research, this may involve a simple statement such as: You will be asked to complete a short survey, participate in a interview, participate in a focus group.

For health related procedures, each procedure should then be listed, preferably in the order in which it occurs, and discussed. If the study involves screening procedures, these should be mentioned first and identified as tests that will determine eligibility to continue in the study. The Procedures section should clearly state what will be done to the individual as a result of participation in the study, and, where appropriate, how this differs from standard treatment or what would happen to the individual if he/she did not participate in the study.

When a study involves randomization, it should be described as a study procedure, and the term "randomization" explained in lay language. Information about the probability of assignment to each treatment or condition should be given. Other terms, which might not be familiar to the average layperson (e.g., "placebo") should be defined the first time they are mentioned in the form or a lay term should be used.

If a standard medical procedure is being done as part of the study, it should not be referred to as "standard" or "routine," since this could easily imply that the procedure would be done  for clinical reasons anyway. Rather, what should be conveyed is that this procedure is an extra laboratory test that is commonly done for clinical purposes, but is being done here for research purposes.

If patient records will be reviewed for purposes of the study, this should be listed as a procedure.

Amounts of blood or tissue to be taken for study purposes should be specified, using lay equivalents (e.g., teaspoons, ounces) for metric terms.

The number of times a procedure will be done, the time involved for each procedure, and the total amount of time for participation in the study should be specified. The location(s) where the procedures will be done should also be stated.

 

E. Risks and/or Discomforts:

The risks and/or possible discomforts of all study procedures should be listed and explained in this section. For social science and behavioral research this might include notifying subjects that there is a possibility that they may be upset by the content of the survey or find an interview embarrassing. For medical and health related studies, this might be a discussion of physical discomfort or pain.

It is usually best to describe the risks of each procedure in a separate point. Risks should be arranged and described according to their severity and the likelihood of their occurrence. Where appropriate, it should be indicated what precautions will be taken to avoid certain side effects or outcomes from occurring, and what will be done should they occur. A statement should be included that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject.

To the extent possible, consent forms should characterize the likelihood of risks using words like "likely," "frequent," "occasional," and "rare." The first time these words are used in a form they should be defined using percentages, as follows:

Likely events: Expected to happen to more than 50% of subjects Frequent events: Will probably happen to 10-50% of subjects Occasional events: Will happen to 1-10% of subjects Rare events: Will happen to less than 1% of subjects

For studies involving investigational agents, or experimental doses or combinations of drugs and/or treatments, subjects should be warned that there may be as yet unknown risks associated with the drug/treatment but that they will be advised if any new information becomes available that may affect their desire to participate in the study.

 

F. Confidentiality:

Since one of the risks of participating in research is a loss of privacy, a discussion of confidentiality issues should be included. It should describe briefly how the confidentiality will be protected, i.e., coding of records, limiting access to the study records, not using any individual identifiers in publications or reports resulting from the study.

For all statements regarding confidentiality of research records, it should be kept in mind that there is no legal privilege between investigator and subject as there is between physician and patient or counselor and client. Thus, a guarantee of complete confidentiality, or "strictest confidentiality," should not be given or implied. One should always state instead that confidentiality will be protected "as far as is possible" or "as far as is possible under the law."

 

G. Benefits:

Any potential direct benefits to the subject should be described first, followed by potential general benefits (e.g., the group of patients to which the individual belongs, to medical knowledge, etc.). It is usually recommended that the description of possible direct benefits be qualified with the phrase, "... but this cannot be guaranteed." If there is no direct benefit to the subject anticipated from the study, this should be stated at the beginning of the section.

 The FDA recommends that possible benefits such as medical or societal benefits resulting from a research study be considered separately from payment for participation in the study. Thus, the discussion of payment or reimbursement should be separated from the benefits statement and placed in its own separately labeled section.

 

H. Alternatives:

This section should discuss the various alternatives to participation in the study. This can be a short statement, but it should make clear the possible choices (e.g., no treatment, standard therapy, other experimental treatments, or some or all of the protocol treatment, but without participating in the study) that are available if the individual chooses not to participate in the study. When alternative therapies are available, brief objective descriptions of their important benefits and risks should be included.

When the only alternative is to decline participation in the study (e.g., if the study involves only normal, healthy volunteers), this need not be mentioned in a separate section, since the individual's right to choose not to participate will be made clear in the last section of the form.

 

I. Costs/Financial Considerations:

When there are no costs at all to be charged to the subject, this should be clearly stated in the form. In some medical situations, however, a simple statement that there are no costs is usually not sufficient and could be misleading. The more typical situations are that the subject will have to pay for the usual costs of his or her medical care but will not be charged any extra for participating in the study or the cost of the study medication will be covered by the study but the subject will have to pay all other charges.

When participation in the study may result in any costs whatsoever to subjects, clear information must be provided in the consent form regarding these costs. Special attention must be paid to this issue in studies in which the subjects are also patients. In such cases, where individuals may be undergoing various procedures, tests, or hospitalizations that are part of their clinical diagnosis and treatment, and others that are part of the research study, the costs section of the consent form should clearly distinguish which costs will be charged to the patient or his third party carrier, and which costs will be covered by the study. In addition, when appropriate, a statement should be included, warning subjects that because the therapy is experimental, the insurance carriers may not cover the costs involved.

 

J. Reimbursement/Payment:

When referring to money that subjects will receive in return for participation in a study, either "reimbursement" or "payment" may be used. However, the term "compensation" should not be used, since it is used on consent forms to designate compensation for injury. Investigators should avoid connotations of undue influence to participate or that the subject is being employed by the investigator. Rather, the sense should be that subjects will be reimbursed for their time, travel expenses, and the inconvenience of being a research subject. However, unless the subject has actual receipts (e.g., parking, taxi, babysitting), the person is not being reimbursed in the strictest sense of the word, for either accounting or tax purposes.

This section should state the total dollar amount that the subject will be paid for participation in the study, and should give any other relevant information such as pro-rating if a subject does not complete the study, or bonus payment at the end of the study. If appropriate, a payment schedule should be included in this section. Subjects should not be required to complete the entire study in order to be reimbursed and bonus payments for study completion should be modest. Subjects should be informed how payment will be made (e.g., in cash, by check) and when they will be paid (e.g., immediately after the interview, approximately six weeks after individual completion of the study.) Payments for research participation in excess of $600 per calendar year are considered taxable income. If subjects will be paid more than $600, the Reimbursement section should explain that the University will report this income to the IRS.

If there will be no payment or reimbursement of subjects for the study participation, this information should be so stated in this section.

 

K. Questions:

This section should provide contact information for the subject in case of questions about the study. At least one permanent name and telephone number of one investigator, usually the principal investigator, must be typed into this section as submitted. Blank lines to be filled in later may be included for additional contact persons. If the principal investigator is a student, the faculty advisor's name and phone number should be included in this section as subjects often wish to contact the person who is supervising the project.

You also must include  contact information for the chair of the IRB in case of questions about their rights as human subjects.  An example of this would be:

"If you have any questions about your rights as a subject/participant in this research, or if you feel you have been placed at risk, you can contact the Chair of the Human Subjects Committee, Institutional Review Board at 423-425-4289.  Additional contact information is available at www.utc.edu/irb"

 

L. Tissue and/or blood banking or storage:

Some studies include the option to have tissue specimens or blood stored (or banked) for studies that may come available in the future, future diagnostic testing, or other purposes not yet determined. Subjects should have the option to participate in the study whether or not they agree to tissue banking.

 

M. Consent:

This section should state that the subject has been given (not just "offered") a copy of the consent form.

This section should then state the information that participation in research is voluntary, and explain the individual's right to decline to participate, or withdraw from the study at any time. If the subjects are patients, students, or employees, a phrase may be added indicating that refusal or withdrawal will be without jeopardy to status or care. The investigator may also wish to advise subjects that they may be withdrawn from the study if the investigator deems it in the best interests of the subject or for other reasons that should be specified (e.g., medical interests, failure to keep appointments).

The IRB discourages such wording as "You have read this form and understand it; based on this understanding, I hereby agree to participate," since this does not guarantee an individual's comprehension, legally or otherwise. Rather it is recommended that investigators simply state that if the person wishes to participate in the study, he or she should sign the form; signature will then indicate agreement to participate.

 

N. Signature Section:

Unless waiver of signed consent is approved by the IRB, this section should include lines for the subject's signature and the date of signature. The consent form also should include a signature line for the specific individual that secured or was present to obtain consent so that subjects have a record of who explained the study to them.

 

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