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Guidance & FAQs

Consent Process & Forms

Consent Form Help

Below is some standard information to explain the consent form process. TIP: Click on the titles to open/close the topics.

What must be included on a consent form?

Federal Requirements

Every consent form must include these essential elements of informed consent as described in federal regulations:

  1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
  2. A description of any reasonably foreseeable risks or discomforts to the subject;
  3. A description of any benefits to the subject or to others which may reasonably be expected from the research;
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  6. For research involving more than minimal risk, an explanation as to whether any compensation and/or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research?related injury to the subject; and
  8. A statement that participation is voluntary, refusal to participate will involve no penalty or decrease in 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.

Regulations further provide that the following additional information be provided to subjects, where appropriate:

  1. A statement that the particular treatment or procedure may involve risks to the subject (or to an embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
  2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
  3. Any additional costs to the subject that may result from participation in the research;
  4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
  6. The approximate number of subjects involved in the study.

Additional University of Minnesota Requirements

  1. The statement "This study is being conducted by researchers from the University of Minnesota" should appear on the front of the consent form, with the name of the campus or clinic included. The department should also be identified.
  2. The form should not say that the study is "sponsored" or "endorsed" by the University. The group conducting the study can be identified in the text of the document, but not at the very top of a consent form, and the identification should not advertise the group.
  3. If the project is conducted by faculty or staff, the first page of the consent form should be printed on departmental letterhead, and the Principal Investigator should be identified by name on the first page.
  4. For student projects, the words "University of Minnesota" should appear in the header on the first page, and advisers' names and phone numbers should be given with the student's name and contact information.

IRB Preferences

Standard Language
The University of Minnesota IRB has established standard language and style guidelines for consent forms. The sample consent forms include the standard language preferred by the IRB.
Typeface Preferences
The IRB prefers that all documents be printed in an appropriate typeface no smaller than 12 point type to assure readability. If the study population is known to have difficulty handling small print, reasonable accommodations should be made in the formatting of the consent documents.
Title Page of Consent Form
The title of the study should appear on the first page of the consent form. The title should be listed as it is in IRB files unless there is a compelling reason to shorten or change the title and the IRB has approved the change.
Page Numbering
Following the title page of the consent form, each subsequent page should be numbered so that pages appear in a logical order and missing pages are readily noted, e.g., "page 2 of 4."
IRB Code Numbers
After a study is approved, the IRB code number pertaining to the study should be added to the bottom of the consent form.
Version Dates
Consent forms should include a "version date" which should be updated each time the consent form is revised. Each study has an IRB approval and expiration date and that approval must be renewed at the time of IRB continuing review for the study to remain active. The consent form itself does not "expire" and the most recent version date should remain on the form until the next time the form is revised. Periodic check on the status of currently approved consent forms may occur as part of continuing review mandates from the federal regulators. Researchers should refrain from noting "IRB-approved on XXXX date" on consent forms. This may be misunderstood by subjects as the IRB's endorsement of a study. IRB approval of a study does not reflect endorsement, rather, it indicates that the study has met federal requirements and may proceed.
Readability
Researchers are encouraged to use simple declarative sentences in their consent forms. The IRB strives for an eighth-grade reading level in sample forms and encourages researchers to use available software packages to check their "readability" scores and make changes and define terms as necessary to achieve a reasonable readability score. Also, check the Common Language Dictionary for help.
For Complicated Study Designs
In many instances, a study involves numerous visits and complicated tracking based on eligibility at different times during the study period.
A flow chart or calendar-like diagram may be useful to subjects as an attachment to the consent form. The IRB encourages the use of these tools to enhance understanding by research subjects.
For Video, Digital Media or Web material
Provide the IRB with copies of final videos, cd copies of digital media, or URLs for review and approval. See IRB Advertising Guideline

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How to avoid problems with consent forms

Consent forms with these problems cannot be approved; consent forms with several of them may be returned for rewriting and thus delay an application's scheduling for committee consideration.

  • Consent forms should not be entitled, "Informed Consent." Informed consent is a process and a state one strives to approximate; it is not a piece of paper. The title tends to obscure the nature of the process, and carries some risk by implying a degree of completeness that the form may not have.
  • Strike out formats ("You/Your spouse/your child"). These should not be used where they make the form difficult to read.
  • Where children or vulnerable adults are among the subjects, appropriate consent forms should be prepared:
    • a fairly standard consent form for the competent adult subject (18 years or older)
    • a simplified statement a fairly standard consent form for the guardian or parent
    • of assent for the 8-17 year old, or
    • assent for the adult who is not competent to give consent alone.
  • Consent forms should not begin with a statement advertising the service or group conducting the study. This is coercive. A simple, factual statement of who's running the study may be inserted in the text of the document.
  • Consent forms should not indicate that the patient's physician recommends participation; nor should they "offer the opportunity" (as opposed to "invite") to participate. These are considered coercive.
  • Fill-in-the-blank formats, in which the features of a given study are "plugged in" to a stock format are discouraged.
  • The clause "only aggregate data will be presented" should be used only when it is true.
  • Statements summarizing foregoing consent information should be used only when they genuinely clarify; they should be avoided particularly when they suggest a warning or limitation of liability or opportunity for redress. Problem Examples:
    • The possible risks associated with this study have been presented.
    • The method and purpose of administration of this study have been explained to you. (Also objectional for lack of clarity.)
    • You have been made aware of certain risks and consequences...
  • Assertions that drugs or studies have been approved for human use by the FDA may not be in the consent form if any part of the study is outside the licensed and approved indications of the drugs or devices used. Patients interpret this to mean "licensed and approved as given," not "has granted permission for experimentation."
  • The patient/subject should not be asked to affirm that the physician will do something, i.e. "My doctors will watch for this problem".
  • It is appropriate to point out adverse consequences of study withdrawal. It is not, however, appropriate to point out, in the right-to-withdraw part of the consent form, risks that are not known but might conceivably turn out to be the case if the study works out as the investigators hope. That's coercive.

In treatment studies, a clear distinction must be drawn between consent for the study and consent for the treatment. If the consent form is complex enough that the two may be confused, they should be presented in separate consent forms as described below:

  • The benefits described should be those of the study, and should usually include a clear disclaimer that there may be no benefit of getting treated "on study" as opposed to "off study". The benefits of being treated are a different issue;
  • The risks described should be those of the study, and should usually include a statement that there are or are not risks of getting treated on study that are not present if treated off study.
  • The alternatives described should be those of being on the study, and should usually include a statement whether the study treatment is or is not available outside of the study context.

Where a consent form lists procedures or drugs used in a study, they should make clear the investigational/regulatory status:

  • standard
  • standard, but being used in a non-standard manner (such as unapproved dose, route, or indication for a licensed drug)
  • experimental
  • do not say "new" or "improved"

When the list of drugs' and procedures' risks is long, it may often be preferable to list only the major risks in the body of the consent form, and remove the others to a treatment consent form or to an appendix.

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Appropriate Consent Form Language for Studies that Exclude Women

Once one has reached the conclusion that the exclusion is valid, the consent form approach should be to present the information rather than simply state a proscription.

The idea is to be informative and respectful, leaving the decision to the informed woman when possible, and ALWAYS leaving the decision to her if the risk/benefit balance is such that real justice issues are raised.

Appropriate examples:

  • "This is a new drug, and we don’t yet know if it is safe to give to women who are pregnant. If you could be pregnant now, or could get pregnant during the study, we suggest that you not participate or that you use reliable contraception while you are in the study."
  • "This is a new drug, and we don’t yet know if it is safe to give to women who are pregnant. Other drugs in the same family have caused birth defects in animals. For this reason, we don’t want anyone to be in the study who is pregnant, or who might get pregnant during the study. We will do a pregnancy test before you start the drug; if you are sexually active, we will ask you to use a reliable form of birth control during the study (we’ll give you our recommendations about the best choices)."
  • "This drug is known to cause birth defects in animals, and we think it may cause birth defects in people. We do not intend to enroll any patients who are pregnant or who might become pregnant. We will do a pregnancy test before you start the drug; if you are sexually active, it is very important that you use a reliable form of birth control during the study (we’ll give you our recommendations about the best choices)."

It may also be appropriate to add some language about contingencies. One of the basic principles of IRB review, "respect for persons," necessitates a description about the exclusion telling them why and using polite language. Examples:

  • "If your pregnancy test is positive, we will discuss with you whether you wish to proceed with the study. (appropriate if risk relatively low or unknown, and chance of benefit is real)"
  • "If you think you may have gotten pregnant during the study, please let the study doctors know about it right away. We will discuss with you whether you wish to stay in the study; whether you stay in the study or not, we will want to know if you have any problems with the pregnancy."
  • "If you think you may have gotten pregnant during the study, let the study doctors know right away. It will then be dangerous for you to stay in the study. We will discuss with you what other options might be available to you."

 

Adapted from "What is appropriate wording for the consent form for a study that
excludes women or a subset of women?"
Dale Hammerschmidt, M.D.
June, 2000

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Common Language Dictionary

Term Definition
acute new, recent, sudden
adverse effect side effect
assay lab test
benign not malignant, usually without serious consequences
bolus an amount given all at once
carcinogenic capable of causing cancer
catheter a tube for withdrawing or introducing fluids
chronic continuing for a long time
clinical trial an experiment with patients
controlled trial a study in which the experimental procedures are compared to a standard (accepted) treatment or procedure
culture test for infection, or organisms that could cause infection
double blind study in which neither investigators nor subjects know which drug the subject is receiving
dysplasia abnormal cells
edema increased fluid
efficacy effectiveness
extravasate to leak outside of a blood vessel
hematoma a bruise, a black and blue mark
heparin lock needle placed in the arm with blood thinner to keep the blood from clotting
monitor check on, keep track of, watch carefully
morbidity undesired result or complication
mortality death or death rate
necrosis death of tissue
oncology the study of tumors or cancer
percutaneous through the skin
placebo a substance of no medical value, an inactive substance
PRN as needed
protocol plan of study
random by chance, like the flip of a coin
relapse the return of a disease
retrospective looking back over past experience

 

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New Out-of-study Contact Language

for Medical/Health study Consent Forms

The following out-of-study contact language should be included in consent forms for medical studies.

“If you have any questions or concerns regarding the study and would like to talk to someone other than the researcher(s), you are encouraged to contact the Fairview Research Helpline at telephone number 612-672-7692 or toll free at 866-508-6961. You may also contact this office in writing or in person at Fairview Research Administration, 2344 Energy Park Drive, St. Paul 55108.” 


Federal Genetic Information Non-Discrimination Act (GINA)

The IRB has recently provided consent form language in response to the Genetic Information Non-Discrimination Act (GINA). The Act prohibits group health plans and health insurers from denying coverage to a healthy individual or charging that person higher premiums based solely on a genetic predisposition to developing a disease in the future. The legislation also bars employers from using individuals' genetic information when making hiring, firing, job placement, or promotion decisions.

The legislation gives comprehensive protection against all forms of genetic discrimination and intends to ensure patients are comfortable availing themselves to genetic diagnostic tests. The IRB recommends the following language be included within consent forms based on the OHRP recommended language:

“The risks to you and your family from genetic research are very low. Your samples will be identified only with your study code number. In the event of an unexpected breach of confidentiality, a recent federal law (Genetic Information Non-Discrimination Act, GINA) will help protect you from health insurance or employment discrimination based on genetic information obtained about you through research such as this. If you have questions about GINA or the risks of research on genetic information, please ask study staff.”


Language and Cultural Considerations

If the majority of the anticipated subjects do not speak English or will be unable to understand the consent form written in English, the consent form must be translated into a language understandable to the subjects.

However, if the majority of subjects are English speakers, but there are a portion of the subjects who will not be able to understand the consent form written in English a short form may be used.

Learn more about Short Forms & to download the forms

Information About Exempt Consent Forms

Even though the IRB may determine that some research is exempt from the federal regulations, adequate provisions still need to be in place to protect research participants. 

In making its consideration of exempt status, the HRPP/IRB office still has to determine that:

  1. The research involves no more than minimal risk to participants
  2. Selection of participants is equitable
  3. If there is recording of identifiable information, there are adequate provisions to maintain the confidentiality of the data
  4. If there are interactions with participants, there will be a consent process that will disclose such information as:
    • that the activity involves research
    • a description of the procedures
    • that participation is voluntary
    • name and contact information for the investigator
  5. There are adequate provisions to maintain the privacy of participants. 
More Information

Resources on Informed Consent

Informed Consent Online Tutorial

The Process of Consent

from the Protecting Human Subjects Guide: What to discuss, Subject understanding, What must be said about the research

FAQ about Informed Consent

Subject Recuitment & Contact Issues

Advertising, Medical Records Contacting, Finder's Fees