UK Office of Research Integrity

IRB Application: Informed Consent/Assent Process

Section 2
FORM C. Instructions for Informed Consent Document - Medical IRB

Except under certain conditions where the IRB can waive the requirements for documentation of informed consent, 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.

Informed consent is one of the primary ethical considerations underlying research with human subjects. It is too often forgotten that informed consent is an ongoing educational process that takes place between the investigator and prospective subject. The consent process should allow for an exchange of information between the investigator and the subject, and afford ample opportunity for the subject to ask questions and consider whether or not to participate in the study. In most cases the federal regulations require that informed consent be documented. It should be reiterated, however, that the consent document does not substitute for discussion.

To develop a consent document for your study, follow the instructions and use the template provided to ensure inclusion of required elements. UK IRB policy dictates that only consent/assent documents with a valid "IRB Approval" stamp can be used when enrolling subjects, unless waiver from this requirement is approved by the IRB.

Instructions

  1. Use the link provided below to the sample informed consent template. Note this is not a form to be completed, but a guide to be followed when developing your consent document(s). When applicable, you should also use it to help prepare any scripts (i.e., phone scripts).
  1. The consent form should be written in language understandable to the subject. Whenever possible, simple sentences should be used instead of complex ones. Do not use medical or technical jargon.
  1. If you are recruiting non-English speaking subjects, the consent document needs to be in the subject's native language. If you are recruiting Spanish-speaking subjects, ORI has translated consent form templates in Spanish to help you get started. Click HERE for links to the Informed Consent Template in Spanish. The WORD or RTF version may be saved to the location of your choice, and then used as a guideline while editing for your specific protocol.
  1. AVOID EXCULPATORY LANGUAGE through which the subject or the representative is made to waive or appear to waive any of his legal rights or release the investigator, the sponsor, the institution or its agents from liability for negligence.
  1. If the RESEARCH INVOLVES THE PARTICIPATION OF CHILDREN (under 18 years of age), please read the UK IRB Policy on Children in Research available by visiting ORI's IRB Survival Handbook web page at: http://www.research.uky.edu/ori/IRB-Survival-Handbook.html#Children or contact the Office of Research Integrity for a copy (859) 257-9428. Also, see the Informed Consent SOP. The informed consent template of the IRB application can be used as a guide for development of the parental permission form. Revise the template so that it is written from the perspective of the parent (i.e., "your child is being..."; and/or "...I voluntarily consent on behalf of my child..."). In addition, if a child is between the age of 12 and 18, attach an assent form [See Section 2, Form D of the IRB application for guidance]. If a child is age 6 to 11, attach an assent script to be followed when discussing the study with the child. Also, you must complete and attach Form W to your IRB application.
  1. If the RESEARCH ACTIVITIES ARE DIRECTED TOWARD PREGNANT WOMEN, both the mother and father must give consent after having been fully informed regarding the impact of the research on the fetus. (NOTE: The federal regulations do specify certain conditions under which the father's consent is not necessary. For a list of those conditions contact ORI.) Also, you must complete and attach Form U to your IRB application.
  1. If the RESEARCH COULD POSSIBLY PUT AT RISK (1) AN UNBORN CHILD, (2) A MAN OR WOMAN'S ABILITY TO PROCREATE or (3) A WOMAN'S ABILITY TO CONCEIVE OR CARRY A CHILD, the following statement(s) (revised to meet the needs of your particular study) should be included in the consent form:
    If you are pregnant, you cannot participate in this study. If you are a woman who could have children, it will be necessary to have a urine (or serum) test to see if you are pregnant before you start this study. If you are a sexually-active male or female, you must agree to take precautions to avoid the possibility of impregnation because it is not known how this drug (treatment, device, etc.) will affect an unborn child. If you are a woman and become pregnant during the course of the study, you must notify the principal investigator of this fact as soon as possible.
  1. If the research is part of a National Institutes of Health (NIH)-sponsored multicenter clinical trial, copies of the NIH-approved sample informed consent document must also be included in the application packet.
  1. If the research involves INVESTIGATIONAL DRUGS, DEVICES, OR BIOLOGICS, inform the subject in the purpose statement that the study includes evaluation of both the safety and effectiveness of the test article. Clearly state that the drug, device, or biologic is investigational (i.e., experimental / not approved by the Food and Drug Administration). As applicable, include the template statement to inform subjects the clinical trial will be registered with a national clinical trial registry data bank. NOTE: You must also complete and attach Form O for Investigational Drugs and/or Form P for use of Investigational Devices with your application.
  1. FDA Regulated Research Data Retention and Subject Withdrawal and for Informed Consent for Continued Limited Participation: According to FDA guidance regarding subject withdraw and data retention [PDF], the FDA takes the position that, data collected in a clinical trial remains part of the study database and may not be removed when a subject withdraws from a study. An investigator may ask a subject if he/she wishes to provide continued follow-up and/or further data collection subsequent to withdrawal but the subject’s written informed consent is required. The option for partial withdrawal and limited participation such as record review for clinical outcomes may be included in the initial protocol informed consent form. If a subject withdraws from the interventional portion of the study and does not consent to continued follow-up the investigator must not access the subject’s medical record or other confidential records for research purposes. This is true even if there is valid HIPAA authorization (to access protected health information) in effect. Public records, such as survival status data may be consulted.
  1. The informed consent should describe the DOSE ESCALATION aspect of the study (i.e., as the research progresses, the dose for each new subject gets larger).
  1. For research involving HIV SCREENING and/or AIDS RESEARCH, there are additional IRB requirements for designing and implementing the research and for obtaining informed consent. See ORI's handout for "Protection of Human Subjects in Research Involving HIV Testing", visit the Office for Human Research Protections web site for statements on AIDS research, or contact the Office of Research Integrity at 859-257-9428 to obtain copies.
  1. For research involving DNA BANKING and GENETIC RESEARCH, additional issues must be addressed when obtaining informed consent.  For additional information, see ORI's handout for "Issues to Address in Obtaining Informed Consent Involving DNA Banking and Genetic Research" [PDF], or contact ORI at 859-257-9428 to obtain a copy of the handout. You may be asked to obtain a federal Certificate of Confidentiality to exempt your research project from subpoena of data to protect it from third parties (e.g., insurance companies, employers) if you are collecting identifiers on genetic materials.  If you are setting up a specimen banking repository, see ORI's handout for "University of Kentucky Issues to be Addressed and Sample Consent Language for Tissue/Specimen Repositories or Individual Studies Banking Material for Future Use" [PDF].

A new Federal law, called the Genetic Information Nondiscrimination Act (GINA), requires that investigators include appropriate language in the informed consent documents for genetics research (genetic testing and/or collection of genetic information). See "Summary and Guidance Regarding the Genetic Information Nondiscrimination Act of 2008 (GINA)" [PDF] for more information. Sample language that can be modified based on the nature of the research and the types of human subjects involved:

A new Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:

  • Health insurance companies and group health plans may not request your genetic information that we get from this research.(1)
  • Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.
  • Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.

Be aware that this new Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.(2)

(1) Note that if an insurance company or health plan administrator is engaged in the research in accordance with the requirements of the research exception, this bullet should be modified accordingly.

(2) For genetic research that involves determining whether subjects have an already manifest genetic disease or disorder, investigators and IRBs may wish to consider including additional language in the informed consent document indicating that GINA does not prohibit discrimination on the basis of an already manifest genetic disease or disorder.

  1. Certificate of Confidentiality:  When a researcher obtains a Certificate of Confidentiality, the potential subjects must be told about the protections afforded by the certificate and any exceptions to that protection. That information should be included in the informed consent form. The National Institutes of Health Office of Extramural Research provides an example of appropriate language (See also Informed Consent Template). Researchers may adapt the language to the needs of the potential subjects and to the subject matter of the study. However, the language used must cover the basic points.

For additional information on obtaining Certificates of Confidentiality, visit NIH's Frequently Asked Questions (FAQs) web page.

  1. A signed copy of the consent/assent form should be given to the subject or the subject's legally authorized representative.
Informed Consent Template

Click HERE for links to the Informed Consent Template in English. The WORD or RTF version may be saved to the location of your choice, and then used as a guideline while editing for your specific protocol.

 

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