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How do I develop consent forms and who reviews them?

Informed Consent 

Informed Consent
a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects research.
forms are the primary way to inform a research participant about the details of your study. Once enrolled, participants may refer to this document for facts about the frequency of study visits, who to call for questions and other study-related information.  It is very important that Informed Consent forms are easy to read, understandable and that all technical language is explained and defined.  Participants must understand the potential risks and benefits, the difference between standard care and investigational care, the concepts of voluntariness and ability to withdraw consent at any time during the study. 

The Code of Federal Regulations (45 Part 46.116) provides guidance on general requirements for a Informed Consent form.  An Informed Informed Consent Checklist from OHRP 

Office for Human Research Protections (OHRP)
HHS office overseeing human subject protection for HHS-supported research. OHRP protects the rights, welfare, and well-being of subjects involved in research conducted or supported by HHS and helps ensure that such research is carried out in accordance with the regulations described in 45 CFR 46. OHRP Homepage.
clearly describes the basic required elements and additional elements in Informed Consent forms.  Most IRBs will request that Informed Consent forms be written at a 6-8th grade reading level.  Microsoft Word has a readability program which can be found under “Tools - Options”.  But more importantly, you may want to ask persons similar to your study participants in age and educational level to read the form, ask questions, and provide suggestions for improvement. 

Once your IRB 

Institutional Review Board (IRB)
a board or committee designated by an institution to ensure the protection of rights and welfare of human research subjects and reporting to the Office for Human Research Protection (OHRP). IRBs make ongoing independent determinations to approve, require modifications in, or disapprove research protocols based on whether human subjects are adequately protected. Also known as Research Ethics Boards (REB) or Ethics Committee (EC).
has approved your study Informed Consent forms, you must send the approved version to your Program Director.  Please forward the accompanying approval letter or the Informed Consent form with the official IRB stamp and date.  NHLBI 
National Heart, Lung, Blood Institute (NHLBI)
a NIH 
National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage.
Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage.
has Guidelines for Informed Consent forms in Multicenter Clinical Studies which outlines content and format for Informed Consent forms that will be used at multiple centers for a single protocol.

Your IRB may require that you include HIPAA 

Health Insurance Portability and Accountability Act (HIPAA)
a Law to improve portability of health insurance coverage, promote medical savings accounts, improve access to long-term care services and coverage, and simplify administration of health insurance. Implications for research can be found at: Clinical Research and the HIPAA Privacy Rule.
Privacy Rule information in your Informed Consent form 
Consent form
a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects 
Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction 
Interaction
any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102 and full 45 CFR 46.
or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.
research. Also known as Informed Consent.
or that you create a separate form to explain this to research subjects. For more information see: What is HIPAA and how do I abide by the requirements?  

Other resources to guide you in creating a good Informed Consent document:

  • Simplification of Informed Consent Documents from NCI
  • NHLBI Guidance for Addressing Tissue Sharing in Informed Consent
  • Glossary of Clinical Trial 
    Clinical Trial
    A clinical trial is a controlled experiment, conducted in human beings, that is designed to evaluate and/or compare the effects of specific regimens or strategies on one or more pre-specified health outcomes in a defined population over a defined period of time. (Clinical Trials: Phase I 
    Phase I Clinical Trial
    testing in a small group of people (e.g. 20-80) to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).
    , Phase II 
    Phase II Clinical Trial
    study in a larger group of people (several hundred) to determine efficacy and further evaluate safety.
    , Phase III 
    Phase III
    study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use.
    , Phase III(as defined by NIH) 
    Phase III(as defined by NIH)
    is a broad-based, prospective study, including community and other population-based trials, usually involving several hundred or more people, to compare an experimental intervention with a standard or control or compare existing treatments. It often aims to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy and includes community and other population-based intervention trials.
    , Phase IV 
    Phase IV Clinical Trial
    studies done after an intervention has been marketed to monitor its effectiveness in the general population and to collect information about any adverse effects associated with widespread use.
    )
    Terms provides lay persons definitions


Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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