Informed Consent 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.
a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects research.
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) 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
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
Once your IRB
Institutional Review Board (IRB) 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
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).
National Heart, Lung, Blood Institute (NHLBI) 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.
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
Your IRB may require that you include HIPAA
Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule information in your Informed Consent form
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
Consent form 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?
a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects
Legally defined term for living persons about whom an investigator obtains specimens or data through direct 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.
Other resources to guide you in creating a good
Informed Consent document:
of Informed Consent Documents from NCI
- NHLBI Guidance
for Addressing Tissue Sharing in Informed Consent
of Clinical Trial
Clinical Trial Terms provides lay persons definitions
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
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.
Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov