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The Informed Consent Resource
Explore the basic elements of informed consent that are required by the Common Rule and that are relevant to genomics.
… This webpage discusses basic elements of informed consent that are required by the Common Rule (45 CFR 46, Subpart A) and that are relevant to genomics. It also provides sample … that can be used as a guide when crafting informed consent forms. … information, and share them, now and in the future, with researchers who are studying a variety of different topics or …
News Release
An online Informed Consent Resource created in 2009 by NHGRI has been updated to keep pace with advances in genomics over the past several years
… of the Human Genome Project continues to expand, and genome sequencing technologies become increasingly … to medical advances cannot be underemphasized, and the choice to play this important role must be … Genome Research Institute (NHGRI) has helped thousands of researchers navigate the informed consent process. To date, …
The Informed Consent Resource
Explore genomics-relevant considerations for informed consent and guidance on how to approach them.
… discusses genomics-relevant considerations for informed consent and provides guidance on how to approach them. It also … important content to include in their consent forms and how to use clear and concise language to inform … samples and data used for research on certain topics. Researchers may include options for data use limitations in …
The Informed Consent Resource
Examples consent forms used by genomics research projects.
… These consent forms were used in various NIH-funded research projects and have been approved by the relevant local IRBs. These … by NHGRI, but as references to inform investigators and IRBs considering these issues. Consent forms should be … a useful list of consent templates for NIH Intramural Researchers . These include consent templates that have been …
Data Sharing Policies
Sample informed consent language, aligned with each of the informational elements of consent for genomic data sharing (GDS) outlined by NIH as important to convey, in language understandable to prospective participants.
… Informational Elements Outlined by NIH Guidance  Genomic and phenotypic data, and any other data relevant for the … used for future research in a manner consistent with the participant’s informed consent and all applicable federal and … or other types of research. These studies may be done by researchers at this institution or other institutions, …
Policy Issues
Participating in genomics research is an opportunity to support exploration of the genome and help scientists understand, prevent, detect and treat disease.
… to support scientific exploration of the genome and to help NIH in its mission to understand, prevent, detect and better treat disease. In some cases, research … is conducted ethically. The Common Rule requires that researchers provide research participants with complete …
Policy Issues
Informed consent shows respect for personal autonomy and is an important ethical requirement in research.
… It is essential to respect the rights and interests of research participants, given that their … for the success of most human scientific research. Researchers and research participants should engage in a … decision-making.  In designing an effective informed consent process for genomics research, researchers should …
Fact Sheet
Participation in genomics research is essential for improving the health of everyone.
… on the sequence of the four letters of life — A, C, G, and T. The dissimilarities among human genomes, referred to … across different human populations; some are rare and unique to specific families, while others are common and found across populations.  Genomes from distinct …
Fact Sheet
Informed consent is more than a form; it’s a process. What does it involve?
… The Big Picture  The informed consent process ensures that research participants can make voluntary and knowledgeable decisions about whether to take part in a … be accessible and understandable to the potential research participant. Accessibility and comprehension can be achieved …
Clinical Research
FAQs for participants in the Autoinflammatory Diseases Study.
… like? We tailor study activities to meet clinical needs and a patient’s ability to participate, so each participant’s experience with the study will look a bit … we may remotely collect samples for genetic testing and basic medical information. Others may need to travel to …