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- Ethical, Legal and Social Implications (ELSI) Research Program7
- Genomics-Enabled Learning Health Systems (gLHS)2
- Genome Technology Program4
- Human Genome Reference Program (HGRP)2
- Impact of Genomic Variation on Function (IGVF) Consortium3
- Encyclopedia of DNA Elements (ENCODE) Project1
- Molecular Phenotypes of Null Alleles in Cells (MorPhiC)1
- Genomic Innovator Awards2
- NHGRI Genomic Data Science Analysis, Visualization and Informatics Lab-space (AnVIL)3
- Genomics Research to Elucidate the Genetics of Rare Diseases (GREGOR) Consortium2
- Developmental Genotype-Tissue Expression (dGTEx)1
- Multi-Omics for Health and Disease (Multi-Omics)1
The Informed Consent Resource
Explore the basic elements of informed consent that are required by the Common Rule and that are relevant to genomics.
… are required by the Common Rule (45 CFR 46, Subpart A) and that are relevant to genomics. It also provides sample … information, and share them, now and in the future, with researchers who are studying a variety of different topics or … Whether researchers will have access to a research participant's medical records and, if so, who and through …
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 … which investigators communicate with each potential study participant and is vital to ensuring that the research … 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.
… genomics-relevant considerations for informed consent and provides guidance on how to approach them. It also … to seek consent for more narrowly defined research uses of participant samples and data. In addition, a biobank or data … 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 … 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 … that you understand what you will need to do to be a participant, and how much time it will take. What healthcare … 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 … process is an important touchstone to maintain research participant autonomy. This page contains information about …
Fact Sheet
Informed consent is more than a form; it’s a process. What does it involve?
… 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 … that arise from the sequencing of their DNA. … How do researchers make the informed consent process accessible to …
Research Funding
The following are research areas of interest that have been identified by the participating NIH institutes and centers (ICs). Program Officer contact information is also included.
… have been identified by the participating NIH institutes and centers (ICs). Program Officer contact information is … approaches to these challenges  Studies on models of participant and community engagement or participatory … genomic research among diverse stakeholders including researchers, clinicians, patients, community members, …
Fact Sheet
Several regulations and policies stipulate the information that must be given to research participants prior to their enrolling in a study.
… participants are stipulated by several regulations and policies.  U.S. regulations may not require informed … with the NIH Genomic Data Sharing (GDS) policy , researchers who intend to use human-derived biospecimens or … to continue to respect any known preferences of a research participant (e.g., as articulated in an advance directive) …