Search Results
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 …
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 …
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 …
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) …
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 …