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.
… 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 language that can be used … This Research Study Being Done? [Examples:] We are asking for your permission to collect samples and health information …
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
… integral to the advancement of a spectrum of disease-based research. As knowledge stemming from the completion of the … sequencing technologies become increasingly affordable, genomics research is playing an ever-larger role across biomedical … important role must be thoughtfully considered and fully informed," said Laura Lyman Rodriguez, Ph.D., director of the …
The Informed Consent Resource
Explore genomics-relevant considerations for informed consent and guidance on how to approach them.
… This webpage discusses genomics-relevant considerations for informed consent and provides guidance on how to approach them. It … The informed consent process and consent form should reflect the research … are an important and complex topic to discuss during the informed consent process for genomics studies. If individual …
Policy Issues
Informed consent shows respect for personal autonomy and is an important ethical requirement in research.
… as samples and health-related information, are critical for the success of most human scientific research. … reproductive decision-making.  In designing an effective informed consent process for genomics research, researchers should … with any study involving genetic or genomic analyses, the informed consent process for "whole genome" studies should …
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 … and comprehension can be achieved in a variety of ways.  Genomics research requires careful explanation about how the … How do researchers make the informed consent process accessible to research participants? …
The Informed Consent Resource
Examples consent forms used by genomics research projects.
… These consent forms were used in various NIH-funded research … Network Consent and Community Consultation Workgroup Informed Consent Task Force   NA Exome or Genome Sequencing … NA Organ and Tissue Donation Authorization Authorization for Tissue Donation in National Institutes of Health Research …
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.
…  Genomic and phenotypic data, and any other data relevant for the study (such as exposure or disease status) will be … research in a manner consistent with the participant’s informed consent and all applicable federal and state laws and … information will have a code number.  - Credit: GA4GH consent clauses for genomic research v1.0 …
News Release
NHGRI researchers asked patients, parents and physicians in the sickle cell disease community (SCD) what they wanted and needed to know about genome editing to make informed decisions about participating in genome-editing clinical trials.
… families and the scientific community to improve the informed consent process. … the risks. This makes properly understanding informed consent, the full knowledge of risks and benefits of … As genome-editing trials become more common, informed consent is changing …
Fact Sheet
Several regulations and policies stipulate the information that must be given to research participants prior to their enrolling in a study.
… The Big Picture:  Informed consent is crucial in research as it ensures individuals have … a research study.  In the United States, the requirements for obtaining informed consent from research participants are … Are there instances where it might be appropriate to obtain informed consent even if regulations do not require it?  Not …
News Release
Four NIH grants will support research on the ethical, legal and social questions raised by genomics research advances and genomic information.
… grants from the National Institutes of Health will support research on the ethical, legal and social questions raised by advances in genomics research and the increasing availability of genomic … research projects: Ethical, Legal and Social Issues for Precision Medicine and Infectious Disease Gail Geller, …