Search Results
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 … the United States, the requirements for obtaining informed consent from research participants are stipulated by several regulations and policies.  U.S. regulations may not require informed …
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.
… NHGRI researchers work with patients, families and the scientific community to improve the informed consent process. … As public interest and expanded research in human genome editing grows, many … especially important. In response to this emerging need, researchers at the National Human Genome Research Institute …
Policy Issues
Federally-funded research with human participants must comply with regulations that protect the rights and welfare of the participants.
… The use of human participants in biomedical, clinical and social-behavioral research can provide insights and discoveries that could not be otherwise obtained using … rights and welfare of the participants, and require that researchers clarify the benefits and risks of participating …
Research Funding
The following are research areas of interest that have been identified by the participating NIH institutes, centers, and offices (ICOs) on the investigator-initiated ELSI Research Grants (R01, R21, R03). Program Officer(s) contact information is also included for each ICO.
… identified by the participating NIH institutes, centers, and offices (ICOs) on the investigator-initiated ELSI … on a wide range of topics. ELSI research addresses the new and sometimes unexpected ways that genomics interacts with … and responsibilities of individuals, communities and researchers related to genomic research and the uses of …
News Release
NIH submits new policy that requires all NIH-funded investigators who conduct sensitive, health-related research be issued Certificates of Confidentiality.
… under the new policy, as of October 1, 2017, NIH-funded researchers and their institutions will automatically be issued a … of Confidentiality under the new policy will prohibit researchers from disclosing names or other identifying … 21st Century Cures Act, genetic privacy, genomic privacy, researchers and privacy, researchers' certificates of …
Policy Issues
Clinical research may yield new health-related information about volunteers who have chosen to participate in the studies.
… in the studies. This raises the question of when and how it is appropriate for the scientists to look for and share such research findings. … There are ongoing discussions among researchers, ethicists, policymakers, and research participants about the return of individual …
News Release
The National Institutes of Health (NIH) Genomic Data Sharing Policy includes expectations for how researchers should obtain, share and access genomic data from human and non-human sources. As a leader in genomics, including relevant policy development and implementation, the National Human Genome Research Institute (NHGRI) encourages data sharing practices that go beyond the NIH expectations.
… Genomic Data Sharing Policy includes expectations for how researchers should obtain, share and access genomic data from human and non-human sources. As a leader in genomics, including … that will generate genomic data and share it with other researchers through genomic data repositories . This …
Research at NHGRI
The NHGRI Intramural Research Award recognizes research achievements by trainees in basic, clinical, and social behavioral science research.
… achievement or a larger body of work of exemplary quality and significance. … Intramural Research Program, including basic, clinical, and social behavioral science research. To date, thirty … to make valuable contributions in the area of genomics and related fields. Our well-deserving recipients are …
Staff
Cristina Kapustij was the chief of the Policy and Program Analysis Branch at the National Human Genome Research Institute until June 2024.
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… Cristina Kapustij, M.S., is chief of the Policy and Program Analysis Branch at the National Human Genome … to understand the policy implications of genomics research and technologies, assess policy needs for the field, and develop policy positions on issues arising from the …
Clinical Research
The Institutional Review Board (IRB)Â is responsible for protecting the rights and welfare of the human subjects of research protocols that are conducted by intramural investigators in NHGRI and a number of other institutes.
… Board (IRB) is responsible for protecting the rights and welfare of the human subjects of research protocols that are conducted by intramural investigators in NHGRI and a number of other institutes. … The OHSRP promotes the protection of rights, safety and welfare of human subjects, and the NIH’s research …