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Policy Issues

Hay leyes y políticas que sirven para proteger la privacidad de la información genómica de un individuo.

… tal como la Base de datos de genotipos y fenotipos ( database of Genotypes and Phenotypes , dbGaP), la Base de … para las investigaciones sobre el autismo ( National Database for Autism Research , NDAR), y el Atlas del genoma …

Policies and Guidance

Data Sharing Policies and Expectations

A webpage with information and associated FAQs that describe various expectations for data sharing that are specific to NHGRI-supported studies.

… registration in dbGaP is required for large-scale human genomic studies, including those submitting data to AnVIL and … of scientific data, with the following exception: for genomic data, NHGRI expects non-human genomic data that are subject to the NIH GDS Policy to be …

Policy Issues

Informed Consent

Informed consent shows respect for personal autonomy and is an important ethical requirement in research.

… the specific considerations associated with contributing genomic data. In addition to being personal and unique to every individual, genomic data may, for example: Be stored and used … seek consent for these activities. For instance, the NIH Genomic Data Sharing (GDS) policy expects that researchers …

Policy Issues

Regulation of Genetic Tests

Most genetic tests today are not regulated, meaning that they go to market without any independent analysis to verify the claims of the seller.

… As the field of genomics advances, genetic and genomic tests are becoming more common in, and out of, the … (CMS), and the Federal Trade Commission (FTC). Genetic and Genomic tests, like other types of diagnostic tests, can be … testing today, the growth of direct-to-consumer (DTC) genomic testing, and FDA's mounting concern that unregulated …

Policy Issues

How a bill becomes a law

The 9 steps a bill can go through before becoming a law, using the Genetic Information Non-Discrimination Act of 2003 as an example.

Data Sharing

NHGRI Data Sharing Governance Committee

The NHGRI Data Sharing Governance Committee is responsible for the activities necessary for the Institute to implement and maintain NIH and NHGRI data sharing policies.

… Members Erin M. Ramos, Ph.D., MPH Co-chair Division of Genomic Medicine Barbara Thomas, Ph.D. (DAC Chair) Co-Chair … Core Executive Secretary Elena Ghanaim, M.A. Office of Genomic Data Science … NHGRI Data Sharing Governance …

Policies and Guidance

NHGRI Guidance on Writing a Resource Sharing Plan

This page provides an overview of Resource Sharing Plans, a required document in most NIH funding applications. Most applicants for NIH funding must provide a Resource Sharing Plan (RSP) documenting plans for sharing resources that result from their federally funded work. NIH Policies that govern the sharing of resources include the NIH Model Organism Sharing Policy and the NIH Research Tools Policy.

… research, spanning the various research areas (e.g., genomic science, genomic medicine, ELSI research), produces research tools … of January 25, 2023, plans for sharing scientific data and genomic data are to be documented via a Data Management and …

Policy Issues

Return of Research Results

Clinical research may yield new health-related information about volunteers who have chosen to participate in the studies.

… research results (IRRs) and incidental findings (IFs) from genomic research. These issues are not new or unique to genomics, but advances in genomic technologies have brought them to the forefront. … of fields of human health research. However, the volume of genomic data, the potential for its broad application, and …

Policy Issues

Highlights of Revisions to the Common Rule

Revisions to the Common Rule modernize, simplify, and enhance oversight for human subjects research in the United States.