Issues in Genetics
Policy, legal and ethical issues in genetic research

Learn more about human subjects research

People with letters of A T C GThe use of human subjects in the field of genomics raises a number of key policy considerations that are being addressed at NHGRI and elsewhere. Learn more about his important topic with a new fact sheet from the Policy and Program Analysis Branch. Read more

NHGRI updates online resource on informed consent for genomics research

Read moreInformed consent is the basic and primary tool through which investigators communicate with each potential study participant and is vital to ensuring that the research purpose, any risks and possible benefits, or other implications of participation are understood.  NHGRI's online Informed Consent Resource has helped thousands of researchers navigate the informed consent process since 2009.  Now, the ICR has been updated to keep pace with advances in genomics over the past several years. Read more



NIH Genomic Data Sharing Policy Issued

Globe with genomic data circling around

NIH has issued a position statement on the use of public or private cloud systems for storing and analyzing controlled-access genomic data under the NIH Genomic Data Sharing (GDS) Policy. Read the Position Statement

FDA proposes oversight of laboratory-developed tests

FDA logo The U.S. Food and Drug Administration (FDA) today announced steps it will take to ensure that certain tests used by health care professionals to diagnose and treat patients provide accurate, consistent and reliable results to inform patient care. These steps come at a critical time for genomic, or precision, medicine. As more and more genetic tests are developed and marketed, the public must be able to rely on the accuracy and clinical validity of these tests.
Read the FDA Release
Read a statement from NIH Director Francis Collins

Last Updated: May 8, 2015