Privacy in Genomics

Should research on de-identified biospecimens such as newborn blood spots be considered human subjects research and be subject to informed consent requirements?

• YES, they count as human subjects and SHOULD require informed consent

• NO, they don't count as human subjects but they SHOULD require informed consent

• YES, they count as human subjects but SHOULD'NT require informed consent

• NO, they don't count as human subjects and they SHOULD'NT require informed consent

What are some privacy concerns with Genomic research in identifiable populations (i.e., racial/ethnic groups, geographically defined communities and people with ultra-rare disease)

Fill in the blank. _____________ makes it illegal for health insurers to request genetic info from participants or their family members for prejudiced reasons

• NIH Racial Privacy Genetics Act

• Genetic Privacy for Research Participants Act

• Anti-Prejudice Genetic Information Act

• Genetic Information Nondiscrimination Act

Fill in the Blank: ___________ is the Federal Bureau of Investigation (FBI) program of support and software for criminal justice DNA databases.

• Combined DNA Index System (CODIS)

• Criminal Justice Genetic Database (CJGD)

• Investigative Genome Index Software (IGIS)

• Federal DNA Storage System (FDSS)

Guess the acronym: ____________ (IGG) is a new investigative tool that combines genetic analysis with the investigation of publicly available genealogy information, which increases the pool of potential leads for law enforcement.

True or False: Direct to Consumer Genetic Testing (ie. ancestry.com) is tightly regulated

• True

• False

What federal law prevents surreptitious DNA testing (testing without the knowledge of the person being tested)

• Health Insurance Portability and Accountability Act (HIPAA)

• Genetic Information Nondiscrimination Act (GINA) of 2008

• Certificates of Confidentiality (issued by NIH)

• None

The Common Rule establishes the baseline standard of...

• morals for prokaryotic participant experiments

• modernized empirical studies for babies in the United States

• government-funded human subjects research

• governmental research settings for the FDA

What is included as "meaningful informed consent" under the Common Rule

• inform subjects of potential risks of the study

• inform subjects of risks associated with release of their private information

• clarify the uses of research results

• information on who may receive or access the information

The NIH Genomic Data Sharing Policy establishes guidelines on how to protect research participant privacy while...

• allowing the government to access scientific research

• allowing the public to access valuable research data

• allowing private investors to access private patient files

• allowing scientists to access valuable research data