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Suggested Consent Language: Genetic Research

ORI

Procedure Language

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DNA: Your genes are made up of DNA. DNA is short for deoxyribonucleic acid. DNA contains information that determines in part the traits, such as eye color, height, or disease risk, that are passed on from parent to child. RNA: RNA is short for ribonucleic acid. RNA is a genetic material that has a major role in making proteins. Proteins: Proteins are the building blocks of your body, cells, and organs. Genetic research – Research to identify genes that cause or contribute to a disease or trait is an increasingly important way to try to understand the role of genes in human disease.

Risk Language

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Genetic research studies may present unique risks to human subjects and their relatives. These involve medical, psychosocial, and economic risks, such as the possible loss of confidentiality (private information), loss of insurability and employability, paternity, and social stigmas. Knowledge of one’s genetic make-up may also affect one’s knowledge of the disease risk status of family members. Genetic research raises difficult questions about informing you and other subjects of any results, or of future results. Some people feel anxious about the possibility of having a defective gene that would place them or their children at risk. Some people want to know what is found out about them; others do not. The risks of knowing include anxiety and other psychological distress. The risks of not knowing what is found include not being aware if there is treatment for the problem being studied. But these risks can change depending on whether there is a treatment or cure for a particular disease and on how clear the results are. If there is a medical reason to seek specific information from you, your doctor will tell you this. A process called “genetic counseling” is often appropriate in such cases; you should ask your doctor or nurse about this if you have any questions.

South Carolina law, mandates that your genetic information obtained from any test or from this research, be kept confidential. Our state law prohibits an insurer using this information in a discriminatory manner against your or any of your family in issuing or renewing insurance coverage for you or your family. Our state law further prohibits our sharing your genetic information with anyone except in a few narrow circumstances, one of these being a research project of this type, approved by the Institutional Review Board and then we must take all steps to protect your identity. You will still be responsible for paying for health care, however. The Medical University of South Carolina will not be responsible for such costs, even if care is needed for a condition revealed during research or clinical testing.

Additional Applicable Language

Genetic Information Non-Discrimination Act (GINA)

Genetic Research: Use for studies that involve genetic testing of the subject’s DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes. While the protections of the Act apply in the US whether this language is included or not, the subject needs to know when they are not protected under the Act (see last paragraph).

Genetic Research: Use for studies that involve genetic testing of the subject’s DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes. While the protections of the Act apply in the US whether this language is included or not, the subject needs to know when they are not protected under the Act (see last paragraph).

A federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:

  • Health insurance companies and group health plans may not request your genetic information that we get from this research.
  • Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.
  • Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.

Be aware that this new federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance, nor does it protect you against genetic discrimination by all employers.

Genome Wide Association Studies (GWAS)

Use of this language is appropriate whenever the study is being funded by a grant that requires such language, or you are applying for funding from an agency that requires such language and are seeking a declaration of concordance. For protocols that are considered Genome-Wide Association Studies (GWAS), MUSC must certify that plans for the submission of genotype and phenotype data from GWAS to the NIH meet the expectations of the policy. For applicable protocols, include the following:

Genome-wide association studies (GWAS) look at the genetic differences between individuals that may be found in the human genome (the complete set of all human genes) to find out if there is a relationship between certain traits (such as blood pressure, or weight) and the presence or absence of a disease or condition.

As part of this study, we will be collecting genetic data about you and these data will be sent to the National Institutes of Health (NIH) GWAS repository (a repository is a place where data are stored for use in future research). The data will not be labeled with any information that can be used to identify you. GWAS data may be shared with other researchers around the world. Researchers will have to get approval from an ethics board to use this information for research prior to getting access to this data.