Consent Template Language by Topic
The following consent language has been reviewed and approved by the IRB Policy Committee. This language can be inserted in the designated sections of consent documents, as applicable. Instructions [red italicized text in brackets] should be deleted. Language that must be used verbatim will be labeled [Required as written].
Certificate of Confidentiality (Section: Confidentiality):
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the [National Institutes of Health or other issuing agency]. This Certificate will be used to resist attempts to force us to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings.
The Certificate cannot be used to resist a demand for information that is used for auditing or evaluation of federally funded projects or for information that must be disclosed to meet the requirements of the Food and Drug Administration (FDA).
A Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your participation in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then we will release the information even though we have the Certificate of Confidentiality.
The Certificate of Confidentiality also does not prevent us from disclosing voluntarily, without your consent, information that would identify you as a participant in the research if required by state and/or federal law. In Ohio, if we have reasonable knowledge that a felony has been or is being committed we are required to notify state officials.
[Researchers should include language such as the following if they intend to make any other voluntary disclosures about things such as child abuse, intent to hurt self or others, or other voluntary disclosures:]
[If applicable] If we learn of possible child abuse or elder abuse, we are required to report this to state officials. If we believe that you may harm yourself or others, we will obtain help to make sure you and/or others are safe.
[If applicable] If the research shows that you have a disease that can be spread and puts others at risk (for example, measles, hepatitis, meningitis, or HIV/AIDS), we are required to report this to state officials.
[If applicable] The Certificate does not protect study information that is placed into your medical records.
Clinical Trials (Section: Will my study-related information be kept confidential?):
[Required as written]
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.
[For “applicable” clinical trials; see Clinical Trials Registration for more information]
Commercialization of Specimens and/or Data (Section: Will I be paid for taking part in this study?)
[Required as written]
If you agree to participate, your samples will be considered a gift to The Ohio State University. The university may sell or share your samples and personal information with others, such as private companies, government agencies, or other universities. The university will be paid if your samples and personal information are sold.
- Your samples and personal information may be used to make new products or technologies. You will not be paid if these new products or technologies are sold or make money.
- You cannot choose how your samples and personal information will be used. If you do not want to let others decide how your samples and personal information will be used, then you should not donate your samples.
[Required for banking/repository protocols to permit commercialization under state law]
Compensation for Injury, Industry-Sponsored Research (Section: What happens if I am injured because I took part in this study?):
To pay your medical expenses, [SPONSOR NAME] will need to know some information about you, like your name, date of birth, and social security number. This is because [SPONSOR NAME] has to check to see if you receive Medicare. If you do, [SPONSOR NAME] has to report the payment it makes to Medicare. [SPONSOR NAME] will not use this information for any other purpose.
[Used to describe sponsor reporting required by MMSEA: Medicare, Medicaid, and State Children’s Health Insurance Program Extension Act of 2007]
dbGaP, NIH, and other external, publicly-accessible scientific databases (Section: Confidentiality):
Example #1 (for protocols that are not banks or repositories):
If you agree to take part in this study, some of your specimens and genetic and/or health information will be placed into one or more publicly-accessible scientific databases. For example, the National Institutes of Health (an agency of the federal government) maintains a database called “dbGaP.” A researcher who wants to study information from these databases must work with the group overseeing the database to obtain the information.
Researchers with an approved study will be able to see and use some of your information, but your name and other information that could directly identify you (such as your address or social security number) will never be placed into the database. Because your genetic information is unique to you, however, there is a small chance that someone could trace it back to you or your family. The risk of this happening is very small.
Please note that if you decide to withdraw from the study as outlined in this document and your data have already been submitted to an NIH database and distributed to other researchers, or your data have been de-identified, it is possible that your data will not be able to be removed. When possible, however, your data will be withdrawn upon your decision to leave the study.
Example #2: (for banking or repository protocols with limitations on withdrawal already addressed in the consent form):
Some of your specimens and genetic and/or health information might also be placed into one or more external publicly-accessible scientific databases. For example, the National Institutes of Health (an agency of the federal government) maintains a database called “dbGaP.” Your name and other information that could directly identify you (such as your address or social security number) will never be placed into these external databases. A researcher who wants to study information from these databases must have an approved study and work with the group overseeing the database to obtain the information.
Focus Groups (Section: Risks)
While we ask other group participants to keep the discussion in the group confidential, we cannot guarantee this. Please keep this in mind when choosing what to share in the group setting.
GINA (Section: Risks)
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 from this research.
- Health insurance companies and group health plans may not use your genetic information when making decisions about your eligibility or premiums.
- Employers with 15 or more employees may not use your genetic information from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.
All health insurance companies and group health plans must follow this federal law. This law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. Under Ohio law, health insurance companies cannot ask about the results of a genetic test or use any information obtained from genetic testing to make decisions about providing coverage or benefits for health care services.
Internet/Email Data Collection (Section: Confidentiality):
We will work to make sure that no one sees your survey responses without approval. But, because we are using the Internet, there is a chance that someone could access your online responses without permission. In some cases, this information could be used to identify you.
[If survey is encrypted, please include the following text]:
Your data will be protected with a code to reduce the risk that other people can view the responses.