Consent Template Language by Topic

This language should be inserted in the designated sections of consent documents, as applicable. Language that must be used verbatim will be labeled "Required as written".

Section: Will my study-related information be kept confidential?

• Required as written

The NIH has issued a Certificate of Confidentiality for this study. This Certificate provides extra protection for you and your study information, documents, or samples (blood, tissue, etc.). The Certificates are issued so that we cannot be required to disclose any identifiable, sensitive information collected about you as a part of this study in a lawsuit or legal proceeding. We are also prevented from releasing your study information without your consent. This is a layer of protection over and above the already existing protections in place for you and your information, documents, or samples.

However, these protections do not apply in some situations. For example, we may have to release your information if a law requires us to do so, the Agency that is funding this study requests the information, or if the FDA tells us to release this information. We may also use your information to conduct other scientific research as allowed by federal regulations.

Study information that has health implications may be placed in your medical record where authorized employees may see the information. Further, authorized requests for your records (medical record release for continuity of care) may result in research-related information being released.

Please talk to your study team, or contact the Office of Responsible Research Practices at 614-688-8641, if you have questions.

You may also visit the NIH website at https://grants.nih.gov/policy/humansubjects/coc.htm to learn more.

Section: Will my study-related information be kept confidential?

• Required as written
• For “applicable” clinical trials; see Clinical Trials Registration for more information

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.

Section: Will I be paid for taking part in this study?

• Required as written
• Required for banking/repository protocols to permit commercialization under state law

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.

Section: What happens if I am injured because I took part in this study?

• Replace [Sponsor Name] with the sponsor's name
• Used to describe sponsor reporting required by MMSEA: Medicare, Medicaid, and State Children’s Health Insurance Program Extension Act of 2007

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.

Section: Will my study-related information be kept confidential?

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 future research use. For example, the National Institutes of Health (an agency of the federal government) maintains a database called “dbGaP” (database of Genotypes and Phenotypes). Summary study information and study results that do not include individual-level data may be made available to researchers without restrictions. Certificate of Confidentiality protections do not apply to summary results.

A researcher who wants to study individual-level information from these databases must work with the group overseeing the database to obtain the information. These researchers must have an approved study and 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 and use it to discriminate against you or your family. The risk of this happening is very small. There may also be unknown risks due to technologies or techniques used to analyze the data. There is no direct benefit to you from the further use of your data. 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 from the repository 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 genetic and/or health information might also be placed into one or more external publicly accessible scientific databases for use in future research. For example, the National Institutes of Health (an agency of the federal government) maintains a database called “dbGaP” (database of Genotypes and Phenotypes). 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. 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 and use it to discriminate against you or your family. The risk of this happening is very small. There may also be unknown risks due to technologies or techniques used to analyze the data.

Summary study information and study results that do not include individual-level data may be made available to researchers without restrictions. A researcher who wants to study individual-level information from these databases must have an approved study and work with the group overseeing the database to obtain the information.

Section: What risks, side effects or discomforts can I expect from being in the study?

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.

Section: What risks, side effects or discomforts can I expect from being in the study?

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.

Section: Will my study-related information be kept confidential?

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.