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Protocol and Consent Form Additions

Protocol
In general, the Board will want to know that you are considering the risks and the needs of the participants in your study. Take a little extra time to make sure that you have addressed the likely scenarios for an adverse event, etc. The Board is more likely to agree with your procedures if they are well-designed and explained. More specifically, please include the following in your protocol:
  • State that the nature of the data you are collecting requires you to obtain a Certificate of Confidentiality and that you are in the process of applying for a Certificate of Confidentiality. Describe how you will collect and store your data so that participants’ identities will be protected. 
  • Describe the risks to the participants, including the risk of lost confidentiality with your data (if a participant's identity became known to their victimizer, for example), and explain your procedures for protecting your participants (i.e. data storage security procedures and obtaining a Certificate of Confidentiality).

Consent Form
In the consent form, the NIH will require that you include specific text regarding the Certificate of Confidentiality. The Board will also require that the text in the consent form is easy to read and understand, particularly if your participants’ reading comprehension level is low. It can be difficult to balance both the need to include all the necessary information and the need to do it in a way that can be understood. Please know that your pre-reviewer will be able to either help you with this effort or refer you to other experts as well.

The following consent template text is from the NIH website. Please tailor this text to your study and to the participants involved (i.e. appropriate reading level, language appropriate for minors).

Certificate of Confidentiality: To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced 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 researchers will use the Certificate to resist any demands for information that would identify you, except as explained below.

The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of federally funded projects.

You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information. (The researchers should include language such as the following if they intend to make voluntary disclosure about things such as child abuse, intent to hurt self or others, or other voluntary disclosures.) The Certificate of Confidentiality does not prevent the researchers from disclosing voluntarily, without your consent, information that would identify you as a participant in the research project under the following circumstances. (The researchers should state here the conditions under which voluntary disclosure would be made. If no voluntary disclosures will be made, the researchers should so state.)

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