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Sample verbage for IRB applications

Last updated at 01/26/2008 10:20:21 AM EST by Caroline Richardson MD

On data storage and confidentiality:

All paper forms containing any identifiers will be kept in locked files. Similarly, any electronic data will be kept in password protected files, and only a limited number of study staff will have access to these. Data will be reported only in aggregate, without potential identifiers.

On avoiding coercion of research participants:

Participants will be assured that their participation is voluntary, and their decision to participate or not is not related to their medical benefits or treatment. At each stage of recruitment, potential participants will be encouraged to ask questions. All subjects will be advised that participation is completely voluntary and they may leave the study
at any time without penalty or effect on medical care.

On describing the consent process:

Potential subjects will be offered information about the study during or after their participation in the third interview for the parent survey study. Study personnel will provide scripted information about the study, answer questions, and obtain verbal consent over the telephone or in person. If interested, an interview appointment will be arranged. At the time scheduled for the in-person interview, the study will be explained again and the consent process will be explained. The participant will have the opportunity to sign the consent form and be interviewed, decline to participate, or take time to reconsider whether or not they want to participate.

 

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