Studies qualifying for an exempt determination that involve interactions with research participants are required to utilize an informed consent process, as defined by 45 CFR §46.104. This informed consent process must involve each of the following components:
- A disclosure that the activities involve research.
- The procedures to be performed.
- That participation is voluntary.
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The expected duration of subject’s participation.
- Foreseeable risks of participating in research.
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The extent to which confidentiality of participant responses will be maintained.
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The name and contact information of the researcher that subjects can contact with questions.
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The contact information of the IRB (610-758-2871, inirb@lehigh.edu)
Additional information to be included in the consent process, when applicable:
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If the project involves deceiving subjects about the nature or the purpose of the research, the project will not qualify for exempt review unless the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research and prospectively authorizes the deception. In instances involving deception in exempt research, the following language should be added:"You will not be made aware of all the specific details of the research at the outset of the study. However, you will be provided with all specific details of the research after you have finished participating.”
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In such instances, subjects must be debriefed upon the conclusion of their participation.
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If the research will be conducted online, the consent form must state where subjects must be located at the time they take part in the study. If subjects will be located in the European Economic Area and if identifiable information will be collected, the consent form must meet the requirements of the European Union’s General Data Protection Regulation.
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If the project involves video and/or audio recordings, this must be clearly disclosed in the consent form. In addition, the consent form must describe:
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How long the recordings will be stored before they are permanently deleted.
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How the recordings will be protected before they are permanently deleted.
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If the research will be conducted via video-conferencing and recordings will be stored to the platform’s cloud, researchers must disclose this in the consent form and must provide a link to the platform’s privacy policy. See guidance here for additional details.
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If there are any conditions under which subjects will not receive compensation for their participation, these conditions must be described clearly in the consent form.
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For international research, all phone numbers must be formatted for international calls.