Pre-screening participants. Participants will be fully informed after screening, and before continuing the study. Other: Describe why not all of the required information will be disclosed: _______. Process to Document Consent in Writing I have read and will follow the Documentation of Informed “INVESTIGATOR GUIDANCE: Consent (HRP-803)”. Item #1 Select – I have read and will NOT follow the Documentation of Informed “INVESTIGATOR GUIDANCE: Consent (HRP-803)”. Item #2 Select – 1. Written consent (signatures) WILL be obtained from all participants (Use TEMPLATE Consent (HRP-500) and PROCEED to Item #12). 2. Written consent WILL NOT be obtained (Use TEMPLATE Information Sheet). (Check ALL that apply ) Waiver of Documentation of Consent (Select one below). 2.1 The research presents no more than minimal risk of harm to participants and involves no procedures for which written documentation (signatures) is normally required outside of the research context. The researcher obtaining consent will write a note in the research record. participant’s OR: 2.2 The only record linking the participant and the research would be the consent document. The principal risk is harm resulting from a breach of confidentiality. The researcher obtaining consent will write a note in the research record. participant’s OR: Request for Alteration of Documentation of Consent. (Some or all information in the consent is changed or omitted. Participants will be debriefed, or fully informed of research.) Explain how participants will be informed:_________ The following should be included if participant signatures will not be collected: The investigator/researcher will provide a written statement regarding the research that embodies the elements of consent (i.e., an Information Sheet). Verbal consent will be noted for each participant in the specific AND research record. (Example: participant’s On [DATE], participant was provided information about the study. Participant was provided an opportunity to ask questions. Verbal consent was obtained/not obtained to participate in the study.) If not providing an information sheet, or documenting verbal consent in the research record, provide justification: ________ Non-English Speaking Participants Skip to Item #13 Not applicable - Yes Indicate what language(s) other than English is (are) understood by prospective participants or representatives:
Pre-screening participants. Participants will be fully informed after screening, and before continuing the study. Other: Describe why not all of the required information will be disclosed: _______. Process to Document Consent in Writing I have read and will follow the “INVESTIGATOR GUIDANCE: Documentation of Informed Consent (HRP-803)”. – Select Item #1 I have read and will NOT follow the “INVESTIGATOR GUIDANCE: Documentation of Informed Consent (HRP-803)”. – Select Item #2 1. Written consent (signatures) WILL be obtained from all participants (Use TEMPLATE Consent (HRP-500) and PROCEED to Item #12). 2. Written consent WILL NOT be obtained (Use TEMPLATE Information Sheet). (Check ALL that apply ) Waiver of Documentation of Consent (Select one below). 2.1 The research presents no more than minimal risk of harm to participants and involves no procedures for which written documentation (signatures) is normally required outside of the research context. The researcher obtaining consent will write a note in the participant’s research record. OR: 2.2 The only record linking the participant and the research would be the consent document. The principal risk is harm resulting from a breach of confidentiality. The researcher obtaining consent will write a note in the participant’s research record. OR: Request for Alteration of Documentation of Consent. (Some or all information in the consent is changed or omitted. Participants will be debriefed, or fully informed of research.) Explain how participants will be informed:_________ The following should be included if participant signatures will not be collected: The investigator/researcher will provide a written statement regarding the research that embodies the elements of consent (i.e., an Information Sheet). AND Verbal consent will be noted for each participant in the specific participant’s research record. (Example: On [DATE], participant was provided information about the study. Participant was provided an opportunity to ask questions. Verbal consent was obtained/not obtained to participate in the study.) If not providing an information sheet, or documenting verbal consent in the research record, provide justification: ________ Non-English Speaking Participants Not applicable - Skip to Item #13 Yes Indicate what language(s) other than English is (are) understood by prospective participants or representatives: