Get Informed Consent Observation/evaluation - Ouhsc

Filling out the Informed Consent Observation/Evaluation form is an essential step in the research process. This guide will provide a clear, step-by-step approach to completing the form online, ensuring that all necessary information is accurately captured and that participants' rights are respected.

Follow the steps to successfully complete the form online:

1. Click the ‘Get Form’ button to secure the form and access it for filling out online.
2. Begin by entering the general information. This includes the principal investigator's name, applicable department, and IRB-stamped dates on the informed consent form (ICF). Be thorough and accurate in documenting this data.
3. Indicate the type of observation being conducted. Select between 'Routine' or 'For Cause', and provide the appropriate expiration date and IRB number.
4. Document the name and role of the individual conducting the consent process to ensure proper accountability.
5. Describe the physical environment where the consent process takes place. Note if it is an office, exam room, hospital room, etc., and detail the atmosphere such as 'quiet' or 'chaotic'.
6. Record how many people were present during the consenting process, differentiating between study personnel and non-study acquaintances.
7. Verify whether the participant was offered the option to review the ICF with family or friends, and record their response.
8. Assess if the participant is able to provide their own consent, and note how this was determined.
9. If surrogate or legally authorized representative consent is applicable, document the corresponding approvals and processes.
10. Confirm the provision of translated materials, where necessary, documenting the language and translating personnel present.
11. Ensure all discussions regarding the study and consent, risks, and alternatives were sufficiently covered with the participant.
12. Record the participant's level of understanding and comfort during the consent process, noting whether they had any questions.
13. Finalize the documentation by ensuring all required signatures are obtained from the participant, consent provider, and any witnesses.
14. Once completed, save your changes, and choose to download, print, or share the finalized form as needed.

Complete your informed consent documents online today to streamline your research processes.