Sample recruitment and consent text for IRB application
Members of the study team will prescreen the OR schedule to determine eligibility and identify patients who are scheduled for surgery and meet the inclusion/exclusion criteria. We will record the inclusion/exclusion criteria as well as the name and MRN. Attached is a request for waivers of consent/HIPAA Authorization for prescreening purposes.
A member of the clinical team will first approach an eligible patient to tell them there is a research study and a member of the study team would like to talk with them. If the patient is agreeable, a member of the study team who is not involved directly in the patient’s clinical care
(research coordinator, investigator} will then approach an eligible patient in a private setting in the preoperative area, the morning of the surgery, in order to discuss this study. Investigators will approach patients in this setting at least 90 minutes prior to their surgery.
We will only approach patients who have received no premedication or sedation. We will review the patient’s chart to ensure that no sedating medication has been given prior to approaching that patient for inclusion into this research study. The study tea m will use their discretion when speaking with patients to ensure a patient is not impaired at the time of consent. As clinicians, if we deem the patient is in a state that impacts their decision-making or comprehension of the study, we will not recruit them to be in the study.
The investigator will briefly describe the study and ask if they are interested to hear more about participation. If the patient is interested, they will be given the consent form, and HIPAA
Authorization form and a detailed discussion of the study and participation will ensue.
Investigators will give eligible patients plenty of time to read and ask questions they have about the study. If the patient agrees to participate, the investigator will obtain his/her informed consent.
The approach and consent discussion will be presented in an open, non-intimidating and educational format. We will tell patients that their choice to participate is completely voluntary and they have the right to refuse participation and their clinical care will remain unaffected, irrespective of their participation in the study. We will give ample time to each patient to consider participating in the study. We will make sure the patient is comfortable with the explanation of the research study, and we will ask each patient if they have any questions, and will ensure they understand that they have the autonomous decision to participate or not in this study.
We are requesting permission to approach patients and obtain their consent and HIPAA
Authorization in the preoperative setting and before any sedation because it would not be feasible to approach patients pre-operatively in either the surgeon’s offices or the pre-anesthesia clinic.
[Provide a justification such as:]
-- We anticipate identifying patients eligible for this study within hours before surgery since that is when the anesthesiologist will determine whether or not a breathing tube will be placed for standard clinical care.
--Less than 30% of patients that will qualify for inclusion in this study will go through the Pre-
Anesthesia Clinic. Therefore, it is not practical to approach patients for this study in that setting.
Our patients experience conversations for which they are asked to make significant decisions and sign documents on the day of their surgery. In our experience, we believe that approaching and consenting subjects in the pre operative areas for this type of study poses no risks to patients and allows for sufficient time to make an informed decision about participating in this study.