Tier Advancement Assessment Candidate name: Click or tap here to enter text. Research Operations: Informed Consent Procedures Date: Click or tap here to enter text. Candidate testing level: F ☐ S ☐ A ☐

Mode: Direct Observation

Competency Fundamental Skilled Advanced Conduct and document Conduct and Demonstrates Performs at a skilled level consent for participants in a document additional fluidity in and provides self- variety of studies, including according to the the delivery. documentation of instance(s) complex studies and/or protocol. Follows Reads patient where the competency has those that require DUHS the consent plan. cues and closes been applied outside of the billing. the feedback loop. individual’s job tasks.

Check the box that applied to the informed consent process observation.

Initial Recruitment Contact

Yes No NA

Ask candidate how participant was first approached for study. Does response suggest that “no cold contact” policy was followed? ☐ ☐ ☐

Discussing the Study Was the location of the consent meeting appropriate and private? ☐ ☐ ☐ Was the location comfortable with minimal ambient noise? ☐ ☐ ☐ Were family members involved in the process as appropriate? ☐ ☐ ☐ Did candidate review all elements of consent with the potential participant? ☐ ☐ ☐

Dealing with the Potential Participant’s Questions Were participant questions or issues answered or addressed appropriately? ☐ ☐ ☐

Did the candidate give the potential participant the opportunity to ask ☐ ☐ ☐ questions and provide clear answers and/or refer the question to the appropriate trained personnel?

Assessing the Potential Participant’s Understanding Did the candidate assess that the potential participant understood the ☐ ☐ ☐ difference between clinical treatment and research?

Did the candidate assess the potential participant’s understanding of the ☐ ☐ ☐ study using an open-ended (tell me…) approach?

If the participant did not speak English as a first language, -Were provisions for understanding appropriate? ☐ ☐ ☐

Assessment – RO: Consent - Page 1 -Were potential literacy issues addressed appropriately? ☐ ☐ ☐ OR If not an issue for the subject being observed, can the candidate express how they would address a literacy issue that came up ☐ ☐ ☐ during the study consenting process?

Did the candidate assess/confirm the participants’ capacity to provide consent as described in consent plan approved by IRB? ☐ ☐ ☐

Did it appear that NO cultural factors may inhibit the potential participant’s understanding and ability to provide informed consent? ☐ ☐ ☐

Allowing Time to Make the Decision Was the amount of time appropriate between being approached about participating in the study and deciding to sign the consent form? ☐ ☐ ☐

Handling the Informed Consent Form Did the appropriate person provide written consent? ☐ ☐ ☐

Did the appropriate person provide verbal assent? ☐ ☐ ☐

Was the current IRB watermarked consent form used? ☐ ☐ ☐

Did the candidate enter the subject identifiers appropriately or place correct label? ☐ ☐ ☐

Did the candidate keep the original signed form with the research record? ☐ ☐ ☐

Did the candidate provide a signed copy of the form to the participant? ☐ ☐ ☐

Did the candidate send a signed copy to Health Information Management? ☐ ☐ ☐

Did the candidate obtain a signed a Duke Health Enterprise Notice of Privacy ☐ ☐ ☐ Practices if non-Duke patient?

Did the candidate document the informed consent process appropriately, and within the appropriate timeframe, in the participant’s Maestro Care record? ☐ ☐ ☐

Did the candidate document the process in MaestroCare using appropriate template required? ☐ ☐ ☐

Did the candidate follow Duke’s age policy in gathering consent and assent ☐ ☐ ☐ of a minor?

Assessment – RO: Consent - Page 2 If an LAR was used, was the use approved by IRB? ☐ ☐ ☐

If an LAR was used, did the LAR provide appropriate documentation prior to ☐ ☐ ☐ obtaining consent?

If the participant was part of a vulnerable population, were ☐ ☐ ☐ additional protections in place for the participant?

General Were all of the procedures followed as indicated in the consenting process ☐ ☐ ☐ in the IRB approved documents?

Was the candidate listed on the Delegation of Authority Log with the authority to consent participants? ☐ ☐ ☐

If the subject did not express full understanding of the study, or if special circumstances arose during the consent procedure, how did the candidate handle the situation? Click or tap here to enter text.

Additional comments on observation of informed consent process that may speak to the candidate’s skills in the consent process. [Complete for skilled or advanced only] Click or tap here to enter text.

Advanced Only: Describe any instances where you have demonstrated advanced application of your knowledge and understanding of consent process/procedure outside of your individual job or assigned studies. Some examples might include:  a description of difficult challenges you have met or helped others to address  providing mentorship to others outside of your team  developing and provided training to others, and/or  evidence that you are seen as a go-to resource for several faculty or staff Click or tap here to enter text.

Candidate Signature: ______Date:

Assessment – RO: Consent - Page 3 Evaluation Level

This documentation demonstrates: ☐ Fundamental Competency ☐ Skilled Competency ☐ Advanced Competency

Attester comments about candidate’s competency level: Click or tap here to enter text.

Attester Name (Print): ______

Attester Title (Print): ______

Attester Signature:______Date:______

Assessment – RO: Consent - Page 4