The Art of Consenting: Tips to Meeting Enrollment Goals David A. Cox, MD FSCAI FACC Lehigh Valley Health Network Allentown, PA CRT 2013

David A. Cox, MD Consulting: Legal Review Honoraria: Abbott Vascular Boston Scientific Corporation Medtronic theMedicinesCompany

Recent Findings in Clinical Investigator’s Brain Clinical Med Sex Hunger Survival Research Docs Ability to Obtain Informed Consent 5

Consent is key to enrollment

Research Nurse Concerns “I’ve screened lots of patients for this protocol,….none seem to fit!” “I’ve been scanning the labs to see if patients qualify…none do” “Mrs. Jones qualifies, but I couldn’t get her to sign the consent” “I asked Dr B to talk with Mr White about the protocol…he wouldn’t”

Research Doc Concerns “Why are we screening so many patients but enrolling no one?” “I really don’t have time to explain the protocol to anyone” “Its not my job to get consent and get the protocol signed” “I don’t really need to explain all of the protocol to get consent”

Patients should feel a consent is a consent

Be Kind When Asked

Nurses: Keystone of Clinical Research Visit a site doing research in a setting similar to yours to focus upon how to consent….or skype, call, FACEBOOK Learning how to screen better and less painfully makes consenting easier Getting consent in appropriate fashion MUST be done correctly Talk with each other

Screen and Consent Better All patients are potential research candidates 7-8 AM—research nurses and doc meet at cath lab to identify possible patients to consent Consenting by research nurses with MD back-up…often after MD initial approach Research nurses in lab with patient as cath done to help with protocol question PI availability….team meetings each week.

Your job as study PI Know the protocol All events in the protocol at your site belong to you Report any issues/events of significance to national PI STAT OVERSIGHT OVER CONSENT PROCESS IS KEY… HELP NOT HURT THIS IMPORTANT STEP MD explaining the protocol before consent is obtained improves chances of signing

The Role of the Investigator in Clinical Research Pat Beers Block Good Clinical Practice Program February 27, 2004

Subinvestigator(s) Other members of the team Should be directly involved with subjects in the study It is the investigator (and not the subinvestigator[s]) who is held responsible for the study site and subject to enforcement action for violations of FDA regulations

Avoid jail and public FDA warning letters

Research Nurse Responsibilities Identify and consent patient Gets PI for any pt queries Miss no one PI aid critical….you set the tone! Know protocol so if PI absent, sub PI follows it HELP ANSWER LATER CONSENT QUERY

Tips for Consent Screen smartly Be sure Inclusion/Exclusions are checklisted. Resolve I/E questions before consent. Approach patient in quiet setting with family present if able. Allow time for patient to read and raise questions. Always state research is voluntary