These are example consent forms that were used in a study
ENHANCING NURSE-PHYSICIAN COLLABORATION IN ICUs
Diane Boyle, RN, PhD, Principal Investigator
University of Kansas Medical Center, School of Nursing
Project Number 1 R15 NR04207-01
Informed Consent, Intervention Participants
INTRODUCTION
I understand that as a nurse or physician leader in my intensive care unit, I am being invited to participate in a research study to determine the effect of enhancing nurse-physician collaboration on intensive care unit patient and organizational outcomes. This study will be performed in the University of Kansas Medical Center Burn Center and in the Critical Care Unit of Shawnee Mission Medical Center.
PURPOSE
The purpose of this study is to deliver a collaboration building intervention with intensive care unit nursing and physician leaders. The effect on organizational and patient outcomes then will be followed for the period of 6 months.
PROCEDURE
My participation in this study will involve the following. Both pre-intervention and post-intervention, I will complete a written questionnaire and a written simulation on the collaboration skills addressed in the intervention--this will take about one hour each time. I then will participate in an experimental intervention that contains 8 modules spread over a period of 8 months, one module per month. The modules vary from 3 to 4 hours each, with the total classroom time for the modules being about 30 hours. These modules will be given during working hours. There will be 4-5 other nursing and physician leaders (for example, nurse manager, physician director, clinical nurse specialist) from my unit in my intervention group. There will be 11-12 participants from 2 intensive care units altogether.
The modules of the intervention target the collaboration concepts of ICU leadership, communication, coordination, problem solving/conflict management, and team oriented culture. Some modules focus on group situations and some on one-on-one situations. They all incorporate the following elements: (a) multiple learning activities, (b) small group practice and problem solving sessions, (c) feedback and reinforcement of newly learned skills, (d) planning assignments for on-the-job applications of newly learned skills, and (e) post-assessment and feedback.
RISKS
There are no foreseeable physical, psychological, social, or legal risks associated with this study. I may experience some discomfort or awkwardness during the skill practice sessions of the intervention. The intervention instructor will be trained in helping me through this discomfort.
BENEFITS
I may benefit from this study by gaining enhanced interpersonal collaboration skills that I can use at work or elsewhere. I also will receive continuing education or CME credit.
PAYMENT TO SUBJECTS
I will not be paid for my participation in the study.
COSTS
I will be responsible for cost of transportation to the intervention site.
CONFIDENTIALITY
I understand the investigators will keep secret all research related records and information from this study. I understand that a unique identification number will be assigned to me to match my study data. These numbers will be known only to the investigators. The roster linking numbers to names will be kept in a locked file cabinet and also will be kept separately from any data. My name will not appear on any data. I understand the investigators will not reveal my identity if they publish or present the results of this study.
QUESTIONS
I have read the information in this form. The investigators have answered my questions to my satisfaction. I know if I have any more questions after signing this form, I may contact Diane Boyle, RN, PhD at 913-588-1686. If I have any questions about my rights as a research subject, I may call or write the Human Subjects Committee, 5015 Wescoe, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, Kansas, 66160-7700, telephone 913-588-1240.
CONSENT
The investigators gave me information about what will be done to me in this research study. They also told me how it will be done, what I will have to do, and how long the research will take. They told me about any inconvenience, discomfort, or risks I may experience due to this research. They explained to me how this research may affect me or my health. I agree to take part in this study as a research subject. I am aware that I may quit at any time. I also may refuse to answer any questions on the pretest and posttest or I may refuse any part of the research study. I understand that quitting will have no effect on my job or employment.
I understand that the investigators will give me a copy of this form to keep for my records.
______________________________________________
Type/Print Subject's Name
______________________________________________
Subject's Signature Date
RESPONSIBLE INVESTIGATOR
______________________________________________
Responsible Investigator's Signature, Telephone Number, Date
Example Consent Form 2
ENHANCING NURSE-PHYSICIAN COLLABORATION IN ICUs
Diane Boyle, RN, PhD, Principal Investigator
University of Kansas Medical Center, School of Nursing
Project Number 1 R15 NR04207-01
Informed Consent, ICU Staff Nurses
INTRODUCTION
I understand that as a nurse in an intensive care unit, I am being invited to participate in a research study to determine the effect of enhancing nurse-physician collaboration on intensive care unit patient and organizational outcomes. This study will be performed in the University of Kansas Medical Center Burn Center and in the Critical Care Unit of Shawnee Mission Medical Center.
PURPOSE
The purpose of this study is to deliver a collaboration building intervention with intensive care unit nursing and physician leaders. The effect on organizational and patient outcomes then will be followed for the period of 6 months.
PROCEDURE
My participation in this study will involve the following. I will participate in one research data collection during working hours. I will complete a written questionnaire that includes questions about me as an individual and about several aspects of my work. I will be asked questions about my perceptions of the physician and nursing leadership in my unit. Approximately 65 other ICU nurses from the 2 intensive care units also will be asked to participate.
RISKS
There are no foreseeable physical, psychological, social, or legal risks associated with this study. I may experience some discomfort in answering questions about the leadership in my unit.
BENEFITS
I will not benefit directly from this study. However, the health care industry may benefit in the future by data obtained in this study.
PAYMENT TO SUBJECTS
I will not be paid for my participation in the study.
COSTS
I will not be charged anything for participation in this study.
CONFIDENTIALITY
I understand the investigators will keep secret all research related records and information from this study. I understand that a unique identification number will be assigned to me to track my study data. These numbers will be known only to the investigators. The roster linking numbers to names will be kept in a locked file cabinet and also will be kept separately from any data. My name will not appear on any data. I understand the investigators will not reveal my identity if they publish or present the results of this study.
QUESTIONS
I have read the information in this form. The investigators have answered my questions to my satisfaction. I know if I have any more questions after signing this form, I may contact Diane Boyle, RN, PhD at 913-588-1686. If I have any questions about my rights as a research subject, I may call or write the Human Subjects Committee, 5015 Wescoe, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, Kansas, 66160-7700, telephone 913-588-1240.
CONSENT
The investigators gave me information about what will be done to me in this research study. They also told me how it will be done, what I will have to do, and how long the research will take. They told me about any inconvenience, discomfort, or risks I may experience due to this research. They explained to me how this research may affect me or my health. I agree to take part in this study as a research subject. I am aware that I may quit at any time. I also may refuse to answer any questions on the questionnaires. I understand that quitting will have no effect on my job or employment.
I understand that the investigators will give me a copy of this form to keep for my records.
______________________________________________
Type/Print Subject's Name
______________________________________________
Subject's Signature Date
RESPONSIBLE INVESTIGATOR
______________________________________________
Responsible Investigator's Signature, Telephone Number, Date