Consent Document
RESEARCH SUBJECT CONSENT
Title: Communicating Effectively about Donation – Improving Decisions and Outcomes with Black Americans (CEaD-I DO)
Protocol No: IRB Protocol # 29921
Sponsor: Gift of Life Foundation
Principal Investigator:
Laura A. Siminoff, PhD
Siminoff Research Group
College of Public Health, Temple University
1700 N Broad, Suite 417
Philadelphia, PA 19121
Daytime Phone Number: 215-204-9186
Study E-mail: cead-ido@temple.edu
You are being asked to participate in a research study. Before you agree, the investigator must tell you about the following:
(i) Purposes, procedures, and duration of the research
The research study tests the effectiveness of a newly developed eLearning platform called Communicating Effectively about Donation – Improving Decisions and Outcomes with Black Americans (CEaD-I DO) for donation professionals who lead organ donation discussions with Black American families. You are being asked to participate in this study because you lead organ donation discussions as part of your employment at an Organ Procurement Organization (OPO).
Study participation entails creating a user account on the eLearning platform and completing the asynchronous CEaD-I DO training on your own. When creating a user account, you will be asked for basic contact information, so that the research team can keep track of your progress and send you periodic training reminders. After your account is created, you will be asked to complete a survey that will help the research team measure the impact of the CEaD-I DO training. The survey will collect sociodemographic information (e.g. age, OPO, level of education), self-reported experience with prior related training, and self-reported ratings of knowledge about, preparedness for, and comfort and confidence with approaching families of Black donor-eligible patients.
1. All data collected will be stored in the eLearning system (Moodle LMS) and protected by the platform’s privacy standards. The platform does not sell, monetize, or independently use participant data; data are managed solely by the research team in HIPAA-compliant environments. Moodle’s privacy policy is available here: https://moodle.com/security-privacy/.
The training is estimated to take 2-3 hours to complete, but you can complete the training over multiple sittings. Pre- and post- surveys are not included in the training time estimate. The pre-survey will take about 10 minutes, The post-survey will take 10-15 minutes. You will have at least one month to complete the training. Any interim and final deadlines will be communicated by the research team.
The CEaD-I DO consists of three modules. The Communication Skills and Tasks Skills modules provide didactic material to master the communication and task skills and exercises to test your understanding of the material upon completion. In the Scenarios Module, you will watch previously recorded, simulated discussions with families considering organ donation. You will be prompted to formulate a response to the families’ concerns and questions. You will record your response using your device’s (e.g. computer, tablet) webcam and microphone video recording using your device’s (e.g. computer, tablet) webcam and microphone. You can record as many responses as you choose and then submit the response you are satisfied with using the eLearning platform. Your responses will be scored by the research team for the sole purpose of providing you tailored feedback. Your responses are completely confidential and are not shared with your employer. After completing the training, you will receive personalized, skill-based feedback that evaluates your use of the skills taught in the CEaD-I DO training using both scores and written observations. The feedback will highlight strengths while offering clear, practical suggestions to help you further strengthen your communication effectiveness when leading donation discussions about organ donation with families.
After finishing the training, you will be asked to complete a survey about your experience with the online training and your views on the effectiveness of the CEaD-I DO training. You will also receive a completion certificate for your records and eight (8) Category I CEPTCs from the American Board of Transplant Certification (ABTC).
(ii) There are no experimental procedures involved in this research.
(iii) Foreseeable risks, discomforts, and benefits of the research
As with most studies, there is minimal risk of accidental release of confidential or personally identifying information.
Benefits include the possible improvement of your skills and confidence when leading organ donation conversations with Black American families.
There are no costs for participating in this study. Individuals who complete all parts of the CEaD-I DO by the deadline prescribed by the research team, will receive eight (8) Category I CEPTCs from the American Board of Transplant Certification.
Participation in this study is voluntary. Your alternative is not to participate in this study, but you are free to proceed with obtaining Category I CEPTCs via other methods, outlined by the ABTC.
(iv) There are no potentially alternative procedures or treatments associated with this research.
(v) Confidentiality
To protect your confidentiality, however, you will be assigned an alphanumeric ID in our databases, and we employ best practices to protect participants’ data. Your participation will have no impact on your employment or evaluation of your performance at your OPO. Neither your manager nor your OPO’s leadership will have access to any individual performance or results of the training except in the aggregate.
We may publish the results of this research. Any findings in future presentations and publications will be reported in the aggregate and/or will not be tied you individually.
Your private information may be shared with individuals that conduct this research or organizations that watch over this research, such as Temple University and the Institutional Review Board (IRB) that reviewed and approved this research.
We protect your information from disclosure to others to the extent required by law, but we cannot promise complete secrecy.
De-identified data collected in this research might be used for future research or distributed to another investigator for future research without your consent.
(vi) Other information
There are no anticipated circumstances when the investigator may halt participation.
There are no consequences for people who choose not to complete the training.
You may contact the research team at the phone number above or at cead-ido@temple.edu any time you have questions about the research.
You may contact the Temple University IRB at (215) 707-3390 or at irb@temple.edu if you have questions about your rights as a research subject.
Your participation in this research is voluntary, and you will not be penalized or lose benefits if you refuse to participate or decide to stop.
By proceeding onto the next page, you acknowledge that you have read the above information and that you voluntarily agree to participate.