CONSENT FORM FOR LACTATION EDUCATION PROJECT-H24-00337
RESEARCH TITLE: Effectiveness of pedagogical scaffolding of an interprofessional lactation curriculum.

Research Team:
Principal Investigator: Dr. Suzanne Hetzel Campbell PhD, RN, FCNEI, IBCLC, CCSNE Professor, School of Nursing

Co-investigators:
Carrie Miller, PhD, RN, CNE, CHSE, IBCLC Associate Professor, Montana State University, School of Nursing, Billings, MT, USA Email: carrie.miller6@montana.edu
Sunny Gayle Hallowell, PhD, Associate Professor, Villanova University, Villanova, PA, USA Email: sunny.hallowell@villanova.edu
Jolynn Dowling, PhD, NP, IBCLC, Associate Educator, Wichita State University, Wichita, KS, USA Email: jolynn.dowling@wichita.edu
Tina Revia, MSN, RN, IBCLC, Instructor, North Island College, Vancouver Island, BC, Canada Email: tina.revai@nic.bc.ca
Melanie Willson, MSN, RN, Assistant Professor of Teaching, UBC-Okanagan, Kelowna, BC, Canada Email: melanie.willson@ubc.ca
George Oliveira Silva, PhD (c), RN, UBC-V, School of Nursing, VIRS, Statistical support, Federal University of Goiânia, Goiás, Brazil Email: georgeoliveira@discente.ufg.br

Study Purpose: You are being invited to participate in a study, “Effectiveness of pedagogical scaffolding of an interprofessional lactation curriculum” which is being conducted as part of faculty research. You are being invited to participate in this study because you are presently enrolled in a course where you are receiving exposure to and instruction in lactation as part of the course. The purpose of this study is to learn more about students’ experiences learning clinical application skills for supporting parents with breastfeeding and lactation management. Research on health professional students’ knowledge, attitudes, self-confidence and clinical skills supporting new parents has not previously been compared by various models for teaching. As part of a multi-site study, students in different nursing programs are engaged in a range of learning strategies for learning core lactation content. In this study, students’ experience and translation of knowledge, attitudes, self-confidence and perception of skills are being compared across sites to inform future curriculum development and advance clinical practice learning for all health care professionals.

Funding for the Study: No Funding.

Study Procedures: Involvement in the study is voluntary and will require you to identify your location (city, state/province and country), and the type of learning you experienced. You will be asked to complete a pre-learning 10 minutes in total, that incorporates basic demographic information (e.g. location, experience personally and professionally supporting breastfeeding parents) and a survey including attitudes and knowledge of lactation. When you have completed learning on lactation (or the course), you will be asked to complete another survey related to your learning experience, your attitudes, and your self-confidence related to providing breastfeeding support (20-30 minutes in total)(these surveys will not be graded and are voluntary participation). All the surveys are anonymous, not linked in any way to student personal identifiers, and faculty will not know who has participated or not. Participants may choose to create their own personal ID to link their pre- and post-test score, but this is optional, and the research team will not be able to identify you by this ID.

Submitting the completed survey indicates consent for participation. Data will be reported in an aggregate format that will not disclose students. Comparisons will be made between types of learning, students experiences learning, and student knowledge, attitudes, and confidence. Results of the research will be congregated by group and available for dissemination within one year of completion of the project. Students will have an opportunity to request results that will not be attached to their survey.

If you decide to participate in the study, you will be asked to do the following:
Complete the pre-learning survey prior to class with information on lactation.
Complete a post-learning survey on your experience learning, knowledge about breastfeeding, attitudes, self-confidence related to providing breastfeeding support, specific to your location and the type of learning.

Study Results: Results of this research could be presented at professional conferences or published in journals and online health education sites. Data from the study will be combined by group and no personal identifiers will link you to specific outcomes. In none of these cases would any information that could identify you be used.

Potential Risks of the Study:  There are no known harms associated with participation in this study.

Potential Benefits of Participating in the Study:   The primary benefits produced are related to program and curriculum management and the advancement of knowledge in this important area of the scholarship of teaching and learning. You will benefit from a variety of learning options for breastfeeding, and all students will be offered access to open education resources (online modules), links to independent learning, and depending on your site, different forms of instruction depending on your location. Theoretical- practical classes and scenarios will be created based on scientific evidence. In addition, the knowledge and skills you acquired can be applied in clinical practice as health care providers. The results of the study could direct new clinical research involving breastfeeding and support the teaching of breastfeeding using clinical simulation for multiple disciplines.

Confidentiality:  The confidentiality of the data and participant privacy will be maintained during data collection and analysis, including electronic files. Standard measures will be taken like password protecting electronic files, no hard copies of study materials are being collected. The researcher will have no access to personal information (identifying information, email, or URL) that can link survey findings with survey participants. Survey findings will be aggregated by group, analyzed and reported using an alpha-numeric code which is not based on any identifying information. Original data of study will be retained on the secure drive in the UBC School of Nursing shared drive where folders and files are password protected and encrypted. Only the PI will have access to the data and only aggregated data will be provided to the statistician and to the research team for discussion and reporting.

By clicking the submit button at the end of the online survey you are providing consent to participate in the study.

Payment There is no payment to you for participating in the study.

Contact for Information about the Study:  If you have any questions about this study or would like further information, please contact the Study Coordinator and Principal-investigator, Dr. Suzanne Hetzel Campbell, suzanne.campbell@ubc.ca, 604-822-7748 (leave voicemail). You may also direct questions to the site champion listed above.

Contact for Concerns about the Rights of Research Subjects:  If you have any concerns or complaints about your rights as a research participant and/or your experiences before or while participating in this study, contact the Research Participant Complaint Line in the UBC Office of Research Ethics at 604-822-8598 or if long distance e-mail RSIL@ors.ubc.ca or call toll free 1-877-822-8598. Please reference the study number (H24-00337) when calling so the Complaint Line staff can better assist you.

Consent: Your participation in this study is voluntary and you may refuse to participate or withdraw from the study at any time. By completing the surveys online and submitting them you are providing consent to participate in the study and indicating that:
- You have read and understood the information in this consent form.
- You have had enough time to think about the information provided.
- You have been able to ask for advice if needed.
- You have been able to ask questions and have had satisfactory responses to your questions.
- You understand that all the information collected will be kept confidential and that the results will only be used for scientific purposes.
- You understand that your participation in this study is voluntary.
- You understand that you are completely free to refuse to participate or to withdraw from this study at any time.
- You understand that you are not waiving any of your legal rights.
- You understand that there is no guarantee that this study will provide any benefits to you.
- As the data is collected anonymously, it cannot be withdrawn once submitted.

If you would like to receive information about the results of this research, please contact Dr. Campbell or one of the site champions via email with details about where to send the information.

Thank you so much for considering participating in this research project, your time and expertise in providing us feedback is greatly appreciated.

Sincerely,
Suzanne H. Campbell

Suzanne Hetzel Campbell, PhD, RN, FCNEI, IBCLC, CCSNE
Professor, The University of British Columbia-Vancouver, School of Nursing
suzanne.campbell@ubc.ca