STUDY00023396
Approval: 2/27/2024
Version Date: 6-25-2024
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CONSENT FOR RESEARCH
The Pennsylvania State University
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Title of Project: iLookOut for Child Abuse: PA Microlearning to Improve Knowledge Retention
Principal Investigator: Benjamin H. Levi, MD, PhD
Address: Department of Humanities/Pediatrics
500 University Drive MC H 085
Hershey, PA 17033
Telephone Numbers: Weekdays: 8:00 a.m. to 5:00 p.m. (717) 531-4552
We are asking you to be in a research study.
Whether or not you take part is up to you. You can choose not to take part. You can agree to take part and later change your mind. Your decision will not be held against you, and there will be no penalty or loss of benefits to which you are entitled.
This form gives you information about the research. Please ask questions about anything that is unclear to you and take your time to make your choice.
KEY INFORMATION
The following is a short summary of this study to help you decide whether or not to be a part of this research. More detailed information is provided later in this form. If you have any questions, be sure to ask the study team.
Why am I being invited to take part in this research study?
We are asking you to take part in this voluntary research study because you are a mandated reporter in the state of Pennsylvania.
What is the purpose of this research study?
· The purpose of this voluntary research study is to determine the impact and effectiveness of the iLookOut online mandated reporter and advanced training programs. The study will also look at the current knowledge, feelings, and behaviors regarding mandated reporting in Pennsylvania.
How long will the research study last?
· Total participation in this study may be up to 12 months, depending on the access group you are placed in. Active study participation will be between 5.5 and 6.5 hours over that time. Each course you complete will take about 3 hours to complete the core-mandated reporter portion of the study, and you will be asked to complete one final follow-up check-in 3 months after you complete Advanced Training 1. You can start and stop the training programs when it is convenient for you, and you do not have to complete everything at one sitting.
· Depending on when you have access to advanced training, you may have a waiting period during the study. By volunteering to participate, you consent to be contacted by the study team in time intervals regarding completion and access to the microlearning.
What will I need to do?
· The first step in this study is the online registration process. You must be 18 years of age or older to take part in this research study. After completing registration, you will be asked to complete a survey or pre- training check-in that asks about your knowledge and feelings about mandated reporting before completing the training.
Once the pre-training check-in is complete, you will move to the mandated reporter training.
After completing the mandated reporter training, you will complete a post-training check-in that asks about your knowledge and feelings about mandated reporting. You will also be asked to complete a course evaluation at this time. Individuals who do not report an occupation or job as an early childhood professional, early childhood volunteer, Pre-k Teacher, or Kindergarten teacher will receive access to the advanced training 1 course instantly.
Individuals reporting a job or occupation as an early childhood professional, early childhood volunteer, pre-k teacher, or kindergarten teacher will receive access to the advanced training 1 course according to a randomly assigned group. Early childhood professionals will be randomized to one of four groups (instant access, 3-month access, 6-month access, or 9-month access).
If you decide to complete the research program, you are free to stop at any time. You do not have to answer any questions that make you uncomfortable, by exiting the program.
By continuing and completing the following modules, you are implying your consent to participate in this research study.
What are the main risks of taking part in the study?
· Risks from participation include: 1) Loss of confidentiality if your name or other identifiable information is obtained by someone other than the investigators and JPL D’VINCI, who is hosting the online training. Precautions to prevent this from happening include keeping data in password protected files and locked filing cabinets at (D’VINCI) and Penn State Hershey Medical Center. 2) Psychological discomfort due to the nature of the subject matter –though efforts were made to minimize this in the presentation of the material.
What are the possible benefits to me that may reasonably be expected from being in the research?
There are no benefits to you from taking part in this research. Results of the study may benefit other people in the future by helping us learn more about the impact and effectiveness of the iLookOut online mandated reporter and advanced training programs.
What happens if I do not want to be in this research?
Participation in research is completely voluntary. You can decide to participate or not to participate.
You may choose not to take part in this research study.
DETAILED INFORMATION
The following is more detailed information about this study in addition to the information listed above.
1. Why is this research study being done?
This research is being done to find out the impact and effectiveness of the iLookOut online mandated reporter and advanced training programs. The study will also look at the current knowledge, feelings, and behaviors regarding mandated reporting in Pennsylvania.
Approximately 6000 people will take part in this research study across Pennsylvania.
2. What will happen in this research study?
What are my responsibilities if I take part in this research?
If you take part in this research, your major responsibilities will include:
· The first step in this study is the online registration process. You must be 18 years of age or older to take part in this research study. After completing registration, you will be asked to complete a survey or pre- training check-in that asks about your knowledge and feelings about mandated reporting before completing the training.
Once the pre-training check-in is complete, you will move to the mandated reporter training.
After completing the mandated reporter training, you will complete a post-training check-in that asks about your knowledge and feelings about mandated reporting. You will also be asked to complete a course evaluation at this time. Individuals who do not report an occupation or job as an early childhood professional, early childhood volunteer, Pre-k Teacher, or Kindergarten teacher will receive access to the advanced training 1 course instantly.
Individuals reporting a job or occupation as an early childhood professional, early childhood volunteer, pre-k teacher, or kindergarten teacher will receive access to the advanced training 1 course according to a randomly assigned group. Early childhood professionals will be randomized to one of four groups (instant access, 3-month access, 6-month access, or 9-month access). Early childhood professionals will be randomly assigned the same Advanced Training 1 course in one of four different time intervals. This means whichever time interval group you are assigned will be determined purely by chance. You will have a 1 out of 4 change.
· During the training, you will be asked if you are completing this training for state licensure. If you respond yes to this question, you will be asked a few additional questions such as social security number, date of birth, licensing type/board, and license number. This information along with your name and training completion date will be send to the Pennsylvania Department of State. The Department of State cannot give you appropriate credit for state licensure without the transfer of this information. The study team will not access this information for any study related purposes, and it will not be connected with specific responses you provide throughout the learning program. Your information will NOT be shared with your employer or with others.
· If you enter a PA Key ID, your training completion will also be sent to the PA Key to provide you with the appropriate professional development credit.
What are my responsibilities if I take part in this research?
If you take part in this research, your major responsibilities will include:
· Completing the Core Mandated Reporter training for Pennsylvania; completing the Advanced Training 1 course according to the time interval assigned to you; and completing all follow-up surveys.
3. What are the risks and possible discomforts from being in this research study?
There is a risk of loss of confidentiality if your information or your identity is obtained by someone other than the investigators, but precautions will be taken to prevent this from happening. The confidentiality of your electronic data created by you or by the researchers will be maintained as required by applicable law and to the degree permitted by the technology used. Absolute confidentiality cannot be guaranteed.
4. What are the possible benefits from being in this research study?
4a. What are the possible benefits to me?
There is no guarantee that you will benefit from this research. The possible benefits you may experience from this research study include the education provided in the training.
You will not receive any additional benefit from this research study.
4b. What are the possible benefits to others?
The results of this research may guide the future education of mandated reporters.
5. What other options are available instead of being in this research study?
You may choose not to be in this research study.
6. How long will I take part in this research study?
· If you agree to take part, total participation in this study may be up to 12 months, depending on the access group you are placed in. Active study participation will be between 5.5 and 6.5 hours over that time. Each course you complete will take about 3 hours to complete the core-mandated reporter portion of the study, and you will be asked to complete one final follow-up check-in 3 months after you complete Advanced Training 1. You can start and stop the training programs when it is convenient for you, and you do not have to complete everything at one sitting.
· Depending on when you have access to advanced training, you may have a waiting period during the study. By volunteering to participate, you consent to be contacted by the study team in time intervals regarding completion and access to the microlearning.
7. How will you protect my privacy and confidentiality if I decide to take part in this research study?
7a. What happens to the information collected for the research?
Efforts will be made to limit the use and sharing of your personal research information to people who have a need to review this information. Reasonable efforts will be made to keep the personal information in your research record private. However, absolute confidentiality cannot be guaranteed, and there may be situations where disclosure is required by law.
· This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot disclose information that identifies you to anyone not connected with the research. This protection also prevents this information from being used or disclosed for legal proceedings, such as being accessed through a court order. The Certificate of Confidentiality however does not prevent disclosures required by law, such as information about child abuse or neglect and harm to yourself or others. Also, your information may be disclosed in accordance with any consent you provide, including for your medical treatment or use in other research. Additionally, the Certificate of Confidentiality does not prevent your information from being disclosed to NIH in order for it to evaluate or audit the research, or prevent disclosures required to meet FDA requirements. For additional information ask the principal investigator or a member of the study team or contact the Human Research Protection Program at (814) 865-1775.
In the event of any publication or presentation resulting from the research, no personally identifiable information will be shared.
We will do our best to keep your participation in this research study confidential to the extent permitted by law. However, the following people/groups may check and copy records about this research.
· The Office for Human Research Protections in the U. S. Department of Health and Human Services
· The research study sponsor, NIH
· The Penn State Institutional Review Board (a committee that reviews and approves human research studies) and the Penn State Human Research Protection Program
· The investigator, Penn State study staff, and other Penn State professionals who may be evaluating the study or need this information to do their jobs (such as for treatment, payment (billing), or health care operations)
· JPL D’Vinci
Sometimes a Principal Investigator or other researcher moves to a different institution. If this happens, your identifiable information and samples may be shared with that new institution and their oversight offices. Data will be shared securely and under a legal agreement, if applicable, to ensure it continues to be used under the terms of this consent and authorization.
7b. What will happen to my research information and/or samples after the study is completed?
Researchers can do studies that are more powerful when they share with each other the data or information they get from research studies. They share this information with each other by putting it into scientific databases. Your research information may be put in one or more databases and used for future research. Your information stored in these databases will not include any identifying information. Your research data will only be available to researchers who have received approval from the scientific database and/or Institutional Review Boards. Some of these databases are maintained by Penn State, some are maintained by the federal government, and some are maintained by private companies and other institutions.
9. Will I be paid to take part in this research study?
· If you are an early childhood professional placed into a randomized group, you will receive a $15 Amazon gift card for your participation in this research. Individuals who are not early childhood professionals will not receive a gift card.
· Non early childhood professionals will not receive any compensation for completing the training.
10. Who is paying for this research study?
The institution and investigators are receiving a grant from NICHD to support this research.
The sponsor Berks County IU is paying Penn State for the research to be done.
Dr. Benjamin Levi, the Principal Investigator, is the inventor of the learning module being studied and is a consultant for the company that has licensed the learning module. If research shows the new learning module is effective, Dr. Levi could receive a part of future profits from any sales of the learning module. This financial interest has been reviewed by the PSU Institutional Review Board and Conflict of Interest Review Committee. If you would like more information, please contact the College of Medicine Conflict of Interest Program at (717)531-0003 ext 283526.
11. What are my rights if I take part in this research study?
Taking part in this research study is voluntary.
§ You do not have to be in this research.
§ If you choose to be in this research, you have the right to stop at any time.
§ If you decide not to be in this research or if you decide to stop at a later date, there will be no penalty or loss of benefits to which you are entitled.
You have the right to ask any questions you may have about this research. During the course of the research you will be provided with any new information that may affect your health, welfare or your decision to continue participating in this research.
12. If I have questions or concerns about this research study, whom should I call?
Please call the head of the research study (principal investigator), Benjamin Levi, MD, PhD at (717) 531-4552
§ Have questions, complaints or concerns about the research.
§ Believe you may have been harmed by being in the research study.
You may also contact the Penn State Human Research Protection Program (HRPP) at (814) 865-1775 or visit the HRPP website at https://www.research.psu.edu/irb/participants if you:
§ Have questions or want information regarding your rights as a person in a research study.
§ Have concerns, complaints or general questions about the research.
§ Have questions about your privacy and the use of your personal health information.
You may also call this number if you cannot reach the research team or wish to offer input or to talk to someone else about any concerns related to the research.
A description of this clinical trial will be available on https://www.ClinicalTrials.gov, as required by U.S. Law or policy. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
VERBAL/IMPLIED CONSENT TO TAKE PART IN RESEARCH
I have read this consent form and the research study has been explained to me. I agree to be in the research study described above. A copy of this consent form will be provided to me or I will print a copy for my records. By agreeing to participate, I have not given up any of the legal rights that I would have if I were not a participant in the study.