Pain & Neuroaesthetics Participant Screening
CONSENT FOR RESEARCH SCREENING PROCEDURE
The Pennsylvania State University
Title of Project: Pain and the Brain in Different Virtual Reality Environments
Principal Investigator: Elizabeth R. Losin
Address: 208 Biobehavioral Health Building, State College, PA 16802
Telephone Numbers: Weekdays: 8:00 a.m. to 5:00 p.m. 814-863-5405
Why am I being invited to take part in this research screening?
We are asking you to take part in screening procedures because you have expressed interest in participating in the main research study. This consent form will explain the screening procedures. The main research study will be explained in a separate consent form. Agreeing to complete the screening does not mean that you agree to be in the main study. You are urged to ask questions about anything that is unclear to you.
What is the purpose of this research screening?
The purpose of the screening is to determine if you are eligible and if you are, to prepare you for the first research visit.
What will I need to do?
If you agree to participate in this screening, you will be asked to provide us with your contact information and answer a series of questions in the form of a survey. If you are eligible, then we will contact you via phone and we will ask you a series of questions to confirm your eligibility. If the phone screening confirms your eligibility, then we will schedule your visit and send you instructions with what to do before the visit. The instructions will include the withholding of pain medication, alcohol, caffeine, tobacco, food and exercise for a few minutes to a few hours before the study.
How long will the screening procedure last?
It will take you approximately 5 minutes to fill out the questionnaire, and 20 minutes to go through the phone screening.
What are the main risks of the screening procedure?
The main risks of the screening procedure include feeling uncomfortable from some of the questions asked during the screening and loss of confidentiality in case our data security is compromised.
What are the possible benefits to me that may reasonably be expected from being in the screening?
You will not benefit from taking part in this screening procedure.
What happens if I do not want to be in the screening?
Participation in research, including this screening procedure, is completely voluntary. You can decide to participate or not to participate. However, if you do not agree to complete the screening procedure, you cannot be in the main research study.
What happens to the information that is collected as part of this screening procedure?
Your screening data will be treated as research data if you are determined to be eligible. If you are determined to be ineligible or you decide not to participate in the main study, your screening data will be labeled with a code and kept in a secure area.
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 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)
Future Use of Screening Data:
We may use your research information in future studies or may share your information with other investigators for future research without your additional informed consent. Before we use or share your information, we will remove any information that shows your identity.
What if I have questions?
You have the right to ask any questions you may have about this research. If you have questions, complaints or concerns or believe you may have been harmed from participating in this research, you should contact Dr. Elizabeth R. Losin at 814-863-5405. If you have questions regarding your rights as a research subject or concerns regarding your privacy, you may contact the Penn State Human Research Protection Program at 814-865-1775. You may call this number to discuss any problems, concerns or questions; get information or offer input.
You do not have to participate in this research. Taking part in the research study is voluntary. Your decision to participate or to decline the research will not result in any penalty or loss of benefits to which you are entitled.