Title of Project: Emotion dynamics and alcohol use in NIAAA-defined recovery from alcohol use disorder
Principal Investigator: Braden K. Linn, PHD, LMSW, MCMP
Address: Department of Family and Community Medicine
700 HMC Cres Rd
Hershey, PA 17033
Mail code A050
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 initial eligibility for the main study. This screening is not a method of requesting help for mental health concerns, crises, or drinking. At the end of this screening, the study team will provide a list of mental health and alcoholism treatment resources to you. Screening data will be used as study data.
What will I need to do?
If you agree to participate in this screening, you will be asked to answer questions about your age, history of alcohol problems, and if you live within commuting distance of the Hershey Medical Center. There are no right or wrong answers to these questions and you may skip questions if you do not wish to answer.
How long will the screening procedure last?
The screening procedure will take 2-3 minutes.
What are the main risks of the screening procedure?
The main risks of the screening procedure include breach of confidentiality and feeling some distress from the questions you will be asked.
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 and samples if you are determined to be eligible.
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, National Institute on Alcoholism and Alcohol Abuse
• 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)
HIPAA: The research team may use your past, present, and future medical information and records for the purpose of your participation in the screening procedure specifically identified in this authorization. Information that will be disclosed may include information developed as a result of the research study, information that identifies you, and information in your medical record, such as HIV/AIDS diagnosis, drug/alcohol treatment and mental health data. Your authorization will remain in effect until you revoke it. You may change your mind and revoke (take back) this authorization at any time and for any reason. However, any information previously disclosed under this authorization may not be retrieved and may no longer be protected by federal or state privacy laws. To revoke this consent and authorization, contact the Principal Investigator using the information found on the first page of this form. Revocation of, or refusal to sign, this consent and authorization will not impact the care you receive at Penn State that is not related to the research; however, you will be excluded from participation in this screening procedure if you do not provide this consent and authorization.
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.
Who is paying for this screening procedure?
The investigators received a grant from the National Institute on Alcoholism and Alcohol Abuse to perform the research.
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 Braden K. Linn, PhD, LMSW, MCMP at (717) 531-0003 x321641 or blinn1@pennstatehealth.psu.edu. 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.
VERBAL/IMPLIED CONSENT TO TAKE PART IN SCREENING
I have read this consent form and have contacted the study team by email or phone to ask any questions I have. I agree to be in the screening described above. I will print a copy of this screening form for my records or contact the study team by email or phone to have one sent to me. By agreeing to participate, I have not given up any of the legal rights that I would have if I were not participating in this screening.
