A Mixed Methods Study to Develop an Instrument to Assess Family Quality of Life Among Caregivers of Adults with Traumatic Brain Injury

TITLE OF RESEARCH: A Mixed Methods Study to Develop an Instrument to Assess Family Quality of Life Among Caregivers of Adults with Traumatic Brain Injury

UAB IRB Protocol: X110628006

INVESTIGATORS: Stephen L. Firsing III, Dr. Brian F. Geiger, Dr. Laura K. Vogtle, and Dr. John Dantzler

EXPLANATION OF PROCEDURES: You are invited to participate in a research study to discuss Family Quality of Life among caregivers of adults (19+ years of age) with moderate to severe traumatic brain injury. Caregivers provide regular support and assistance to an adult family member with moderate to severe traumatic brain injury. Caregivers may include many people, such as mothers, fathers, spouses, partners, siblings, adult children, grandparents, aunts, uncles, etc. The information you provide will be helpful to researchers at the University of Alabama at Birmingham (UAB) who are developing new tools to measure Family Quality of Life. You must be 19 years of age or older to volunteer for this research study. The survey will take about 20 minutes to complete. Read this form before deciding whether to participate. No one will visit your home. Your personal information will not be told to others. Your responses are confidential.

RISKS AND DISCOMFORTS: Risks are not greater than those encountered during daily life. If there are any specific questions you do not wish to answer, please skip them and move on to the next question. There is a possible risk of loss of confidentiality; however, no identifying information will be collected.

BENEFITS: You may not personally benefit from your participation in this research study; however, your participation will be helpful to develop new tools to measure Family Quality of Life among caregivers of adults with moderate to severe traumatic brain injury.

ALTERNATIVES: You may choose not to participate with no penalty.

CONFIDENTIALITY: Information obtained about you for this research study will be kept confidential to the extent allowed by law. However, research information that identifies you may be shared with the UAB Institutional Review Board (IRB) and Office for Human Research Protection (OHRP). The results of the research study may be published for scientific purposes. Your identify will not be told to others.

REFUSAL OR WITHDRAWAL WITHOUT PENALTY: You are free to withdraw and stop participation in this research study at any time.

COST OF PARTICIPATION: There will be no cost to you to participate in the research study.

PAYMENT FOR PARTICIPATION IN ASSESSMENT: There is no payment for participation in this research study.

QUESTIONS: Call Mr. Stephen L. Firsing III at (910) 232-6450, or Email: firsing@uab.edu if you have any questions about the research study. If you have questions about your rights as a research participant, or concerns or complaints about the research, you may contact the Director of the Office of the Institutional Review Board for Human Use (OIRB) at the University of Alabama at Birmingham (UAB). The Director may be reached at (205) 934-3789 or 1-800-822-8816. If calling the toll-free number, press the option for “all other calls” or for an operator/attendant and ask for extension 4-3789. Regular hours for the Office of the IRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday. You may also call this number in the event the research staff cannot be reached or you wish to talk to someone else.

LEGAL RIGHTS: You are not waiving any of your legal rights by participating in this research study.