Consent to Participate in TBI Research Opportunities and Outreach for Participation in Studies (TROOPS)

Military Traumatic Brain Injury Initiative’s TBI Research Opportunities and Outreach for Participation in Studies

Principal Investigator: Dr. Michael Roy

This is a referral program that is looking for individuals who want to take part in research studies aimed at improving our understanding of the diagnosis and treatment of traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD). If you decide to take part, you will be asked to provide some information about yourself and your health, which will be used to determine your eligibility for Military Traumatic Brain Injury Initiative (MTBI2) funded and collaborative studies. The program will continue for at least five years but may last longer. You will be contacted for participation in studies until you withdraw from the program or the program is closed.

Introduction

You are being asked to be a part of the TBI Research Opportunities and Outreach for Participation in Studies Referral Program because you are interested in being referred to MTBI2 and collaborative studies. Your participation in this program is voluntary. Please ask any questions you may have about participating in this referral program by contacting MTBI2 at MTBI2-studies@usuhs.edu

Purpose

The program aims to reduce participant burden by evaluating eligibility for research studies while also protecting privacy. TBI Research Opportunities and Outreach for Participation in Studies Referral Program will collect and store contact information, self-reported medical history, and other relevant information to refer participants to MTBI and collaborative studies.

Procedures

If you agree to participate in the program, you will be asked to provide some demographic information as well as information related to your injury. MTBI will evaluate eligibility for potential referral into MTBI2 and collaborative research studies and send your contact information to studies for which you may be eligible and interested.

Benefits

Participation in the program is not likely to benefit you personally, medically or financially. However, the information we gather may enable us to refer you to other research studies that may be investigating the diagnosis and treatment of TBI and/or PTSD. TBI and PTSD are signature injuries of the wars that have been fought in Iraq and Afghanistan and with your participation, you can help the Department of Defense (DoD) and CNRM develop a better understanding of TBI and PTSD to improve diagnosis and treatment.

Risks

We do not expect that there will be any significant risks as a result of participation in this program, since this is a referral program. However, there is always a risk of breach of confidentiality of personally identifiable information (PII).

Alternatives to participating in the program

Your alternative is to not participate in this program.

Confidentiality

Referrals are limited to only MTBI2 and collaborative studies. Your referral program information will be labeled with a participant identification number and stored on secured computers and servers protected with encryption and passwords.

Who has access to your data?

Referral program staff will have access to the information you provide. If deemed eligible for a MTBI2 study, only your contact information will be sent, via secure file transfer, to the study team. If you are eligible for a collaborative MTBI2 study, you will receive an e-mail requesting permission to share your contact information with the collaborator.

Security measures

Data will be captured, stored and secured using MTBI2’s Capture, Access, Sharing and Analytics (CASA) system firewall-protected server. CASA is a National Institutes of Health intramural collaborative development project for a clinical research information system at the National Institute of Neurological Disorders and Stroke (NINDS).

Withdrawal

You can withdraw from this program at any time without penalty. Data collected up to that point will be kept in the database but you will no longer be contacted for additional study participation. Your information collected as part of the program, even if identifiers are removed, will not be used or distributed for future research studies.

Questions?

If you have any questions about the registration process or about participation in the referral program, please contact MTBI2 at MTBI2-studies@usuhs.edu. To inquire about your rights as a participant in the referral program, you may also contact the Director of Human Research Protections Programs at the Uniformed Services University of Health Sciences: 4301 Jones Bridge Road, Bethesda, MD 20814, 301-295-0819

Is participation in a clinical trial guaranteed?

Although one of the main goals of the registry is to make it easier for participants to participate in research, there is no guarantee that an individual participant will be eligible for a particular trial or contacted about a clinical trial.

Electronic Signature Agreement:

Participant’s full legal name (First MI Last):

By selecting the “I Accept” button, you are signing this agreement electronically. You agree your electronic signature is the legal equivalent of your manual/handwritten signature on this agreement. You further agree that your electronic signature on this document is as valid as if you signed the document in writing. You are also confirming that you are at least 18 years of age and have the ability to self-consent. If you fail to electronically sign this document, we will be unable to process your information.