59th MDW Human Research Protection Program

The mission of the 59th MDW Human Research Protection Program (HRPP) is to protect the rights and welfare of human research participants recruited to participate in research training conducted under auspices of the 59th Medical Wing. The HRPP aims to:

• Create an atmosphere of respect for and awareness of the rights and welfare of human research patient
• Train and inform researchers about the changes and ongoing application of DoD, Federal, State, and local regulations and ethical principles of research in order to keep researchers current with evolving standards
• Develop new approaches that better serve the overarching mission of the HRPP, making the IRB regulatory process user-friendly as possible by minimizing regulatory burdens

What is the Association for the Accreditation of Human Research Protection Programs (AAHRPP)?

The 59th MDW’s HRPP has been fully accredited by AAHRPP since first seeking accreditation in 2017. AAHRPP accredits Human Research Protection Programs that demonstrate superior research subject safeguards, surpassing the threshold of state and federal regulatory requirements. Our HRPP strives to adhere to the utmost ethical standards in its protection of human research participants and seeks to further enhance current methods and mechanisms for protecting these participants.

Who are the key personnel responsible for the 59 MDW HRPP?

Institutional Official (IO): The 59 MDW Commander is identified by DoD policy as the senior leader responsible for the overall establishment, implementation and regulatory compliance of the HRPP.
 

Alternate Institutional Official (AIO):The 59 MDW Chief Scientist is appointed AIO by the IO, and through delegated responsibilities serves as the point of contact for all daily operations of the HRPP.
 
Human Protections Administrator (HPA): The HPA is the institution’s subject matter expert on the HRPP and assists the AIO in managing daily operations of the HRPP on behalf of the IO.

If I have questions, comments, or concerns regarding the 59 MDW HRPP, who can I contact?

The IO, AIO and HPA have open-door policies regarding the HRPP. 
For general inquiries or comments, contact the Office of Protocol Support at 210-292-4683/5819 or email usaf.jbsa.59-mdw.mbx.wing-crd-protocol@health.mil.
For concerns and/or urgent issues regarding study conduct or the safety of study participants, HRPP senior leaders can be contacted at:

-   HPA - 210-292-2977
-   AIO – 210-292-5687
-   IO – 210-292-7069

What is a research study?
A research study is an organized way of learning more about a problem or answering a question.

A research study may be done to:

• Understand health needs, concerns or feelings people have about an illness or their general health.
• Test if a product, such as a drug or piece of equipment, is safe and/or effective.
• Determine the best way to treat or prevent an illness.
• Find out what health care practices work best.

Like your medical record, information in your research record will be kept confidential.

Are there benefits to being in a research study?
There may or may not be a direct benefit to your health or health condition if you take part in a research study. The study may not help you personally, but your participation may provide information that will improve the lives of others in the future. If you are considering participating in a specific study, the benefits of that study will be discussed with you during the informed consent process.

What is an Institutional Review Board (IRB)?
An IRB is an appointed committee that reviews, approves, disapproves or request changes to research projects involving human subjects, regardless of funding source. As required by law and Department of Defense policy, research study can begin only after it is approved by an IRB. 

The San Antonio IRB provides oversight of all human participant research studies conducted within the 59th Medical Wing. IRB members ensure the proposed research protects the rights and welfare of human subjects and that the study has undergone a thorough review of the ethical considerations of Respect for Persons, Beneficence and Justice.

What is Informed Consent?
Informed consent is the process of learning important facts about the research study before you decide whether or not to volunteer. This process is required by law. Once complete, you should have a sufficiently clear understanding of what will take place in the study and how it might affect you.

Informed consent begins when the research staff explains the study to you to include details about the study, tests or procedures you may receive, the benefits or risks that could result and your rights as a research volunteer.

If you have any questions while participating in the process of informed consent, ask the research staff to explain. You may ask as many questions as you need to feel informed and comfortable with your decision to participate.

It may be helpful to talk with family members, friends, or your health care providers before you make a decision. If you determine that is the case, it is your right to pause the informed consent process to make a thoughtful decision about participating. You may come back at a later time to continue the process or decline to participate.

Who can I contact if I would like to be a study participant?
If you are interested in a specific study that is being advertised, reach out directly to the contacts that are listed in the study advertisement. If you are generally interested in supporting research as a participant but don’t have a specific study in mind, please e-mail:
usaf.jbsa.59-mdw.mbx.wing-crd-protocol@health.mil

Who can I contact if I have questions or concerns about any studies currently being conducted in the 59 MDW?
If you are currently enrolled in a study as a participant, contact the study personnel listed on the informed consent paperwork you were provided when you enrolled. If you can’t find that paperwork, contact the Office of Protocol Support staff (see below). They can notify your study coordinator to contact you.

For general inquiries or comments, contact the Office of Protocol Support at 210-292-4683/5819 or email: usaf.jbsa.59-mdw.mbx.wing-crd-protocol@health.mil

Who can I contact regarding a potential institutional or financial conflict of interest (COI)?
CIRS Protocol Office: (210) 292-5819/1928/6095
Human Protections Administrator (HPA): (210)-292-2977
COI Org Box E-mail: usaf.jbsa.59-mdw.mbx.chief-scientist-hrpp@health.mil
COI Phone: (210)-292-1016
 

To access the most current 59 MDW HRPP Policies, Guides, Templates and Worksheets, visit the DHA Knowledge Exchange at (CAC only):  https://kx.health.mil/kj/kx8/ClinicalResearchJBSALackland/Pages/home.aspx
 
Who can I contact to submit feedback or recommendations regarding the HRPP?
For general inquiries or comments, contact the Office of Protocol Support at 210-292-4683/5819 or email: usaf.jbsa.59-mdw.mbx.wing-crd-protocol@health.mil
 
Who can I contact to report concerns regarding study conduct? 
For concerns and/or urgent issues regarding study conduct or the safety of study participants, HRPP senior leaders can be contacted at:

• HPA - 210-292-2977
• AIO – 210-292-5687
• IO – 210-292-7069

 
What do you do if a research subject has a complaint? Who do you report it to and when?
All complaints received regarding 59 MDW institutional HRPP concerns under the jurisdiction of the 59 MDW HRPP will be investigated accordingly. Complaints can be reported via email (usaf.jbsa.59-mdw.mbx.wing-crd-protocol@health.mil) or anonymously by phone: 210-292-2977 to the HRRP via the 59 MDW Office of Clinical Research Support. Complaints are considered sensitive issues and the relative information provided by the complainant and the identities of individuals or an institutional entity named in a complaint will be handled appropriately with discretion and confidentiality until a final determination is made by the 59 MDW AIO or designee addressing the complaint.
 
Who can I contact regarding a potential institutional or financial conflict of interest?
CIRS Protocol Office: (210) 292-5819/1928/6095
Human Protections Administrator (HPA): (210)-292-2977)
COI Org Box E-mail: usaf.jbsa.59-mdw.mbx.chief-scientist-hrpp@health.mil
COI Phone: (210)-292-1016