What is an Institutional Review Board (IRB)?

What is an Institutional Review Board (IRB)?

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving any human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. IRB’s are registered with the FDA (21 CFR 56.106).

Does Dr. Bastuba use an IRB?

In 2019, Dr. Bastuba created an IRB to provide oversight to research being performed at Male Fertility & Sexual Medicine Specialists, Fertility Center of California and Family Fertility CryoBank. The IRB (Internal Review Board) for Martin D Bastuba, MD., FACS has been registered under the name “Horizons Medical Review Board”.

The general responsibilities of IRB members include but are not limited to:

• Providing written evaluations of the research protocol and informed consent document(s) to MFS in advance of the IRB meeting;
• Utilizing the IRB Reviewer Checklist as a guide when reviewing protocol submissions;
• Basing their review and approval decisions for industry-sponsored clinical trials on the information presented in the sponsor’s clinical protocol and investigator’s brochure and IRB research application;

Each member of the Board signs a code of ethics. As a member of Horizons Medical Review Board, these professionals, dedicate themselves to carrying out the mission of this organization.

We follow these guidelines:

• Recognize that the chief function of the Horizon Medical Review Board at all times is to serve the best interests of the patients.
• Accept as a personal duty the responsibility to keep up-to-date on emerging issues and to conduct ourselves with professional competence, fairness, impartiality, efficiency, and effectiveness.
• Respect the structure and responsibilities of the Board, provide them with facts and advice as a basis for their making policy decisions, and uphold and implement policies adopted by the Board.
• Keeps the community informed about issues affecting it.
• Conduct operational duties with positive leadership exemplified by open communication, creativity, dedication, and compassion.
• Serve with respect, concern, courtesy, and responsiveness in carrying out the organization’s mission.
• Demonstrate the highest standards of personal integrity, truthfulness, honesty, and fortitude in all our activities in order to inspire confidence and trust in our activities.
• Avoid any interest or activity that is in conflict with the conduct of our official duties.
• Respect and protect privileged information to which we have access in the course of our official duties.
• Strive for personal and professional excellence and encourage the professional developments of others.

Some of the members of the Horizons Medical Review Board include:

• A medical research investigator
• A primary care physician
• An embryologist
• A project manager for a large financial Group
• The owner of a full facility blood and genetics testing lab
• Manager of a head and neck (ears, nose, and throat medical practice)
• A financial adviser
• A homemaker
• A fireman
• A sales representative
• etc.

If you live in the San Diego area and want to become a member of Dr. Bastuba’s at arm’s length IRB known as Horizon’s Medical Review Board, please send your resume or CV to [email protected] for consideration.

What IRB research is Dr. Bastuba Involved in?

Dr. Bastuba is conducting instrumental on-going research dedicated to continuously trying to improve pregnancies and live birth rates. They have been approved through an IRB such as Horizons Medical Review Board. Some of these research projects include:

DNA Fragmentation Index (DFI): The lowering of DNA fragmentation identified in the head of sperm that can lead to an increase in miscarriages. (Rocco, et. al., 2019, Western Section AUA).

Testicular Sperm Aspiration (TESA) Procedure Improvement: The ability to increase the volume and quality of sperm recovered from obstructive males for use in ART procedures. This abstract / paper will soon be published. --- Still ongoing

Comparison of) Testicular Sperm Aspiration (TESA) to Testicular Sperm Extraction (TESE) sperm analysis. An abstract to soon be published establishing with confidence that both types of sperm retrieval yield adequate and viable sperm for ART procedure.

Nutritional Supplements: Research comparing the semen analysis difference of a patient on specific nutritional supplements over a 3 month period.

Post Vasectomy Sperm Freezing: A research project designed to determine how much time after receiving a vasectomy a patient can continue to donate viable sperm. --- Still ongoing

Comparison of sperm wash techniques for IUI: A study on Pregnancy Rates Comparing Sperm Preparation via Sperm Wash Technique vs. Microfluidic Sperm Separation Device in Same Sex Patients --- Just started