About BIOMED IRB

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History

The BioMedical Research Institute of America (BIOMED) is a non-profit corporation dedicated to promoting the sciences in research and education. BioMed was founded in 1955 by the same advanced group of engineers and physicians who developed San Diego's first heart-lung pump. Many highly skilled specialists, while filling a full time professional position, wished to pursue individual research of their own. The Institute was founded as a non-profit corporation to assist these specialists in many fields, in coming together for the mutual exchange of knowledge, both physical and biomedical, and to provide them a facility for private research. Many of the area's institutions collaborated and provided space for the early beginnings.

The Founding Purpose

The founding purpose was to establish an institution where many scientifically diverse talents of San Diegans could be molded together for the singular purpose of understanding and, wherever possible, relieving disease. A second, and important, purpose was to provide a place where grants (from foundations, government agencies and individual persons) could be received and administered for those who chose to devote their spare time to better mankind. A third purpose was to encourage the young men and women in our colleges and senior high schools to pursue a career in one of the scientific fields.

BioMed Today

Today BioMed's primary purpose and motivation is the sponsorship of organizations within our community which promote science and research. This is accomplished by revenues generated by the IRB which was developed in 1980.

All Board of Directors and Institutional Review Board members, with the exception of IRB staff, volunteer their time for the benefit and good of the community and the satisfaction of investing in the future by rewarding students' interest in science.

Our Mission

The BioMedical Research Institute of America is a non-profit independent Institutional Review Board dedicated to providing scholarships and programs for young students to further their interest and education in science and research. BioMed IRB is committed to superior human research subject protection by maintaining the highest ethical standards while providing prompt personal services in an efficient and cost effective manner.

FDA Controversies

FDA Controversy Close Out Letter

IRB Apology to Investigators

IRB Response to the FDA Restriction

FDA Restricts the IRB

Congressional Subpoena

2007 Congressional Subpoena

March 2016 Congressional Subpoena from Energy & Commerce Committee | Read more from E & C Committee

BioMed IRB Events

The IRB holds a voting meeting once per week. Please call the office if you need more specific scheduling information.

Board of Directors

BioMed has many opportunities for Honorary Directors with specialized know-how donated to guide us. BioMed recruits volunteers to serve on its Board of Directors. Volunteers are not paid, and, we discourage direct connections to current customers, vendors or stakeholders with missions even if complimentary to our programs to promote science and education. We do get help from volunteers, we have many ambassadors who bring us intellectual and financial strength for our efforts to maintain independent citizen engagement in advancing education and health care.

Most of our volunteers do not become members of our Board of Directors. Most of our volunteers do become members of the Institutional Review Board (IRB) and directly oversee clinical research. All of our volunteers encourage awareness of our accomplishments and goals. Members of the Board of Directors (BoD) personally and most often contribute to our mission in ways that do not win any recognition beyond our deepest appreciation and respect. Board members are selected on the basis of their demonstrated record of sharing their experience and commitment to improving the world regardless of commercial advantage or political gain. We reach out and recruit for volunteers to help BioMed in all of our activities. Every member of the BoD donates more than time to help our mission. Nominations to our BoD must be made prior to May 24 of each year for action by the BoD.

Past Beneficiaries

For donation or volunteer information about any of our beneficiary organizations, please contact us at .

Information for Study Subjects

What is a clinical trial?

A clinical trial (also called research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health.

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. Before joining a clinical trial, a participant must qualify for the study.

Benefits

  • Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
    • Play an active role in their health care.
    • Gain access to investigational medications before they are widely available.
    • Help others by contributing to medical research.

Risks

  • There may be unpleasant, serious or even life-threatening side effects to treatment.
  • The study medication may not be effective for the participant.
  • The study plan may require more of their time and attention than routine medical care, including trips to the study site, hospital stays or complex dosage requirements.

Every clinical trial in the U.S. must be approved and ethically overseen by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB by definition, is an appropriately constituted group that has been formally designated to review and oversee biomedical research involving human subjects. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

The purpose of an IRB 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 to ensure protection of the rights and welfare of human subjects of research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The consent document is a written summary of the information that should be provided to the subject. Many clinical investigators use the consent document as a guide for the verbal explanation of the study. The subject's signature provides documentation of agreement to participate in a study, but is only one part of the consent process. The entire informed consent process involves giving a subject adequate information concerning the study, providing adequate opportunity for the subject to consider all options, responding to the subject's questions, ensuring that the subject has comprehended this information, obtaining the subject's voluntary agreement to participate and, continuing to provide information as the subject or situation requires. Te be effective, the process should provide ample opportunity for the investigator and the subject to exchange information and ask questions.

You can contact the IRB Monday through Friday, from 8am to 5pm, Pacific Standard Time.

BioMed IRB
P.O. Box 600870
San Diego, CA 92160-0870

Phone: (800) 643-0730

www.biomedirb.org

For additional information regarding clinical trials, please visit the FDA Information sheets at http://www.fda.gov/oc/ohrt/irbs/default.htm.