Ovacome

What are the risks and benefits of clinical trials?

Potential benefits:

The possibility of early access to improved treatment.

The chance that even if it doesn’t work for everyone in the study, it may work for you.

Frequent check-ups to observe treatment response and possible side effects.

The sense that you are taking an active role in your care.

The knowledge that you are helping to change the future of cancer care.

Potential risks:

Possible unknown side effects or results.

The chance that the new treatment may not work as well as the current standard of care.

The chance that even if a new treatment works for some, it may not work for everyone.

The very remote chance that the strictest means of protecting your personal health information would fail to ensure confidentiality.

What is done to protect participants?

Doctors and nurses associated with clinical trials watch participants very closely to ensure their safety and comfort.  Less visible, but not less powerful, is the protection mandated by legislation and regulatory groups.

The Health Insurance Portability and Accountability Act (HIPAA) was enacted by US Congress in 1996.  Title I of HIPAA protects health insurance coverage for workers and their families when they change or lose jobs.  Title II of HIPAA requires the establishment of national standards for electronic health care transactions and national identifiers for providers, health insurance plans, and employers. Title II also addresses the security and privacy of health data, which has had a huge impact on clinical research policies and procedures.

Scientific Review Committees (SRCs) exist in every facility that conducts clinical research. SRC members are clinician-scientists who assess the protocol’s importance, innovation, and scientific integrity as well as the appropriateness and adequacy of the research team.  Every protocol undergoes scrutiny by that facility’s SRC prior to submission to the IRB.

Institutional Review Boards (IRBs) approve, monitor, and review biomedical and behavioral research that involves people.  IRBs exist to protect the rights and welfare of participants in clinical research.  No clinical trial may go forward until the study protocol and related documents, such as the informed consent form, have been IRB-reviewed and IRB-approved. The IRB requires progress reports, approves modifications to the protocol, and conducts annual reviews.