Research Studies, Consent Forms, and Subject Protection

Another role of the IRB is to monitor the research.  Every six months, researchers must make available to the local IRB copies of all consent forms, a summary of the research results and a list of any complications of the research.  Severe complications, know as severe adverse events (SAES) must be communicated to the IRB within 24 hours of the researcher learning of it.

It should be fairly clear that studies involving human research are taken very seriously.  You, a member of your family or a friend should be able to enter into a research study with a strong belief that there are layers of safeguards that should help protect you from serious ethical concerns.  These safeguards do not necessarily protect you form something going wrong.  After all, it is research.  If there was certainty about the procedure or treatment, there would be no need to do the research.  However, it is with this research that our insight into, understanding of, and ability to treat Alzheimer's disease continues to grow.  All of us owe a lot to the many people who volunteer for research studies.  At this time of year as we rejoice for many things, let us appreciate the research volunteers, the IRB committee members and the dedicated researchers who are helping us to diminish the impact of Alzheimer's disease.