Protection of Human Subjects Training

  • Saint Francis University endorses the core principles of protection of research involving human subjects as expressed in the Belmont Report.

     

    All individuals involved in human subjects research are required to complete this course and submit the certificate of completion of protection of human subjects with the IRB application.  Certificates will be valid for 3 years from completion.  If you have an official certificate of protection of human subjects from another accredited institution (within 3 years of date of submission of your IRB application) you may provide that to the Saint Francis University IRB.  It is the Principle Investigators responsibility to assure that all members of the research team has completed the training program and follow the core principles.

     

    Use the link below to complete the IRB training and receive the certificate (Remember to submit your certificate with your IRB application):

     

    NIH Training for the Protection of Human Subjects

     

    In 1978, the Belmont Report (Belmont report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research) was published.  This report serves as a foundational guideline to assist scientist in the protection of human subjects that participate in our research.  Although there can be a blurry line between practice and research, for this purpose the intention of the research activity is understood to be an activity  "designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge." (Belmont Report,  page 2)   Core to the Belmont Report and to a researchers responsibility towards their human subjects are 3 concepts.

     

    Respect for Persons

    There are 2 aspects to this principle.  The first is the acknowledgment that individuals who participate in our research are autonomous agents.  The second aspect is that sometimes our research with involve individuals with a diminished autonomy, this requires us to insure a protection of their autonomy.  This principle is manifested in our acknowledgment that individuals are capable of choosing goals when provided necessary information.  This belief in self-determination matures with age, but is sometimes limited either by age, illness, disability or circumstance.  It is these individuals that we must extend our protection from exploitation.

     

    Beneficence

    This principle relates to the above principle of Respect for Person in that as researchers we have the obligation to  our subjects' well-being.  Essentially, we are required to follow the Hippocratic maxim - do no harm.  However, this must be balanced with the pursuit of knowledge.  As researchers, we are asked to balance our pursuit of knowledge with the safety of our participants.  We are asked to maximize possible benefits to our subjects against the possible harms that they may experience.  Conducting research with human subjects does not mean avoiding potential risk, but our inclusion of risk for human subjects must be justified and disclosed to our subjects so that they may make a informed voluntary decision.

     

    Justice

    If we believe that all people are equals, then all people should be treated equally.  The principle of justice is threatened when a group of individuals are identified and used in our research, but will not benefit from the findings.  The history of research, internationally and nationally, as marked with examples of injustice.  As researchers, it is our responsibility to  be aware of an equitable distribution of participation.