Persons who conduct investigations and research with humans must have an appreciation for the significance and impact of their work on the subjects. To that end, training is required before any research can be initiated both by federal mandate and Cal Poly Pomona policy. As of January 1, 2007, all persons (students, faculty, collaborators, etc.) listed as investigators on the protocol must show evidence of human subjects training before the protocol will receive approval by the IRB to conduct the proejct.
In 2006, the Cal Poly Pomona IRB adopted the Collaborative Institutional Training Initiative (CITI) series of modules as the means of training. Collectively, it is called the “CITI course in the protection of human research subjects” and is available on-line at https://www.citiprogram.org. It consists of more than 30 modules addressing topics in both social science and bio-medical research with people, followed by quizzes to test your knowledge. The IRB has grouped these modules for various educational purposes at Cal Poly Pomona. Though you may already have experience and background with human subjects, the IRB could ask that you take additional training appropriate to your proposal application as part of the approval process.
Bioethics training: http://videocast.nih.gov/PastEvents.asp?c=22
US Dept. of Health and Human Services, Office for Human Research Protections (DHHS/OHRP) items:
- educational materials website: http://www.hhs.gov/ohrp/education/#materials
- IRB training videos, http://www.hhs.gov/ohrp/education/training/ded_video.html
- IRB training webinar, transcripts and link on YouTube, http://www.hhs.gov/ohrp/education/training/ded_webinar.html
- If you have trouble with this registration process, review this PDF of a PowerPoint demonstration (updated 17 August 2010). CITI may have made changes to its screens, so the PowerPoint "shots" may not match exactly.
- Register the first time at https://www.citiprogram.org using any name and password you chose. Select California State Polytechnic University, Pomona as the institution.
- Select the group in which you must train as defined by the IRB (for a CPP class, for the basic CPP Introduction to human subjects 101, as a researcher with minors, as an IRB member, etc.). Most need the "Intro 101 course" unless working with a vulnerable subject population. The groupings and the modules composing them are located here in an Excel file.
- You may take any other modules and repeat modules after you complete (obtain a passing score) the group of modules in which you originally enrolled. Simply click on OPTIONAL MODULES which is on the CITI main menu page. A passing score - set by the CPP IRB - is 80% over all of the modules; professors and courses may have other requirements, e.g., some in CEIS require 80% for each module.
- The CPP IRB has set five (5) years as the length of time for which the training is valid. This is subject to change should there be changes in regulations, campus policies, or research methodology. Investigators may be asked to complete additional training to fulfill requirements.
- Navigate through the “General Information” area to become familiar with the site. You may also review this page at CITI.
- Once registered, provide your user name and password each time you log-on and you will go to the appropriate learner’s group. You can change your learner group should it be necessary. You may also affiliate yourself with other institutions that recognize the CITI training.
- The CITI does not cost you; the University pays a subscription fee. It is available on-line 24/7. You may log out and return at a later time, but it is suggested that you complete the module you are working on, including the quiz, first. A transcript (completion report) is generated when you complete the required group of modules, which can be used to show evidence of training to the IRB or for a classroom activity.
for students, by Bruce W. Kennedy MS RLATG CMAR CPIA, administrator of the IRB
as excerpted from the PRIM&R Newsletter of 27 June 07 ...
“I thought it necessary to study history, even to study it deeply, in order to obtain a clear meaning of our immediate time.” - Paul Valery
In considering current events that relate to the field of research ethics, it is important to reflect upon and to commemorate the field’s past. On June 16, 1966, the New England Journal of Medicine published Henry K. Beecher’s “Ethics and Clinical Research”. The article was a courageous exploration of human experimentation that spurred the creation of the contemporary IRB system. Beecher may have written his remarkable article over forty years ago, but he still stands as one of the great icons of ethical research.
The article details 22 instances of unethical experiments involving human subjects including such vulnerable groups as infants and the mentally impaired. Interestingly, despite his insistence that informed consent is essential to the ethical conduct of research, Beecher was not convinced that either informed consent or an ethics review committee would be effective measures for the protection of human subjects. ("Laying ethical foundations for clinical research," by Jon Harkness, Susan E. Lederer, Daniel Wikle. Bulletin of the World Health Organization, 2001, 79 (4)).
[H]e expressed scepticism that ‘consent in any fully informed sense’ was obtainable. Rather than formal rules for human experimentation, Beecher argued that the presence of an intelligent, informed, conscientious, compassionate, and responsible investigator offered the best protection for human research subjects. For the same reason, Beecher was not an advocate of the mechanism of the ethical review committee, now a fixture in health research. (Harkness et al.)
The world is, nevertheless, indebted to Beecher for bringing to light the prevalence of ethical breaches in medical research and the need to protect those who participate in it.