Early in 2019, the Common Rule was updated to include some major changes. (Keep in mind that the Common Rule is found in 45 CFR 46 and relates to government-funded studies.) Many colleges and universities will be updating their standard operating procedures to include the changes in the Common Rule because some of the changes will have a major impact on how research is conducted within their organizations. Also, remember that Title 45 requires IRBs to have operating procedures.
Your assignment:
- As part of your responsibilities in the Suffolk Community College system research department, you have been asked to review the IRB processes and procedures to identify changes that should be made in it to be compliant with the new Common Rule. This will involve your review of the Common Rule changes and comparison with the rules and processes within the Community College Standard processes. You will be presenting this information to the Community College Advisory Board.
Assignment A
- You will create a fully developed written script to be used as a voice-over narration to the Assignment B PowerPoint presentation. The scripted narration should be a minimum of 3 minutes, not to exceed 5 minutes in length. It should include responses to the Community College Board explaining the following:
Introduction of the purpose of the Common Rule and its applicability to research funded by the federal government. (2 paragraphs)
Why the Common Rule was updated (1 paragraph)
Why the Community College should/should not update its procedures (2 paragraphs)
References should be included and should be on a separate 2nd page.
Assignment B
You will create a PowerPoint presentation with 10-12 slides that outline the changes, or lack of changes, to the standard procedures that you will be presenting to the Community College Board. Keep in mind that if you do not think there should be changes to the standard procedures, you will need to explain why in the PowerPoint and scripted document.
Assignment C
The community college has asked you to investigate the major elements of implementing animal research at the college.
In two pages (double-spaced) explain to them the salient federal regulations and the role of the IACUC
(references should be on another page).
Additional Resources
IRB operations:
- Please review 45 CFR 46 (Links to an external site.) and 21 CFR 56 (Links to an external site.), are operational procedures a requirement? Why do you think they are required?
Please look at the Standard Operating Procedures from these two institutions – are there similarities, differences? Do they seem to address the rules and regulations?
Suffolk County Community College IRB
Columbia University (Links to an external site.)
IACUC operations:
- Please review the “Blue Book (Links to an external site.)” – what is its purpose? What government agency (Links to an external site.) publishes this book? Why do you think this agency is appropriate for oversight?
- Please look at the IACUC rules on page 32 of the Blue Book – are there similarities or differences between these regulations and IRB regulations?
- Cornell University (Links to an external site.) has a website with IACUC procedures – check it out.
- Biosafety Committees and Operations:
The National Institutes of Health is highly involved in the oversight of Biosafety and Biosafety Committees from a national perspective, please read the NIH’s powerpoint(Links to an External Site) (Links to an external site.) what other agencies are involved in the oversight of biosafety concerns? What is all the fuss about biosafety, how should it concern us in research?
Radiation Safety Committees:
Radiation Safety Committees are a little different from other committees because they are overseen by several state and federal entities, depending on the type of committee (university, research, hospital, etc.) In most cases, radiation safety committees are overseen by state radiation safety or radiologic health departments which issue licenses for the use of radioactive materials. The state is active in monitoring any kind of safety concern regarding spills, human exposure to radiation, and other safety issues. At the federal level, the Occupational Safety and Health Administration and the Environmental Protection Agency also have oversight of various aspects of radiation exposure, use, or research.
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