It seems that every day there are more and more rules and regulations that must be followed, while conducting research of any kind. At first glance, it’s easy to view these regulations and associated paperwork as either unnecessary, requiring too much time, another hindrance or something to ignore. In reality, these laws actually help in our efforts to conduct quality research. In a field where resources are limited and competition is fierce, quality, regulatory compliant research is a key to success. The following are just a few of the reasons to be compliant.
Compliance Can Make and Save You Money
- Following the correct processes from the beginning eliminates the possibility of lost time and delays and the possibility of missing an application or funding deadline.
- Proper training for support staff and students assures that productive time is not lost as a result of injury to an employee or student or damage to your lab.
- Proper training and safety measures also protect the integrity of your research, as well as the health and safety of your employees and students. It also shows your employees and students that you care.
- If the appropriate committee approvals are not obtained, it is possible that you might not be able to use the data from your research.
It’s Your Reputation
- Word travels in every community, whether it is on or off campus, at the national or international level. Everyone knows who conducts quality research that is compliant with the appropriate regulations.
- Developing a reputation for quality research will help you obtain funding and advance or maintain your career.
- It will help with recruiting and retaining staff. People are attracted to laboratories where quality research is safely conducted.
It’s the Law
- Failure to follow the regulations can result, not only in a loss of funding for the investigator, but also for the investigator’s college and the University.
- Failure to follow the regulations can result in a monetary fine for both the investigator and the institution.
- Just one incident of serious non-compliance with regulations can result in the loss of research privileges for the entire institution.
- Failure to follow the regulations in a serious incident of non-compliance can result in a jail sentence for the investigator.
How to Comply
Federal, state, local, university, and private funding agencies have rules about the conduct of research involving vertebrate animals; humans; radiation; recombinant or synthetic nucleic acid molecules; pathogens of humans, animals, and plants; and toxins. The Office of Research Ethics (ORE) is here to help you stay abreast of the rules and to help you keep your research in compliance with applicable regulations.
Compliance Committee Approval
ORE provides administrative services for four research compliance review committees. If your research, teaching, or testing activities involve research in the areas listed in the table below, you must obtain approval from the appropriate research compliance review committee(s) before initiating the research and collecting data. All investigators — undergraduate students, graduate students, professional and scientific staff, and faculty — are required to obtain any necessary approval(s), regardless of whether their funding is internal or external.
Use the table below to determine where to obtain and submit forms for project approval.
|If your project involves:
|You will need approval from:
|For more info, contact:
|Live vertebrate animals
|Institutional Animal Care and Use Committee (IACUC) IACUC Forms
|Human research participants
|Institutional Review Board (IRB) IRB Forms
|Radioisotopes or radiation producing devices
|Radiation Safety Committee (RSC) RSC Forms
|Radiation Safety Officer
|Use of recombinant or synthetic nucleic acid molecules, including transgenic animals or plants; use of human or animal pathogens (e.g., bacteria, viruses, prions, parasites); use of soil, seed, plants, plant pathogens (e.g., bacteria, viruses, or parasites) or other material received under a USDA APHIS compliance agreement or permit; use of biological toxins; administration of experimental biological products to animals; field releases of plant pests received under a USDA APHIS PPQ permit; field releases of genetically modified organisms that are under a USDA APHIS PPQ or BRS permit or notification (e.g., not commercially available GMOs).
|Institutional Biosafety Committee (IBC) IBC Forms
|Import from a foreign country, interstate transport, field test of biohazards (i.e., federal permit requirements)
Note: While the discussion below gives an overview of the general approval process, each committee has its own unique requirements and timelines. For more detailed information about a particular committee’s approval process, please contact the committee office or visit the committee’s web pages.
Changes to a Study
If you wish to make any changes to an approved protocol, it is your responsibility as principal investigator to notify the committee(s) of the changes and to obtain approval before implementing them.
When you obtain approval from the appropriate research compliance review committee(s), it will be granted for a specific period of time; each committee has different time requirements for submission of renewal applications. In most cases, federal law or guidelines require continuing review of active research projects at least annually to ensure that they are still compliant with the applicable regulations. As a courtesy, the committee administrator will notify you of the approaching continuing review date. However, you are responsible for submitting the continuing review application in time to permit its review and approval prior to the expiration date.
If the committee does not receive and approve an application renewal before the expiration date, the approval for the project will lapse, and all research, teaching, or testing-related activities for the project must stop until approval is once again granted. In order to reestablish approval, you may be required to submit a new application for the committee’s review and approval.
This renewal process does not apply to projects approved by the Radiation Safety Committee (RSC). The Department of Environmental Health and Safety (EH&S) was empowered by the RSC to provide continuous oversight of authorized radiation users. Each authorization is reviewed on a quarterly basis to ensure compliance. Those users who are not compliant will have their authorization for use of radioisotopes or radiation-producing devices revoked and must follow the procedures established by the ORE and EH&S to reobtain approval.
Once a project is complete, you should notify the appropriate review committee(s) so that the file can be moved to inactive status.
Training for investigators and key personnel is often required by the federal regulations for each of the research areas listed above. Also, remember to retain documentation of research-related education or training that you receive, as well as documentation of any training that you provide for your laboratory or project personnel.