Laboratories operate in a complex regulatory environment. One or multiple regulations govern nearly all aspects of laboratory operations. Scientists can easily be overwhelmed by the challenges of complying with all the policies that apply to their laboratory activities.
What is research compliance?
Funding agencies, governments, and research organizations need to ensure the safety, security, and integrity of research activities. They have also become increasingly concerned that research activities meet ethical standards. Universities and other research organizations have research compliance offices that are responsible for increasing awareness, monitoring compliance, and handling non-compliance incidents.
The administrative oversight of research compliance may give the impression that compliance is the responsibility of the organization. This impression is misleading as, ultimately, the organization delegates the responsibility to employees in charge of individual research groups. In the US, these employees are called Principal Investigators.
Principal investigators can hold positions like faculty or research scientists. Generally, people who can apply and receive funding from funding agencies are ultimately responsible for complying with applicable regulations and policies. As a result, they are liable for the consequences of not complying with applicable regulations. Research compliance is an essential aspect of properly managing a laboratory.
The University of Washington publishes a list of federal, state, and local laws and regulations that apply to its research activities. The document’s 19 pages give a sense of the complexity of the regulatory environment in which research laboratories operate.
Most research compliance offices organize areas of compliance into four main categories:
- Integrity: responsible conduct of research, research integrity, conflict of interest, intellectual property
- Security: export controls
- Ethics: stem cell research oversight, animal care and use (IACUC), human subjects (IRB)
- Safety: biosafety, radiation safety, chemical safety
The most effective way to ensure compliance is to develop a list of all the regulations and policies that apply to the research performed in a lab. Principal Investigators should understand that nobody else knows as well they do what research activities are taking place in their group. The institution research compliance office will rely on the principal investigators’ voluntary disclosures to help them comply with applicable regulations. It should be regarded as a resource to help principal investigators meet their obligations.
Managing compliance is best achieved in three steps that go from a general analysis of regulatory requirements down to individual tasks that need to be executed periodically to maintain a compliant research operation. Like many other aspects of laboratory management, maintaining compliance requires to put appropriate systems in place.
Step 1: Identify compliance areas
Some compliance areas apply to all research groups irrespective of the nature of their research activities. Managing conflicts of interests, policies relative to intellectual property, and ensuring the integrity of research activities apply to any research group.
Other compliance areas regulate specific research activities and may not apply to particular labs. A laboratory that does not perform animal experiments would not be subject to IACIC oversight. A laboratory that does not perform research on human subjects does not need to be familiar with the processes of the Institutional Review Board.
Step 2: Develop a list of applicable approvals.
It is helpful to think of compliance as the collection of all the institutional approvals necessary to operate a research program. Assessing one compliance area at a time, Principal Investigators can build a list of all the authorizations needed to operate their laboratories. When developing this list, it is useful to record:
- Approval granting body: different offices or administrations may be responsible for specific aspects of the laboratory operations.
- Approval documentation: a site or document describing the process of seeking the approval.
- Approval submission site: the site where the approval application may be submitted.
- Approval recipient: Some approvals are granted to the lab or the Principal Investigator for the entire group. In other cases, all laboratory personnel need their own approval. For example, a laboratory may be authorized to work with a specific biological agent, but each laboratory personnel needs proper biosafety training.
- Approval duration: Most approvals need to be renewed periodically.
Step 3: Maintain a list of current and past approvals
Once the laboratory has established the catalog of necessary approvals, the next step consists of keeping track of approvals received. A laboratory is compliant when all the necessary approvals have been received.
It is recommended that all approvals be documented in central locations accessible to the principal investigator, lab manager, and other personnel in charge of laboratory operations. At the minimum, the laboratory should keep track of:
- The type of approval by pointing to the list developed in Step 2.
- The date the approval was approved
- To whom the approval was granted
- The approval expiration date.
- The project it applies to (if applicable).
- Approval number if applicable
- A record (email, training certificate) documenting the approval
Keeping records of current approvals is important to determine what operations can take place in the laboratory today. In addition records of previous approvals should also be kept to demonstrate past compliance. These records would be valuable to handle investigations of incidents that took place in the past.
The list of approvals should be reviewed monthly to ensure that approvals are renewed in time and that they don’t lapse.
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