What is Research Compliance & Why Does it Matter?

Research teams are responsible for groundbreaking innovations that shape our future, from new technology to medical breakthroughs. However, there are many regulations in place to ensure research is conducted safely and ethically for the benefit of research subjects, staff, and organizations. 

Whether these regulations stem from state laws, federal laws, or an institution’s best practices, researchers and research administrators must be aware of their scope and impact to ensure their efforts are compliant. 

In this blog, we’ll review some of the most common areas of compliance, potential repercussions of non-compliance, and how modern software can help ease compliance management. 

Research involving human subjects

Biomedical and behavioural research often relies on the use of human subjects. In order to ensure such research is ethically conducted and safe for participants, all projects involving human research subjects must undergo independent evaluations by Institutional Review Boards (IRBs). 

IRB evaluations aim to confirm that ethical principles are followed and that appropriate safeguards are in place to protect the rights and welfare of research subjects. Common elements investigated during IRB reviews include confirmation that participants have provided informed consent, that subjects were selected equitably, and that all risks to the subjects are minimized and reasonable in relation to anticipated benefits.

Research involving animal subjects

Just as research involving human subjects must undergo compliance reviews to ensure subject safety, so too must research projects involving animal subjects. While IRBs are responsible for human research integrity, projects that use animal research subjects must submit animal use protocols (AUPs) for evaluation by an Institutional Animal Care and Use Committee (IACUC).

The IACUC is responsible for checking that a study’s AUPs conform to guidance from the NIH Office of Laboratory Animal Welfare (OLAW). This includes assurance that animal research subjects are provided with species-appropriate living conditions and medical care from qualified veterinarians, that procedures avoid discomfort, distress, and pain to animal subjects, and that all personnel working on a project are qualified and trained on their procedures.

Research involving hazardous materials

While IRBs and IACUCs focus on protecting research subjects, compliance reviews are also important for ensuring the safety of researchers themselves. This is especially important for research projects that involve biohazards, which must undergo review by an Institutional Biosafety Committee (IBC).

As with IACUC reviews, IBCs check study protocols for compliance with regulations. However, in this case, the committee reviews a study’s protocols to ensure appropriate safety measures are taken for any projects involving animal subjects, biological toxins, human and non-human bodily fluids, pathogens and microorganisms, or recombinant and synthetic DNA.

Potential conflicts of interest in research

Research compliance isn’t just about physical safety; it also covers institutional and individual integrity, most frequently through checks for potential conflicts of interest (COI).

COI reviews screen for situations where an investigator’s personal, financial, or other interests (such as other roles that may conflict with a project) may inappropriately influence a project’s design or conduct. COI can be particularly tricky to manage, as investigators may not realize that they have a conflict. For this reason, all PIs involved in a project need to report their potential conflicts, no matter how seemingly unrelated they may be to the research at hand.

Consequences of non-compliance

Consequences for non-compliance with any of the above areas of research can range in impact, but are always serious. Failure to comply with IRB, IACUC, IBC, and COI regulations can lead to the following issues:

1. Harm to research subjects and PIs, with severe cases leading to disability, chronic health issues, or death
2. Financial repercussions, including lawsuits and the loss of funding
3. Reputational damage that can make a lasting negative impact on individuals, teams, departments, and even institutions as a whole
4. Loss of accreditation eliminating the ability to conduct future research

Because these consequences can be devastating, institutions must do everything in their power to maintain compliance with all relevant regulations. 

While compliance workflows can be difficult to navigate, modern research software like the Cayuse Compliance Management Suite helps automate and streamline processes to ensure all potential hazards are addressed before they become major issues.