The question of whether independent review board (IRB) approval is required for human factors studies is debated on almost every study we conduct. The short answer is: it depends.
A more considered response is presented below:
The US Health and Human Services (HHS) states that research involving human subjects must receive IRB approval in accordance with CFR policy Title 45 (Public Welfare), Part 46 (Protection of Human Subjects). 45 CFR 46. The policy defines research and human subjects as:
- Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
- Human subjects are living individuals about who an investigator conducting research:
- obtains information through intervention or interaction with the individual, and uses, studies, or analyses the information, or
- obtains, uses, studies, analyses, or generates identifiable private information.
Since usability studies are arguably both research and include human subjects per the definitions above, it is certainly best practice to obtain IRB approval. That said, it’s important to recognise that the definitions and origin of the policy comes from the clinical trials landscape. During the early days of HF being applied to medical devices, in the advent of the guidance from FDA, many med tech and pharma organisations turned to their colleagues working in clinical trials to help define appropriate SOPs and ways of working for HF studies. By virtue, the adoption of IRB processes were woven into many HFE SOPs and internal processes. While some HF studies do carry low levels of risk to participants, the risk profile is typically multitudes lower than those associated with a clinical trial. Additionally, IRB is not typically sought for market research studies, even in the US, despite the definitions of ‘research’ and ‘human subjects’ being met in this field too.
Commonly, we see the need for IRB approval in the US being determined on a case-by-case basis. For minimal to low-risk studies, the sponsor sometimes determines that IRB approval is not required (e.g. a study involving only HCPs who will interact with a device very similar to one they are deeply familiar with). While some sponsors make the determination that IRB is not required for themselves, others advise that only an IRB should determine the necessity, and that exemption should be determined by an IRB, not the sponsor or CRO.
At Rebus, we take a case-by-case approach depending on the risk profile for the study and guidance from our own client’s internal procedures. Typically, for studies in the US which involve patients, we will seek IRB approval as a measure of best practice. However, for a study which only involves skilled surgeons or OR staff and a new surgical device, we may determine that IRB is not necessary.
Regardless of your stance on when IRB approval is required or not, it’s important to remember that at a foundational level, the IRB is there to protect human subjects, including the physical, psychological, and social risks associated with a study. Therefore, if there is any doubt over the safeguarding in place, it’s strongly recommended to seek IRB approval in the US.
In the UK, the landscape is much clearer. The BHBIA guidance for legal and ethical framework for healthcare research states that market research (under which usability studies are considered to fall) is outside of the scope of governance overseen by the National Institute for Health Research (NIHR). Thus, ethical approval is not mandatory for such research studies.
Additionally, unlike the USA, commercial IRB panels do not exist. Instead, ethical reviews are performed by university institutions and hospital trusts with teaching faculties. Typically, these panels will only review research studies being conducted in conjunction with their institution, making it challenging to seek ethical approval for an externally conducted research study.
The origin of seeking IRB approval for HF studies in the US came from a time when the advent of HF best practices turned to long-standing clinical trial procedures and processes for guidance on how to safeguard human subjects in research. Many companies adopted existing SOPs and procedures from clinical research and applied these to HF studies, since both are considered Human Subject Research.
Interestingly, in the UK, human factors research falls outside the governance of the NIHR and health ethic review process, since the purpose of the research is recognised to be different from that of clinical research which is the focus of NIHR. That said, in the past we have had to obtain NIHR ethical approval in order to conduct UK hospital based contextual inquiry studies. In this instance, because the research required carrying out observations within UK hospital sites involving patients and HCPs during actual procedures, ethical approval was an essential requirement for the study.
On a side note, most students who’ve undertaken a degree at a UK university will have gained some level of exposure to seeking ethical approval. Unfortunately, it’s common to hear candidates during job interviews say: “We weren’t able to speak to that user group because of the ethical review process. I had to speak to a different user group as it was easier.” This experience inadvertently creates a negative perception towards ethical review panels as a barrier to research, as opposed to a facilitator teaching them how to better safeguard human subjects and ensuring best practices are followed. While it is acknowledged that there will be limitations to the scope of research an undergraduate can complete within the available time, we feel universities could do more to help students view ethical review as a proactive step to better research design, rather than unnecessary red-tape.
To circle back to the original question, of whether ethical approval is required for HF studies, there is no short answer. It truly depends. Regardless of the route you take, we believe every HF study should be built upon the following components:
- The study team and sponsor should place human subject protection at the forefront of their minds when designing a study protocol.
- A detailed study risk assessment should be documented to identify and control potential risks to both study participants and study staff. The outcome of which should provide a clear indication of whether further ethical review is likely to be necessary.
- Regardless of whether ethical approval is sought, all HF studies should have a clearly written, well structured, and detailed informed consent form. The ICF should include a description of all potential study risks and the measures being taken to protect participants, so an informed opinion can be made by potential participants prior to the study.
- If a determination is made that ethical approval is not required, this should be documented alongside a clear justification within the study protocol.
- If a determination is made that ethical approval is required, we believe it pays dividends to work with an experienced IRB panel (if in the USA) who understand and have experience of reviewing submissions for HF studies. A sure fire way to slow your submission down is to partner with an IRB who does not understand the difference between HF studies and clinical research.
Written by Rebus Medical Director, Ian Culverhouse