Optimizing Your Human Research Protection Program: The Role of Quality Training

As research institutions are designing studies and recruiting participants for them, they must maintain compliance and ensure their study is compliant and safe for participants. For research administrators, having a robust human research protection program (HRPP) in place is vital.

A program designed for an entire organization, HRPPs are typically coordinated internally, with members consisting of executive officers and research review committees. An HRPP is responsible for protecting participant rights and the welfare of research conducted or reviewed at an organization.

Understanding HRPP and its Key Elements

Research institutions must take their HRPP seriously. As they engage in research, participants rightfully expect their safety to be top-of-mind, and do not expect their participation to cause harm.

Designed to provide ethical oversight of research, the organization’s institutional review board (IRB) has the sole responsibility of making sure the rights and welfare of participants recruited to be in a study is protected at all times. This also has downstream effects on research altogether – people won’t want to participate in trials if they know it is unsafe or risky for them to be involved.

There are specific elements research administration staff are responsible for, including:

• Minimizing subject risk while protecting their rights and welfare
• Guaranteeing IRB approval ahead of the research study
• Collecting informed consent
• Disclosing conflicts of interest
• Fulfilling any sponsor-specific requirements
• Completing necessary training requirements for HRPP

Training Requirements for HRPP

An HRPP involves many different roles throughout an organization, and everyone must be up to date on training. Typically, those in the following roles should take HRPP training:

• Principal investigators (PIs)
• Research staff interacting with participants
• Research staff who do not interact with participants

Any investigators or staff members who are involved in National Institutes of Health (NIH)-funded human subjects research must undergo sufficient training on the protection of human subjects in research. There are various ways to fulfill this, such as taking training from the Office of Human Research Protection (OHRP).

HRPP training helps staff understand the position they are in, and why it’s critical they take something like HRPP seriously in research. Having a robust HRPP – and staff who understand it – not only affects their organization, but it can bolster the success of studies by providing best practices for keeping participants safe and engaged throughout their time in a study. This training can be especially impactful in times where participant retention is difficult, or when recruiting a diverse pool of candidates.  Ensuring participants’ safety is of utmost importance and goes a long way in making them feel valued and safe throughout the life of the study.

The Role of Quality Training in HRPP

As organizations work towards an optimal HRPP, there are state and federal regulations to keep in mind, as well as federal guidance, institutional policies, and best practices. It’s a lot to consider and to be mindful of. Keeping up quality standards in HRPP training can help keep many of these considerations in line.

Staying in compliance with regulations, guidance, and policies throughout HRPP training is an opportunity for all stakeholders to understand more about HRPPs, including faculty, IRB members, and participants. This also gives someone the opportunity to speak up in order to improve quality within an organization regarding HRPP. The more knowledgeable and trained stakeholders are, the more likely they are to achieve study milestones. This all contributes to the organization’s integrity surrounding HRPP activities.

Running and maintaining a compliant, quality HRPP at an organization is a sizable task – one that requires everyone involved to take seriously and understand the downstream effects it has on not only the organization, but participants as they move through trial phases. Implementing a strong training program enables staff to build upon their current HRPP for the betterment of their participants.

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