Human Subjects Research policy

Why have a formal Human Subjects Research policy?

The Ronin Institute is built on two core principles: truth and empathy. Pursuit of the truth is a bedrock principle, but scholarship does not take place in a vacuum. We have a duty of care to consider how scholarship is performed, and to collectively ensure it is performed in ethical and humane ways, especially when it involves other people.

US-based academic institutions have “Institutional Review Boards” (or IRBs – they go by various other names in other countries; in the European Union they are called “ethics committees”) whose role is to review studies involving people or their data (“human subjects” is the term that institutions typically use). IRBs cover not just research that involves direct interaction with people, but also data collected via surveys with people.

The IRB process has been formalized and codified by many US Federal agencies, such as the US National Science Foundation and the US National Institutes of Health.

Thinking critically about the ethical issues raised by human subjects research very much aligns with the Ronin Institute’s core value of empathy. Furthermore, the ability for some Research Scholars to publish and fund their research at all often requires IRB approval, and enabling scholars to do that work is very much in keeping with our core mission of supporting their scholarship.

We are therefore attempting to design our ethics review process to keep the core focus on the reason IRBs exist in the first place: to prevent harm, while conforming with all relevant US legal codes. Ultimately we want Research Scholars to carefully reflect on ethical issues surrounding research involving human subjects, rather than viewing this merely as a set of bureaucratic hoops to jump through.

To this end, we have developed the following Ronin Institute Human Subjects Research policy (below). We require all Research Scholars to abide by this policy, whether or not you are currently planning to do human subjects research. Even though these considerations may be irrelevant to the work of many Research Scholars (research in theoretical physics or musicology come to mind), it is important for all scholars to be aware that the potential exists for a formal review of research involving human subjects.

Summary of our policy

Being a legal document, we realize it may not be obvious how the policy below will work in practice. Here are the plain language highlights per section:

  • I. Ronin Institute Human Subject Research (RI HSR) INVESTIGATORS will follow US federal rules AND any other local regulations. For example, if you are working with human subjects in Italy, you need to make sure you are following both US and Italian regulations.
  • II. If you are planning to do any research that involves human subjects, you should come talk to us. You should NOT make your own determination that your research is exempt from IRB review. There are just too many issues of conflict of interest, confirmation bias, motivated reasoning, etc. for us to be good judges of our own work. We will help to make two determinations: 1. Is this “Human Subjects Research” in the sense meant by US federal code? 2. If so, is it exempt from IRB review (e.g., if it is very low risk)?
  • III. RI HSR INVESTIGATORS must provide proof of HSR training to us.
  • IV. RI HSR INVESTIGATORS may have their protocols reviewed at the Ronin Institute or elsewhere; we encourage researchers to have their protocols reviewed at another institute if possible, since our own resources to review protocols are limited.
  • V. Non-exempt protocols or exempt protocols raising issues may be recommended for review at an external IRB (Institutional Review Board), which is currently Rutgers University.
  • VI. This policy is guided by international and federal policy concerning HSR.
  • VII. This policy is relevant to RI INVESTIGATORS as well as their collaborators. There are mechanisms available for institutional agreements around HSR ethical review to help support a shared system of oversight for collaborative HSR projects.
  • VIII. This policy applies to all research involving human subjects. Research using surveys, interviews, observation, secondary datasets etc that include people and data sourced from people can all be considered HSR.
  • IX. All active HSR studies must submit annual reports to the Ronin Institute.
  • X. RI HSR INVESTIGATORS should reach out to us if any problems or changes occur in their protocol that might affect its HSR ethics determination.
  • XI. We cannot overturn any previous ruling on a protocol (i.e., downgrading it), but we can disapprove of a study that has been exempted. We can also add requirements to an exempted protocol, such as requiring that informed consents are used.
  • XII. This section describes the historical development of this policy.

The Ronin Institute Human Subjects Research Policy