In this interview, the Director of ORI’s Division of Investigative Oversight Dr. Alex Runko answers your questions about how the proposed updates to the PHS Policies on Research Misconduct will affect the U.S. research community. 

Question: 

It looks like the proposed revisions to the regulation will require institutions to do additional work. Is that right?

Dr. Runko: 
In the proposed revisions, we propose that institutions put more detail into their inquiry and investigation reports, so ORI receives the information we need to conduct our oversight review. This is not only for ORI’s benefit but also for the benefit of the institutions.

In current practice, for some cases, ORI may ask the institution to conduct a second inquiry or investigation, because their initial report was deficient. The proposed revisions would help prevent that situation, because the proposed revisions would more clearly spell out what we need the reports to include. The NPRM also proposes revisions that would streamline the whole process for institutions and ORI. 

Question: 

Can you explain more about what you mean by “streamlining the process”?

Dr. Runko: 
The cases of alleged research misconduct are becoming more complex. Some of the research in these allegations appears in numerous publications and grant applications; it may involve several institutions and multiple possible respondents. 

Under the proposed revisions, if there is an active investigation and new allegations come up or the institution identifies additional researchers who also may be culpable, the institution can just add new allegations, publications, or additional respondents to the ongoing proceedings. The research institution will not have to go back and restart the entire process—which will save a lot of time, energy, and resources.

Question: 

Are there other proposed changes that will save institutions time and resources?

Dr. Runko: 
Yes. As I mentioned above, under the current regulation, if a report is missing any of the key information or data that ORI needs to conduct our oversight analysis, we need to go back to the institution to request the missing material. It is unnecessarily time-consuming and frustrating for everyone. 

ORI has provided checklists for institutions for their inquiry and investigation reports; this level of information to be reported to ORI was not explicitly included in the 2005 regulation.  For the NPRM, we moved the checklists into the proposed rule itself, so institutions will be fully aware of ORI’s reporting requirements. 

We also went into more detail about what ORI expects to see in the inquiry and investigation reports—such as transcribed interviews, information about the respondent, what PHS-funded research is involved, which papers are affected, and which data or figures are being questioned. 

We hope this will put an end to all the back-and-forth between ORI and research institutions over missing or incomplete information, which will save the research community time and resources. 

Question: 

Will the proposed rule help reduce delays in other ways?

Dr. Runko: 
Yes. Over the years, we have found that many institutions need additional time to conduct their investigations and end up requesting an extension, which creates an added review burden for ORI and slows down the whole investigation process for the research institutions. So, we have proposed lengthening the investigation period, from 120 days to 180 days.

This means that under the proposed revisions you would have an additional 60 days from the outset. Hopefully, most research communities will be able to complete a full investigation in 180 days. However, ORI can still grant extensions if circumstances warrant additional time for an institution to complete their process. 

Question: 

Why did ORI propose changing the rule about when to determine whether suspected misconduct was an “honest error”?

Dr. Runko: 
Based on our experience in reviewing cases, we concluded that “honest error” should not be determined at the inquiry phase. The purpose of the inquiry is preliminary information-gathering and preliminary fact-finding, not decision-making about intent. ORI has found that many of the “honest error” determinations made at the conclusion of the inquiry phase were premature. 

In the proposed rule, institutions would determine “honest error” during the investigation, because that is when they conduct a full examination of all available evidence; sequester additional records that were not initially obtained at the onset of the inquiry; conduct interviews; and fully consider the scope of the alleged misconduct. Once they do all that, institutions can make a proper determination about whether it was an honest error, with all the evidence and information at hand to make a well-informed decision.

Question: 

Why did ORI propose updates to the key terms in the rule?

Dr. Runko: 
We wanted to make ORI’s expectations clearer, so we explained the key terms we had not defined before; explained some terms in greater detail; and introduced new terms with a precise explanation of each. 

We hope the more concrete terminology will help institutions conduct a more thorough analysis at each stage, so they can come to a fully considered determination once they have all the necessary information. 

Question: 

Do you have any closing remarks or take-aways for the research community?

Dr. Runko: 
The proposed, updated regulation will save all of us unnecessary pain. It truly pains me to send a report back. I hate having to tell an institution they have to reopen a case! 

I have been a bench scientist and have seen inappropriate data-use by others and reporting incidents in the lab. I know from personal experience that when suspicions of misconduct arise, it is difficult for everyone.  Investigating an allegation is a high-stakes, time-consuming, very stressful process.  The last thing we want to do is make it even more challenging. 

The proposed updates you see in the NPRM are designed to make the process less time-consuming for institutions—as well as for ORI.  Our objective is to help you provide the data we need to conduct a thorough review as efficiently and quickly as possible. 

PLEASE SUBMIT YOUR COMMENTS ON PROPOSED UPDATES TO THE REGULATION

ON OR BEFORE DECEMBER 5, 2023, online at:

https://www.regulations.gov/document/HHS-OASH-2023-0014-0001