Tom Temin Let’s start with a brief overview of the Office of Research Integrity. What agencies does it cover and what does it typically do first?

Sheila Garrity The Office of Research Integrity is part of HHS, Tom, and we are part of the Office of the Assistant Secretary for Health (OASH). Our responsibilities therefore include monitoring research funded by the public health service. And so, if there are questions about this research, issues with the integrity of the research, we look at those questions. We also provide funding and training for the responsible conduct of research. PHC agencies include the NIH, CDC, National Cancer Institute, generally anything you can think of is inside.

Tom Temin So the big grant agencies? Not just the seat. And these regulations, I mean, what are the research integrity issues that they cover in the first place?

Sheila Garrity So what people think of when they hear about research integrity is research misconduct. You probably see journals like Retraction Watch that cover cases of research misconduct. And when those allegations involve federal funds, PHS funds, the institution needs to look into them. And then, once the investigation is complete, we do regulatory oversight. So people hear the wrong things. But PHS funding also does a lot of good things. Life-saving treatments are possible thanks to funding for public health services.

Tom Temin And these rules about research integrity. What are the areas where integrity might be lacking?

Sheila Garrity Integrity may be lacking in the way research is carried out. The definition of research misconduct is therefore fabrication, falsification or plagiarism. And they offer to carry out, report or review research or research results. So in a research grant there may be research misconduct in the numbers, in a publication there may be fabrication or falsification. This all falls into these categories of research misconduct and integrity.

Tom Temin And what about, say, failures by omission? For example, sometimes we hear that this or that industry was behind this research, and that may not have biased it, but it should have been disclosed.

Sheila Garrity These questions therefore do not concern the interior. These are research integrity issues, but they are outside our regulation. Your listeners will be aware of scientific integrity, the scientific integrity policy, which applies to government employees. And many disclosure issues are addressed there. We are all required, as government employees, to disclose all of our outside interests once a year. And if you publish your research, remember that federal employees do a lot of federally funded research themselves. You have to say: Okay, I was funded by this grant or I helped here, I was on this board. All of this simply needs to be disclosed.

Tom Temin Okay, coming back to the misconduct, then the rules cover the things you mentioned. Fabrication, falsification, plagiarism. What was obsolete compared to 2005?

Sheila Garrity 2005 when I entered this field when this regulation was published. We have gained a lot of experience and research has evolved since 2005. Look around you and see how your studio has changed. You told me you’ve been in this business for 40 years. I’m sure it didn’t look like this before. It was completely different. Research, technologies for conducting research have changed. Research also has no boundaries in collaborative research conducted between institutions from different states and countries. This problem was not addressed in the old policies. So we set to work to develop a policy that would be timeless, last for the next 20 years, and have enough flexibility to allow us to grow as research develops.

Tom Temin We speak with Sheila Garrity. She is director of the Office of Research Integrity within Health and Human Services. And this technological idea, I imagine, one of the things on the minds of the writers of these regulations must have been artificial intelligence, which has the potential to really improve research and also really screw it up.

Sheila Garrity Artificial intelligence is on everyone’s minds and we cannot escape it. We can’t ignore it, it’s here. And like you said, it can have many good uses, but it also has many bad uses. Artificial intelligence is not mentioned in the regulations, but suffice it to say how much research methods have changed so that we can develop as we get better at things.

Tom Temin Now, reading some of the changes you’ve highlighted, they seem rather administrative and nitpicky, nitpicky, clarifying institutional obligations regarding confidentiality, providing clearer descriptions of requirements for research, misconduct and investigation. This seems a bit meta in terms of the research itself. So maybe tell us.

Sheila Garrity Difficult, picky leads to a lot of lawsuits, Tom. So we had to be careful. And I come from academia, so I’ve been responsible for research integrity for almost 30 years at two different institutions, one being Johns Hopkins, which is the number one recipient of federal funds in this country. And then I was at George Washington for nine years. Institutions must therefore follow a very specific process to respond to these allegations, and this is intended for their protection and that of those accused of research misconduct and those who make these accusations. So in order to protect the process, we have provided some clarifications, modified the definitions to help the institutions and to help us. There is a delicate balance between overstepping, whether on the institutional side or on our side. Privacy is a concern. Let’s say you are accused of misconduct, we don’t want to automatically assume that you have engaged in misconduct until a process is followed. The institutions therefore keep these questions confidential. And we see a lot of it in the press. We cannot comment on ongoing matters. So we made sure to resolve this issue.

Tom Temin And these rules were considered major in terms of federal regulatory requirements. If it has a certain level of cost, it becomes what they call a grand rule or a major rule, and so it has to go through the White House, the (Office of Information and Regulatory Affairs (OIRA)). Was this the case for these rules?

Sheila Garrity It was adopted by OIRA, not because of the cost, but because when the NPRM was released and OIRA leadership told OMB, these changes would not receive much comment . People will love them, so don’t worry. So it was allowed to waive OMB review? Well, when the (Notice of Proposed Rulemaking (NPRM)) came back with almost 300 comments, many of them were quite opposed to the content of the NPRM. OIRA said: Hey, now we have to look at this. You received a lot of comments. That’s what they did.

Tom Temin We should clarify for the public, Office of Information and Regulatory Affairs, that even many Feds don’t know about this little OMB office.

Sheila Garrity Created by Ronald Reagan.

Tom Temin Indeed. Yes. Because the development of rules is always a subject of political discussion, let’s say. And do the comments mainly come from academics who are recipients of research grants?

Sheila Garrity Most of them came from academics who received research grants. Some attorneys interviewed also spoke out and expressed concern that the rule was too prescriptive in terms of process and that it would take so many days to complete an assessment.

Tom Temin They saw what I saw there.

Sheila Garrity Yes. And so they wanted a little more discretion, and we gave them that. And for those federal employees listening, I’m a new federal. I’ve only been here a year and a half. The number of people it takes, the number of different offices to get a settlement across the finish line is incredible. And I think the outside world thinks the feds are still passionate about each other. People have been incredibly helpful. This is what we need, Sheila. Here’s how we need to get it through OIRA, do this, do that. And I’m really grateful for all the teamwork I had.

Tom Temin And I imagine some of the institutions that are doing research through grants. If you have a large land-grant university or one of the large private academic institutions, they probably often have dozens of projects going on across their campuses and facilities, all working separately, all funded by the federal government. It’s kind of a side hustle for a lot of schools as federal funding. My own alma mater receives tens of millions of dollars a year in federal funding. It might be good for them to understand that so that there is some sort of governance underlying this very dispersed activity.

Sheila Garrity Thus, once the final rule was published, regulated institutions were relieved. And they appreciated the changes that came after commenting on the NPRM. This is rule-making at its finest. People have commented as requested, we are reviewing these comments as required by the preamble. We talked about each comment we received and how we responded to it. So I think the end product is a good balance.

Tom Temin And now you’re a little sunburned after pushing through a major federal regulation even though you’ve only been in office for a year and a half.

Sheila Garrity Yes, I’m delighted.

Tom Temin And is there something on your wall that means that?

Sheila Garrity No, because we still have a lot of work to do. We must now issue directives. We must help our regulated communities understand and listen to them. I think it opened the door to new forms of communication. And I appreciate it, and we’re going to build on it.

Tom Temin I hear the printer printing a thousand pages of draft advice.

Sheila Garrity Nobody prints anymore. No printing, we try not to use paper.