9
Aug2018

This post originally appeared on Under The Poliscope, the NIH Office of Science Policy blog (authored by NIH Associate Director for Science Policy Carrie D. Wolinetz, PhD). To learn more and subscribe to Under the Poliscope, visit their website.


Before I came to NIH, I spent my career working with advocacy groups in the biomedical research community. A big part of my job was writing comment letters in response to proposed policies and rules developed by federal agencies. Now that I’m in a position where I read and consider feedback from stakeholder communities when developing NIH policies, I find myself looking back on my own comment letters and cringe just a little.

Why? Because although those comments may have been beautifully composed (if I do say so myself!) and accurately represented the views of the organizations or constituents that I was representing, I recognize now that they may not have been as effective for NIH or other federal agencies in developing their final policies and rules. So, with that knowledge in hand, what does make feedback on a proposed policy useful? How can you all learn from my experiences to be more effective in shaping biomedical research policy?

Be specific: If you read a lot of comment letters, a common thread is enthusiastic endorsement or opposition to whatever is being proposed. Knowing whether affected stakeholders like or don’t like what you are trying to do is critically important information, but it falls into the category of necessary but not sufficient. Many times such statements tend to be general and sometimes hyperbolic. As a policymaker, what I want to know is: why do you like or not like it? How will it specifically impact you, your organization, or your ability to engage in the mission of the agency? When thinking about where to go next, I want to know if your concerns can be addressed through alterations of the policy (and if so, specific language suggestions about how to alter the policy) or through further guidance or additional resources or, in contrast, whether they represent a deal-breaking obstacle that will send us back to the drawing board. Is this a policy going to have inadvertent negative effects that are important for NIH to be aware of or does dislike represent resistance to change?  Similarly, if you are supportive of a policy provision or proposal, tell us why. Those comments can be helpful to us in navigating the pathway to moving policy forward.

Provide data: There is seldom complete consensus on a proposed policy. It is more common to see some stakeholders strongly in favor, some strongly opposed, and a range of views in between. When considering how to weigh opposing viewpoints or when thinking about how to be responsive to the comments, it is immensely helpful when commenters provide examples and/or data to support their point. For example, a commenter might say a policy will have a great financial impact, either positive or negative, on their organization. What does that mean? Are we talking tens of thousands of dollars, hundreds of thousands of dollars, or millions? What is your evidence, even if there are many built in assumptions, for that estimate? Commenters might say they will have to hire more staff to implement a new policy or that they don’t have the expertise. How many staff are we talking about here?? What kinds of expertise, and how hard is it to find?  When input is unspecific or lacking data, it puts policymakers in the position of having to “read between the lines”, which is not ideal for evidence-based decision making or finding appropriate solutions to make the policy more palatable.

Answer the questions: When agencies are seeking feedback, whether via part of a Request for Information (RFI) or via the formal rulemaking or policymaking process, it is because there is genuine need of input from the community before a decision is reached. In true Robert Frost fashion, multiple policy options might be possible, and we need guidance from those who know the topic best or have a true on the ground perspective before choosing a way forward. When comments are non-responsive to the question being asked, a decision might be made based on our best judgement and/or input from those stakeholders who did take the time to answer. If you have a reason for not responding – doesn’t apply to me, don’t care about it, don’t have enough data to answer – that can be helpful to know, too.

Include new ideas: Have you and your organization found a creative solution to a problem that we are trying to solve via this policy? Is there something that we haven’t thought of or asked that we should have? One of the reasons I love venturing away from the NIH campus – or welcoming visitors to it! – is because interacting with the biomedical research community, from scientists to research participants to universities to advocates, is where many of the best ideas emerge. Yes, I know I just told you to answer the questions but going beyond the information we are seeking and helping us think outside the box with specific or alternative ideas can also spark innovative and creative approaches to policy.

Emphasize what matters to you most: When reading through a long, complex set of comments, it can be difficult to determine order of magnitude. You might have strong feelings about one policy provision but have a more neutral sense of another. Because you have followed all of the advice above, you may have provided very detailed comments on every piece of the policy being proposed or questions posed. This makes it very difficult to discern the priorities of the commenter. Providing that context will help the agency prioritize the areas that most need to be addressed or retained versus those that may present less of an issue.

At the end of the day, NIH science policy is all about creating the framework that facilitates the mission of the agency: supporting science and improving human health. Understanding the strengths and gaps of that framework, the push and pull tension by which policies incentivize or present barriers to achieving the highest quality, publicly funded research: this is the foundation of sound policy. Nobody understands that framework better than those who live on it and in it, day to day. So keep those comments coming in… and I will look forward to reading them!

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