by Amy Davis, JD, MPH, Senior Director for Programs and Publications at PRIM&R
Remember the Johns Hopkins-Michigan study in which the Michigan Hospital system implemented an intensive care unit-based check-list system for inserting a catheter to reduce central line infections? The project was submitted to the Johns Hopkins Medical Institution’s (JHMI) institutional review board (IRB) in 2004, who categorized the project as “exempt” from the federal regulations at 45 CFR 46 because data provided to Johns Hopkins researchers was de-identified and the project posed minimal risk.
Based on this determination, the project leaders did not ensure that the hospitals in which the study was conducted were federally approved to conduct “research” with “human subjects.” Neither did they obtain individual, written informed consent from the patients who were part of the pilot program. In 2006, OHRP received a complaint that the project violated federal regulations, and the rest is history.
The John Hopkins-Michigan study highlights the difficulty of determining the line between research and practice, or in this case, between research and quality improvement. The case is neither unique nor new. This issue was discussed prominently in the 1979 Belmont Report and over the years, examples that do not fall tidily within the definition of “human subjects research” have raised ethical questions about ethical oversight: activities that occur in the practice of public health, quality improvement, clinical innovation, and community-based health initiatives, to name a few.
The fact is that sometimes people carry out activities that resemble both ordinary practice and the development of generalizable knowledge, a central characteristic of research. These individuals, and the human subjects office at their institutions, then find themselves wondering “does this activity require IRB review?” Such longstanding ambiguity and confusion leads to wasted resources at a minimum, and exposure to undue risk at worst. It is time to provide more guidance to institutions, practitioners, and IRBs about how to manage the ethical issues that lie at the border of research and practice.
This is the goal of PRIM&R’s project titled “The Boundaries Between Research and Practice.” This initiative was launched last year when PRIM&R hosted a meeting on the topic facilitated by PRIM&R board members, Alex Capron, LLB, Scott H. Bice Chair in Healthcare Law, Policy, and Ethics in the Gould School of Law at the University of Southern California; and Hugh Tilson, MD, MPH, DrPH, Adjunct Professor and Senior Advisor at the University of North Carolina at Chapel Hill School of Public Health. That meeting led to a follow-up gathering in National Harbor, MD during the 2011 Advancing Ethical Research Conference, titled Town Hall Meeting: “Bumping Into Things: What are the Boundaries of Research and Why Might We Want to Know?”
During this dynamic event, the moderators and participants discussed examples of borderline situations from different areas of practice, and discussed the salient characteristics that define them as either “like” or “unlike” research. Characteristics such as level of risk, extent of deviation from common practice, nature of potential benefit, and extent of systemization have emerged from the discussions to date. Participants also discussed alternative review mechanisms that they have used for non-research activities that raise ethical concerns. Review systems such as ethics audits, human subjects office staff review, and consultations with ethicists were described.
The participants were gratified to learn how their peers were handling borderline cases, but they confirmed the need for effective guidelines that advance ethical conduct and encourage creativity and action. The more information that we receive about these experiences, the better informed we will be to develop useful guidelines. So we are coming to you to ask for your input. Please contribute your expertise, your questions, and/or your experiences with managing cases at the “border.” Here are some questions to prompt your thinking.
- As a practitioner, have you struggled with the question of whether your IRB should review a project before its implementation?
- As an IRB member, have you heard about a project that was not submitted for IRB approval that you thought should have been? Or have you been asked to review a project proposal that you felt was outside the IRB’s jurisdiction, but that raised ethical questions requiring oversight?
- As an administrator, have you established or employed alternative systems for review?
- What project characteristics do you believe should determine whether an activity requires ethical oversight and what kind of entity would you recommend for this purpose?
Please share your thoughts here.
Thanks, Dr. Davis (Amy), for this terrific summary of what has been an exciting and very informative process, still on-going.
As a career public health physician, I have seen this boundary between public health practice (in my specific case) and research from both sides of the wall, and understand well how mis-understandings and mis-steps occur, having experienced my share of bot. So I am eager to hear from you readers in the PRIM&R Blogosphere about your stories so that we may include them in our growing list of such experiences and proposed solutions. Learning from our shared struggles is quintessentially PRIM&R.
Let me emphasize that we’re looking for three different sets of ideas.
First, we learn from the case examples of how others have approached the decision to submit (or not) and/or require review (or not).
Second, we would benefit from your nomination of a criterion or two which you have found useful in deciding whether to submit or review(or not).
Third, we are assembling brief descriptions of review/safeguard mechanisms other than/short of IRB review, which help us all to achieve our shared vision of protecting human subjects while minimizing bureaucratic and unnecessary administrative procedures on the way to being a learning society.
In turn, Dr. Capron (Alex) and I … along with Dr. Davis … will try our best to bring this process to a close (well, at least a stable platform) so that all of us can have a working strategy for decision-making under boundary conditions.
Let us hear from you.
We get a ton of these but – as an independent – from a whole different segment of society.
Piece of advice #1 – Never just defer to an exemption. It will just get you in trouble. You came from an academic program and you know IRB is required for everything. But don't assume.
Piece of advice #2 – Hang the decision tree within eyesight.
Work through it with each client with questions. It save time later.
Piece of advice #3 – Use words like activity and clients until it is established that there is HS Res. Using these words does not presume that the activity is research. It could be an activity
Piece of advice #4 – Risk is irrelevant
There are lots of risky things going on is this world over which IRBs have no authority. Exemptions are not risk-based. The writers may – or may not – have chosen them as low risk and they may – or may not – cause harm someday.
Q: Who is funding your activity and why are they doing that?
A: The County Health Authority wants a report on midwife home births, who does them, and how they turn out.
They really didn't tell us why they want this information but we presume they intend to improve midwifery in the county.
Feel free to look at our forms: http://www.eandireview.com/index.php?option=com_content&view=article&id=148&Itemid=26
This is a great topic. We're actually planning to discuss this at our upcoming monthly professional development for reviewers. I believe this article and the PRIM&R town hall will be good resources. I was also wondering if anyone had any other articles (scholarly or otherwise) regarding "is it research?" – especially for SBR. Thanks!
One additional word of caution: unless you reach out to the practice and QI communities, you risk a biased analysis. I offer as an example of the bias possible, the work by Jeremy Sugarman, et al, the definition of QI that is totally unused by those who work in the space.