Legal Review Can Help Your Research Protocol Stay on Track
By Amanda Abbott, Esq.
Medical researchers are very reluctant to involve legal counsel in the early planning and drafting of their research protocols, and understandably so. After all, a researcher wants to focus on the areas of clinical study and medicine that are driving them to make innovative discoveries, and not be mired in legal details. However, an attorney experienced in clinical research and institutional red tape can be a great resource to the research team as early as the study-planning phase.
As a healthcare and life sciences attorney, I routinely see research protocols that have already sailed through Institutional Review Board (IRB) review despite having serious inaccuracies or inadequacies or legal and compliance issues that must be addressed before the study can realistically progress to enrollment. This is sometimes because IRB scope is far more limited than many researchers have come to believe. For all but the most simplistic studies, IRB approval should not be viewed as the only pre-study hurdle worth attending to, and certainly doesn’t supersede the legal and regulatory requirements that may be applicable to various aspects of a study.
Attorneys are sometimes hesitant to jump in to the early stages of research planning, knowing they will be met with resistance and possibly disdain. Researchers want control over study design without being slowed by legal and compliance barriers. Seasoned legal counsel are sensitive to these concerns.
At the same time, attorneys know that if potential issues are not addressed and resolved early, the research project could be subject to lengthy delays closer to the intended enrollment period, multiple protocol amendments; and in the long run, unfortunately, protocol deviations, unverifiable results, and findings of research misconduct. All of this after funds have been allocated and expended, data submitted to funding sources, and commitments made to other organizations.
Obtaining a solution-oriented legal opinion early and structuring a path forward efficiently is critical for tough issues that, if ignored too long, can become major obstacles to progress. Let’s look at some of the pros and cons for integrating legal review early into the medical research process.
Pros of Early Legal Involvement
Here are some of main reasons to engage an attorney advisor in the early stages of the medical research process.
- Attorneys help researchers identify potential regulatory compliance issues, including with HSRP and ethics, HIPAA, AKS, financial relationships with physicians, CLIA, non-profit tax exempt private use, and more, and by doing so, they help structure the protocol and research contractual relationships to avoid noncompliance.
- Attorneys are trained to write and explain concepts clearly and precisely. Working in conjunction with the medical researchers, an attorney will improve the organization and accuracy of the research protocol. Additionally, attorneys are trained in deep thinking and strategy. This skill enables lawyers to work with researchers to think through the operational complexities and other aspects of the planned study.
- Healthcare attorneys understand how to comply with the policies, procedures and other red tape that researches encounter with healthcare providers, health plans, government agencies, and researchers’ own academic, commercial, or non-profit organizations. Additionally, by identifying and removing legal and regulatory obstacles, they can help navigate compliant and efficient implementation of a study from IRB submission through publication of results.
- Attorneys readily identify necessary third party relationships that must be documented in written agreements before study inception, as well as structure and draft terms in required ancillary agreements that align with the protocol, such as Material Transfer Agreements (MTA), Data Transfer Agreements (DTA), and Business Associate Agreements (BAA).
- Attorneys help with the early identification of potential research misconduct allegations around protocol deviations, manipulation of results, and the appearance of improper relationships with industry sponsors, referring providers, servicing laboratories, and more. These misconduct issues are often what invalidates research after it’s already been concluded. Identifying the issues early on helps avoid even inadvertent misconduct.
Cons of Early Legal Involvement
Most often, the concerns I hear about involving attorneys in early review of medical research are based on a fear of time-consuming detours from progress toward initiating a study, and a general feeling that only scientists should have input on the content of a protocol. Here are a few common qualms and why I recommend reconsideration.
- Consulting an attorney may slow down the initial process of getting to IRB review as quickly as possible. However, a short delay for the additional review, meetings and revisions, will save future time handling protocol amendments, reporting of protocol deviations, stalled activity at sites due to lack of necessary contracts, or difficult and sloppy structuring leading to confusion around party obligations, data transfer, intellectual property, privacy and security of identifiable information, and institutional relationships.
- Attorneys may provide feedback to researchers they do not want to hear in the creative phase. This feedback may require changes inconsistent with funding proposals that have already submitted. Again, the initial feedback can save time and funding in the long run, which will make the research process more valid and result in more usable, publishable, and valuable results.
It’s smart and practical to work with an experienced healthcare and life sciences attorney in the early phases of research planning, study design, and protocol drafting. Integrating a legal team resource early into the medical research process can save money, time and costly errors.
Amanda Abbott is a partner at Vanst Law who specializes in healthcare and life sciences. She draws upon her prior experiences as a nurse, litigator, and in-house corporate counsel to provide uniquely pragmatic yet comprehensive legal services and strategic guidance to clients.