Yes Ma’am!

A Perspective on Women in Research Compliance

As a consultant I’ve had the opportunity to work with a number of Research Compliance (IRB and IACUC) offices across the country as well as working exclusively in one for several years and there has been a single unmistakable theme that’s ubiquitous in all of these interactions; the prevalence of female workers. As a Southern gentleman (picture me in a seer sucker suit in the month of June with a glass of iced tea) I find myself, quite naturally, responding yes ma’am to staffs from East Coast to West Coast. Now I don’t think this is a shock to anyone. Everyone in Research Administration (Grants, Contracts, IRB, IACUC, EHS etc…) recognizes the significant dominance of women at most, if not all levels of this world. I thought it might be worthwhile to casually examine this very interesting dynamic and understand how it might have come to be, what are the complexities involved, see how the field is transforming around them, and whether this dominance is helpful.

There’s of course no better way to get the answers you seek than to ask, so I spoke recently with a woman whom I consider to be an absolute professional in the compliance world. Our interviewee, whom we’ll refer to as “Director” hereafter is in fact a Director of Research Compliance at a major US institution having served there for 9 years with over a dozen years of research compliance specific experience. She represents an institution in transition/transformation with regard to regulatory compliance, technology, human resources and vision. She also has experience in both private and public academic institutions.

~Commence Interview~

Phillip: What are your general feelings regarding the industry and female representation?
Director: There seems to be based on attending conferences such as Public Responsibility in Medicine and Research (PRIMR) and others, that there are far more females than males and I think that’s because research compliance seems to be viewed as an administrative role. And it is. Traditionally administrative roles tend to be populated more by females than males.

Phillip: Do you feel that there is a difference in sentiment and reaction to Human Subject Research, something more gut felt and internal for women?
Director: No, I think that the people that are involved in research compliance administration have a certain quality. It seems to be that either you have it or you don’t. It’s something that you really get on some internal level in my experience, whether male or female.

Phillip: Do you feel Research Compliance is a field of employment in which someone sets out to gain a degree towards and/or receive additional training in? Do people really start out with this field in mind?
Director: Yes, and that’s sort of what I mean about the kind of people who get it and belong in this world. When I entered this realm 12 years ago you couldn’t get a degree in this, there was no such thing as a bioethics degree. Now there are actually masters programs in research administration. It’s all becoming more and more professionalized and that’s a good thing.

Phillip: Do you feel that there are any cultural or generational reasons for the growth of women in research administration, especially Research Compliance.
Director: I have been involved from the beginning with a former institutions interdisciplinary bioethics program and Robert “Bob” Levine one of the “crafters” of Belmont report. I’ve also been in that rarified environment with those people who were involved with the government aspects of this whom had a working group on research ethics and human subject’s protections. There were equal numbers of men and women on the national committee which eventually created the Belmont Report. I actually think there has been a fair balance of gender representation at least from the regulatory perspective.  Again administratively it’s been primarily females and so I don’t think there’s necessarily been a shift because females have been in positions of power in this field since the beginning.

Phillip: What are your thoughts on women in leadership/managerial level research compliance roles and men tending to be in executive level academic/research governance. With roles like Vice President of Research, Associate VPR, and Assistant VPR etc…?
Director: Upper or executive level administrators in the sciences tend to be male and I think that’s a function of the fact that there are fewer females than males in the sciences. The academic environment, I think is more egalitarian and your credentials speak for you. It’s more gender neutral in Research Administration. This differs from a medical/hospital environment where I’ve also spent time and where administration was heavily male.

Phillip: Do you feel that there is a certain level of experience, education or training that makes a person a good suit for a role in Research Compliance?
Director: It matters! And it’s a combination of personality aptitude and that quality I referred to earlier of people who get it. When I started I didn’t know the field existed and it appealed to me. The ethics combined with the intellectual rigor, ensuring scientific merit and regulatory compliance was the perfect storm for me. And the other people in this field who have the same aptitude for this kind of thing are the ones who are good at. So yes it requires a degree of knowledge and expertise but also that personality aptitude.

Phillip: What is required to stay professionally competitive in Research Compliance Administration?
Director: That’s an interesting question. This is certainly applicable in my situation but you have to be adaptable because things change and they change quickly both internally and externally.  It’s really important to be focused on the people that you serve so that it’s not about meeting bureaucratic requirements but helping the people who you serve. So that you are a resource to them and you intern are valuable.

Phillip: Is there a “good ol’ gals club?”
Director: Not the equivalent of what I know to be a “good ol’ boys club.” Now that doesn’t mean there aren’t clique’s, groups or affinities but just because this field might be populated by more females than males doesn’t mean that there is any restriction; unspoken or otherwise, about opening  the field up to more males. I think the more balanced everything is the better everyone is for it.

Phillip: Do you have any advice you would give to up & comers in the world of Research Compliance?
Director: I’ve actually been asked by a few different students throughout the years who have expressed interest in the field and I’ve shared that if this is something that you love and really find fascinating the possibilities are really endless and there are so many different avenues that you can go down with research compliance. There’s Industry, CROS, Consulting, Academic Environment and the Medical Environment. So there are so many possibilities if you love it and you really find it fascinating. There are educational opportunities and as I mentioned earlier; degrees specific to research administration. We invite graduate student to sit on our IRB. The younger generations are much better at research compliance than the older generations. They’ve grown up in an environment where it’s just expected. Whereas the older generation remembers the good old days when they could do what they wanted to vytorin 10 20. So actually I believe Research compliance is going to start shifting. It’s not going to be this inquisition as it’s been perceived in the past. It’s going to be a more collaborative effort between researchers and administrators. It’s got to be because the bureaucracy is starting to drive everyone crazy. We have to find a way to make it meaningful and not just a process of filling out forms.

~Interview Concluded~

Going over these questions with the Director was a treat for me and while there isn’t a lot of information out there regarding gender dynamics in Research Compliance or Research Administration for that matter, there were some important takeaways in our unscientific foray. For one, the obvious dominance of women who inhabit Research Compliance offices grew out of a necessity for administrative functions in the oversight of human subject research. Here we’re talking about multifarious paper work responsibilities, meeting minutes, scheduling, and correspondence which have traditionally been associated with female personnel. However, with the continual advancement of the regulatory environment, it’s also been necessary to acquire additional training and expertise to go along with these regulatory complexities and you now see a growth of people, still mostly women, with certifications and advanced degrees related to research compliance.

What is more, the academic environment fosters a more equitable playing field at least for research compliance that appreciates experience and credentials, specifically with regard to women serving in regulatory compliance leadership/managerial roles or moving up all-together. However, executive level roles such as VPRs and AVPRs still appear to be dominated by men, which speaks to a different but well documented issue in the sciences as they relate to academia. One could additionally gather that although the arena is currently flush with women, it doesn’t mean that there aren’t opportunities for men here as well. In fact based on some of the Directors comments a combination of desire, personality and experience are traits that make for ideal candidates who “get it.” These characteristics regardless of gender are always welcomed.

I think the world of Research Compliance is continuing to evolve. No longer is the Committee the sole source of experience in the oversight of research. IACUC and IRB offices are steadily becoming populated with staff that historically were counted as administrative or clerical in nature that now serve in a greater analytical role. Right now that tract still incorporates a higher degree of women than men and that may always be the case but as these roles grow and the specializations expand, Research Compliance becomes an even more attractive career option for anyone looking to establish a meaningful livelihood.

I greatly appreciated the Director offering her perspective and giving of her time for this article. So to you, and you know who you are, thank you ma’am!

Share This Post