Could the Bioethics Commission’s criteria for ethical study design become central to an IRB’s deliberation?

By Elisa Hurley, PhD, Education Director at PRIM&R

In its December 15 report, the Presidential Commission for the Study of Bioethical Issues (the Commission) makes 14 recommendations to improve the current system of research protections.

One of the most nuanced and interesting parts of the Commission’s 193-page report is the section on ensuring ethical study design.  It is relatively uncontroversial that scientifically flawed studies are unethical—they expose subjects to risks without any corresponding benefit to society.  (This is not of course to say that determining what is a scientifically sound study is always straightforward.)  The really difficult ethical questions about study design emerge when rigorous scientific design threatens to come at the expense of adequately protecting or respecting human subjects.  

Regarding ethical study design, the Commission favors a “middle ground” position between the “placebo orthodoxy”—the view that comparing an experimental drug ensures scientific validity, and that it is therefore ethical to use placebos as controls, even when alternative therapies exist—and the “active-control orthodoxy”—the view that placebos are never ethical if an alternative therapy exists, and that, therefore, the best available alternative must be used as the control.  In brief, the Commission suggests that if certain criteria are met, some research designs can be ethically justified if control arm subjects receive less than the best-proven treatment. 

The Commission offers three specific criteria for evaluating the methods and risks of study design and determining if the study is ethically justified.  One criterion is that the design be adequate to yield usable results, which, in turn, places differing methodological constraints on trials, depending on the type of trial one is conducting (e.g. placebo-controlled or equivalency design). 

A second criterion involves looking at local treatment standards to determine an appropriate control arm.  The Commission is careful to say that this does not mean that if, for instance, the local standard of care is no care at all, it follows that an ethically appropriate control arm for a study in that location is placebo.  But neither should the standard of care against which an experimental intervention is tested always be the “best-proven” treatment, regardless of where the study takes place—after all, “best-proven” treatments may not be the best for a particular population. Rather, “standard of care” is a normative, but also contextualized notion—it is determined by local features such as underlying health status and behaviors of the population, as well as the medical and logistical infrastructure.

The third criterion is that the risks to which subjects are exposed—which may be higher in trials in which, for methodological reasons, subjects are receiving less than the optimal standard of care—be minimized.  This means that protocols for studies that pose additional or greater risks to subjects by departing from current best-proven treatments as controls should include not only explicit justification for that design, but also mechanisms for closely monitoring those subjects as well as for addressing serious symptoms and withdrawing subjects who experience adverse events.   But it also means that a study meeting the other two criteria might nevertheless be determined to be ethically problematic on this third ground.  That is, if by receiving a less then optimal standard of care a subject is exposed to substantially increased risk of mortality and morbidity, or severe discomfort, then a study in which that standard of care is the control is not ethically justified. 

Just before it summarizes its discussion of the three criteria in recommendation 12, the Commission suggests that “IRBs should scrutinize the elements of study design as a distinct focus of their review.” Presumably, then, what the Commission is suggesting is that determining whether and when these criteria have been adequately met should be part and parcel of an IRB’s discussion and deliberation about a research protocol.  

What do you think of these as criteria for IRB review?  Do they represent an expansion of review criteria, or are IRBs already, implicitly or explicitly, using such standards?   Is it feasible for IRBs to apply these criteria?  Would IRBs have adequate information to apply these criteria?   I look forward to hearing your thoughts.

'Science Times' synthesis

As revelers across the country gear up for the holidays, the federal government remained busy with two major reports released this week. The first, published by the Institute of Medicine, is already changing the way chimpanzees are used in research. While the second, drafted by the Presidential Commission for the Study of Bioethical issues, makes new recommendations for human subjects compensation. Learn more in this week’s ‘Science Times’ synthesis and share your thoughts in our comment section!

Week of December 20
The US will not finance new research on chimps:  In response to an Institute of Medicine report that concluded that chimpanzees are not necessary for most biomedical research, the National Institutes of Health (NIH) has suspended all new grants for research involving chimpanzees.

Elevation of the chimp may reshape research: New York Times journalist James Gorman analyzes the NIH decision to suspend all new grant funding for research involving chimpanzees.

Studies suggest acetaminophen-asthma link: Physicians and researchers debate whether acetaminophen has played a role in the increased prevalence of asthma over the past 30 years.

And, because the world of human subjects protections also had a big week, we would like to share an article from The Washington Post…

Bioethics panel urges system to compensate those hurt in medical experiments: The Presidential Commission for the Study of Bioethical Issues released a report that concluded existing regulations adequately safeguard human subjects, while recommending compensation for volunteers who participate in medical research.

Week of December 13
Rats to the rescue in cage experiment: In a lab experiment, rats freed their trapped counterparts from a caged enclosure, leading scientists to attribute empathy with the rodents.

Headers may be hard on soccer players’ brains: Researchers at the Albert Einstein College of Medicine found a pattern of white matter loss among soccer players who frequently bounced balls off of their heads.

What constitutes a prisoner in research?

PRIM&R is pleased to bring you a post from Dawnett Watkins, a member of the PRIM&R Blog Squad at the 2011 Advancing Ethical Research Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging prior to, live from, and after our conferences.

How do the current guidelines define who is a prisoner?  45 CFR 46 states: 

‘Prisoner’ means any individual involuntarily confined or detained in a penal institution.  The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

This definition includes situations where a human subject becomes a prisoner after the research has commenced.

But, what about a mental health jail diversion program that is an alternative to prison, where the participants are not detained per se? Instead, they are court-ordered to participate in a non-residential community program, where they wear ankle monitors for a portion of the time. These participants are not under Department of Corrections (DOC) supervision, but instead are under court supervision.  The CITI training definition of who constitutes a prisoner is important to review when considering this particular situation. CITI states:

Individuals who are detained in a residential facility for court-ordered substance abuse treatment as a form of sentencing or alternative to incarceration are prisoners; however, individuals who are receiving non-residential court-ordered substance abuse treatment and are residing in the community are not prisoners.

The guidance surrounding the use of monitoring devices is also unclear. CITI training says, “individuals wearing monitoring devices are generally not considered to be prisoners; however, situations of this kind frequently require an analysis of the particular circumstances of the planned subject population.”

When our campus asked our state DOC representative about the situation described above, the answer was, “it depends.”  The book, Institutional Review Board: Management and Function, by Elizabeth A. Bankert and Robert J. Amdur, expanded further: “One of the difficulties in the use of subpart C lies within the definition of ‘prisoner’. Many of the current alternatives to incarceration were not even in existence at the time of the writing of subpart C, such as house arrest with electronic monitoring. “ 

We are told over and over again at PRIM&R conferences that the guidelines are a minimum.  Our institutional review board (IRB) also recognizes that other groups may not meet the definition of a prisoner, for example, parolees or probationers, persons court-ordered to attend non-residential treatment programs in the community, and those adjudicated to reside in halfway houses.  As we found out via our prisoner representative, the DOC may or may not consider these people to be under its jurisdiction, and if they aren’t under the DOC, are they even prisoners? 

All of these people have impingements on their freedom, and as a result, the potential for coercion exists.  For these vulnerable subjects who may not be protected under subpart C, our IRB has decided that they should be afforded additional protections under subpart A, which charges IRBs to be particularly cognizant of the special problems of research involving vulnerable populations.

There aren’t always clear-cut answers in human research protections, which makes the jobs of those in the field both interesting and challenging.  The bottom line is, however, ensuring the protection of human subjects, and when in doubt, I feel it is always best to go beyond the minimum.

Featured Member Profile: Judith-Samans-Dunn

Welcome to another installment of our featured member profile where we will continue to introduce you to more of our members—individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Judith Samans-Dunn, MSIA, CIP, IRB administrator at the Philadelphia Department of Public Health and director of the Strawberry Mansion Health Center.

When and why did you join the field?
In 1994, the secretary for the Committee for the Protection of Human Subjects retired from her position with Philadelphia Department of Public Health (she was director of nursing). I was always interested in learning about additional areas of the department, and so I volunteered for this small add-on duty to my then regular position as director of the city's STD clinic. Little did I know how this small task would take on a life of its own, as the number of studies under review blossomed over the years from about 11 to more than 100.
 
What is your favorite part of your job?
I consider part of my role to be a resource to department administrators, researchers, graduate students, and anyone else with interest in human subjects research. As such, my favorite part of the job is when I can guide individuals through the combined government and research ethics requirements to facilitate their projects while ensuring proper protection of research subjects. Any time I can educate a person before they step in administrative pitfalls, I feel I have been of service. I also love the intellectual stimulation that comes from reviewing all of these diverse proposals and meeting and conversing with the multitude of researchers that come our way.
 
Which living person do you most admire?
Answering a question like this is always full of pitfalls. I'm going to go out on a proverbial limb and say Hillary Clinton. The reason is not so much because I agree with everything she has ever done. It is because she has done two things that I consider next to impossible, and is still standing strong. Under her husband's presidency, she pushed for health care reform in this country far before it was politically feasible. She stood out as an advocate. She worked tirelessly in the face of certain failure, because she believed in her convictions. I truly admire that.

Then, when her husband so publicly had his own ethical issues with their private life, she held her tongue. Although both she and her husband held public roles, she retained her dignity, and kept her private feelings just that, and maintained a blemish-free public persona. She is an amazing person.

What do you most value in your friends? 
This question is easy for me to answer. They must be reliable, but by this I do not mean that a person is there to do anything and everything I want them to do. I mean that the person will do what they say they will do. A good friend will be honest with you, even if it is not what you want. That same good friend will accept when you have differences, and still be your good friend. Such a friend is a friend for life, because we can overcome any hurdles together and rely on each other.
 
Why did you join PRIM&R?
Having two demanding jobs is much easier when there are adequate resources available to keep you abreast of the latest developments. PRIM&R affords me easy access to the latest research ethics developments, provides me with resources that I can select from, and enables me to focus on the areas most relevant to the research we review. Attached to that professional development is the ability to test my knowledge through the CITI Collaborative and to become a Certified IRB Professional® (yes, at a reduced rate). It is embarrassing to admit that one significant reason I joined PRIM&R was to network, and at that I have as yet mostly failed. Hopefully this request for my information will spur me to make the time for this very important aspect of membership!
 
If you were planning our next conference, who would you select as a keynote speaker?
As a keynote speaker, I would ask Susan Reverby. I find it amazing that something as horrendous as the US involvement in the Guatemala Syphilis study could have, until recently, remained totally buried out of sight of the ethics community. I think it would be especially interesting to ask what she was looking for when she stumbled across this study? How did she feel when she realized what she had found? What steps would she recommend to the research community? Finally, I would ask her, how has this discovery changed her?
 
What motivates you to maintain your commitment to advancing ethical research?
Despite the occasional horror stories that one reads about in the news, I believe that researchers want to improve our world. My motivation in advancing ethical research is to be involved in the small way that my talents allow. I have organization skills, writing skills, analytical skills, but I am not a researcher. So my motivation comes from being able to coordinate the ethical review of research. Despite the belief that researchers want to improve our world, I also know that they are predisposed to bias that blinds them from seeing where their procedures may coerce individuals, may be too obscure for participants to reasonably understand, or other faults. If my participation in the process helps channel the investigators' enthusiasm into a more participant-friendly product, then I have been an important cog in the ethical research wheel.

Thank you for being part of the membership community and sharing your story, Judith. We hope you enjoyed the presentation by Dr. Reverby at the 2011 Advancing Ethical Research Conference.

If you’d like to learn more about becoming a member, please visit our website today.

Alternative Models of IRB Review

By Amy Davis, JD, MPH, Senior Director for Publications and Programs at PRIM&R

There was a lot of talk about alternative models of institutional review board (IRB) review at PRIM&R’s 2011 Advancing Ethical Research (AER) Conference:

• There is the Advance Notice of Proposed Rulemaking’s (ANPRM) request for comments on a proposed requirement that all domestic, multi-site research rely on central IRBs;
• There are National Institutes of Health (NIH) research grants that favor central IRB models;
• The National Cancer Institute (NCI) is piloting a central IRB model; and
• The Department of Veterans’ Affairs relies on central IRB review for some multi-site research. 

So, why all this talk about centralization? Efficiency, reduction of duplication of effort, harmonization, speed of review, reduction of institutional conflicts of interest, improved availability of reviewers who have expertise in the research area, were just some of the reasons that I heard.

Few people would challenge the idea that multi-site IRB review can be cumbersome, time consuming, and perhaps, redundant.  Based on what I heard at two breakout sessions at the 2011 AER Conference, there is much work to be done to figure out a better system.

At session C5, ‘Two Roads Diverged in a Yellow Wood:’ The NCI Central IRB (CIRB) Considers a Model Change’, the presenters discussed the NCI’s initiative to pilot an independent CIRB system.  In recent years NCI has been using a facilitated IRB review model that relies on a partnership between local IRBs and the CIRB. Under this model, local investigators are allowed to download protocols and informed consent documents that have been pre-approved by the NCI CIRB. The local investigator then submits the pre-approved documents to his or her local IRB for a review of local context concerns. Designated individuals from the local IRB decide whether they are comfortable relying on the CIRB as the primary reviewing IRB for the protocol, or if local concerns are an issue, they may submit the protocol to the local IRB for full board review.  The goal of facilitated review is to reduce the number of local IRBs conducting independent review of a single protocol. 

NCI is now exploring further refinement of this process in an effort to eliminate local review, so that the CIRB becomes the single IRB of record. NCI is conducting a pilot study of this process in collaboration with approximately 30 institutions. This model will require all participating institutions to rely fully on the CIRB. Local issues would be managed through the use of forms that prompt investigators to submit information about local context to the CIRB.

At D5 session, ‘Independent IRB Models’, there was a discussion of how independent review boards external to the institution review research.  This model is distinct from the NCI CIRB model in that it is a review system that is independent of the researching organization, and may review research for single-site or multi-site research. However, the discussion during this session was focused on how to set up a central review system for multi-site research.

The questions that came up in both sessions related to how to review unanticipated problems that involve risks for subjects. How should these be reported and managed? Similarly, how should local issues related to conflicts of interest be managed? Other questions related to the management of informed consent documentation were raised. In all cases it seems that local concerns and operations cannot be ignored.

A key lesson I took away from these sessions is that institutions and researchers who rely on a central or independent review system must always remember that the research enterprise is conducted by a human research protections program that involves the researcher, the IRB, (regardless of where it is located or with whom it is affiliated), the sponsor, the sites where the research takes place, and of course, the research subjects. No matter what model is used for the review of human subjects research, no entity that is part of the HRPP relinquishes responsibility for the protection of subjects.

"Science Times" synthesis

After the commemoration of World AIDS Day last week, it’s encouraging to hear that researchers have found renewed hope and inspiration in the search for a cure. In this week's "Science Times" synthesis, learn about the new developments in HIV research, and share your thoughts on the current state of AIDS research and the potential impact of President Obama’s speech in which he committed to significant increases in funding.

Week of November 29

How exercise benefits the brain: 
A major new study finds that the fat mass and obesity-associated (FTO) gene, common in people of European or African descent, may be controlled by even small doses of physical activity. The new report couldn’t come at a better time with holiday indulgences right around the corner.

New hope of a cure for HIV
: Medical researchers are still in pursuit of a cure, and two patients’ experiences are providing the impetus they need to move forward. Learn more about these patients, and why researchers are encouraged by their progress.

Less salt isn’t always better for the heart
: Researchers studying the effect of sodium consumption on the heart in men and women over 55 reveals that while high sodium intake does increase the risk of heart problems, too little sodium may be just as bad.

Week of December 6

Vast and fertile ground in Africa for science to take root
: Opportunities are growing for Africans trained in Africa to conduct scientific research. Read on to learn more about how Dr. Venansius Baryamureeba’s graduate program at Makere University in Uganda hopes to turn out dozens of scientists who will help to push the boundaries of global research.

Computer scientists may have what it takes to help cure cancer
: According to David Patterson of the University of California, Berkeley, the war against cancer is moving into cyberspace. Read on to learn why he believes that computer scientists may have the best skills to fight cancer in the coming decade.

Can't we all just get along?

PRIM&R is pleased to bring you a post from the third day of the 2011 Advancing Ethical Research Conference and the PRIM&R Blog Squad. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging prior to, live from, and after our conferences.

I heard again today what I've heard many times over my last eight PRIM&R conferences, "Institutional review boards (IRBs) are just a hassle," "IRBs get in the way." It seems again and again I hear that investigators feel that IRBs are a necessary evil. Why is this?

A couple years ago my IRB chair went to a conference and when she mentioned to her discussion group her practice of collaborating with her institution’s IRB before applying for review she received a bunch of blank stares followed by questions such as, "You can do that?" My chair informed the group that she did this quite often and that many other investigators at our institution did as well. Until my chair related her story to me, I thought our culture was a normal one. Our IRB has a supportive, open door atmosphere.

What we have found is that if we take the time to visit with investigators while their study is in the development stage, the review process generally goes a lot more smoothly.  Everyone gets to ask questions and we can educate one another.

I have found that when an investigator calls me wanting to know if their study qualifies for IRB review that if I ask questions and explain to them why I'm asking each question that they quickly go from being a bit confrontational to appreciating my position. To me, it's all about being reasonable and respectful.

I have had many new  professors tell me that our IRB is much easier to approach than at their previous institutions. Every time I hear this I am amazed. Our IRB goes into classrooms and visits with students about their studies and gets them started on their CITI training. Are we setting our graduate students up for a big disappointment when they go elsewhere? Why are many other IRBs so unapproachable? We are all on the same team after all.

As we depart this year’s conference, I would like to leave you with this thought: We all get along and collaborate in workshops here at the conference, let’s take this spirit of collaboration back to our respective institutions and start a trend of getting along. Maybe, just maybe, we'll quit hearing what a pain in the rear IRBs are, and instead, start hearing about how well everyone works together.

One topic, many views: The ANPRM

PRIM&R is pleased to bring you a live post from the second day of the 2011 Advancing Ethical Research Conference and the PRIM&R Blog Squad. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging prior to, live from, and after our conferences.

Yesterday's quote of the day? “Sending a consent form to multiple institutional review boards (IRBs) for multiple separate tweaks is a bureaucracy that needs to be muzzled.”

Clearly, Robert Califf, MD, a speaker on Panel I—Increasing the Public’s Understanding of Clinical Research: Opportunities for the Research Community, is in favor of the way the Advanced Notice of Proposed Rulemaking (ANPRM) addresses multi-center studies.

My afternoon has been filled with ANPRM, and I have to say that I’m getting what I came for from this conference!  I felt like a dunce, but I finally mustered the courage to raise my hand and ask, ”So where did the ANPRM come from?"  No one laughed, so I guess it was ok to ask. The speaker said it exploded after an article written by Ezekiel Emanuel and Jerry Menikoff was published in the New England Journal of Medicine. According to my sources, the article did a good job of explaining how the Common Rule has not been revised since 1991 and pointing out the limitations in the existing regulations. Thus, following a Presidential Executive Order to review all regulations, the ANPRM was born.

Ivor Pritchard, my all time favorite Fed, made some clarifications about ANPRM in Panel
I. The ANPRM poses the question whether all biospecimens should be treated as though they are identifiable so that they always fall under human subjects regulations. The ANPRM also proposes the application of HIPAA-like privacy protection rules for protecting data rather than the HIPAA rules themselves.

Ivor also reviewed some of the comments that were received in response to the ANPRM:

1. Investigator registration of excused research:  No one likes it!!
2. Single IRB review for multi-site research:  Respondents were split.
3. Templates for informed consent: Respondents were split.

PRIM&R’s point of view was also discussed:

1. High efficiency is not a moral imperative in IRB work.
2. The responsibility for better protocols and less legalistic consent forms should be "on" principal investigators (PIs) and sponsors.
3. Sanctions should be applicable to PIs and sponsors, not only to the institution as a whole.
4. Consent should be a process. It should not be confined to a single document. Central IRB review of multi-site studies should not be mandated, but should be an option available in addition to local review.

When asked when the new rules would be final, Ivor got up from his chair and felt around in his pockets for a few minutes.  After an awkward silence, he said he forgot his crystal ball.

I also really enjoyed the keynote this morning and Seth Mnookin`s presentation. At lunch, I found myself discussing our electronic submission system the whole time, so  I failed to poll my table on the ANPRM today. I guess I`ll have to save that for Speed Mentoring later tonight!

How safe are we, really?

PRIM&R is pleased to bring you a live post from the second day of the 2011 Advancing Ethical Research Conference and the PRIM&R Blog Squad. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging prior to, live from, and after our conferences.

We can run, but can we hide? We create avatars, multiple online personas, use different types of devices to log on, but are we really safe? I attended a panel this morning, Would Margaret Mead Have Blogged? How Social Media Has Changed Research, in which one of the presenters stated that both kids and adults no longer see a separation between their personal lives and their online lives. Both groups fail to consider future audiences of the content they put online.

Online safety is a moving target. Facebook, for instance, is constantly making changes to their privacy policies, and as of a year ago, the Library of Congress is now archiving all tweets. Heck, as far as I know, I've signed my first born over to Mr. Zuckerberg! Have fun with that, sir. I’m happy to relieve the college payments up to you!

So, how do institutional review boards (IRBs) handle the constant changes in the cyber world? One answer I heard today was that IRBs go by the "expectations" of the individuals that are posting on the sites that the researchers use. In an effort to understand this concept, I sent my 20-year-old son a Facebook message to ask him what his expectations were for researchers who engage with his online gaming communities. He shared that he was under the impression that these communities were private. This was an understanding that he also extended to Facebook. Many of these online tools make changes to their privacy settings so often that I think a person could have a full-time job just teaching others how to secure their information on these sites. Techies seem to be able to keep up with these changes, but the average Joe doesn't seem to have a clue that things have changed until someone points out that they saw something salictious on their wall.

I have done my own informal “research” on Facebook, and have found that many people don't have their account as secure as they think they do. Does this mean that because their information is public that they want their data mined? Is it ethical to do so? Personally, I don't think it's ethical to mine data from people's Facebook accounts just because it isn't secured. If researchers want to do studies on Facebook accounts, consent should be obtained. The argument that it's public knowledge is a pretty thin one when it comes to social media. Many people will sign their first born away with out realizing it because they don't read the privacy policy, and they don't take the time, or don't understand how, to figure out how to keep their posts and other information private.

There are numerous issues to look at when it comes to research and social media. The sheer number of people attending these sessions is a clear indication that the issues are becoming more and more front and center. With technology constantly changing, it's difficult to keep on top of it all. Now there are clouds to consider, hackers to worry about, and data to keep safe. I'm not sure if most people understand that their digital footprint never goes away, and that it just continues to build. Ultimately, the more we use social media and mobile devices, the less we can hide.

Introducing the newest member of the PRIM&R Blog Squad: Beth Brakewood

Welcome to a special installment of our featured member interview series in which we introduce you to our 2011 AER Conference Blog Squad members. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and why they're excited about blogging for PRIM&R!

Today we’d like to introduce you to Beth Brakewood, CIP. Beth has a Bachelors of Science in Biomedical Engineering and is currently working on her Masters in Public Health in Epidemiology at the Texas A&M School of Rural Public Health. Beth will be blogging about PRIM&R's Virtual Meeting.

When and why did you join the field?

I'm a rare case in that I joined the field by starting at an Institutional Review Board (IRB).  I was switching fields, trying to break into clinical research, and found an opening with Integreview Ethical Review Board, a private commercial IRB. I moved over to work for a Phase I pharmaceutical unit as a compliance supervisor, then came back to the IRB side by working at The University of Texas at Austin. Recently, I've had the chance to move back to the researcher side of the table at the same institution.

What is your favorite part of your job?

I love being able to work as a member of a team with technical and scientific professionals.  Protecting subjects is a vital component of any research enterprise and at my institution I have the opportunity to act as an expert member of the research team. I get to work with the researchers to ensure that the ethical treatment of subjects is their primary concern, while I can handle the technical details of ensuring that our compliance obligations are met.  As a member of the research team, I can ensure that students and researchers think about ethical treatment of subjects first rather than focusing exclusively on compliance with regulatory requirements.

What's your after-hours guilty pleasure?

My not-so-guilty after-hours pleasure is rowing. I have "adult onset athleticism." After 30 years of a generally sedentary life, I joined a rowing club and fell in love with the sport.  I may not be particularly competitive, but nothing beats ending a workday with a row with my team down a beautiful river.

Why did you join PRIM&R?

I joined PRIM&R for the networking and educational opportunities. I think having the opportunity to read about the experiences of other research ethics professionals and talk to them over email or at conference is the best way for me to grow as a professional.

What is your favorite member benefit?

Honestly, it's the discounts on conferences and meetings! IRB professionals often work in isolation, particularly those at small institutions. Being able to meet people in person and really see that we aren't alone is a huge benefit.

With whom have you made a lasting professional connection through your membership?

At every meeting or conference I've attended, I have met at least one person with whom I've "clicked" professionally and who I've contacted later. I've bounced ideas off of the chair of an IRB at a small liberal arts college, shared SOPs with an IRB administrator at a large clinic, and talked about the challenges of instituting cultural change with an IACUC/IBC/IRB coordinator at a growing academic institution.

What advice do you have for young professionals interested in pursuing a career in ethical research?

I think getting my Certified Institutional Review Board Professional (CIP) certification was one of the most valuable things I've done for myself. Having an in-depth understanding of all of the regulations and the certification to back up that knowledge has made me a member of the research team. It has also freed me up to think more about the issues of justice, beneficence, and respect-for-persons when approaching a problematic situation, confident in my ability to ensure that the ethical solution is also a compliant solution.

What are you most excited to blog about from the upcoming 2011 AER Conference?

I'm very interested in the Living Room Conversation - In Their Own Voices: What Do Research Subjects Have to Say About Informed Consent. IRBs and researchers can often lose sight of the individuals for whom the consent process is most important, substituting their own judgment or impressions about what subjects want or need to know.  Keeping the focus on subjects, rather than researchers, compliance personnel, or risk management requirements is one of the hardest cultural changes for many institutions. Conversations like this help IRB professionals reinforce the need to hear from the people we are all trying to protect.

My exploration into the vast world of internet research

PRIM&R is pleased to bring you a live post from the first day of the 2011 Advancing Ethical Research Conference and the PRIM&R Blog Squad. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging prior to, live from, and after our conferences.

Yesterday, I attended Oh, What a Tangled Web We Weave: Regulatory, Ethical, and Technical Challenges in Internet Research and it was seriously good!

My institutional review board (IRB) sees its fair share of SurveyMonkey studies, but Facebook, avatar, and World of Warcraft studies were all new to me. This session applied human subjects regulations to internet research, a topic for which the Office of Human Research Protections (OHRP) has historically provided limited guidance.

As you may know, internet research can refer to two things:  using the internet as a tool for research or using the internet as a medium/locale of research.  It is up to the IRB to decide what is reasonably considered private in chatting, messaging, email, video, voice chat, file sharing, blogging, and discussion groups. It is also the responsibility of the IRB to decide how identifiable the information may be.

Data protections range across nations. For a glimpse at the degree of data protections in different countries, take a look at this map. For instance, did you know that photo sharing can provide the GPS location of the photo along with the date and time the image was taken? So, if you are ever on the run from the law, make sure you’re are not posting road trip pictures on your Facebook account! Overall, this session provided amazing information that will impact my IRB deliberations as I consider the criteria for approval.

Of course, there is still a great deal that is uncertain in internet research. The recent Advanced Notice of Proposed Rulemaking (ANPRM) has many talking. The presenters, Laura Odwazny, Scott Bradner, and Elizabeth Buchanan, discussed the unpopularity of applying Health Insurance Portability and Accountability Act (HIPAA) standards to all information (i.e. not just health information) and the proposed excused categories of research.

At lunch, I informally polled my table:

• One person had heard of the recent proposed changes, but had not yet read them; 
• Two people were first-time attendees, so I let them slide; 
• Two others felt the biospecimens proposals would be difficult; and finally, 
• One thought that multi-site studies sounded dreamy, but threatened local IRB job security.

Through my conversations on this topic, I think I found two new friends. Perhaps I will connect with them on Facebook, or maybe not considering my idea of privacy may not match that of some researchers studying Facebook profiles of individuals that "like" PRIM&R!

Annual Freak-Out!

 PRIM&R is pleased to bring you a live post from the first day of the 2011 Advancing Ethical Research Conference and the PRIM&R Blog Squad. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging prior to, live from, and after our conferences.

Every year, when I come to the Advancing Ethical Research Conference, I have a freak-out moment.  It’s the moment when I learn something new about the way research protections works, and I realize, with a sinking feeling, that I have a lot of work on my hands when I go back home.

Today, I attended the pre-conference program Institutional Biosafety Committee (IBC) Basics: An Introduction to the NIH Guidelines and the Oversight of Recombinant DNA Research. I attended this class because I'm a “newbie” to IBC administration. At the end of the day, after listening to all of the presentations, I am pretty sure I'm going to have to go back and look at our policies and training. My institution’s forms will need to be assessed as well.

Unfortunately, we don’t  have any IRB members that sit on an IBC, so it's now going to be up to me to make sure that any potential IBC concerns are raised. Suddenly, I’m overwhelmed. Did I miss something?  Is our one IBC protocol on campus funded by the National Institutes of Health?   I almost started hyperventilating!

As I sat listening to  the day’s presentations, my brain began to wander to the one protocol that fits into the IBC category at my institution, an ongoing, longitudinal study in which the principal investigator collects DNA samples from study participants (without personally idenitifable information).

Since, I'm quite familiar with this particular study, I started reviewing the IRB protocol in my mind.   What conditions would require this protocol to undergo  IBC review?  To be honest, I didn't have a clear idea on what rDNA is before attending the program today. Hearing the definition of rDNA t left me anxious until I realized that this protocol’s research team does not take two strains of DNA and combine them into one, nor are they altering the DNA they are obtaining.  Thank goodness for the information and clarification! Freak out averted!  No IBC review is necessary. 

But, it’s only day one! There’s still three days of conference left, and therefore, still plenty of time left for my Annual Freak-Out!