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!

Planning your 2011 AER Conference experience

It’s hard to believe that in a few days I will be bound for the airport and off to AER 2011. Going to a PRIM&R conference is like a breath of fresh air. It gives me a chance to “get outta Dodge,” and to gather with others that have chosen this career path. It’s always amazing to me that there are thousands of other people that do what I do. It’s rare that I find anyone who can rattle off the regs like I can, but at PRIM&R events I find a convention center full of “reg geeks” just like me, but with new ideas!

Now that I have “ANPRM” rolling off my tongue like butter, it will be my four-day PRIM&R goal to know the 23 separate proposals and 74 questions of the ANPRM intimately. I’m also dying to know what HRPP professionals really think about the proposed changes to the “Common Rule.” 

I’ve considered emulating Ivor Pritchard and trying to come up with a “Four Days of PRIM&R” rendition of “The Twelve Days of Christmas” about the ANPRM as a conference opener, but I don’t play the ukulele, harmonica, or anything else, so doubt I’d be as riveting!

If you’re left scratching your head about all this, ANPRM stands for Advance Notice of Proposed Rulemaking, and is the federal government’s way of proposing changes and collecting public comments on an issue.  OHRP has a really nice table comparing the existing rules with some of the changes being considered. 

Huron Consulting Group put on a really helpful webinar in September, offering additional insight into the ANPRM proposal by polling participants. Key results are available here.

My personal favorite proposal is the elimination of the “Common Rule” for expedited research. I also detest the idea of allowing investigators to make their own determinations regarding institutional review board (IRB) exemptions. I’m looking forward to hearing the pros and cons from the experts, and I will share any juicy insight I gain from the conference in subsequent blog posts.

Don’t forget to check out the posters at the Conference Connection. This is another way to see what your colleagues are doing and to find collaborators if you’re interested in a particular project. Poster presentations will also be made during some of the breakout sessions. I try to walk away with a list of my favorite speakers each year so that I know who I will contact if I ever have the nerve to plan my own conference.  If you love a speaker, let them know. Talk to them after the session and make a connection!

My last words of pre-conference advice are: Don’t be a hermit! Don’t go up to your room and hide under the covers of the comfy bed (this is not from experience…ha!).  Branch out and attend the welcome reception, the networking lunches, and the Meet and Greet with exhibitors and supporters. And make sure to watch the respected PRIM&R icons boogie at the DJ and Dancing on Friday. I hear they are taking requests!

Come talk to me and share your ideas on the ANPRM or challenge me on my knowledge of the regs. I’ll be the straight-haired redhead in the Blog Squad tee!

Wishing you safe travels to National Harbor!

Science Times synthesis

As we contemplate the things we are thankful for as part of our annual holiday celebration, you may find it interesting to know that researchers believe gratitude has real health benefits. Learn more about how being thankful can improve your health and relationships, and enjoy your day!

Week of November 15

Chimps’ days in lab might be dwindling
The NIH has commissioned a report on the usefulness of chimps in research, and the federal  Fish and Wildlife Service is considering a petition to declare chimps an endangered species. How will this impact biomedical research? Read on to find out.

Cloaks of invisibility, switched in a flash
Research shows that some species of cephalopods have developed the ability to switch between two “disguises” designed to ward off predators. Learn more about the study, authored by Duke University ecologist Sarah Zylinski.

The claim: Exercise can ward off migraines
A recent study shows that exercising 40 minutes three times a week may decrease migraines, as can use of topiramate (a drug that helps prevent migraines) and regular relaxation exercises.

Scientists decode the protective element sickle cell anemia offers against malaria
Scientists have figured out how the genetic mutation that causes sickle cell anemia also protects against fatal malaria. Learn more about the new study published in Science.

Solvent linked to higher Parkinson’s risk
A new study of twins finds that trichloroethylene (TCE) is associated with a higher risk of Parkinson’s disease. Find out more about this solvent, widely used in refrigerants and as a metal degreaser.

A watch-and-wait prostate treatment
Jane Brody reports on one doctor’s proposal that the least invasive approach should be taken for most men with early-stage cancer that is not particularly aggressive.

Week of November 22

A serving of gratitude may save the day
A new series of studies shows that gratitude is linked to better health, sounder sleep, lower rates of aggression, and less anxiety. Read on to learn how being thankful can positively impact your health.

In body’s shield against cancer, a culprit in aging may lurk
Researchers at the Mayo Clinic have reported that in a body purged of its senescent cells, tissues remain youthful. Learn more about senescent cells and how they work.

The case of the birds that knew too much
In the age of information overload, a new study of the European starling suggests that less information may result in better choices. Read about the study here, or review the findings in the journal Science.

Chewing gum can prevent ear infections
Researchers at the University of Toronto take on the claim that chewing gum can prevent ear infections, finding that children who chewed xylitol gum were 25% less likely to develop acute ear infections.

Getting a handle on why 4 equals green
Neuroscientists in England are trying to determine why the brains of those who suffer with grapheme-color synesthesia see colors when thinking about letters, numbers, or words. A new study appearing in the journal Current Biology suggests that those who suffer from this condition experience heightened activity in the region of the brain that controls vision.

Presidential Commission: Research ethics norms and professional standards

by Elisa Hurley, PhD

Last  week, the Presidential Commission for the Study of Bioethical Issues held its seventh public meeting in Boston. This was the final meeting devoted to President Obama’s charge to assess how well current regulations protect human subjects in research. The President’s instruction came in response to the revelation last year that from 1946 to 1948 the US Public Health Service (PHS) supported research on sexually transmitted diseases in Guatemala involving the intentional exposure and infection of subjects. Much of the commission’s agenda was devoted to discussion of a draft of the report it will deliver to President Obama this December.

As I sat in the audience, I was particularly intrigued by a session launched by commissioner John Arras’ observation that John Cutler, the principal investigator of the US PHS Guatemala Study, viewed the norms of research ethics as onerous obstacles to conducting research. This led the commission to grapple with the question of how to help researchers see research ethics norms as professional standards. 

At first glance it might seem that there is a tension between approaches to protecting human subjects that focus on external sets of rules or regulations, and those that focus on the internalization of ethical norms. Certainly the previous generation of physician-researchers viewed things this way.  As Arras pointed out, Henry Beecher—the anesthesiologist who exposed unethical practices in research in a seminal 1966 New England Journal of Medicine—was against the imposition of external, law-like regulations on research ethics.  He believed that the intelligent, informed, conscientious, and  compassionate investigator—who Aristotle would have called the “virtuous” researcher— would make ethically sound decisions.

But Beecher’s view is as dubious as Cutler’s. The protection of human subjects should not be left solely to the discretion of the “benevolent” researcher. With research this complex, varied, and large-scale, we need a system of public rules that is transparent, enforceable, and practically applicable.  Yet there is a kernel of wisdom in Beecher’s view, one that seems to have been lost amid the layers of complex regulations and guidance around human subjects research: the idea that the norms of research ethics should be part of the researcher’s professional identity. In other words, such norms must be embodied in the very idea of what it means to be a good researcher. 

The key, according to the commission, is to promulgate a system of regulations that fosters an ongoing and lively engagement with ethical norms among those who are involved in research.  And with the release of the recent Advance Notice of Proposed Rulemaking (ANPRM)  regarding human subjects protections, we have an opportunity to transform the regulations to do just that—to, in the commission’s language, “prune” away the unnecessarily onerous aspects of the regulations and strive for harmonization.  If we mindfully pare down the regulations, we might end up with a set of rules that elicit greater respect from investigators.  Of course, as the commission suggested, and as PRIM&R and many others noted in their comments on the ANPRM, a revised “Common Rule” must first address investigator responsibilities and obligations directly, something the current “Common Rule” fails to do.

 

As the commission recognized last week, regulations that speak directly and palatably to investigators so they feel supported, as well as responsible, solve  only half the puzzle of how to help professionals internalize research ethics norms.

The missing pieces involve education. Here we probably need better data, but the commission seemed to be in agreement on three recommendations regarding research ethics education:

1. It should begin long before people are research professionals, perhaps in high school and certainly at the undergraduate level;
2. It needs to be interactive, case-based, and focused on details; and
3. It must be ongoing, in the form of collegial mentoring and, once professionals are established, coaching and consulting.

In the words of one commissioner, “How do we institutionalize a lively culture of ethical thinking in our professional organizations?” 

What do you think?

Being an IRB coordinator: What it means to me

Why do I enjoy being an IRB coordinator? At the University of Tulsa, the IRB’s focus is primarily on social and behavioral research (SBER). Of the many things I enjoy, at the top of my list is the interaction with faculty and students. I appreciate it when researchers stop by to discuss their projects before they get started.  I like the collaborative atmosphere and enjoy listening to bright new ideas. I get warm fuzzies when I think about doing something with my life that serves the greater good.

Although most SBER protocols reviewed on campus fall into the exempt or expedited categories, there is still a risk of harm to participants. In studies that are designed to be anonymous, subjects’ identities must be protected to minimize the risk of potential physical or financial harm. For example, compromising a battered woman’s anonymity could incite further  abuse, if her attacker were to learn that she spoke up.

I am proud that my institution studies post-traumatic stress disorder (PTSD). I get those warm fuzzies—a feeling of real satisfaction—again when I hear a piece on National Public Radio (NPR) about our soldiers, and that PTSD is now being recognized as a serious but treatable disorder by the military.

The University of Tulsa has also run ground breaking studies on people who endure chronic nightmares, and we are seeing real results. I love hearing from one of our graduate students about her work with veterans who suffer with nightmares. When she tells me about the results of her work and how they will help veterans in the future, I am as happy as she is!

Are there down sides to my job as an IRB coordinator? Sure there are. I’ve had more than one sleepless night over a confounding study, and sometimes I feel like everyone on campus has my personal cell phone number.  However, I am glad to say that by and large the pros outweigh the cons, and that I enjoy what I do and its positive impact on others.

An interview with AAMC’s chief scientific officer, Ann Bonham, PhD

By Catherine Rogers
Among the esteemed faculty for the 2011 Advancing Ethical Research (AER) Conference is Ann Bonham, PhD. As the chief scientific officer of the American Association of Medical Colleges (AAMC), Dr. Bonham plays a critical role in advancing ethical research. Conference attendees can look forward to her presentation during the pre-conference program The Buck Starts & Stops Here: Investigator Responsibilities for the Ethical Conduct of Research on December 1. For more information or to register for this program, please visit our website.


What are your key goals/agenda items as chief scientific officer at AAMC?
We have four specific goals. The first is to advocate and educate broadly about the benefits of biomedical research, from basic and clinical research, to community based participatory research (CPBR), to health services research, to implementation science.

The second goal is to work with academic medicine to come up with business models and strategies that will sustain biomedical research through economic constraints. This includes creating models and strategies that focus on quality and impact over growth and ensuring outcomes that matter to patients, the public at large, and Congress. AAMC just released a report showing that in 2009, the immediate economic impact of biomedical research in AAMC member medical schools and teaching hospitals was close to $45B and 300,000 jobs.

The third goal is to help establish pathways for academic medicine to build principled partnerships with industry. The shortage of new drugs and diagnostics in the pipeline call for innovative partnerships in which efforts are combined to ensure the development of new therapeutics to improve health in the next decade. 

The fourth goal is to use science to create an evidence base for improving patient and population outcomes while reducing costs in delivery of care. Health care legislation pointed to the need to fix the fragmented care delivery system and to broaden the concept of comparative effectiveness research.

What other programs or research initiatives are you involved with outside of your work with AAMC?
At AAMC, my responsibilities for engaging with policy makers and the leadership of academic medicine keep me busy.

At the 2011 AER Conference you will be participating as a faculty member for the pre-conference program, The Buck Starts & Stops Here: Investigator Responsibilities for the Ethical Conduct of Research. Given your own experience as a researcher, what do you think is needed to better facilitate effective and ethical research?
I believe that 99.99% of investigators are committed to performing ethical research that advances health and protects the privacy and safety of human subjects. What would be helpful is to clarify the roles and responsibilities for all those involved in clinical research. It would also be beneficial to have a clearer understanding of the rules and regulations surrounding the requirements for research. Clarity about the rules and showing compliance are the most helpful, but then the question is, how best to accomplish that?

What motivates you to maintain your commitment to advancing ethical research?
I believe that research is a social contract to improve the health of the public through discovering new knowledge and applying existing knowledge so that all of society benefits.

What challenges do you see ahead for medical research in general? Any ethical challenges in particular?
Some future research involving personalized medicine based on genomic variations; increased probability of using stem cells; and an emphasis on doing research with communities will bring significant attention to informed consent. However, that will be become complicated in terms of what’s needed to complete the research, and how we go about understanding a community’s perceptions of informed consent and transparency.

What advice do you have for young professionals interested in pursuing a career in research, research ethics, and/or a related field? 
Despite current national economic challenges, it’s a privilege and an opportunity to make and apply discoveries related to improving health. Imagine making a new discovery that will improve the health of not one or two or 10, but thousands of individuals. It would be impossible to have that commitment to improving health without a commitment to ethics, as real and true research must have ethics embedded in it.

Featured member interview: Mathia Sanders

Welcome to another installment of our featured member interviews 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 Mathia Sanders, a retired community representative at Creighton University in Omaha, NE. 

When and why did you join the field?

I am retired after having worked in the field of social work for 30 years.

What is your favorite part of your job?

My favorite part of the field is the opportunity it provides for advocacy work. Hopefully I am a strong advocate for research participants and their families in making sure that consent forms are clearly worded, the risks and benefits are clearly stated, and participants are treated fairly. I feel fortunate being asked to serve in such a capacity .

What is your current state of mind?

I am a very positive person.

What is the last movie you saw? 

I saw Limitless with my family .

What are you currently reading?

I am reading Little Bee by Chris Cleave, and The Immortal Life of Henrietta Lacks, by Rebecca Skloot.

Which living person do you most admire?

I most admire President Barack Obama and his family.

What is your favorite member benefit?

My favorite member benefit is the opportunity to attend all the PRIM&R conferences. At the last conference I attended, the speakers were enthusiastic and extremely knowledgeable, the panel discussions were very good, and the personal testimonies were inspiring.

What motivates you to maintain your commitment to advancing ethical research?

I have very good working relationships with PRIM&R members on the IRB.

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

I would encourage them to become life-long learners regarding cultural diversity. Historically, African Americans  generally have a mistrust of research, and feel they do not need to participate. I believe more education is needed to encourage their participation. It is vital that young professionals look for ways to involve more African Americans and other diverse groups in research.

Thank you for being part of the membership community and sharing your story, Mathia. Enjoy some quality holiday fun with your family!

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

Science Times synthesis

It seems a number of recent studies are taking issue with common myths about weight gain, the benefits or drinking eight glasses of water a day, and how coffee impacts sleep. Put your feet up, grab a cup o’ joe and read on to learn more about recent myth-busting studies.

Week of November 7

Decoding the brain’s cacophony
Read this profile of Dr. Michael Gazzaniga, professor of psychology at the University of California, Santa Barbara, and learn about the brain’s “split personality.”

Snakes’ feat may inspire heart drugs
Researchers say a better understanding of the process by which pythons digest their prey could help them develop new ways to treat various hereditary diseases in humans.

Midnight labs and martini time
Some observations by Michael Gazzaniga from a recent interview with Benedict Carey.

In some cases, even bad bacteria may be good
Read about a study that suggests the overuse of antibiotics may contribute to an increase in obesity, allergies, inflammatory bowel disease, asthma, and acid reflux disease.


For a more restful nap, drink a cup of coffee beforehand
Sleep researchers in England find that drinking a cup of coffee and immediately taking a 15- minute nap is more effective than either coffee or napping for tired drivers.

Study suggests obesity hinders flu vaccine
A new study suggests that flu vaccine effectiveness has a direct relationship to a patient’s weight.

Week of November 14

Focus on home, not meals, led spiders to diversity
A new study by Dimitar Dimitrov, a biologist at the University of Copenhagen, suggests that spider web diversification started with a need to create specialized habitats.

Drink eight glasses of water a day to protect the kidneys
Enjoy a cool glass of water while you learn about research that suggests drinking extra water helps the kidneys to clear sodium, urea, and other toxins from the body.

Four-year test seeks better ways to treat a persistent disease spread by sand flies
Learn about kala azar, a widespread parasitic disease prevalent in India and Bangladesh, and the four-year study that hopes to find the most effective and practical treatment.

‘Freshman 15’ is a myth, a study suggests
College freshman will be happy to hear that a recent study at Ohio State University suggests the “freshman 15” is a myth, and that students typically gain between 2.5 and 3.5 pounds during their first year of school.

IVF brings a slightly higher cancer risk
Dutch researchers have concluded that women undergoing in vitro fertilization (IVF) are at a slightly higher risk for borderline ovarian cancer, bringing the risk to .71 percent. According to the author of the study, this should not be a concern to women who choose to undergo IVF.

Introducing the newest member of the PRIM&R Blog Squad: Mindy Reeter

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 Mindy Reeter, BS, CIP, director of the office of human research oversight at the University of Illinois College of Medicine in Peoria, IL.

When and why did you join the field?

1999. My first job out of college actually using my degree!

What is your favorite part of your job?

Wrapping my head around some of the really cool research we review in order to allow the research to happen in the most ethical way possible.

Why did you join PRIM&R?

Because it is the biggest community of human subject professionals available.

What is your favorite member benefit?

The discounts of course… and meeting “human subjects” icons at the meetings. I once had Greg Koski sign his autograph on a PRIM&R sticker and I have a picture with Ivor Pritchard from a conference.

If you were planning our next conference, who would you select as a keynote speaker?

I think Neal Dickert is a great resource for planned emergency research and he should team up with my emergency room physician IRB chair, John Hafner, who is an excellent researcher and research mentor!

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

It never gets old.

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

What vendor booth offers the best pens… ha! And all the opinions regarding the ANPRM!