Data in the Cloud

by Julie Fine, BS, Legal Specialist, Worldwide Research and Development, Pfizer Inc., La Jolla, California

While the 2013 Advancing Ethical Research (AER) Conference has drawn to a close, PRIM&R is pleased to continue sharing reflections from members of the PRIM&R Blog Squad to provide our readers with an inside peek of the conference.

During the 2013 Advancing Ethical Research (AER) Conference, I attended two panels that challenged conventional wisdom about transparency, control, and crowdsourcing of research data. The first, Panel VII: Data Sharing on Steroids: Demands for Transparency of Subject-Level Research Data, touched on the increasing demand for transparency in clinical research on a broad scale, and included representatives from an institutional oversight organization and a pharmaceutical company, and a patient advocate, who shared their insights into data transparency.

The demand for public access to aggregate research results has lead biotech companies and the European Medicines Agency (EMA) to rethink the way in which data can (and should) be shared. Greater openness could generate opportunities to reassess research results and perhaps expand the utility of secondary analysis. It is important, however, that the process of gaining access to the data also be transparent.

The initiatives of the EMA and other biotechnology companies highlight the merits of legitimate, purposeful data sharing. That is to say, if a qualified researcher with a well-defined research proposal has no significant conflicts of interests and possesses the requisite skills to conduct the proposed analyses of the data, the sharing of research results can be highly beneficial. Still, such transparency does raise concerns, several of which were discussed by the panelists. For example, scientific inquiry and the public good may not be well served if uncontrolled open sharing leads to misuse or junk science.

The second, Panel VIII: Taking Control: Ethical Challenges for Participant-Centered and Participant-Led Research, examined instances in which participants become the driving force behind the initiation of, and at times actually take an active role in the conduct of, research projects. With the help of social media and other digital technologies, online communities can engage in projects with their own data outside of standard regulation-controlled research. Though crowd-sourced data and self-policed affinity groups may be a novel approach with certain advantages, it’s difficult at this stage to envision an FDA-approved drug entering the market from this model. What do you think?

Please note that the views presented here are Julie’s own and do not reflect the positions or policies of Pfizer, Inc.

Research Ethics Roundup: New recommendations on incidental findings, considering personhood, and more

by Maeve Luthin, JD, Professional Development Manager

Oh, the weather outside is frightful, but Research Ethics Roundup is so delightful! So, we hope you’ll bundle up, hunker down, and enjoy some of the research ethics stories that are making headlines this week. We, here at PRIM&R, wish you a joyous holiday season and good health in the New Year and always.

GM Maize, Health and the Séralini Affair: Smelling a Rat: The Food and Chemical Toxicology journal retracted a September 2012 study that suggested genetically modified maize causes cancer. Critics of the article complained that the rats used already had a pre-disposition to cancer, that too few animals were included in the study, and that researchers did not distinguish between spontaneous tumors and those that may have been caused by the maize. The publisher said there was no evidence of intentional misrepresentation of the data or fraud. Some members of the scientific community have been concerned that the backlash against genetically modified food has undermined efforts to use genetically modified food, such as Golden Rice, to feed children in resource-scarce nations.

Harvard Fined for Violating Animal Welfare Law in Care of Monkeys: The United States Department of Agriculture fined Harvard Medical School $24,000 for eleven violations of the Animal Welfare Act in its care of nonhuman primates used in research. These infractions, which occurred in 2011 and 2012, led to the deaths of four monkeys. Earlier this year, Harvard announced it would shut down its New England Primate Research Center by 2015.

Medics Should Plan Ahead for Incidental Findings: Earlier this month, the Presidential Commission for the Study of Bioethical Issues (PCSBI) released a report outlining how researchers, physicians, and companies should handle incidental findings discovered in the course of genetic analyses, imaging scans, and other tests. PCSBI contends that researchers have a duty to plan for how they will handle incidental findings.

Rare Cancer Treatments, Cleared by Food and Drug Administration (FDA) but Not Subject to Scrutiny: The New York Times explores the challenges of the FDA’s humanitarian device exemption policy, which was implemented in 1997 and grants companies permission to sell products that are safe and have a “probable benefit” for the treatment of conditions that affect less than 4,000 patients annually—a subject pool generally not large enough to warrant clinical trials. Under the policy, companies are not required to collect safety and efficacy data.

What is Personhood?: The Nonhuman Rights Project (NhRP) filed a series of lawsuits in New York courts demanding writs of habeas corpus, which challenge a person’s alleged imprisonment or unlawful detention, on behalf of four chimpanzees. NhRP contended that the chimps qualified as persons with a fundamental right to freedom because of their autonomy, self-determination, and self-awareness. In response to the lawsuit, James Carroll, a columnist for The Boston Globe, considers the issue of personhood in this thought-provoking piece.

Reflecting on Therapeutic Misconception

by László M. Szabó, Esq., Director of the Office of Research Regulatory Affairs at Rutgers, The State University of New Jersey

While the 2013 Advancing Ethical Research (AER) Conference is over for the year, PRIM&R is pleased to continue sharing reflections from members of the PRIM&R Blog Squad to provide our readers with an inside peek of the conference happenings.

On the second day of the 2013 Advancing Ethical Research (AER) Conference, I attended Paul Appelbaum’s keynote address, Therapeutic Misconception in Clinical Research: A 30-Year Retrospective. Dr. Appelbaum is an expert on informed consent, decisional capacity, and related issues, and has written widely on research ethics. Importantly, Paul was the first to identify the phenomenon of “therapeutic misconception” about 30 years ago, and reflected upon the matter with his depth of experience.

Therapeutic misconception takes place when a research subject incorrectly attributes therapeutic or ordinary treatment benefits to participation in research, thereby misconstruing the intent of research and treatment. Obviously, the impact on the informed consent process is substantial. Therapeutic misconception can be triggered when established treatment options are lacking or when a research study is similarly designed to clinical care. For the latter, subjects often either underestimate the risks associated with the research or are overly optimistic about the outcomes of the research.

Because the informed consent process is so vital to overcoming therapeutic misconception, it is important to convey several points to subjects to construct a clear distinction between research and clinical therapy:

• Explain that research = experiment = unknown/untested methods. Research is intended to test hypotheses (it is, after all, an experimental undertaking) that will ideally lead to theories that can be translated to clinical treatment. 


• Clearly define how the research differs from treatment (e.g., the use of placebos), and incrementally prompt the subject for understanding. A recommended way to accomplish this is to have fewer open-ended prompts and, instead, more structured assessments.


• Explain that one key aspect of how research differs from treatment is that the protocol spells out what needs to be done for research, whereas in treatment the treating physician has greater professional discretion to decide on a course of treatment. The effects of this, for example, may be that if the subject needs more medication they may not be able to receive it because it may be prohibited under the research protocol.


• Limit the use of study acronyms that sound overly optimistic (e.g.,  “BEST”, “MAGIC”—both real acronyms).


• Pay attention to the connotations of verbiage. For example, many researchers avoid the term “experimental” in lieu of “study,” or “project,” which can increase the likelihood of therapeutic misconception.

A key consideration—really a threshold matter to address the possibility of such misconception taking place—is to first consider how close the research resembles treatment. This assessment, of course, should disregard the intent of the researcher and be made from the perspective of the target subject population.

So, what can you do to avoid therapeutic misconception? Clearly define ways by which the research is different from treatment (e.g., by explaining what random assignment is), pay attention to the verbiage used in the study, and conduct informed consent face-to-face to support a comprehensive understanding by the subject.

Resources cited by Paul:

• False Hopes and Best Data: Consent to Research and the Therapeutic Misconception

A Tribute to Nelson Mandela: An Exemplar and Inspiration to Us All

by Joan Rachlin, JD, MPH, Executive Director

The eight days since Nelson Mandela’s death on December 5 have been among the most inspiring of my life. The words and images that have poured forth from South Africa have caused me to experience several “driveway moments” (defined by NPR as those times when you’re driving along listening to a story, and although you reach your destination, you’re so riveted that you sit in your idling car to hear the piece all the way through).

I have long admired and been in awe of Mandela. In fact, the first protest to which I took my then two-year-old daughter was one urging the Commonwealth of Massachusetts to divest its holdings in South Africa. I also took my 11-year-old son, Micah, and one of his friends to hear Mandela speak at Harvard on September 16, 1998. The boys and I were quite close to the stage, and the combination of feeling Mandela's aura, hearing his powerful voice, and listening to his profound yet humble words, is among my most enduring and cherished memories.

I thus decided to write this post despite the lack of an explicit link to research ethics, but, as my PRIM&R co-worker, Avery Avrakotos, reminded me, there are echoes of what Mandela stood for in PRIM&R’s own core values. Although our work is only a thin link in the powerful global chain that Mandela created, I am struck by the manner in which both the Belmont principles and our organizational creed reflect his teachings.

Mandela’s life was a paean to ethics, justice, and humanitarian ideals, and he innately embodied so many of the fundamentals on which our field and this organization are based. For example, the Belmont principles of respect for persons, beneficence, and justice were tightly woven into the fabric of Mandela’s life and legacy. His thirst for dismantling apartheid (which literally means “apart-hood”) so that black South Africans could be free of white minority rule represents respect for persons writ large.

His beneficence is legendary, and the example that has awed me most is a story I heard from a guide at Victor Verster Prison, from which Mandela was released after more than 27 years in captivity (20 years of which were spent on Robben Island, off the coast of Cape Town). I learned that Mandela, when he was told he was to be released the next day, declined to leave until a few days later because he needed time to “thank his jailers for caring for him.”  Mandela even invited a few of those jailers to his inauguration, and later appointed F. W. de Klerk, the last state president of apartheid-era South Africa, to join his cabinet.

Yet another example of Mandela’s beneficence is captured in the film Invictus, which tells the story of his actions following the mostly-white South African team’s victory in the 1995 Rugby World Cup. Finally, his formation of the Truth and Reconciliation Commission is representative of his determination to keep bitterness and conflict at bay despite his many reasons for feeling, or fueling, both.

Nelson Mandela’s every act reflected his commitment to and passion for justice. His speech on April 20, 1964, at the Rivonia Trial changed the course of South African history because of its moral force and the case it made for justice, which of course was to be delayed for him for 27 long years.

I’m grateful that PRIM&R’s core values are also reflective of this once-in-a-generation man. I’ve included our list of values below, with a Nelson Mandela quote on each:

• Excellence: “There is no passion to be found in playing small—in settling for a life that is less than what you are capable of living.”


• Community: “Let there be justice for all. Let there be peace for all. Let there be work, bread, water, and salt for all.”


• Diversity: “If you talk to a man in a language he understands, that goes to his head. If you talk to him in his language, that goes to his heart.”


• Integrity: “If I had my time over I would do the same again. So would any man who dares call himself a man.”


• Knowledge: “Education is the most powerful weapon you can use to change the world.”


• Respect: “For to be free is not merely to cast off one’s chains, but to live in a way that respects and enhances the freedom of others.”


• Social Responsibility: “I hate race discrimination most intensely and in all its manifestations. I have fought it all during my life; I fight it now, and I will do so until the end of my days.”


• Creativity: “If you want to make peace with your enemy, you have to work with your enemy. Then he becomes your partner.”

Although the latter quote is not about traditional forms of creativity, but rather about ways of creative governance, there has been much talk since Mandela’s passing about the art, music, comics, and movies that he inspired. Two poems that I have found incredibly stirring include one written by Maya Angelou six days ago called “His Day is Done,” and another by Elizabeth Alexander titled “A Poem for Nelson Mandela.”  There are also poems that, while not inspired by Mandela, served as a source of comfort and strength for him during his imprisonment such as “Invictus,” by William Ernest Henley. Mandela embodied, and often quoted, an excerpt that reads:

It matters not how strait the gate,
How charged with punishments the scroll,
I am the master of my fate:
I am the captain of my soul.

If you’ve made it this far, I would like to thank you for reading Mandela’s extraordinary words. He walked the talk, and I hope to honor him by trying harder to do the same. President Obama urged those at the memorial service for Mandela on December 10 to apply Mandela’s lessons to our own lives—for if we do, it will be a far better world.

Rest in peace, Nelson Mandela. Thank you for inspiring and teaching us. We know that your immortal light will continue to shine brightly.

Introducing “Anticipate and Communicate”

by the staff of the Presidential Commission for the Study of Bioethical Issues

This piece, which originally appeared on the blog of the Presidential Commission for the Study of Bioethical Issues, has been reposted with permission. 

We all need to know how to better manage health information that we did not expect. Today, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released its report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. Commission Chair Amy Gutmann, PhD, discussed the report in a Policy Forum piece published today in Science.

No one is immune from the prospect of discovering something unexpected when undergoing a routine test at the doctor’s office, participating in research, or even submitting a cheek swab to a direct-to-consumer (DTC) company for analysis. Regardless of the setting or the test or procedure, when it comes to incidental findings, the Bioethics Commission offered this piece of overarching advice: anticipate and communicate. The Bioethics Commission recommended that all practitioners anticipate and plan for incidental findings so that patients, research participants, and consumers are informed ahead of time about what to expect.

Incidental findings, traditionally defined as results that arise outside the purpose for which a test or procedure was originally conducted, give rise to a range of practical and ethical challenges for recipients and practitioners. Secondary findings, like incidental findings, are not the primary target of a test or procedure but are actively sought in the process of testing. Incidental and secondary findings can be lifesaving if their discovery leads to treatment that would not otherwise have been possible, but also can lead to uncertainty and distress with no corresponding benefit if they identify conditions for which no effective treatment is available.

The Bioethics Commission concluded that certain actions should be taken regardless of where incidental or secondary findings arise, and made five recommendations intended to apply across contexts. The first overarching recommendation aimed to ensure that individuals are informed about the possibility of incidental and secondary findings before they are tested, and of any plan for disclosing and managing these findings. Because of the fundamental importance of informing potential recipients—including respect for recipient autonomy, beneficence, and informed decision making—the recommendation was further specified and applied in the clinical, research, and DTC contexts.

The Bioethics Commission also recognized the importance of developing an evidence base to inform decisions about how best to manage incidental and secondary findings. In its second overarching recommendation, the Bioethics Commission called on professional groups to develop guidelines to categorize the findings likely to arise from each diagnostic modality and develop best practices for managing these findings. The third recommendation called for research about the types and frequency of incidental and secondary findings; the costs, benefits, and harms associated with these findings; and recipient and practitioner preferences with regard to these findings.

Informing individuals works best when those involved—both practitioners and potential recipients—are informed about the consequences of incidental and secondary findings. Accordingly, in its fourth recommendation, the Bioethics Commission called for the preparation of educational materials to inform all stakeholders—including practitioners, institutional review boards, and potential recipients—about the ethical, practical, and legal implications of incidental and secondary findings.

Finally, the Bioethics Commission recognized that existing disparities could lead to inequitable access to the counseling and care needed to appropriately manage incidental and secondary findings. In its fifth recommendation, the Bioethics Commission noted that the principle of justice and fairness requires affordable access to quality information, both before and after testing, about incidental and secondary findings that could arise.

These overarching recommendations are supplemented by recommendations specific to the clinical, research, and DTC contexts that will be described in subsequent posts on the Bioethics Commission's blog.

2013 AER Conference: What You Liked

by Maeve Luthin, JD, Professional Development Manager

For the second post in our two part series highlighting the evaluation results from the 2013 Advancing Ethical Research (AER) Conference, I'll be sharing your favorite parts of the meeting. We hope that we will be able to recreate some of these successes (and that you’ll be with us to witness them!) in Baltimore, MD, on December 5-7, 2014 for the 2014 AER Conference!

Finding Posters: We tried something new, and you told us that it worked! (We love it when that happens.) We’re talking about a new series—titled “Innovations in…”—that featured individuals who submitted exemplary poster abstracts as panelists. These sessions focused on controversial topics, genomics and biobanking, influences on research participation, and communication with research subjects. You enjoyed hearing the authors present their work and take questions on their research, and, as one of you shared, this format “does the presenters and their material far more justice” as compared to poster sessions in the past.

Star Wars: Our keynote speakers brought energy and inspiration to the podium! You cited Atul Gawande as a master storyteller; George Demetri as brilliant and inspiring; Paul Appelbaum as fascinating and enlightening; Esther Duflo as engaging and impressive; and Joan Rachlin as moving and motivating. We hope that next year’s slate of keynote speakers meet the high expectations set by this year’s group.

A Few Good Arguments: There was a lot of enthusiasm about the moderated debate on risk and consent in standard of care interventions. Why? Mostly because it was a true debate—the kind in which the speakers don’t agree with one another. Moderator Jeremy Sugarman and panelists Leonard Glantz and Robert Truog outdid themselves with their whip-smart, witty dialogue in their discussion about this controversial topic.

Once again, many thanks to everyone who shared their thoughts about their time in Boston!

2013 AER Conference: What You Asked Us to Improve

by Maeve Luthin, JD, Professional Development Manager

Many thanks to all of you who completed your 2013 Advancing Ethical Research (AER) Conference evaluations! We have poured over your feedback, and are pleased to be able to share with you the items you flagged as our top successes and those most in need of improvement. In today’s post, I’ll share what we’re working to fix before the 2014 AER Conference in Baltimore next December.

The Hunger Games: We ran into problems with lunches during the conference: there simply wasn’t enough lunch for everyone. We promise to work more with our food and beverage provider to do better next year and we are grateful for your patience with us.

About a Poster: While the “Innovations In…” series was a big hit, many of you spoke up about how we could do a better job of highlighting the posters onsite (and online!), and in connecting authors with attendees for Q&A. You gave us some great suggestions for how to improve the visibility of the poster display, and for anyone who was wondering—all abstracts are available on the Passport!

Mr. Smith Goes to All the Sessions: We tend to schedule multiple concurrent events during any given timeslot, and so far, none of our attendees have been able to successfully bilocate (although PRIM&R staff members have come close). Many of you felt that there were too many breakout sessions to choose from at any given time, which not only made the what-session-do-I-attend decisions difficult, but also left you with a nagging anxiety over your final selections. While we do have constraints in solving the quantum physics side of the equation, we will work on developing some new approaches to this challenge for 2014.

The Social, Behavioral Network: To our social science, behavioral, and educational research (SBER) friends—thank you for your feedback! We will do a better job of incorporating topics important to your work in our plenary sessions, and we’ll work on ways to improve onsite networking opportunities for SBER attendees in 2014. To that end, we encourage you to contribute to our Call for Session Proposals and Speaker Suggestions.

Some Like it Advanced: Some of you shared that breakout sessions labeled as advanced ended up covering basic information, and that you would like presenters in these sessions to focus on applying the regulations, instead of reading them. We will continue to work closely with faculty members to ensure that the descriptions of the sessions match the content presented.

Look for another post later today about what you liked at the 2013 AER Conference, and thanks again for sharing your feedback!

The search is over!

by Joan Rachlin, JD, MPH, Executive Director

As most of you have by now read or heard, change is in the air at PRIM&R since I will be stepping down on March 31, 2014 after 39 years at the helm. On Tuesday, December 3, the PRIM&R Board of Directors announced the appointment of my successor, Elisa A. Hurley, PhD.

I want to congratulate Elisa, with whom I have been fortunate enough to have worked for the past three years. I also want to thank the search committee, which was chaired by Dr. Cynthia A. Gómez, for its determination to find the best possible leader for PRIM&R’s next chapter.

When I initially met Elisa, I wondered whether a moral philosopher could find happiness with a research ethics nonprofit, but quickly learned that her stellar academic background was but one of her many strengths. Upon joining our staff, she rolled up her sleeves and did whatever it took to get her assigned tasks done, and done well. It has turned out to be an excellent fit, and the news of Elisa’s selection has therefore filled me with great optimism for PRIM&R’s future. Elisa has already assumed, and successfully managed, many of the most complicated and difficult parts of PRIM&R’s educational programming and public policy work, and, she is respected and liked by our extraordinary staff, without whom any leader would be lost.

Elisa and the staff will, I know, ensure the continuity of the essential PRIM&R trifecta: our commitment to high quality education, to keeping our members informed and connected, and to professional development and credentialing programs. Under Elisa’s leadership, the legacy that PRIM&R has established will not merely live on but get stronger. I also feel confident she’ll help PRIM&R to chart new territories and remap old ones. As Heraclitus said in about 500 BC, “change is the only constant,” and the research landscape is no exception. As we all recognize, change is in the research world’s air, and it’s thus important that PRIM&R have a leader who can navigate both our internal transition and the one taking place in the field.

I know that Elisa Hurley will set a reliable compass for this organization, and I look forward to watching—and cheering her on—as she does.

Learning about AAHRPP accreditation

by Jennifer Vergara-Jimenez, MD, MS Bioethics, assistant director of research compliance, Jaeb Center for Health Research and Adjunct Faculty, South University Health Programs

While the 2013 Advancing Ethical Research (AER) Conference has drawn to a close, PRIM&R is pleased to continue sharing reflections from members of the PRIM&R Blog Squad to provide our readers with an inside peek of the conference happenings.

My institution, the Jaeb Center for Health Research, is currently starting the accreditation process with the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), which has generated a certain amount of anxiety for me. When an organization decides to become accredited, many questions arise. Thankfully, however, AAHRPP offers amazing support prior to and during the accreditation process.

Accreditation is a voluntary process through which an organization can measure the quality of its work and its performance against recognized standards. The accreditation process involves a self-assessment by the organization, as well as a detailed evaluation by a team of external experts or site visitors from AAHRPP. According to AAHRPP, “the primary purpose of the accreditation is to strengthen protections for research participants. Each accreditation advances that objective and helps build public trust and confidence in research.”

Being accredited by AAHRPP is beneficial for any institution that conducts research activities. It signifies that the institution complies with established human subjects protections standards and has effective mechanisms of self-regulation and quality assurance.

To prepare for my institution’s accreditation, on the first day of the 2013 AER Conference, I participated in a workshop titled Comprehensive Human Research Protection Program (HRPP): An Overview of the Accreditation Process and Standards, led by Wesley Byerly, Sugatha Sridhar, and Elyse Summers.

During the workshop, Wesley Byerly, assistant systemwide compliance office for research for the University of Texas system, walked attendees thru each domain evaluated by AAHRPP:

• Domain I reviews all aspects of the organization
• Domain II is dedicated to analyzing the IRB’s day to day activities
• Domain III assesses the researchers and research staff

Each domain is equally important, and the elements within each domain must be supported by documentation such as standard operating procedures, investigators’ handbooks, manuals, etc. All of documents applicable to one’s organization should be submitted within the first step of the application process, which is pretty straight forward as it is nicely described on the AAHRPP website. It can take up to nine months to become accredited.

To my delight, Sujatha Sridhar, executive director of research compliance, education, and support services at the University of Texas Health Science Center at Houston, described her personal experiences with AAHRPP accreditation and re-accreditation processes. At that point, I realized that my institution is moving in the right direction.  Having heard such a phenomenal testimonial helped me to create new ideas for my institution’s accreditation process.

What are best practices in research involving the use of biospecimens?

by László M. Szabó, Esq., Director of the Office of Research Regulatory Affairs at Rutgers, The State University of New Jersey 

While the 2013 Advancing Ethical Research (AER) Conference has drawn to a close, PRIM&R is pleased to continue sharing reflections from members of the PRIM&R Blog Squad to provide our readers with an inside peek of the conference happenings.

The 2013 AER Conference was accompanied by a special kind of buzz: many thought-provoking programs and meetings with colleagues who are only seen at PRIM&R conferences. One of the highlights of the first day was a session titled Innovations in Genomics and Biobanking, moderated by Paul S. Appelbaum and featuring panelists Francesca Gould, Dina Paltoo, and Jennifer Shaw.

The panelists discussed how research involving the use of biospecimens is on the rise, while best practices remain lacking. Such research has long been the foundation of medical advancement, but it has also resulted in lessons in the field of human subjects protections (e.g., Henrietta Lacks). Members of this panel leveraged their diverse experiences to explore how to draft best practices through a discussion of thematic and pressing questions about research involving biospecimens. For example:

• What special considerations, if any, should be implemented if the biospecimens are those of children? Similarly, what about findings for adults? 
• Should there be a threshold for disclosing the genomic findings that result from the research?
• How is pharmacogenomic research perceived in communities where past research has resulted in harm to subjects? 
• What best practices exist for biorepositories? How might an accreditation program improve the quality of biorepositories? 

I would add to these questions: What “wrinkles” do state laws and regulations add to the oversight of biorepositories? What considerations are relevant for biospecimens coming from abroad (e.g., how can local context in research be ensured)? Who owns the genomic data, especially in light of the legally developing nature of this question?

The panelists also provided background on the rise of research with biospecimens. In 2008, the National Institutes of Health (NIH) issued a Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS). The purpose of the policy was clear: sharing pre-publication data cuts down on costs and ensures more robust science. The policy lays out a two-tiered access: open to the public and controlled. IRBs must ensure that the level of access is conveyed in the consent forms.

More recently, NIH issued a draft policy that added to the 2008 GWAS policy in an effort to address informed consent, data sharing, and similar communicative concerns. It is expected that this policy will be issued in early 2014. It should be noted that this policy would permit the use of biospecimens collected before the effective date in early 2014, but would require IRBs to review the consent forms and protocols for those biospecimens.

When it comes to possible genomic findings from research, several concerns arise: What is the clinical (not research) veracity of the genomic findings? When children are involved, when should parents be informed of the results? When should the child be informed? I believe that it is more appropriate for the parent to determine whether to inform the child, regardless of whether the child is 8 or 17. Additionally, should parents know “everything”—especially when no genetic counseling is available?

The consensus of the panelists and audience members was that best practices should include: re-consenting subjects at the age of majority; indicating that research findings may not always meet clinical standards (and often lack genetic counseling as a debriefing component); and if disclosure of some genomic findings is deemed necessary, then the IRB and principal investigators need to define the scope of disclosure (e.g., a child carrying the Alzheimer's gene may not need that disclosed because she is a child, not an older adult).

Panelist Jennifer Shaw presented a noteworthy perspective on the perceptions of genomic research by Native Americans. She explained that because Alaskan Native Americans are relationship focused, research and medical outreach must be structured accordingly. The impact of this belief structure on the informed consent process was critical because it emphasized the "process,” as well as the need to continue to keep subjects informed. IRBs should therefore be mindful of local review and remain aware of the possibility of health disparities or societal stigma that could result if research results are shared.

The presentations during the panel drew from three  poster presentations:

• By panelist Francesca Gould: Managing Genomic Findings of Pediatric Clinical Research Studies: Challenges, Ethical Considerations and Best Practices
• By panelist Jennifer Shaw: Risk, Reward, and the Double-Edged Sword: Alaska Native Perspectives on Pharmacogenetic Research and Testin
• By panelist Dina Paltoo: From GWAS to Omics and Beyond: A Large Institution Expands its Expectations for Sharing Genomic Research through the Draft Genomic Data Sharing Policy

My takeaways from this session include:

• Keep state laws in mind when reviewing studies involving biospecimens. 
• For consent forms, remember that such research often goes on for decades and the use of the specimens may evolve beyond the scope of what was initially proposed.
• Research findings are not clinical findings and that needs to stay on the radar for each constituency in the research process: subjects, parents, PIs, and IRBs.

Research Ethics Roundup: Room temperature for lab mice, searching for treatments for rare diseases, and more

After a brief hiatus for PRIM&R’s 2013 Advancing Ethical Research Conference, Research Ethics Roundup is back. During this season of giving thanks, we are grateful for all our loyal readers who are committed to staying up-to-date on the latest research and research ethics news. Before you head off to enjoy time with family and friends, be sure to take in a few of the latest stories from the field:

Chilly Lab Mice Skew Cancer Studies: A new study published by the Proceedings of the National Academy of Sciences suggests that international guidelines for room temperature may be leaving laboratory mice uncomfortably cold, a condition that might affect experimental results.

Trials: A Desperate Fight to Save Kids & Change Science: Using vivid firsthand accounts, journalist Amy Dockser Marcus explores several parents’ quests to find treatments for their children facing rare disease diagnoses and corresponding efforts by researchers  to build partnerships with the sick for the treatment of those diseases.

US to Allow Transplants of HIV Infected Organs: President Obama is expected to sign the HIV Organ Policy Equity Act, legislation that will allow for organ transplants between HIV-infected patients, into law. Transplants aren’t expected to begin for at least another year, as the federal Organ Procurement and Transplantation Network must first develop ethical and clinical standards to guide medical research on positive-to-positive transplants. Researchers will need to closely monitor whether antiretroviral drugs will compromise the immunosuppressants transplant patients must take to prevent organ rejection.

Francis Collins: Politics on the Frontier of Science: Francis Collins, director of the National Institutes of Health (NIH), spoke to the Wall Street Journal about public investment in science and research. Dr. Collins expressed concern that the climate of economic uncertainty that NIH is currently facing will cause irreparable harm to the future of biomedical research, and that talented researchers will leave the US to continue their work, or leave science altogether.

Belmont Principles in International Research: Context Is Everything

by Stephanie Pyle, MFA, Manager of Community and Communications, Schulman Associates IRB

While the 2013 Advancing Ethical Research (AER) Conference has drawn to a close, PRIM&R is pleased to continue sharing reflections from members of the PRIM&R Blog Squad to provide our readers with an inside peek of the conference. 

The Belmont principles serve as the foundation for ethical research conduct in the United States and provide institutional review boards (IRBs) with their mission to ensure that respect for persons, beneficence, and justice are present in any research projects conducted in the United States. Researchers in the rest of the world have similarly been encouraged to apply these principles to their local research activities. But how should we understand these principles within the unique context of each country’s values and culture?

In Panel IV: Applying the Belmont Principles Across Borders and Cultures, panelists presented examples of how human subjects research is evaluated and conducted in places like Romania, Russia, Tajikistan, Nigeria, Sudan, and Japan. The panelists emphasized the importance of the Belmont principles in conducting ethical, responsible research, but they also stressed the significance of culture in how the principles are interpreted and applied (or in some cases not applied).

The panel discussion emphasized the importance of cultural context in determining whether research is indeed conducted ethically. The Belmont principles were established within a culture that celebrates individualism and autonomy; in other cultures, community (and the individual’s role within that community) may be more highly valued. Clement Adebamowo provided a revealing example of this by describing how women in Nigeria choose to participate in a clinical trial; they indicate that they would discuss their participation with their husbands or heads of household in order to maintain harmony within their households. Similarly, Sara Lavinia Brair described how tribal chiefs and religious leaders in Sudan often make the decision of whether research should be allowed in their communities.

While gender politics may also play a part in these examples, we must remain keenly aware of the role that community plays in an individual’s decision. The decision is not necessarily “how will this affect me?” but rather “how will my decision affect the community?” As Dr. Adebamowo noted, cultural identity may not be defined as “I am because I am” but rather “I am because of we.”

It’s also important to note that economic and political elements within a culture that may influence research participation. In Japan, where health care is universally available, patients can access any health care provider, making research participation just one of many options. In some countries, low income levels can make research participation very appealing indeed. Additionally, the great respect given to medical professionals in some regions can contribute to therapeutic misconceptions regarding the research. Politics and corruption can also determine which research projects will proceed and which will be considered undesirable within the culture.

This panel emphasized for me that the Belmont principles were not designed to impose a specific culture’s ideals, but rather to safeguard the rights and welfare of people participating in clinical research. We must always consider a culture’s unique values and social structures. In considering the context in the Belmont principles are applied, we can discover how to best protect research participants within that society.

Checklist, please!

by Julie Fine, BS, Legal Specialist, Worldwide Research and Development, Pfizer, Inc., La Jolla, California

While the 2013 Advancing Ethical Research (AER) Conference has drawn to a close, PRIM&R is pleased to continue sharing reflections from members of the PRIM&R Blog Squad to provide our readers with an inside peek of the conference. 

The keynote presentation by Atul Gawande, MD, MPH, was an excellent kickoff to the 2013 Advancing Ethical Research (AER) Conference.

As the first keynote of the conference, Dr. Gawande’s eloquent storytelling drew us in as he described the challenges of 21st century medicine. He noted that even in the most capable hands and with breakthroughs in medical techniques and devices, patients fail to survive surgery at an alarming rate. The reason for such failure is the complexity of the present medical landscape. Physicians practice in high octane environments and have at their disposal the best that medicine has to offer—diagnostics, drugs, technology, and training—but they can miss important connections, which can result in errors.

Physicians have access to 6,000 drugs and 4,000 medical and surgical procedures to treat some 13,600 diseases, injuries, and ailments, as classified by the World Health Organization. The practice of medicine has become so highly specialized and so technical that clinicians have overlooked an almost too obvious solution—a simple checklist.

A checklist can establish the logical steps for all the players on a patient’s medical team—it’s methodical, sequential, strategic, and coordinated. When each step is checked—no matter the intensity of the environment or the circumstances in which the team operates—all the skills, techniques, devices, treatments, and medications come together cohesively, resulting in better outcomes and higher rates of survival.

Inspired by the ideas expressed by Dr. Gawande, I picked up two of his books from the conference bookstore—The Checklist Manifesto and Complications—and I am looking forward to reading more about his work.

Please note that the views presented here are Julie’s own and do not reflect the positions or policies of Pfizer, Inc.

Institutions and Central IRBs: It’s Different Work

by Stephanie Pyle, MFA, Manager of Community and Communications, Schulman Associates IRB

PRIM&R is pleased to continue our posts from members of the PRIM&R Blog Squad at the 2013 Advancing Ethical Research (AER) Conference. The Blog Squad is composed of PRIM&R members who blog here, on Ampersand, to give you an inside peek of what's happening at the conference on November 7-9 in Boston, MA.

Research institutions have felt the pressure to utilize central IRBs (CIRBs) for years. During Wednesday’s pre-conference workshop, Central IRB Models: Benefits, Challenges, and Role in Clinical Research, presenter Andrew Chase creatively compared the CIRB to a tornado: it’s on the horizon, and our first reaction is, “I hope the tornado doesn’t come my way.” But the tornado continues to approach, and there’s the instinct to run for shelter—but where’s the shelter to run to?

Hopefully, utilizing a central IRB isn’t quite as destructive as the storm metaphor suggests. But, throughout the day, panelists and attendees returned to the idea of building that shelter—establishing a solid infrastructure to handle the inevitable CIRB relationship.

P. Pearl O’Rourke and her co-panelists made it clear that centralized IRB review is the way of the future. Most contemporary research is conducted at multiple sites, and, in this context, the traditional model of multiple institutional IRBs reviewing the same protocol proves inefficient and inconsistent.

 

Several options for centralized IRB review are available, and many in the room indicated their institutions worked with the National Cancer Institute’s CIRB, commercial IRBs, regional CIRBs, and/or CIRBs established through grant-funded research networks. In discussing these CIRB models, several crucial questions kept coming up:

• How do institutions modify their infrastructure to support a CIRB relationship?
• What are the CIRB’s responsibilities, and what responsibilities does the institution retain?
• How do institutions fund the infrastructure modifications needed to interact with a CIRB?

The panelists stressed that bringing in centralized IRB review does not reduce workload. Rather, it’s different work: while the IRB review has been moved outside the institution, the institution is still responsible for activities like institutional regulatory compliance, conflict of interest review, investigator and staff education, and other important oversight activities. Support staff is also needed to manage CIRB interactions. In order to accommodate a CIRB, traditional institutional research offices need to be rethought.

Many sponsors and funding agencies strongly encourage that all sites in a given study utilize a CIRB, and the Advanced  Notice of Proposed Rulemaking suggests that the Office for Human  Research Protection may soon encourage CIRB review as well. Some grants suggest creating a CIRB to serve the network of participating sites—which creates the challenges of establishing a CIRB from scratch. In requiring that sites utilize a CIRB, those sponsors and agencies must realize that they are also asking institutions to redesign the way their research enterprises operate. Agreements between the institution and CIRB must be carefully developed to establish clear responsibilities and communication strategies. New policies must be developed to manage the new CIRB process, and staff must be trained on the new policies. Resources are required to not only implement these changes but also to manage them long-term.

The resource cost of establishing this type of infrastructure is a real concern, and it’s clear we need to do something tangible to make working with CIRBs a real possibility. Perhaps the PRIM&R community can come together to analyze the data and work out practical solutions—after all, the storm’s a-coming.

A Peek Inside IRBs

by Jennifer Vergara-Jimenez, MD, MS Bioethics, Assistant Director of Research Compliance, Jaeb Center for Health Research and Adjunct Faculty, South University Health Programs

PRIM&R is pleased to continue our posts from members of the PRIM&R Blog Squad at the 2013 Advancing Ethical Research (AER) Conference. The Blog Squad is composed of PRIM&R members who blog here, on Ampersand, to give you an inside peek of what's happening at the conference on November 7-9 in Boston, MA.

The responsibilities of institutional review boards (IRBs) are based on ethical principles that ensure the protection and welfare of research subjects' rights. Yesterday, Karen Hale, RPh, MPH, CIP, and Susan Kornetsky, MPH, CIP, successfully conducted the pre-conference program IRB 201: An In-Depth Analysis of the Criteria for Review. They explained each of the approval criteria that IRBs should follow to adequately protect research participants.

They faculty highlighted the principle that IRBs must be independent and capable of making decisions without coercion. This crucial requirement should be adequately reflected in the procedures for the appointment of IRB members, in the requirements for joining the IRB, in the management of any potential conflicts of interest, and in disclosures regarding IRB financing sources. To ensure that its work is executed free of biases and influences that could affect their independence, an IRB includes relevant scientific experts and persons representing the interests and concerns of the community. IRBs also always take into consideration the ethical principles of beneficence, justice, and respect for persons.

To accomplish its mission, the IRB is responsible for reviewing, approving, and monitoring proposed research protocols to ensure compliance with federal regulations and operationalize some of the ethical guidelines concerning the protection of human subjects participating in research such as The Belmont Report, the Declaration of Helsinki, the guidelines from the Council of International Organizations of Medical Sciences, and others. 

The IRB’s responsibilities and obligations start with the initial evaluation of the protocols that involve human subjects research. To approve a protocol, the IRB should find that it meets the following criteria:

1. Risks to subjects are minimized.
2. Risks to research subjects are reasonable in relation to anticipated benefits.
3. The selection of research subjects is equitable.
4. Informed consent is sought from each and every proposed subject or their legally authorized representatives.
5. The informed consent process is properly documented.
6. When appropriate, the data obtained from the research is monitored to protect the safety of the subjects.
7. When appropriate, adequate provisions are made to protect the privacy of subjects and to maintain the confidentiality of data.
8. There are additional safeguards when a vulnerable population is involved in the protocol.

It has been an excellent start to the conference, and I have learned in more detail about each of the criteria that should be considered when the IRBs evaluate a research study involving human subjects.

Moving toward a central IRB model

by László M. Szabó, Esq., Director of the Office of Research Regulatory Affairs at Rutgers, The State University of New Jersey

PRIM&R is pleased to continue our series of posts from the PRIM&R Blog Squad at the  2013 Advancing Ethical Research (AER) Conference. The Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, to give our readers an inside peek of what's happening at the conference on November 7-9 in Boston, MA.

I attended an all-day pre-conference program on Central IRB Models: Benefits, Challenges, and Role in Clinical Trial Networks. The program was introduced and moderated by P. Pearl O’Rourke, MD. In her introduction, Pearl discussed that central IRBs are highly encouraged by the National Institutes of Health. Generally, there are three tiers for central/shared IRB models: tier 1—reliance on central IRB; tier 2—designation of central IRB; and, tier 3—reliance on local IRB. Funding preference generally reflect the numerical ordering of the tiers. Thinking of it on a spectrum, models for central IRBs range from solely local IRB review, to shared review by local and central IRBs (existing in the middle of the spectrum and sometimes referred to as a "federated" model), to sole review by a central IRB.

The reason for central IRBs is fairly commonsense: avoid the cat herding and gridlock that would inevitably take place if several IRBs needed to review a single protocol (especially as every and each IRB could endlessly revise a consent form). Such an approach would raise issues such as: which IRB stamps the consent forms (e.g., all? each? each for their own site?); how are adverse events reported; how is continuing and/or serious non-compliance dealt with; and how is it possible to decrease arbitrariness in the review process (because it's not possible to completely eliminate arbitrariness). IRB review, much like the judicial process, carries with it an inevitable range of human arbitrariness in the decision-making process. This often results in a range within which IRBs change protocols without altering anything truly substantive. Sometimes this is based on group think, IRB institutional cultural practices, or legal liability hyper-aversion. The end result is often increased cost and latency in the review process. I'm sure we've all reflected on how to overcome such matters.

Central IRBs offer a promising solution to this, but, of course, present their own challenges: they standardize review to harmonize practices, but the standardization can overlook or impact certain concerns that a local IRB may not be comfortable with. Similarly, as a matter of IRB culture, many IRBs are reluctant to relinquish review of a study conducted by one of "their" principal investigators. Equally relevant from the local IRB's perspective is how reliable is the central IRB? And, how can their reliability be assessed: AAHRPP accreditation? Reputation in the field?

Another aspect, thinking about it from the perspective of a director who has to consider staffing and costs, is whether central IRBs offer any cost sharing. The data on decreasing the costs associated with IRB review (e.g., staffing, software, etc.) through centralized IRB review is unclear. A common theme appears to be that costs remain, which appears to be due in some part to many institutions opting for a shared/federated model (near the middle of the spectrum I noted above), for fear of wholly relinquishing control over a study.

Julie Kaneshiro, MA, provided the Office for Human Research Protection’s (OHRP’s) perspectives on central IRBs. Julie noted that for shared/federated models, ensuring review of local context is a significant area where a local IRB has to ensure that it is discharging its “Common Rule” obligation. Although "local context" does not appear in the Common Rule, the phrase is a term of art grounded in the Common Rule's sections 45 CFR 46.107(a), (d), (f), and 45 CFR 46.111. It is helpful to keep in mind that a central IRB can also discharge the Common Rule's local context review obligation, just as any IRB reviewing research taking place elsewhere. Finally, Julie noted that the regulations provide IRBs with a significant amount of flexibility in opting to select central IRBs. Given the flexibility in the regulations, as well as the complexity in shared/federated models, central IRBs perhaps are most effective at the end of the spectrum: sole review by a central IRB. This flexibility was reflected to some degree in OHRP's 2009 and 2011 advanced notices of proposed rulemaking, which discussed the use of centralized IRBs. Along these lines, I have found it valuable to frequently remind myself, and be reminded, that the regulations do not just dictate obligations (which are too easily the reflexive focus of IRBs myopically focused on compliance), but also a range of freedom of actions that IRBs have the regulatory discretion to exercise. Often, IRBs incorrectly see this discretion as vagueness or lack of guidance from OHRP. It is important to keep in mind that the regulations and OHRP provide a framework for obligations and authority—not a fact-driven solution applied to each situation. They provide the recipe, we're the cooks.

Next, Emily Chi Fogler, Esq. presented on the legal aspects of reliance agreements. She explained that, as with contracts in general, memorializing the operational aspects and foreseeable scenarios will work to alleviate future contractual wrangling and confusion that can later stall progress on the study. Along these lines, areas to consider: scope (single study or all), updating information and communication, HIPAA, local research context (including site-specific, such as financial conflicts of interests), cooperation (especially for investigations), record keeping, and termination. A valuable aspect of the same agreement Emily discussed  is that it requires the investigator who is the principal investigator (PI) to sign a commitment statement. That document essentially summarizes the reliance agreement, and spurs to get awareness and compliance ownership by the PI.

Finally, Elizabeth Hohmann, MD discussed some of the challenges and elements of implementing a central IRB for clinical trials. Elizabeth gave some first-hand and pragmatic examples of implementation, focusing on: if finances permit, procuring an electronic protocol system to handle large loads (her central IRB, NeuroNEXT, oversees about 7,000 protocols), distributing some responsibility to engaged sites in strategic ways so that staff sizes are kept in check, and keeping NIH (or whatever the funding entity is) apprised of what works and what doesn't.

The program was really well suited to IRB chairs and directors of IRB offices, as well as any staff involved in managing or developing a clinical trial network. The handouts also contained an excellent bibliography (actually, more talks should). A few articles of note:

• Check DK, Weinfurt KP, et al. (2013). "Use of Central Institutional Review Boards for Multicenter Clinical Trials in the United States: A Review of the Literature." Clinical Trials. 10(4): 560-7.
• Klitzman, R. (2011). "How Local IRBs View Central IRBs in the US." BMC Medical Ethics. 12:13.
• Silverman HC, Hull SC, et al. (2001). "Variability Among Institutional Review Boards' Decisions Within the Context of a Multicenter Trial." Critical Care Medicine. 29(2): 235-41.

Takeaway: central IRBs are here to stay, they're likely to increase, and become required for more studies. The framework and resources (such as PRIM&R) to manage these relationships is, largely, there. Cost savings are unclear.

The SUPPORT Debate Continues

by Alice Dreger, PhD, Professor of Clinical Medical Humanities and Bioethics at the Feinberg School of Medicine at Northwestern University

The heated debate about the National Institutes of Health- (NIH-) funded Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) continued on October 27 in Atlanta at the annual meeting of the American Society for Bioethics and Humanities (ASBH). Controversy stems from the Office for Human Research Protection’s (OHRP’s) March 2013 determination that the SUPPORT study of interventions on very premature babies was unethical because of failure of informed consent. Following objections from NIH and others, in June OHRP reiterated its findings but pulled back on enforcement and decided to hold a hearing in late August.

In Atlanta, the debate was between Benjamin Wilfond, MD, of the University of Washington and Seattle Children’s Hospital, and Lois Shepherd, JD, of the University of Virginia Schools of Medicine and Law. Earlier this year, Wilfond led a group of bioethicists in a letter to the New England Journal of Medicine (NEJM) demanding that OHRP back off, while Shepherd led a group response insisting that the OHRP press on. Ruth Macklin, PhD, of Albert Einstein College of Medicine and I co-authored the latter NEJM letter. Of particular concern to our group is the lack of description of the trial’s purpose and the conflation of trial enrollment with “standard of care.” This conflation was compounded by a failure to disclose serious risks involved with being randomized into controlled oxygen saturation arms using oximeters that gave readings either several points above or below true (as a blinding procedure).

SUPPORT ultimately showed that babies in the lower oxygen saturation arm (85-89%) were more likely to die compared to those in the upper arm (91-95%). In Atlanta, Wilfond claimed that the researchers could not have foreseen an increased risk of mortality in one of the arms and that is why a possible increased risk of mortality was not disclosed on the consent forms. He and other SUPPORT defenders have lately taken to arguing that mortality was measured only to avoid muddying data collected on Retinopathy of Prematurity (ROP), a condition that takes weeks to develop (and so will not develop if a baby dies very early). This claim contradicts the study protocol and the information provided at ClinicalTrials.gov.

Moreover, Wilfond did not explain why the consent forms also lacked disclosure of possible increased risk of neurological damage and ROP. Shepherd argued that parents were not informed enough to understand the choice they were making between trusting their babies’ doctors’ best judgment or entering this complex trial. The degree to which the consent forms may have caused parents to misunderstand the difference between standard NICU care and care under SUPPORT enrollment became clear at the August hearing, where a mother named Sharissa Cook stunned the audience by explaining that, when she was offered enrollment in “support” for her very premature baby, of course she said yes.

The SUPPORT controversy promises to continue shedding light in many arenas, including the division about the role of advocacy within bioethics, the question of how 23 institutional IRBs involved in SUPPORT failed to catch major deficiencies in the consent forms, and whether the precipitous years’ long decline in OHRP enforcement will persist. The fact that in June the Department of Health and Human Services asked OHRP and NIH to “align” their views on SUPPORT stands as an extraordinary moment in regulatory oversight, or lack thereof. Whether this approach will become standard for federally funded trials remains to be seen.

Meet the PRIM&R Blog Squad at the 2013 AER Conference: Jennifer Vergara-Jimenez

by Jennifer Vergara-Jimenez, MD, MS Bioethics, Assistant Director of Research Compliance, Jaeb Center for Health Research and Adjunct Faculty, South University Health Programs

PRIM&R is pleased to introduce another member of the PRIM&R Blog Squad for the 2013 Advancing Ethical Research (AER) Conference. The Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, to give our readers an inside peek of what's happening at the conference on November 7-9 in Boston, MA.

This is the second time I have had the privilege to participate in a PRIM&R conference. In June of 2010, I was just starting my current position as assistant director of research compliance at the Jaeb Center for Health Research. Despite my years of experience with clinical research and ethics committees in Colombia, I felt challenged by the complex regulations and policies governing human subjects research in the United States.

When exploring training options, I found that PRIM&R consistently had the best continuing education programs. Two months later I was a PRIM&R member, and by December I was on my way to Boston to immerse myself in the issues relevant to research ethics in the US as an attendee at PRIM&R’s 2011 Social, Behavioral, and Educational Conference and the pre-conference program, Institutional Review Board 101. I was amazed by the organization, speakers, content, and spaces for communication that served to make the conference a perfect place for all those involved in the field of human subjects protections.

Over the years I have gained additional experience, and my interest in the research ethics field has increased significantly, leading me to complete a master's program in bioethics. I am looking forward to coming back to one of PRIM&R’s conferences, now as a member of the PRIM&R Blog Squad, and learning, sharing, and connecting.

Meet the PRIM&R Blog Squad at the 2013 AER Conference: Julie Fine

by Julie Fine, BS, Legal Specialist, Worldwide Research and Development, Pfizer, Inc.,  La Jolla, California

PRIM&R is pleased to introduce another member of the PRIM&R Blog Squad for the 2013 Advancing Ethical Research (AER) Conference. The Blog Squad is composed of PRIM&R members who will blog on Ampersand about the conference to give our readers an inside peek of what's happening November 7-9 in Boston, MA.

I’m thrilled to have been accepted once again as a member of the Blog Squad for PRIM&R’s Advancing Ethical Research (AER) Conference. I had such a great experience as a blogger at the last year’s conference in San Diego, and I’m eager to do it again this year.

As a legal specialist at Pfizer, Inc., I deal with the practical aspects of clinical trials operations and human research protections in sponsored study agreements. My work integrates legal, ethical, regulatory, and research policies and procedures in contract terms. The AER Conference offers food for thought in all of these areas; it’s a veritable smorgasbord of content.

I’m particularly interested in hearing the keynote addresses by the impressive slate of speakers. The topics are spot on for this year’s conference: healthcare delivery in the 21st century; targeted cancer therapies; microeconomics in the fight against poverty; and a retrospective of therapeutic misconception from an ethical, legal, and social perspective. And I’m ready to join in the celebration of, PRIM&R’s executive director, Joan Rachlin’s many achievements in the field of research ethics on Saturday, November 9, when she receives PRIM&R’s Lifetime Achievement Award for Excellence in Research Ethics.

As a Blog Squad member, I will share my impressions and insights from an industry perspective. I’m really looking forward to getting back to Beantown for the 2013 AER Conference.

Meet the PRIM&R Blog Squad at the 2013 AER Conference: David Van Houten

by David R. Van Houten, MS, Research Integrity Advocate

PRIM&R is pleased to introduce another member of the PRIM&R Blog Squad for the 2013 Advancing Ethical Research (AER) Conference. The Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, about the conference to give our readers an inside peek of what's happening November 7-9 in Boston, MA.

Those who are concerned about return on investment and ethics in biomedical research, and who have observed problems such as research misconduct, have an obligation to offer feasible solutions when they might be useful for improving ethics and integrity in research.  Earlier in my career, while in the cell biology (turned “research integrity”) doctoral program at the University of Vermont, I witnessed research misconduct and the factors that allowed it to occur. Although I did not complete the cell biology degree program, I used my observations to present a “thesis” presentation at PRIM&R’s 2010 Advancing Ethical Research (AER) Conference. This workshop, which I facilitated, emphasized an essential pillar in the administration of research protocols: open weekly review meetings of the research team with the principal investigator.

Perhaps more than any other conference in the biomedical research field, PRIM&R’s annual AER Conference incorporates disciplines across many fields. By definition, the protection of the rights of human subjects in biomedical and clinical research requires communication of information on basic scientific techniques, clinical healthcare standards, the changing regulatory environment, and socioeconomic and local community needs.

I have attended PRIM&R’s AER Conferences in person and, when I couldn’t attend in carbon form, as a participant in PRIM&R’s Virtual Meeting. In both cases, the perspectives of those who contributed to Ampersand and who shared on Twitter helped me gain greater insight into the sessions I participated in.

I am thus looking forward to being a member of the PRIM&R Blog Squad at the 2013 AER Conference and to sharing my observations and views. Among the components of this year’s conference I am especially looking forward to are:

• Discussing ideas and challenges with attendees who work in research areas outside of my experience
• Learning about how research professionals and research participants understand and communicate different aspects of medical practice and clinical research
• Discovering  more about central IRB functions, the use of e-media,  and multi-site studies and IRBs
• Reviewing the Food and Drug Administration’s guidance on remote monitoring, including indications of data falsification/fabrication

As in the past I know I will learn from fellow contributors and from other conference attendees.

Meet the PRIM&R Blog Squad at the 2013 AER Conference: Stephanie Pyle

by Stephanie Pyle, MFA, Manager of Community and Communications, Schulman Associates IRB

PRIM&R is pleased to introduce another member of the Blog Squad for the 2013 Advancing Ethical Research (AER) Conference. The Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, about the conference to give our readers an inside peek of what's happening November 7-9 in Boston. 

I have a confession: when I started in clinical research, I knew basically nothing about the industry. I was a total n00b. Research ethics was similarly foreign. Before I began working at Schulman Associates IRB, I’d been a college composition instructor and creative writing student. So when I first started at Schulman, I'll admit there were times I worried that I’d gotten in over my head. However, as I talked with my colleagues at the IRB and learned more about the work they were doing each day, I became intrigued by the many issues and nuances associated with research ethics. Fascinated, I wanted to find out all I could about this multifaceted, incredibly important aspect of clinical research.

It’s been five years since I made the leap from poems to protocols and from rhymes to regs (sorry, I couldn’t resist!), and I’m still eager to learn all I can about research ethics. Clinical research is an ever evolving field, and in research ethics every single situation is unique. As manager of community and communications at Schulman, I really value the role that thoughtful discussion and collaboration can play in examining these unique situations and ensuring that the rights and welfare of human research participants are protected. Those discussions and collaborations are what I’m looking forward to the most at PRIM&R’s 2013 Advancing Ethical Research (AER) Conference.

I’m also excited to be attending this year’s meeting as a member of the PRIM&R Blog Squad. As a past exhibitor at the conference, 2013 marks my third year in attendance. It’s the first year, however, that I’ll be able to explore the aspects of the conference occurring outside of the exhibit hall. I’m eager to take advantage of everything the conference has to offer, and I look forward to sharing with you the intriguing ideas that arise from the discussions and presentations.

So many talented research ethics professionals will be gathered in Boston to examine old challenges and share new views on ethical issues. There’s something amazing about this coming together–the personal interactions, the brilliant conversations–that can only happen when so many great minds convene in one place. Through these conversations we’ll discover new approaches and unexpected solutions to persistent problems.

I think this year’s AER Conference will be a wonderfully revitalizing event. We can sometimes get bogged down by the daily challenges and details of our individual jobs, and this conference is a great way to re-energize ourselves. I hope the stimulating conversations we have in Boston will send us home reinvigorated and ready to accomplish our goals of protecting human subjects and advancing clinical research innovation.

Personally, I can’t wait for the AER Conference. See you in Boston!

Stay updated on the 2013 AER Conference by following PRIM&R on Twitter. Conference updates will use the hashtag #AER13.