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.