Enhancing the contributions of community IRB members

by Elizabeth White, program manager, United States Department of Energy (DOE)

Active participation and input from community/unaffiliated members is critical to any institutional review board (IRB). How do we ensure that community members feel empowered and educated in order to freely express their opinions on proposed research?

This was the topic of a workshop organized by the University of Southern California (USC) and the DOE in December 2010. The pre-conference program, Enhancing the Contributions of Community IRB Members, was held in conjunction with the 2010 Advanced Ethical Research Conference. It was attended by prominent individuals in the field of human subjects protections and community IRB members from more than a dozen research institutions and federal agencies.

As a result of the meeting, participants agreed that a dialogue with the broader human subjects protections community should continue. Organizers and participants agreed to follow up on the proposed strategies generated during the discussion, as follows:

• Developing a best practices white paper and/or finding other opportunities to share successful approaches used by IRBs to enhance the contributions of community IRB members. For example: nurturing an atmosphere in which different points of view are valued; linking new community members with experienced board members; providing opportunities for education; requiring primary and secondary protocol reviewers to develop a one-page summary in layman’s terms and highlighting any issues or concerns; and encouraging community members to serve as primary, secondary, or tertiary reviewers.
• Listening to the archived PRIM&R webinar for community members. Participants will have the opportunity to learn more about the role and experience of the community member, the IRB’s responsibilities, and other initiatives for enhancing community member participation.
• Revitalizing organizations’ community member listservs. See DOE’s community listserv.
• DOE, USC, and other organizations joining together to hold teleconferences on topics of interest for community IRB members.
• Holding regional lunches to provide networking opportunities for community members in large metropolitan areas with multiple IRBs, rotating the location among local organizations.
• Making existing training materials and resource manuals available to the larger community. USC, University of Kentucky, and Research Triangle Institute have some wonderful materials.
• Enhancing organization websites.
• Generating publicity on this topic in journals and spreading the word at professional meetings.

These strategies are a start, but active involvement by every institution and IRB is critical. We’d love to hear your ideas for enhancing the voice of community IRB members.

"Science Times" synthesis

Who doesn’t love July? The month kicks off with fireworks on Independence Day and is soon filled with weekend trips, summer vacations, afternoons in the sun, and family get-togethers. However, along with all the fun in the sun, there is also a marked increase of medical errors in hospitals. Take a look at this week’s Science Times synthesis and learn how the schedule of new doctor training coincides with this pattern.

Please share your thoughts in our comments section, and let us know which article intrigues you and why!

Week of July 2

Thirst for Fairness May Have Helped Us Survive: Studies uncover how the human desire for fairness motivates us and shapes our cerebral, cortical, visceral, and limbic processes.

Researchers Link Deaths to Social Ills: Take a moment to consider how social ills, such as poverty and poor education can be identified as causes of death in the same way as car accidents or lung cancer.

Doctor and Patient; Unsung Heroes at the Front Lines of Patient Care: A new study focuses on the social and emotional demands placed on receptionists and administrative workers involved in patient care.

Prevention: A Better Use for Cotton Swabs Than Ear Cleaning: Forget about expensive disinfecting procedures and materials—cotton swabs may do the best job of maintaining sterile surgical wounds.

Roots of Disease Found to Vary by Continent: A recent analysis of the human genome suggests that diseases may have different genetic roots that vary by continent of origin.

The Then and Now of Memory: Check out the results of new studies that describe memory as a “streaming video” that includes the sensations, thoughts, and facts that surround individual memories.

Week of July 9

Risks: Perhaps July’s Reputation Is Justified: Researchers have uncovered a pattern of increased medical error in hospitals during the month of July.

Drive to Stem Shingles Meets Few Expectations: Learn about some of the issues that have hindered the distribution of the shingles vaccine.

Scientists Turn to Crowds on the Web to Finance Their Projects: While research funding continues to drop, a new wave of science researchers turn to internet “crowd funding.”

Human Swallows Pill. Mosquito Bites Human. Mosquito Dies: Read about how an inexpensive de-worming pill helps prevent malaria, and why there are many complications surrounding its distribution and potential side effects.

Guarding Privacy May Not Always Protect Patients: Find out about the complications surrounding medical privacy for teenagers and young adults.

Company Agrees to Share AIDS and Hepatitis Drugs With Patent Pool: The new international Medicines Patent Pool has reached an agreement with a pharmaceutical company to obtain four different AIDS and hepatitis B drugs.

Bringing Research Ethics into the Spotlight

by Josh Glickenhaus, Swarthmore College senior and PRIM&R intern

In my few months working for PRIM&R, I must confess that, at times, the field of research ethics has felt somewhat academic. The field is rich with past atrocities that led to its creation—Nuremberg, the US PHS Syphilis Study, the Willowbrook hepatitis study—but those sometimes feel like ancient history. Today we’re aware of the ethical hazards intrinsic to clinical research, and have established a sophisticated system of ethics review to prevent them. Informed consent must be secured. Participants must not be subjected to more risk than necessary. Adverse events must be appropriately monitored. And so on. Though you hear about the occasional study gone awry, blatant violations of basic ethical principles should be a thing of the past. Right?

So imagine my surprise upon picking up The Boston Globe on July 2 and seeing the headline, “Journal to Scrutinize Hip Fracture Study: Inquiry Follows Allegation of Ethical Breach”* on the front page of the Metro section. Apparently, a team of Harvard researchers conducted a study to determine whether special padded underwear was likely to reduce the risk of hip fractures in nursing home residents. Their study design used underwear padded only on one side to make comparisons between the padded and un-padded sides easier to draw. The underwear turned out to be very hazardous. Seniors were fracturing their hips on the padded side with significantly greater frequency; data quickly suggested that this was because they were falling toward the padded side more often. Despite the emergence of this compelling data, the study continued and was eventually published in the Journal of the American Medical Association (JAMA) in 2007.

Now JAMA is reviewing the study amid claims that researchers knowingly misled patients and officials as to the increased risk of falls on the padded hip. A significant increase in falls on the padded side is relevant information by any standard, and should have been reported to the IRB overseeing the study. If reviewers found the data to be unacceptable, they might have shut the study down early. At the very least, the increased risk should have been disclosed to future research subjects. Either way, a significant number of seniors could have been spared broken hips without compromising the science of the study.

Covering up data and failing to disclose significant risks to research subjects is just wrong, and these are practices that the modern IRB system should prevent. Yet the Harvard research team responsible for this study seems to have gotten away with just such practices until four years post-publication. It’s this sort of story, plastered in big letters across the front of The Boston Globe, that helps to make research ethics real for me. When people continue to be hurt by this type of fundamental ethical breach, it’s just one more reminder that research ethics is not a thing of the past, and that we must keep on our collective toes to continue to make the system better and keep these stories out of the headlines.

*Lazar, Kay, Chelsea Conaboy and Neena Satija. “Journal to Scrutinize Hip Fracture Study: Inquiry Follows Allegation of Ethical Breach.” The Boston Globe. 2 Jul., 2011. B1-3.

2011 VA Local Accountability Meeting

by Wendy Tate, PSM, CIP

On June 1, 2011, I descended upon Washington, DC, with about 660 of my Department of Veteran's Affairs (VA) and university colleagues responsible for the conduct of research at a VA hospital or health care system.

Simply put, human subjects research at the VA must improve the status of veterans. The purpose of this conference was to discuss the role of privacy and information security in human research projects within the VA system. Each VA institution that holds a Federalwide Assurance (FWA) was invited to have it’s assistant chief of staff, research, administrative officer, IRB administrator, information security officer, privacy officer, and research compliance officer in attendance.

If you have never worked with VA human subjects research, you may not realize how many additional requirements exist. The VA has codified the Common Rule (45 CFR 46) in 38 CFR 16. In addition to the Common Rule, the VA provides handbooks full of other requirements. The handbooks relevant to human subjects are 1200.05 (Requirements for the Protection of Human Subjects in Research), 1058.01 (Research Compliance Reporting Requirements), 1058.03 (Assurance of Protection for Human Subjects in Research), 1108.04 (Investigational Drugs and Supplies), and 1200.12 (Use of Data and Data Repositories in VHA Research).

Like every other institution, the VA must apply FDA regulations in 21 CFR parts 50, 56, 312, and 812 when dealing with FDA regulated products. As a federal agency and treatment facility, in addition to the HIPAA regulations, the VA has to apply 38 USC 7332 and the Privacy Act of 1974. The agency’s definition of VA Sensitive Information is found in Public Law 109-461. The VA handbooks related to privacy and information security are 1605.1 (Privacy and Release of Information), 1907.01 (Health Information Management and Health Records), and 6500 (Information Security Program).

Several top officials from both the Office of Research Oversight (ORO) and the Office of Research and Development (ORD) were at the meeting. They shared many interesting details, including that the VA is the fifth most trusted agency in the United States and a major recipient of research funds. ORO also shared findings from oversight visits and helpful hints to avoid preventable citations. There was a significant discussion about the records retention schedule. Unlike HHS and FDA, the VA does not in its regulations define how long research records must be held. This has resulted in a VA requirement stating that research records must be held forever, which includes the retention of any identifiers, making it difficult to protect human subjects through de-identification.

On the second day, there was a spirited discussion about collaborative research. In what may have been the most tense session of the conference, the VA leadership insisted that there must be separate consent forms for the VA site and any affiliate site (e.g., university), even if the two sites share a subject population. This was followed by a discussion of ethics as they relate to respecting the individual and whether the agency format exists to inform potential subjects or to protect institutions from liability. It reminded me of many AER Conference sessions spent discussing ethical standards versus institutional protections and the role of the IRB.

I also had the opportunity to network with about 75 fellow IRB administrators from VA institutions, universities, and the Central VA IRB. It was a fantastic group of colleagues with great questions, deep insight, and a passion for the ethical treatment of veterans participating in research.

In many ways, the large number of VA requirements makes the agency’s research overly paternalistic with respect to subjects and burdensome for researchers. While HHS is allowing institutions to “uncheck the box,” and AAHRPP is promoting the practice of using flexibility in the regulations, the VA should be a leader, adapting to the changing landscape of research oversight. I urge both ORO and ORD to invite their university affiliates HHS, and AAHRPP to the table as they continue to review their regulations and guidance. In this way, the VA can continue to garner the respect of veterans and the academic world.

Featured Member Profile: Brenda Hayes

Welcome to another featured member interview in which we continue to introduce you to PRIM&R members, a group of dedicated individuals working to advance ethical research on a daily basis. Please read on to learn more about Brenda Hayes, instructor and director, grant and proposal development at Morehouse School of Medicine and director, Community Partnership Development (COEHD).







When and why did you join the field?

I have been in health care for several decades and first served on a hospital IRB in 1985 to represent mental health programs and issues.



What is your favorite part of the job?

I enjoy the educational aspect, which allows me to participate in training a variety of individuals who are unfamiliar with requirements to participate in human subjects research activities.



Which living person do you most admire?

President Obama is at the top of my list due to his leadership qualities and his extraordinary grasp of complex issues, daring solutions, and tenacity in the face of unbelievable challenges.



Why did you join PRIM&R?

PRIM&R offers remarkable educational opportunities that continue to provide contemporary information about innovative and challenging ethical issues.



What is your favorite member benefit?

I enjoy all of the updated and frequent educational offerings using a variety of media.



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

Dr. William “Bill” Jenkins would be a riveting speaker. Dr. Jenkins was one of the plenary speakers at last year’s American Public Health Association Annual Meeting in Denver. He is an epidemiologist, a former researcher with the Centers for Disease Control and Prevention, and was involved in managing the benefits for the US Public Health Service Syphilis Study and President Clinton’s formal apology.



What do you believe is a key challenge facing the field of research ethics?

We live in a world of rapidly advancing technological innovations; however, we do not have all of the ethical tools to protect all of the confidential information that is delivered through social media and other avenues. The advent of handheld mobile devices, Facebook, and electronic medical records provide tremendous opportunities to breach confidentiality. Currently, we are playing catch-up with the technology and must become more proactive in anticipating how we protect information collected during research activities.



Thank you for being part of the membership community and sharing your story, Brenda!



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

"Science Times" synthesis

In New England, we have an expression: If you don't like the weather, just wait a few minutes. Changes in weather patterns, such as an increase in average temperature, have become common in many parts of the world. These signs of global warming may prove to have devastating effects. Take a look at this week’s “Science Times” to learn more about some of the research taking place and how the findings might be applied to global climate change. As always, please share your thoughts in our comments section, and let us know which article is your favorite!

Week of June 13

A Frog Endangered, but Extinct no More: To her amazement, ecologist Evon Hekkala discovered that Vegas Valley leopard frogs are not extinct.

Week of June 20

Perceptions: Cancer Drugs Get on Faster Track in US: A new finding challenges critics who claim the European Medicines Agency maintains a more efficient drug approval process than the US Food and Drug Administration.

Why Study Hyenas?: Check out some of the intriguing questions raised by zoologist Kay E. HoleKamp’s research on the spotted hyena.

Saturn's Sixth Moon's Surface May Conceal Salty Ocean: A new study suggests that active plumes on Saturn’s sixth moon may be connected to a deep saltwater reservoir.

Green Jobs Attract Graduates: A new generation of graduates lean toward careers that involve and promote environmental sustainability.

Week of June 27

Concerns About Costs Rise with Hospices' Use: Take a few moments to consider the financial, social, and medical implications of the current debate on hospice care.

Climate Change in Mongolia: Learn about the history of environmental research in Mongolia and check out some of the interesting studies taking place there today.

Awareness: HIV Campaign Finds 18,000 New Cases: A three-year campaign reveals findings suggesting a need to expand HIV testing and treatment programs.