It’s like a spa for your professional soul – Meet CAREB, PRIM&R’s Canadian counterpart

By Joan Rachlin, executive director

Happy May! I’ve just celebrated the new month’s arrival by traveling to Montreal for the 10th anniversary and annual meeting of the Canadian Association of Research Ethics Boards (CAREB). As I’ve said before (self-serving though it may be), there’s nothing quite like the boost one receives from attending educational events. I feel refreshed and renewed in a way that is hard to replicate in the grind of my daily work life.

Beyond the intellectual infusion, the ego gratification is also balm for a tired soul. Hearing how much PRIM&R means to those in and around the research ethics world embodies my personal definition of professional purpose and relevance, but not all reports of PRIM&R’s value are equal.

For a child of the sixties, I was thus especially warmed when Francis Rolleston, of Canada’s National Research Ethics Board, told me that he urges colleagues to attend PRIM&R’s conferences, and promises that our meetings will "blow their minds" given the amount and quality of important information. That’s about as good as it gets for those of us who search for meaning in both our work and personal lives. PRIM&R matters, and I know that research subjects would agree if they knew about our work on their behalf.

I’d like to tell you a bit about our north-of-the-border friends and colleagues from CAREB, all of whom are committed—just like their PRIM&R counterparts—to promoting responsible research while developing appropriate checks and balances. As I am constantly reminded whenever I travel outside my catchment, so much more unites than divides us. The threads that connect human beings are universal ones: the desire for love, dignity, security, and respect. So, too, with the invisible threads that connect professionals in the research ethics world, we are all committed to protecting research subjects who are key to the advancement of science.

When Alex Karabanow, of Ryerson University, and CAREB’s Board President, kicked off the conference, he posed a few questions that he felt were high on the wish list of Canadian REBs. Among them were:

1. Are REBs best situated within the institutions they serve, or does this embedded status create real or perceived conflicts of interest? (This reminded me of former PRIM&R Board of Directors Chair Leonard Glantz’s longstanding suggestion that the IRB at one institution review the protocols for another so as to get around this "conflicts" concern. Ah, but for the little detail of intellectual property issues, this might work, but there might be other structures for eliminating these concerns.)


2. Should the research ethics system continue to be based on committee membership by volunteers, no matter how knowledgeable they might be?


3. Can there be a more unified governance framework that can represent all stakeholders?

Sound familiar?

In any case, traveling to Montreal for this terrific meeting has my juices flowing, and I’ll be sharing a few of the talks with you in future blog posts.

Happy almost May Day and a lovely weekend to you all!

PRIM&R's Abstract Spotlight

In this series of Ampersand posts, PRIM&R touches base with those who presented programmatic and research-based findings at past PRIM&R conferences.

Spotlight on an abstract from the 2009 Advancing Ethical Research Conference.

Title: Investigator Dissatisfaction with the IRB Approval Process

Authors: Steven Pennell, MBA, MA; Ronald Maio, DO, MS; James Lepkowski, PhD

Affiliation: University of Michigan

Abstract summary: Little empirical data, but much anecdotal information, characterizes researcher experience with the human subjects regulatory system. This research contributes to advancing knowledge about how researchers experience the human subjects regulatory system by asking:

1. What is the relationship between time to approve an application and researcher dissatisfaction with the IRB’s core service;


2. What factors are associated with dissatisfaction with the IRB approval process;


3. Are these correlations system-related, characteristics of researchers, or both; and
   
4. What is the strength of the relationship among these correlations and investigator dissatisfaction?

To answer these questions, the University of Michigan’s Institute for Social Research conducted an IRB approved scientific survey among 1,800 investigators. Results indicate several statistically significant outcomes:

1. Investigators support the concept of ethical/regulatory review of research, but take exception with how IRBs “operationalize” it;


2. Dissatisfaction with the IRB approval process is significantly associated with system-related outcomes and attitudes shaped by those outcomes. The time to approve applications is a key determinant of dissatisfaction: The odds ratio of dissatisfaction increases dramatically when approval times exceed four weeks when controlling for other covariates in the model. Other significant system-related correlates are unanswered investigator inquiries to the IRB, IRB-required application changes, and difficulty using the application system.

The results suggest that reducing dissatisfaction with the IRB approval process will require recalibration of system-related features of HRPPs, above all reducing the time to approve applications. Repeated surveys will monitor system changes and their effect on key outcomes, including dissatisfaction with the IRB approval process. A national survey is planned.

(View the full abstract here.)

PRIM&R Staff (PS): In the months since you presented this abstract at PRIM&R’s 2009 AER Conference, how has your research changed or evolved?

Steven Pennell, MBA, MA and Ronald Maio, DO, MS (SP and RM): IRBs rarely have direct relationships with human subjects participating in research and must rely on investigators and members of their research teams to implement safeguards to protect them from harm. The IRB-investigator fiduciary relationship can be facilitated by monitoring investigator experiences with the local regulatory environment.

Our initial survey identified time to approve research as a key correlate of investigator satisfaction with IRB services. While this relationship is intuitive, institutions can be more deliberate in their actions when they understand the tipping point between satisfaction and time to approve research. Since the initial University of Michigan survey, institutional efforts have been undertaken to streamline the approval process.

Subsequently, in late fall 2009 and early winter 2010, we conducted a follow-up survey to measure investigator satisfaction with IRB services. Those survey results will be available soon. Initial findings indicate that overall satisfaction with the IRB review and approval process has improved.

PS: What challenges have you faced in advancing your research?

SP and RM: There is a dearth of empirical evidence to show whether IRBs, in general, monitor investigator experiences with the local regulatory environment and what actions, if any, are taken. The research conducted at the University of Michigan demonstrates that empirical evidence can lead to positive changes. Nevertheless, some changes require paradigm shifts that can be challenging for institutions to navigate: for example, cultivating customer-centric relationships and systems. A copy of the University of Michigan report is available here.

For questions or comments about this program, please contact Steven Pennell or Ronald Maio.

Interested in submitting an abstract to present at PRIM&R’s next animal or human research ethics conference? Please e-mail us for more information.

Tribe’s DNA lawsuit prevails, ethical questions emerge

by Emily Butler, content coordinator

Aside from some temporary discomfort, most people would agree that drawing blood does not carry major physical or psychological risks. But what if a blood sample is used to tell personal stories about an individual, or about a community? What if DNA research reveals deeply personal information such as mental illness, inbreeding, and genealogical origins? Do you think participants should be informed that their DNA will be used for this kind of research?

The Havasupai Indians think so. Yesterday’s article in The New York Times explains how 41 of the tribe’s members were awarded an unprecedented $700,000 settlement in retribution for the wrongful use of their DNA blood samples collected between 1990 and 1994.

When researchers at Arizona State University sought permission to study the causes of behavioral/medical disorders in the Havasupai tribe, many obliged. One hundred tribe members signed a general consent form, and provided blood samples in hopes that the researchers would discover the origins of the diabetes epidemic that had begun to plague their community.

But in 2003, the donors were shocked to hear that researchers were actually using the DNA to study the incidence of mental illness and inbreeding, and revealed geographical origins that contradict the tribe’s traditional beliefs about their history.

The Havasupai’s story illustrates a critical need to evaluate the informed consent process in DNA research. But as the article points out, some scientists argue that allowing subjects to stipulate the types of research for which their DNA may be used could impede scientific advancement.

What are your thoughts on the Havasupai’s story? And, how do you think research institutions and IRBs can ensure that these same mistakes are not repeated?

Faculty Interview Series: Don E. Workman

In this series of Ampersand posts, PRIM&R introduces you to our faculty, who help bring our educational programs to life. Learn more about their passion for the advancement of ethical research, their professional experiences and aspirations, and what goes on behind-the-scenes in their lives!

Name: Don E. Workman, PhD
Title: Vice President
Organization: Workman & Associates
Years Affiliated with PRIM&R: 10

Don Workman is teaching Institutional Review Board (IRB) 101^sm on May 3, in conjunction with the May Regional Programs.

1. The elevator door just closed and you have 30 seconds to pitch who you are and why someone should attend IRB 101. What would you say?

The experience of attending an all-day workshop focusing on the IRB regulations is a unique opportunity for the new or relatively new IRB professional. IRB 101 will provide a comprehensive historical background to the regulations and then will overview the basic regulations, followed by a lengthy session of case studies to help the adult learner to apply their knowledge of the regulations to a variety of situations like those they will encounter in their professional experience. Having these presented in a large group context allows for questions and answers and exposure to the way in which seasoned professionals think through a variety of complex situations.

2. What other programs or research initiatives are you involved with outside of your work with PRIM&R?

In my role as a consultant I have the opportunity to provide training in human subject protections topics, as well as to review human subject protections programs in order to ensure that the policies and processes are in compliance with federal regulations. In addition, I am able to identify areas for improvement if there are weaknesses in programs or gaps between their practices and national best practices.

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

One of the true joys of this work is the fact that we can all relate to the principles of respect, beneficence and justice. I have not found any kind of work that draws from any deeper passions for me than the advancement of ethical research. In addition, I think it is important that IRB professionals have opportunities to see the end result of their work, which is not only the absence of noncompliance, but much more profoundly occurs when a new drug or device comes to market, or when the results of a social science study have a beneficial impact on society, or on the knowledge base within an academic discipline.

4. Looking back over your tenure with PRIM&R, one of your most memorable moments as a faculty member?

It is really affirming when you get to the end of a session and you feel the excitement in the room that comes from members of the workshop or didactic session “getting it” in a new way. As a presenter, the job of preparing a presentation and then delivering it takes you to new levels in terms of understanding your subject matter, and I very much enjoy seeing the “lightbulbs” going off for attendees as the information is presented, mulled over and digested in a new way.


One of the most memorable moments for me came at the last annual meeting, when I was part of a panel discussion that was scheduled for the end of the day on the last day of the conference. This is a session which often has limited turnout, and folks are often leaving early to catch a ride to the airport. This last year we closed with a panel presentation and discussion of Creative Solutions to Managing Staff and Budgets at Large Research Institutions. We had a surprisingly large turnout, and when we got to the end of the time allotted, the discussion between panel members and the audience had been so interesting and helpful that hardly anyone seemed to want to go. We announced that the session was over and a few people left, but we also mentioned that we would continue the conversation with interested members of the audience and almost everyone stayed for another 15 minutes!

5. What advice do you have for young professionals interested in pursuing a career in research, IRB administration, and/or related field?

Look for opportunities to do something like tour a cancer center with an experienced principal investigator or clinical research associate, and have them show you where and how the research is being conducted. It is very helpful to understand the context, and at times to have them tell you about the positive impact the research has had. IRB professionals at times are only exposed to risk information, problems with protocols and consent documents, and noncompliance issues, and often do not have a balanced perspective on the way in which the research community genuinely shared their interest in protecting the rights and welfare of subjects.

In addition, beyond the regulations and guidance, it is useful for IRB professionals to read relevant literature from social psychology, statistics, or other academic fields that would inform their work as an IRB professional.

6. What was the best form of training/education that helped you prepare your current position for your job?

Attending the PRIM&R annual meetings, and local IRB 101 and 250 sessions were very instrumental in getting a 30,000-foot perspective on the regulations and their practiced application. In addition, a steady diet of IRBForum and the regular use of the search function to read through the archives is a very useful way to prepare for the daily challenges that fill the life of an IRB professional. I also think that training in effective communication and conflict resolution is critical since these are some of the most important skills an IRB professional will bring to his or her job.

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

Our most daunting challenge at present is to figure out sophisticated methods for evaluating the quality of IRB deliberations. As an industry, we have developed more than enough checklists to ensure compliance with the regulations. It is time that we develop our human subject protection programs so that the regulatory requirements are the foundation and background for consistent and high-quality ethical decision-making. But we do not yet have useful methods for evaluating the quality of that decision-making so that we know when we are falling short of the ethical ideals.

And just for fun...


1. What are three websites, newspapers, and/or magazines you visit/read on a daily basis?

• BBC News website
• IRBForum
• Weather channel website

2. Which three people, living or dead, would you invite to dinner?

• J.R.R. Tolkien
• C.S. Lewis
• Fyodor Dostoyevsky-I would ask each to talk about the books they didn’t get to write because they died too soon!

3. List up to three MUST-see/read books or movies (fiction or nonfiction) for those committed to advancing ethical research.

• Managing for Dummies by Bob Nelson and Peter Economy
• Influence: The Psychology of Persuasion by Robert Cialdini
• Tuesdays with Morrie by Mitch Albom

4. Chicago is known for its Chicago-style hot dog and deep-dish pizza. What are you having for dinner following IRB 101, which takes place during the May Regional Programs?

I want to head over to Gino’s East on East Superior and carve my initials in the wall while waiting for my deep-dish crumbled sausage pizza.

PRIM&R's Abstract Spotlight

In this series of Ampersand posts, PRIM&R touches base with those who presented programmatic and research-based findings at past PRIM&R conferences.

Spotlight on an abstract from the 2009 Advancing Ethical Research Conference.

Title: Implementation and Outcomes of a Research Ethics Education Program for Cardiovascular Investigators

Authors: David Solomon, PhD and Sara L. (Sally) Tobin, PhD, MSW

Affiliation: University of Texas Health Science Center at Tyler

Abstract summary: Human subjects protection education that is tailored to specialized researchers and suited to their particular interests or research context may serve to improve their ability to address human subjects protection issues that arise in their practice. In light of this hypothesis, the authors developed a research ethics training program specifically for cardiovascular investigators. The program included modules on different topics including, statistical analysis, emergency research, subject advocacy, pediatric research, genetic research, and subject recruitment. Topics were contextualized to cardiovascular research, but framing principles are widely applicable. Our intended outcome was a transportable, modular program of research ethics education that met the expressed needs of prospective constituents comprised of cardiovascular researchers and others (e.g., IRB members.) Course participants expressed a high degree of satisfaction with our educational content, our delivery methods, and indicated that educational objectives were met. Our methods and instruments are easily replicated by others who are interested in developing specialized educational programs in human subjects protection. Educational materials are currently being prepared for online dissemination at no cost to end-users.

(View the full abstract here.)

PRIM&R Staff (PS): In the months since you presented this abstract at PRIM&R’s 2009 Advancing Ethical Research Conference, how has your program changed or evolved?

Howard Stone, JD, LLM (HS): Since the presentation, we’ve made a number of refinements and updates to the research ethics training program. These include the addition of newly reported scientific findings that will be included in a bibliography accessible to program participants; reformatting of videotaped instructional modules for improved online access; and development of pre and post-program questions to help measure participants’ baseline and acquired knowledge in regard to specific program content.

PS: What challenges have you faced in implementing this program?

HS: Perhaps the most significant challenge that we have faced in implementing our research ethics program is in developing and delivering an onsite, traditional format one-day course that will help meet the diverse needs of cardiovascular investigators whose own experience and prior training in human subject protection vary greatly. While our national needs assessment helped us identify subject areas of interest and general background of prospective research ethics program participants, participants’ uneven experience and expertise in research ethics had to be ascertained contemporaneously with each course in order for program faculty to most effectively tailor their training modules to participants’ knowledge gaps and interests.

For questions or comments about this program, please contact Howard Stone.

Interested in submitting an abstract to present at PRIM&R’s next animal or human research ethics conference? Please e-mail us for more information.

An update on PRIM&R’s strategic planning efforts

In June 2008, in anticipation of our 35th anniversary, PRIM&R’s Board of Directors approved a strategic plan that carries the organization forward through 2011. This plan incorporates several key elements, including a revised mission, a set of core values, and a vision statement.

The strategic plan also features a number of organizational objectives, including efforts to:

Continue Human and Animal Subjects-Related Work.
The core of PRIM&R’s programs focus on furthering our shared understanding of, and commitment to, ethical research practices. This includes research with people and animals, and is best exemplified through PRIM&R’s educational programming. Activity in this area has been a focus since our founding in 1974, and the strategic plan reaffirms these efforts as organizational priorities. Upcoming activities include our May Regional Programs in Chicago, and the 2010 Advancing Ethical Research (AER) Conference, which will be held in December in San Diego.

Another way we work toward this objective is by supporting the development of our certification initiatives. The Certified IRB Professional (CIP®) and Certified Professional IACUC Administrator (CPIA) programs continue to grow, and we are thrilled to report that, as of April 1, 2010, 1,136 people earned the CIP® designation and 164 people earned their CPIA.

We’ve also been strengthening our organizational collaborations to further our commitment to ethical research practices. Some recent developments include:

• PRIM&R is working with the University of Pittsburgh on a research grant designed to overcome barriers to participation by African Americans, Hispanics, and other minority populations in public health and medical research.
• Joan Rachlin, PRIM&R’s executive director, serves on the advisory board of The Center for Integration of Research on Genetics and Ethics at Stanford University.
• We are collaborating with the Society of Research Administrators (SRA) International by offering our QA/QI 101: Fundamentals of Quality Assurance and Improvement in Human Subjects Research program on June 6 in conjunction with their Western and Southern Section Meeting in Tucson, AZ.
  
• With help from board member Barbara Stanley, we are developing a research ethics-focused panel at the 2010 annual meeting of the American College of Neuropsychopharmacology (ACNP) in December.

Reach Broader Audiences.
One important way to reach new audiences within the organization’s core interest areas of human subjects and animal care and use is by leveraging technology to strengthen PRIM&R's services and expand the reach of our programming. Therefore, we are increasing the number of webinars we offer, from five in 2008 to 10 this year. Additionally, our online course for IRB members is nearing completion and is scheduled for launch this spring We have also expanded our social networking presence on Facebook, Flickr, LinkedIn, and Twitter, and have found these sites to be especially helpful in reaching younger members and those who are new to the research ethics field.
Expand Work in the International Human and Animal Subjects Areas.
As we look to expand our efforts outside of the United States, we believed that we will be most successful when working in partnerships with other organizations. To that end, in February, Joan Rachlin and board member Joseph Byrne represented PRIM&R in Berlin at the IALS-Life Sciences University Network Workshop. This participation was the beginning of a dialogue with IALS about possible future collaboration.

In September, PRIM&R will co-sponsor a meeting on research ethics with the National Healthcare Group of Singapore. Board member Alex Capron will serve as the keynote speaker. PRIM&R’s IRB 101sm will be held in conjunction with this meeting, and will be led by board member David Borasky and former board member Helen McGough. PRIM&R will also be offering IRB 201 at this event.

Other activities include an International Scholarship Program (limited to those from resource-scarce settings) at the 2010 AER Conference, as well as an international membership dues option.

This strategic planning process is an important way to advance our mission, and to encourage thoughtful and deliberate organizational growth. Your feedback on our efforts is most welcome; please don’t hesitate to share your suggestions. Thanks for helping us grow, and thanks for being part of our community.

Faculty Interview Series: P. Pearl O'Rourke

In this series of Ampersand posts, PRIM&R introduces you to our faculty, who help bring our educational programs to life. Learn more about their passion for the advancement of ethical research, their professional experiences and aspirations, and what goes on behind-the-scenes in their lives!

P. Pearl O’Rourke Director

Human Research Affairs

Partners Healthcare System, Inc.

Pearl O’Rourke is teaching Tissue Banking in 2010 and Beyond on May 5, in conjunction with the May Regional Programs.

1. The elevator door just closed and you have 30 seconds to pitch who you are and why someone should attend Tissue Banking in 2010 and Beyond. What would you say?

Tissue banking is becoming increasingly pertinent, especially as genetic research becomes more prevalent. Tissue-based research requires access to an enormous collection of tissue and information.

The oversight of repositories is incredibly important for managing the risk involved. However, the regulations are not easy to discern. Opportunities for professionals to come together and share best practices are necessary for the advancement of this field.

2. What other programs or research initiatives are you involved with outside of your work with PRIM&R?

As the director of human research affairs at Partners Healthcare System, Inc., I oversee a large human research protections program, which reviews primarily biomedical research, such as medical records research, tissue banking, invasive devices, and more. I am also involved on a national level with several federal agencies and professional groups, such as the American Association of Medical Colleges (AAMC). I am on the Advisory Counsel to the director of the National Human Genome Research Institute (NHGRI).

(Editor’s note: Pearl O’Rourke is a member of PRIM&R’s Board and Public Policy Committee. She is also very involved in the development of PRIM&R’s educational programs, including regional and pre-conference programs, as well as conferences and PRIM&R’s new online course for IRB members, which will launch May 1.)

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

In the past, I worked as a clinician and clinical researcher; I worked in a science policy office at the National Institutes of Health (NIH); and I participated in the federal legislative process as a member of Ted Kennedy’s Senate staff. All of these experiences have contributed to my perception of how research can be done well. Research is mandatory for any type of advancement and I feel privileged to have a background that helps inform the research process to make it safer and more efficient.


4. Looking back over your tenure with PRIM&R, what is one of your most memorable moments as a faculty member?

Being involved with the development of the tissue banking white paper with PRIM&R, NIH, and AAMC. It was a first-hand opportunity to see PRIM&R’s convening power. That and singing karaoke, of course!

5. What advice do you have for young professionals interested in pursuing a career in research, IRB administration, and/or a related field?

You personally cannot know everything, therefore you need a team. Know what you don’t know. Know where to find the answer. And, respect the source.

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

A key challenge is making sense of existing regulations in a changing research environment. The rules were written during a different era, one that did not anticipate today’s kind of research—especially considering that the public is a much different public today than it was when the rules were written..


And just for fun…

1. What are three websites, newspapers, and/or magazines you visit/read on a daily basis?

• New Yorker Cartoons
• Boston Globe Online
• The New York Times Online

2. Which three people, living or dead, would you invite to dinner?

• Bette Midler
• Eleanor Roosevelt
• Clint Eastwood

3. Chicago is known for its Chicago-style hot dog and deep-dish pizza. What are you having for dinner following Tissue Banking in 2010 and Beyond, which takes place during the May Regional Programs?

I may sneak out for one of the Food Tours in Bucktown!!!

New appointments to the Presidential Commission for the Study of Bioethical Issues

PRIM&R would like to congratulate the following individuals on their appointments to the Presidential Commission for the Study of Bioethical Issues:

• Amy Gutmann, PhD, Chair
• James W. Wagner, PhD, Vice Chair
• Lonnie Ali, MBA
• Anita L. Allen, JD, PhD
• Barbara F. Atkinson, MD
• Nita A. Farahany, JD, PhD
• Alexander G. Garza, MD
• Christine Grady, RN, PhD
• Stephen L. Hauser, MD
• Raju S. Kucherlapati, PhD
• Nelson Lee Michael, MD, PhD
• Daniel Sulmasy, MD, PhD
  

As we wish these people wisdom and courage as they pursue this important work, we’d like to ask you: What do you think are the most important areas for the Commission to explore?

In Sympathy

We wanted to let the many friends and former co-workers of Charles McCarthy, former director of the Office for Protection from Research Risks (the precursor of the Office of Human Research Protections) know that his beloved wife, Estelle, passed away on Easter Sunday.

Charlie wanted the IRB/HRPP community to know of his loss, and so we've included the plans for the wake and service below, as well as Charlie's contact information for those of you who wish to contact him.

A viewing will take place from 2:00 to 4:00 PM, and from 6:30 to 8:30 PM, on Friday, April 9, at Bliley’s Funeral Home, 8510 Staples Mill Road, Richmond, VA.

Funeral services will begin at 3:00 PM ET on Saturday, April 10, at Ginter Park Presbyterian Church, 3601 Seminary Avenue, Richmond, VA.

The burial will take place in a small town near Selma, AL, at a later date.

Charlie's address is: Westminster Canterbury, 1500 Westbrook Court, Apt. 3149, Richmond, VA 23227.

Please note: Estelle McCarthy's obituary was published this morning, and we include it here for anyone who might be interested in learning more about this remarkable woman

In mice and men: Drug development spike brings a new approach

by Emily Butler, content coordinator

In a new twist on the traditional progression of pharmaceutical research, a cancer researcher is testing novel therapies in humans and animals at the same time.

An article in yesterday’s Boston Globe explains how Dr. Pier Paolo Pandolfi’s tandem strategy might help investigators design targeted therapies more quickly and efficiently: “What is learned at the bedside can be integrated with results from the lab bench to speed up and streamline the development of cancer drugs.”

In addition to speeding up the clinical trial process, the strategy addresses the shortage of cancer patients who are available to enroll in cancer clinical trials. The Globe reports “there are about 850 cancer drugs in clinical development, according to the Tufts Center for the Study of Drug Development, a 70 percent increase in three years.”

Pandolfi’s approach could allow investigators to more efficiently discover new and better targeted therapies offering new hope for ill patients who are not responding to standard treatment.

How might tandem human and animal clinical trials affect the process of IRB and IACUC oversight? How closely should IRBs and IACUCs communicate in these kinds of trials? What are your thoughts on how this novel approach might affect the practice of ethical oversight?

PRIM&R joins the University of Pittsburgh in "Building Trust Between Minorities and Researchers"

By Amy Davis

PRIM&R is working with the University of Pittsburgh on a research grant designed to overcome barriers to greater participation by African Americans, Hispanics and other minority populations in public health and medical research, including clinical trials. The $3.96 million grant was awarded to the University's Graduate School of Public Health (GSPH) by the National Center on Minority Health and Health Disparities, a part of the National Institutes of Health (NIH).

The principal investigators on the project are Sandra Crouse Quinn, PhD, associate dean at the University of Pittsburgh for student affairs and education and associate professor, and Stephen B. Thomas, PhD , associate dean for diversity and professor. Co-investigators come from Pitt’s GSPH, School of Medicine, and Center for Bioethics and Health Law.

The representation of racial and ethnic minority populations in public health and biomedical research still lags behind that of whites, and has been identified by the NIH as a serious problem. Over the past 15 years, Drs. Thomas and Quinn have documented multiple factors that influence the participation of minorities, including lack of access to research, lack of knowledge about the research process, and distrust of researchers.

Using qualitative and quantitative methods, the investigators will examine the attitudes, knowledge, and behaviors of researchers; identify best practices in community engagement; determine the level of knowledge about research, informed consent, and willingness to participate in research among a national random sample of minorities; develop, pilot test, and revise a curriculum, "Building Trust," for minority communities; and finally, develop and implement multiple trainings aimed at enhancing the capacity of researchers and IRB members to support recruitment and engagement with minority communities.

The primary goal of the project is to produce effective tools and a national infrastructure of educational initiatives that may be implemented and evaluated to determine the extent to which they contribute to the increase in minority participation in NIH-sponsored research. PRIM&R is proud to participate in this effort.

As a major sub-awardee to the grant, PRIM&R will be involved in the development and coordination of various educational programs over a two-year period that began in November 2009. Some of the educational initiatives that have been or will be undertaken pursuant to this grant include:

• A pre-conference program that was held in conjunction with the 2009 Advancing Ethical Research (AER) Conference, titled What Does it Mean to Represent the Community? A Primer on Community Participation in Research
• A pre-conference program that will be held in conjunction with the 2010 AER Conference
• A program to be delivered during the May Regional Program in Chicago, Building Trust Between Minorities and Researchers: A National Bioethics Research Infrastructure Initiative
• A series of three webinars to be presented in July 2010, January 2011 and May 2011 In addition, PRIM&R will help the University publicize, distribute, and track a survey for IRB professionals about minority recruitment.
  

PRIM&R is extremely proud to be a member of this project team, and we look forward to the presentation of the important and original research that it will generate.

Announcing PRIM&R’s new Refer a Colleague Program

By Joanna Cardinal, Membership Manager

PRIM&R members, as you may have read in PRIM&R’s monthly Newsletter, the new Refer a Colleague Program has launched!

You now have the opportunity to support our shared mission to advance the ethical conduct of research by strengthening the membership community and referring your associates to PRIM&R.

Visit our website to find three easy tools to help you begin reaching out to your colleagues, having fun, winning fantastic prizes, and earning recognition for your hard work!

Nonmembers, if you become a PRIM&R member, not only will you gain access to the benefits of membership, but you will also become eligible to receive rewards from the Refer a Colleague Program.

For more information about our Refer a Colleague Program, please visit our website or contact me at 617.423.4112, ext. 16.

"Circle of miracles" saves and inspires donors and recipients

In a December 2009 Ampersand post, PRIM&R’s executive director Joan Rachlin, JD, MPH, told a moving story about two dear friends’ kidney donation experience:

When Andy Levey, MD, discovered he was not a donor match for his wife, Roberta Falke, MD, the couple contacted an organ exchange program in hopes of finding another source for the kidney Roberta needed.

In an unexpected—but inspiring—turn of events, Andy donated a kidney to a patient in need, whose wife received her kidney from a donor who, like Andy, could not match his spouse.

But the story did not end there.

The change these donors effected reaches far beyond Andy and Roberta. As reported in the Boston Globe on Sunday, Andy and Roberta were actually involved in a three-way, six-person swap: Andy donated a kidney to a diabetes patient whose wife, in turn, donated a kidney to a man whose wife gave one of her kidneys to Roberta, thus completing the “circle of miracles.”

Read the full Boston Globe article here.

PRIM&R files comments on proposed FDA rule for informed consent documents

By Amy Davis

PRIM&R recently filed comments on the FDA’s proposed rule to amend the informed consent regulations at 21 CFR 50 that apply to most clinical investigations.

PRIM&R’s Board of Directors has a Public Policy Committee (PPC) that works with content experts to develop comments on proposed guidance or regulations that might negatively impact the ethical conduct of research by limiting protections for human subjects or by negatively impacting the welfare of animals used in research.

The regulation change, required by the Food and Drug Administration Amendments Act of 2007, states that all informed consent documents and processes must inform subjects that certain information from the clinical trial is included in the government’s clinical trial registry databank , which contains information about federally registered clinical trials.. The proposed change is to 21 CFR 50.25 , the regulation that lists the basic elements of informed consent for clinical trials. The new provision would require all informed consent documents and written processes to include the following uniform statement, which serves to ensure consistency among the information that clinical trial participants receive:

"...clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act: Information, that does not include personally identifiable information, concerning this clinical trial has been or will be submitted, at the appropriate and required time, to the government-operated clinical trial registry data bank, which contains registration, results, and other information about registered clinical trials. This data bank can be accessed by you and the general public at www.ClinicalTrials.gov. Federal law requires clinical trial information for certain clinical trials to be submitted to the data bank."

According to the Federal Register announcement, the purpose of the rule change is to:

• Increase public awareness of the existence of the database, thereby allowing subjects to make more fully informed decisions about participating in a clinical trial;
• Provide greater accountability and responsibility of investigators for outcomes and adverse events, and improve transparency of all clinical trial outcomes information by creating a system of checks and balances for the research community;
• Increase public confidence in the validity of the research process; and
  
• Give sponsors, physicians, and patients access to more information, thus enabling them to make more educated treatment decisions.

PRIM&R solicited input from its members and Board, and the PPC developed comments on this proposed regulation that raised two objections:

• The requirement that specific language be included in the informed consent document is inconsistent with the other provisions of 21 CFR 50.25 that do not dictate the wording of the essential elements of the informed consent document, and
  
• The required wording is too complex and exceeds the reading level that would be necessary to ensure understanding on the part of all subjects in violation of 21 CFR 50.20.
  

What are your thoughts on PRIM&R’s response to the FDA? We welcome any comments and discussion on this issue!