Thursday, May 27, 2010

Featured Member Interview: John Waterson

As part of our Member Appreciation Month, this series of Ampersand posts will introduce you to our members, individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to John R. Waterson, MD, PhD, IRB chair at Children's Hospital & Research Center at Oakland.

When and why did you join the field?
In 1984, shortly after I started working at Akron Children's Hospital. I was young(er), innocent, and naive. I knew nothing about the IRB and was drafted by the president of the medical staff to serve on the IRB since I had a PhD and was interested in research. A year later, the chair of the IRB resigned to become the president of the medical staff and I became chair. I served as chair for 15 years. I moved to California in 2000 to work and a part of the job offer was to chair the committee at Children's Hospital & Research Center Oakland.

What is your favorite part of your job?
Reviewing new research. Also, I enjoy trying to figure out how the regulations apply to given situations.

What's playing on your iPod?
I don't have an iPod yet, but I’m planning on purchasing an iPad.

What are you reading?
I’m re-reading Dragon Riders of Pern after seeing Avatar three times.

What's your after-hours guilty pleasure?
Being with family.

What are three websites you visit on a daily basis?
AOL (e-mail), GeneTests and OMIM (I am a geneticist).

Why did you join PRIM&R?
I believe that you should belong to the professional organization that represents what you do with a lot of your time. It's the best way to find out what is happening in the field and how others are dealing with common issues.

What is your favorite member benefit?
Meetings. Unfortunately, I don't like to travel. I'm looking forward to this year’s meeting in San Diego.

What would you say to someone who is considering PRIM&R membership?
If you are seriously considering further developing your IRB interests/knowledge/career, you should join.

What motivates you to maintain your commitment to advancing ethical research?
Properly conducted research is the best way to further knowledge to help us develop evidence-based care for our patients. That research must take into account the best interest of the subjects.

Thank you for being part of the membership community and sharing your story, John. We look forward to seeing you in San Diego at the 2010 Advancing Ethical Research Conference.

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

Tuesday, May 25, 2010

Featured Member Interview: Mohamed Abdel-Fattah

As part of our Member Appreciation Month, this series of Ampersand posts will introduce you to our members, individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Mohamed Abdel-Fattah, IRB administrator at the U.S. Naval Medical Research Unit No. 3 in Cairo, Egypt.

When and why did you join the field?
I wanted to change from what I was doing.

What is your favorite part of your job?
My favorite part is writing the IRB meeting minutes.

What are three websites you visit on a daily basis?
Three websites I visit on a daily basis are the United States Department of Health and Human Services website, the FDA website, and PRIM&R’s website.

Why did you join PRIM&R?
I joined PRIM&R because it is the association representing my current career, and it is helpful for my career’s progression.

What is your favorite member benefit?
My favorite benefit is feeling a part of something much bigger than myself.

What would you say to someone who is considering PRIM&R membership?
If you are considering membership: Go for it, do not wait!

What motivates you to maintain your commitment to advancing ethical research?
My longing to achieve excellence is what motivates me.

Thank you for being part of the membership community and sharing your story, Mohamed. We’re happy to hear you find our website so useful!

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

Friday, May 21, 2010

US Scientists Create Synthetic Life: The Ethical Implications

A group of well-known scientists in Rockville, MD, have succeeded in transplanting synthetic bacterial DNA into a host cell. This landmark discovery presents several ethical implications for the field, as it advances the capacity for scientists to create life from nonliving material.

This morning’s BBC News article presents several different ways to consider this announcement, ranging from a matter of everyday science, to something much more extraordinary.

What actions should be taken now to make sure that potential hazards are considered and avoided later? How important are semantics in describing this discovery—should the public be referring to ‘artificial life,’ or something less sensational? How might scientists achieve a balance between advancement and ethics?

Featured Member Interview: Joan Sutherland

As part of our Member Appreciation Month, this series of Ampersand posts will introduce you to our members, individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Joan Sutherland, BS, research compliance coordinator at Borgess Research Institute.

When and why did you join the field?
Eleven years ago I was looking to change jobs and asked a college about the job posting. She assured me it was a stable position and that it was a new and growing area for the hospital.

What is your favorite part of your job?
I like being able to use my organizational and creative skills, such as helping researchers submit all the required documents (my husband jokingly tells folks my job title is 'queen of red tape'), and remembering a piece of information about a protocol and being able to document the paper trail.

What's playing on your iPod?
Weezer.

Why did you join PRIM&R?
It’s a professional organization of like-minded professionals, an organization of people like me.

What is your favorite member benefit?
Information! PRIM&R is my best source of information.

If you were planning our next conference, who would you select as a keynote speaker?
I would like to hear from or more about Dr. Timothy Kuklo, who was recently accused of falsifying data. The New York Times covered the story.

What advice do you have for young professionals interested in pursuing a career in ethical research?
When I started I thought I’d have it all figured and organized in a few months. It’s been 11 years and I’m still learning. Document everything and create a system that works for you.

Thank you for being part of the membership community and sharing your story, Joan. We admire your commitment to lifelong learning.

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

Share YOUR ideas and strategies for IRBs/HRPPs

2010 Advancing Ethical Research Conference – Call for Poster Abstracts!

Deadline for Submission – Extended to June 11

We encourage you to consider participating in the Poster Presentation at PRIM&R’s 2010 Advancing Ethical Research Conference!

The development and presentation of Scientific or Programmatic Posters promote interdisciplinary sharing and collaboration, and facilitate the exchange of ideas, information, and practical strategies for managing the many challenges faced by human research protection program (HRPP) professionals. Last year, nearly 100 posters were displayed, four of which were selected for the panel session, and 16 of which were selected for moderated discussions.

Interested in submitting an abstract for poster presentation? Please visit our website for more information, including guidelines, important dates, and frequently asked questions, and instructions to submit your abstract online.

Tuesday, May 18, 2010

Featured Member Interview: Thomas Maloney

As part of our Member Appreciation Month, this series of Ampersand posts will introduce you to our members, individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Thomas Maloney, PhD, IRB member at University of Louisville.

When and why did you join the field?
I am a member of the philosophy department at the University of Louisville and have a PhD in philosophy and an STL in theology with, therefore, considerable training in ethics. With that in mind the vice president for research asked me to sit on the university’s IRB, more than 30 years ago, and I have served continuously ever since, quite willingly.

What is your favorite part of your job?
The free lunch that is served at the noon meetings! Well, er, also the opportunity to both keep abreast of the latest developments in the social and natural sciences, and to engage in meaningful debate with dedicated and bright colleagues on some of the most complicated ethical questions raised today.

What's playing on your iPod? What are you reading? What's your after-hours guilty pleasure? What are three websites you visit on a daily basis?
I have no iPod; I don’t visit any websites on a daily basis; and my after-hours guilty pleasure must remain a secret to all but the CIA and FBI, and of course to the little old lady who lives down the block and who knows everything that is going down. The answer: I love to read novels set in historical periods: surcease from current cares.

Why did you join PRIM&R?
Actually, the university here enrolls all members of the IRBs in PRIM&R. It pays the membership, and I am happy that it does this. I am also happy to say that it is just one example of the comprehensive and generous dedication—let us not forget the lunches!—of my university to the work of our IRBs.

What is your favorite member benefit?
The greatest benefit I derive from PRIM&R is the education and inspiration obtained at the annual conference. That is truly an impressive group of people with which to associate, and the PRIM&R staff is super competent and available. I suspect that our office director and staff benefit from the organization in a myriad of ways of which I am ignorant.

If you were planning our next conference, who would you select as a keynote speaker?
An ethicist, not a lawyer. The one disappointment that I have had with the annual conference and with many of the panels is the lack of trained ethicists as speakers. I have never quite understood why the feds, in defining what areas of competency must be represented on an IRB whose principal duty is to render judgment on the ethical uprightness of a given protocol, omit a requirement for at least one member formally trained in ethics.

Everyone has a sense of (personal) morality, but that is no substitute for a rationally derived understanding of ethical principles and their coherent application. The lawyers tell us what the law is; the ethicists tell us which laws we must obey when we are protecting human subjects and what conduct is appropriate even when the law is silent. So I would like to see much more time dedicated to ethicists as keynoters (and panelists) weighing in on some of the more complex moral issues in current research. Hopefully, the IRB members and the law-makers will listen and learn.

What do you believe is a key challenge facing the field of research ethics?
There are several key challenges facing the field of research ethics today, and they have shifted in the 30-plus years I have sat on IRBs. Were I to single out one of the more serious issues, I would point to the increasing influence of money in the system. The huge sums involved are just about to overwhelm the system. Central IRBs are under huge pressure to judge protocols favorably; investigators’ livelihoods (tenure and promotion in universities) are tied up with bringing in bigger and bigger bucks for their institutions, and this means increasing pressure to please sponsors. How many times do we hear at in IRB meeting: “If we require this change, the sponsor will get mad and the investigator will lose the study!”

Money is driving the system of review to an extent and in ways unimagined 30 years ago, and I see little evidence that things will improve. IRBs have to get together on the national level in order to speak with one voice. For example, it is arguable that at some point sponsors of research should have to be required in all cases to pay for injuries incurred as a direct result of a subject’s participation in research. It is hard to imagine the pharmaceuticals allowing the feds to require this; but if that were a position agreed to on a national level by IRBs, sponsors would be unable to shop the system. If I were a young person (with a few years’ experience on an IRB learning the ropes), I would think seriously about the merit of dedicating a good portion of my time to organizing the IRBs in this country. As things stand now and in the foreseeable future, it looks as if sponsors have far too much weight in determining the outcome of IRB reviews. Money is a powerful force, and there has to be an even more powerful counterforce, if ethics is to secure its proper role.

Thank you for being part of the membership community and sharing your story, Thomas. If we’re ever in Louisville, we hope to stop by your university and partake in the now famous IRB meeting lunch!

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

Monday, May 17, 2010

Featured Member Interview: Penny Yarber

As part of our Member Appreciation Month, this series of Ampersand posts will introduce you to our members, individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Penny Yarber, CIM, regulatory specialist at St. John's Mercy Medical Center.


When and why did you join the field?
I joined the field in April 1998 when I starting working for the St. Louis-Cape Girardeau Community Clinical Oncology Program (CCOP) office. I worked quite a few years in the CCOP office, and then when the position became available in the IRB office at our institution I applied. That was five years ago. I have learned a lot through reading on my own and the conferences that I have attended. All the information on PRIM&R's website has been very helpful.

What is your favorite part of your job?
I enjoy teaching those that are new to research, and learning more myself.

What are you reading?
I am currently reading Chasing Medical Miracles: The Promise and Perils of Clinical Trials by Alex O'Meara. This is a very interesting book about clinical trials and being a research participant.

Why did you join PRIM&R?
I joined for further education, and to keep up-to-date with new information related to research.

What is your favorite member benefit?
The conferences are very exciting. I also enjoy the PRIM&R Newsletter and RED. The webinars look very educational, but I've only participated in one of those several years ago. I'm hoping our institution can do that again soon.

What would you say to someone who is considering PRIM&R membership?
I have told several people about PRIM&R and about becoming a member. I tell them PRIM&R has a lot of educational resources and conferences, and I tell them about the certification.

If you were planning our next conference, who would you select as a keynote speaker?
For the next keynote speaker I would select someone—maybe several people—who have been research participants and let them tell their stories; one with a positive experience and one with a negative experience. I think it is good to hear from research participants. Someone such as Allen Hornblum, who wrote the book Sentenced to Science: One Black Man's Story of Imprisonment in America and was discussed during the 2009 Advancing Ethical Research Conference, would be interesting. He can talk about the problems that he encountered as a prisoner and being in research trials.

What motivates you to maintain your commitment to advancing ethical research? What motivates me is the knowledge that through research, there will someday be medical treatment/drugs/cures for diseases that we don't have cures for now.

What advice do you have for young professionals interested in pursuing a career in ethical research?
I would tell young professionals interested in research that it is a very interesting field and there is always more to learn.

What do you believe is a key challenge facing the field of research ethics?
The key challenge facing the field of research ethics is keeping up with all the new regulations and changes.

Thank you for being part of the membership community and sharing your story, Penny. As a PRIM&R member, we hope you take advantage of the additional webinar discounts offered as part of Member Appreciation Month.

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

Friday, May 14, 2010

Urging proactive, not reactive, response to AZ law

by Joan Rachlin, executive director

This is not, sadly, a blog about our many terrific members. Nor is it a blog about the many complicated issues that cross our desks daily. Instead, I'm writing today to respond to the legitimate concerns that have been raised about PRIM&R’s upcoming quality assurance/quality improvement (QA/QI) course in Tucson, AZ.

When Arizona’s new immigration law was first passed some three weeks ago, I spoke with colleagues about whether to go forward with our meeting plans. Foremost among the reasons that we ultimately decided not to cancel was the fact that those who had already signed up for the course would suffer financial losses (airline tickets had already been purchased, etc.) if we did not go forward. In addition, the QA/QI course is being offered in conjunction with the Society of Research Administrators International’s (SRA’s) 2010 Western/Southern Section Meeting and it is, in fact, our first collaboration with that organization. We are therefore bound to honor that commitment.

In addition, although PRIM&R prides itself on being proactive, it is clear that reasonable people are differing on the advisability and impact of a boycott. In fact, I’ve been doing a lot of reading on the topic and have noticed that some Latinos, Native Americans, and other opponents of the bill explicitly oppose a boycott, owing to the overly broad economic suffering it would impose upon those who can least afford it.

Needless to say, PRIM&R will not be pursuing any new contracts with hotels in Arizona. In addition, I plan to write to several key legislators in Arizona to express my anger and disappointment at the passage of such an explicitly racist measure, and I am urging others with whom I speak about this matter to do the same. I will indicate in my letters that PRIM&R will not bring any new business to Arizona until and unless the law is overturned.

I'd like to say a word to those of you might be on the fence regarding attending the course: Instead of boycotting our meeting, please instead consider similarly writing to key legislators indicating that you will travel to Tucson in June, but that this will be the last time you will set foot in Arizona unless and until the law is overturned.

In a more just world, racism, classism, and all of the other “ism’s” would disappear. In such a world, racial profiling, draconian law enforcement techniques, and all forms of harassment would be abolished. Sadly, no such world yet exists, and so we will instead continue to work toward the healing of this one. You have my assurance that PRIM&R will continue to do whatever it reasonably can to be part of that repair.

Wednesday, May 12, 2010

Featured Member Interview: Jennifer Pacheco

As part of our Member Appreciation Month, we’re launching a series of Ampersand posts that will introduce you to our members, who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Jennifer Pacheco, BS, CIM, IRB analyst at Baystate Medical Center in Springfield, MA.


When and why did you join the field?
In 2004 I began work at a former General Clinical Research Center (GCRC) in Boston, MA. I had just graduated from college and wanted to use my former experience in the medical community to continue to help others. In 2006, I jumped into work for the IRB and have never looked back.

What is your favorite part of your job?
My favorite part is the challenges. I go by the philosophy that no two research projects are the same, and we always have something to learn from the process and the project itself.

What's your after-hours guilty pleasure?
My guilty pleasures are Lindt chocolate and quality time with my husband and kids (four years and three months).

Why did you join PRIM&R?
PRIM&R was recommended to me by a former colleague to further my education in the research field. It was considered a valuable tool for our office, and after becoming a member and attending a conference myself, I was able to see how valuable it was to me.

What is your favorite member benefit?
Do I have to pick just one? The mentoring program, the networking, and the educational programs are all helpful. All of PRIM&R’s programs help with the large territory we have to cover in the field, and the new perspectives on the regulations and their practiced applications are always helpful. I love being pushed to think outside the box.

What would you say to someone who is considering PRIM&R membership?
In this field, PRIM&R membership is essential. Membership includes you in a community that is interested in the same outcome: the ethical practice of research. Research is a unique field that many only understand once they become a part of it. Make as many connections as you can, and utilize the knowledge members are willing to share. Through PRIM&R, I have learned you may have more to offer than you think, and that there will always be another member willing to share the expertise you are missing.

What advice do you have for young professionals interested in pursuing a career in research ethics?
First, be ready for a challenge. Some aspects of the field feel like they are changing constantly. Second, always be willing to learn. Every project is different.


And finally, I would have to echo [PRIM&R board member] Pearl O’Rourke, who I had the pleasure of hearing at the 2008 Advancing Ethical Research Conference: “Know what you don’t know. Know where to find the answer. And, respect the source.” She’s so right! It’s too large of a field to know every detail about everything that comes before you.

Thank you for being part of the membership community and sharing your story, Jennifer. We hope to see you at our upcoming 2010 Advancing Ethical Research Conference where we would like to not only share your expertise, but your Lindt chocolate as well!

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

Tuesday, May 11, 2010

Featured Member Interview: Emily Foster

As part of our Member Appreciation Month, we’re launching a series of Ampersand posts that will introduce you to our members, who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Emily Foster, BA, CIP, protocol analyst at Vanderbilt University’s human research protections program.

When and why did you join the field?
I joined the field in August of 2007. I previously worked as a research coordinator and was fascinated by all aspects of research, including the regulations and guidelines side of things. Working for the IRB seemed like the natural progression.

What is your favorite part of your job?
My job allows me the opportunity to interact with notable doctors and various study coordinators. Every day is different and interesting.

What are you reading?
I am currently reading a book called Twins!, as my husband and I are expecting our first two children this September.

Why did you join PRIM&R?
PRIM&R is a unique organization that offers an unlimited number of resources and contacts for people working in the field. It is one of the few organizations that offers information specific to what we do every day.

What is your favorite member benefit?
I am personally a fan of the member Newsletter. It offers up-to-date information on everything research related. It’s a great tool.

If you were planning our next conference, who would you select as a keynote speaker?
I would love to hear a keynote speaker from the current administration, or hear a political analyst discuss how the health care bill will impact the future of clinical research.

What advice do you have for young professionals interested in pursuing a career in research ethics?
As a young professional myself, I would encourage other young professionals to consider a career in ethical research. It is an area that will always require oversight and is constantly evolving. There are so many areas to get involved in and it’s a career path that offers many opportunities.

Thank you for being part of the membership community and sharing your story, Emily. Congratulations on the new additions to your family!

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

Featured Member Interview: Elizabeth Small

As part of our Member Appreciation Month, we’re launching a series of Ampersand posts that will introduce you to our members, who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Elizabeth Small, MPH, CIP, and the administrative director of the IRB at New York State Psychiatric Institute.

When and why did you join the field?
As many folks did, I joined early in the field (1983!). I started by chance in a field that was not well defined at the time. I was a student in the School of Public Health at Columbia University in New York City, and was looking for a way to earn money close to home and school. My advisor heard about an opening in the IRB office at the Medical Center. Neither of us knew much about the actual work of IRBs then. It seemed like a great opportunity for me to take on the challenge of working in uncharted territory at a time of heightened awareness of biomedical ethics and growing biomedical science.

What is your favorite part of your job?
Since entering the field, there have been tremendous advances in medicine through research and, more specifically, in mental illness treatment. Psychiatric research, which is largely the focus of our IRB, presents ethical issues that are not always well articulated and for which additional protections and special considerations are warranted. Addressing these issues has been a challenge, but a gratifying one.

That said, our office is amazing and a favorite part of my job involves the day-to-day collegiality and support of IRB members and staff who work enthusiastically and tirelessly every day, and from whom I’ve learned more than I’ve shared. (NOTE to my colleagues who are reading this: A sincere thank you! It’s not said often enough!)

What’s your after-hours guilty pleasure?
Auctions, flea markets, eBay. My husband and I are collectors of Wallace Nutting hand-tinted photographs, which were produced and sold between 1900-1941. Guilty or not, our search continues even with some of our collection “hanging” on the floor. We recently stumbled on a very unusual print and, uncharacteristically, decided not to keep it and auction it. We’ll see the results in May.

Why did you join PRIM&R?
PRIM&R has provided, even in its earliest days, opportunities for professional development though networking, educational programs, and conferences. The growth of the field is reflected in the growth of PRIM&R, and in the increased interest and membership.

What is your favorite member benefit?
My favorite benefits are the discounts on conference registration and CIP® certification.

If you were planning our next conference, who would you select as a keynote speaker?
I’d select Kathleen Sebelius. I’d like to hear about the impact and challenges of health care reform on research.

What do you believe is a key challenge facing the field of research ethics?
The key challenge has been fundamental to the field since its beginning and is especially challenging as medical science and technology move forward: How do we balance the interests of the scientist with the interests and welfare of the individual subject? The problem of conflict is not new, but I think research institutions, academic centers, researchers, and IRBs are in an increasingly better position to collaborate and promote the interests and well being of research volunteers.

Thank you for being part of the membership community and sharing your story, Elizabeth. Good luck with your auction!

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

Monday, May 10, 2010

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: Parental Attitudes Toward Pediatric Biobanks

Authors: Jody Harland, MS, CIP; Lucy Miller, RN, BSN, CCRC; Eric Meslin, PhD; James Wolf, PhD; and Scott Denne, MD

Affiliation: Indiana University Department of Pediatrics; Indiana University Center for Bioethics; Survey Research Center, Indiana University Purdue University - Indianapolis; Indiana Clinical and Translational Science Institute (CTSI)

Abstract summary: It can be difficult for IRBs to discern what concerns potential subjects may have relative to their participation in biorepositories (or “biobanks”); and thus, what information should be conveyed to subjects. The establishment of pediatric biobanks can be more challenging due to the additional ethical and regulatory concerns about involving children in research. IRBs rarely have actual data available as to how such pediatric biobanks are viewed by families. This study sought to survey parents/guardians about their attitudes toward pediatric biobanking research.

Parents/guardians of pediatric inpatients and pediatric outpatients at a children’s hospital were offered in-person surveys. Broad support for pediatric biobanking was noted regarding the parents/guardians’ allowance of their child’s blood to be included in a hospital biobank (80.3% ‘agreed’ or ‘strongly agreed’). Areas of concern included general opposition to the commercialization of biobank samples (61.4% were ‘opposed’ or ‘strongly opposed’). Respondents indicated that they trusted the institution to maintain their confidentiality (90.9% ‘agreed’ or ‘strongly agreed’). IRBs can use this data to inform their reviews of pediatric biobanking protocols. We will share the results of this study with IRBs and plan to conduct focus groups with parents and children in an effort to obtain more detailed, qualitative information about attitudes toward pediatric biobanking.

(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?

Jody Harland, MS, CIP (JH): At Indiana University, we are engaged in the creation of a new biobank (which will include both pediatric and adult samples) and as a result, our research is evolving such that we anticipate using these findings to help shape the actual creation of this new biobank. We are exploring the possibility of conducting focus groups with those respondents who agreed to be re-contacted about future participation so that these results can inform the development of the new biobank. Finally, we would like to further explore how to ask these questions of older children in an effort to gain adolescents’ perspectives of the issues.

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

JH: As with many research programs, a major challenge is the development of dedicated time and space to focus on this issue. However, we are committed to pursuing this line of research and to better understanding attitudes toward biobanking research.

For questions or comments about this program, please contact
Jody Harland.

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.

Friday, May 7, 2010

Featured Member Interview: Eileen Callahan

As part of our Member Appreciation Month, we’re launching a series of Ampersand posts that will introduce you to our members, who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Eileen Callahan, MS, research compliance coordinator at the College of Charleston.

When and why did you join the field?
I never set out to work in research administration (does anyone?), but my varied background ended up as a perfect fit. After just finishing my master’s degree at age 42, I took my first job in research administration as a grants information specialist at the University of Scranton in 1994. Frankly, it sounded interesting.

I was a single mom, and they had great benefits. But as I grew in the profession, becoming the director of research services in 1996, the ethics and compliance issues drew me in. Now I am fortunate to be working at the College of Charleston solely in the area of research protections, compliance, and responsible conduct of research (RCR) education.

What is your favorite part of your job?
There are actually two favorite parts.

The first is teaching. I feel that the only way to encourage ethical research is through education. People need to understand what ethics really means, and how it impacts their lives much more broadly than just their own research. And teaching goes beyond the classroom or workshop. One of the best teaching moments occurs when explaining requested protocol revisions to an investigator.

The second is discussing complex ethical issues and dilemmas with colleagues as we review protocols.

Okay, so there’s a third, too, which in some ways ties one and two together--the opportunity to streamline compliance functions so that investigators find it easier to submit a complete application, and reviewers can focus on the important issues. A colleague and I have developed an online IRB application/review process that has been very well received by our faculty. This summer we will be doing the same for our institutional animal care and use committee (IACUC) and institutional biosafety committee (IBC).

And, always, my wonderful, supportive colleagues!

What are you reading?
I’m hooked on mystery and suspense novels. Some are thought provoking, complex, and set in foreign locales or interesting points in history. Others are just plain escapist fun, like Janet Evanovich’s Stephanie Plum series. Right now I’m reading Long Time Coming by a new (to me) author, Robert Goddard.

Why did you join PRIM&R?
PRIM&R is the premier organization for professionals working in research compliance and research integrity. The membership is large and varied, the mentoring program is excellent, and the educational offerings and annual conferences are engaging and well put together.

What is your favorite member benefit?
The mentoring program.

What would you say to someone who is considering PRIM&R membership?
I have strongly recommended PRIM&R membership to a number of people for the reasons I noted above.

What motivates you to maintain your commitment to advancing research ethics?
Students. Every time I have the opportunity to work with students, either one-on-one or in lectures, I am reminded of the significance of promoting ethical research. I know that I am in the right line of work every time I see the “a-ha” moment in a student’s eyes when he or she realizes the extraordinary impact that research has on our daily lives and how essential it is that we are able to trust it.

Thank you for being part of the membership community and sharing your story, Eileen. May we suggest your next book be The Immortal Life of Henrietta Lacks, our book group selection for the 2010 Advancing Ethical Research Conference?

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

Introducing: An engaging online course for IRB members!

by Amy Davis, managing director, programs

PRIM&R is excited to introduce the Ethical Oversight of Human Subjects Research Course (EO Course), a four-hour, in-depth exploration of the functions and purposes of institutional review boards (IRBs). Through an interactive, animated interface and a mock IRB, the course focuses on the roles of IRB members who tackle the challenging, ethical and regulatory issues that they frequently face.

Watch this diverse group of IRB members as they review two different protocols as a means of illustrating the key points of each of the eight modules, which cover the history of our current human subjects protections system, the regulatory framework, how to review a research protocol, the assessment and minimization of risks to subjects, the assessment and maximization of benefits, the informed consent process, appropriate data monitoring systems, and more. Course participants will learn about the ethical principles that govern human subjects research and will learn to apply the rules and principles to both biomedical and social/behavioral case studies.

This is the first online course that PRIM&R has produced. Based on years of feedback from HRPP professionals, we know there’s a need for reliable, affordable research ethics education geared to the IRB member. We also know that institutions are constantly looking for engaging, intelligent educational programs for their IRB members. As the field of human subjects protections becomes more complex, the need for courses that encourage the application of rules to factual scenarios becomes increasingly valuable. We hope that this course meets that need.

Please visit the EO Course overview page to learn more. If you have any questions, please e-mail me, or call 617.423.4112, ext. 12. I look forward to seeing you online!

Thursday, May 6, 2010

Featured Member Interview: Darlene Knox

As part of our Member Appreciation Month, we’re launching a series of Ampersand posts that will introduce you to our members, who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Darlene Knox, human research protection program (HRPP) administrator/program analyst at the Tuscaloosa VA Medical Center.

When and why did you join the field?
In March of 1998 I joined the field because of my interest in research, and to become a part of something bigger.

What is your favorite part of your job?
My favorite part of my job is helping to ensure that human subjects continue to be protected by advising, informing, and instructing investigators and research team personnel about proper submission protocol that is required by federal regulations.

What are three websites you visit on a daily basis?
Three websites I visit daily are VHA R&D, Association for the Accreditation of Human Research Protection Programs (AAHRPP), and the VA Southeast Network – VISN 7 Home.

Why did you join PRIM&R?
I joined PRIM&R to increase my networking opportunities, get current information on research ethics and regulatory matters, and receive updates on PRIM&R activities.

What is your favorite member benefit?
My favorite member benefit is reduced fees for educational programs and the networking opportunities at PRIM&R conferences.

If you were planning our next conference, who would you select as a keynote speaker?
I would select any one of the many veteran subjects who have participated in a research study, so that their stories and experiences are the focus.

What advice do you have for young professionals interested in pursuing a career in research ethics?
If you are looking for a rewarding career that keeps you on the edge of your seat, then the field of ethical research is definitely the avenue to take.
Thank you for being part of the membership community and sharing your story, Darlene. Good luck with all your future endeavors.

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

More from CAREB -- Population Genomics: An Impressive Model

by Joan Rachlin, executive director

I’ve long admired a bioethicist from McGill named Bartha Maria Knoppers, PhD.

At the last week’s CAREB conference in Montreal, Dr. Knoppers spoke about a population genomics research project on which she and collaborators have been working. Genomics is the study of genomes, and the aim of Dr. Knoppers’ work is to build a longitudinal infrastructure (i.e., a database and a biobank) for future research. Population genomics research is increasingly being submitted to IRBs and/or to research ethics boards (the name by which IRBs are known in Canada), so I wanted to share some of the highlights of her presentation.

The primary goals of the project Dr. Knoppers described are twofold: First, to create a platform that is neither disease-specific nor clinical or interventionist; and secondly, to foster the adoption of an ethos that recognizes and encourages solidarity and common good with no immediate personal benefits for contributing citizens.

The Canadian Public Population Project in Genomics (P3G) will enable data sharing in the future among the 40+ countries that are currently involved. In late April, there was “proof of concept” when the P3G members put together 220 comparable variables and created a resultant data set of 6,000,000 people from around the world.

Dr. Knoppers argued that a different type of ethics review is needed for this kind of science, and that transparency in the process, including in the drafting of the consent documents, is key. In P3G, broad consent is obtained, but recontact is provided (e.g. “ If you participate, you agree to the use of your samples over time and you also agree to be recontacted.”) In this model, the provision for recontact is thought to balance the risk of the initially broad consent.

It is important to note that there is no return of research results/incidental findings to those who participate in P3G. In fact, Dr. Knoppers indicated that she finds the term “return of research results” a misnomer, in that if it’s research, that per se means you’re still looking for results, and there will thus not be any individual results. Among the distinct characteristics of P3G are:

  1. It permits unspecified future research.
  2. There are many sites, and the project collaborates with other countries.
  3. Participants agree that their samples can be used after their death (unless they specify otherwise in their wills, etc.).
  4. Researchers must return their enriched results to the database so that the next generation of researchers will benefit from the data; this is part of the access agreement.
  5. There are several communication strategies. Participants can visit the P3G website and see what research is being done. Researchers are required to prepare and post a summary of the research in which they’re involved in lay terms so that participants can see what’s going on. Thus, there is a lot of reciprocity even though there is no direct benefit.

Dr. Knoppers provided plenty of food for thought about the ethical underpinnings of, and distinct ethical issues in, this type of research. She encapsulated one of the key ethical issues in research by posing the question, “What happens to individual privacy/autonomy concerns when the main emphasis is on security and governance?” and she suggests that is the crux of the decision prospective participants must consider before they consent to contribute to a this type of database. Finally, she talked about the safe harbor and the matter of equivalent protections.

Rather than going through her entire talk, please view her slides so that you can have a look for yourselves. Dr. Knoppers is a “shero” of the bioethics field and a global good citizen. It was a privilege to hear her speak. Thank you, Dr. Knoppers for sharing your ideas and time with CAREB and for sharing your slides with PRIM&R!

Saturday, May 1, 2010

2010 PRIM&R Member Appreciation Month

by Joanna Cardinal, membership coordinator

Welcome to May, and to PRIM&R’s inaugural Member Appreciation Month. This month is all about YOU, PRIM&R members! We want you to know how much we value your support of PRIM&R, your volunteer work, and your feedback on all that PRIM&R does.

Just what does "appreciation" mean, you ask? Well:
  • All month long, PRIM&R members will receive an additional 10% discount on proceedings, publications, and registrations for webinars scheduled for June and July.

  • The member registration rate for PRIM&R's Wednesday, May 26 webinar, Speaking Confidence: A PRIM&R Toolbox, will be discounted by an additional 50%.

  • Every weekday in May, we will be featuring member interviews with randomly selected PRIM&R members right here on Ampersand.

  • PRIM&R members attending our May Regional Program in Chicago will receive a special member gift at registration.
How do you take advantage of these tokens of our appreciation? If you are a member, you're already signed up! Stay tuned to our blog and our website for more information.

If you're not a member of PRIM&R yet, maybe this is the incentive you've been waiting for: join today!

Thank you, PRIM&R members. Your work and PRIM&R membership make us proud!
 
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