'Science Times' synthesis

As 2011 approaches, we wish you a year of health and safety! We also want to take this opportunity to thank you for being part of the enterprise that advances science and health. The PRIM&R staff is privileged to support you in that important work, and, toward that end, we are pleased to once again bring you our biweekly ‘Science Times’ synthesis from the New York Times. Have a terrific year!

December 21, 2010

Bones give peek into the lives of Neanderthals: More than 1,800 bone fragments in Spain, and snippets of DNA from the bones, are allowing scientists to see into Neanderthal lifestyles.

In map of brain junction, avenues to answers: A map of brain synapses may help us understand the basis for many diseases.

Five years in, gauging impact of Gates grants: It has been five years since the Gates Foundation began making grants for research on AIDS and malaria, and the Foundation is now deciding which projects will continue to receive that funding.

A doctor’s mammogram mission turns personal: A doctor specializing in breast cancer faces questions as she deals with her own diagnosis.

December 28, 2010

Enlisting the dying for clues to save others: Researchers are examining a new breed of cancer drugs that may help stem tumor growth.

In pursuit of a mind map, slice by slice: With an unusual and unique “contraption,” Harvard researchers are exploring how the mind works.

Managing scientific inquiry in a laboratory the size of the web: Does the act of data gathering on the internet constitute ‘science’?

A writer traces illnesses back to the womb: An author explores the possibility that one can trace serious illnesses back to the time before birth.

Introducing Elisa Hurley, education director

by Elisa Hurley, education director

Greetings! My name is Elisa Hurley, and I am delighted to be joining the PRIM&R family as its new education director. For the past 11 years, I have been teaching and writing philosophical ethics and bioethics. So, when PRIM&R asked me to attend the 2010 Advancing Ethical Research Conference in San Diego prior to starting my new job, I was thrilled. I couldn’t have asked for a better orientation to PRIM&R, or a more fitting introduction to my new role helping PRIM&R continue to strengthen its current educational programs, and develop exciting and innovative new ones. One of the most intriguing and important themes that emerged during the conference was the complicated relationship between regulations and ethics, and how to understand and navigate that relationship.

The relationship between the regulations that govern human subjects research, and the ethical considerations that bear on that research, is complicated. Two of these complexities include:

• Instances when the regulations are silent on an issue that clearly requires oversight committee action; and
• Instances when the regulations appear to actually conflict with an ethical consideration.

Regarding the first, consider the issue of returning research results, the topic of an AER workshop called More on Biospecimen Research: If, When, and How to Return Research Results. As research on biological specimens and genome wide association studies (GWAs) becomes more prevalent, there is a looming question of what to do with results that may have clinical implications for a particular group or individual. Yet, federal regulations are all but silent on this question. It seems that those trying to answer the question find themselves turning to ethics, specifically, looking to the principles that stand at the foundation of the federal regulations—respect for persons, beneficence, and justice.

That is not to say that, once we turn to ethics, the answers come easily. Consider this question asked at the end of the session: Should a participant be allowed to "opt out" of receiving research results that they do not want, when those results are "clinically actionable"? And, does the fact that it is a researcher and not the participant’s personal physician who has the information matter? Some attendees argued that in the culture of genetics research, if an individual makes an informed decision not to be notified of clinically actionable or meaningful findings (such as the presence of BRCA1 mutation) then that decision is respected. Autonomy trumps beneficence. But others in the room disagreed, and thought that providing clinically actionable information to a research participant, even one who may not want to hear it, should be the standard—that is, beneficence trumps autonomy.

A second, more troubling dimension of the complicated relationship between ethics and regulations was illustrated by the panel Research on Pregnancy: A Necessary Risk? (see Wendy Tate’s blog post, 45 CFR 46 Subpart B regulations need updating). During the panel, we discussed the federal regulation 45 CFR 46 Subpart B, which provides protections for pregnant women and fetuses involved in research. The complication comes in when we ask: what if this regulation excludes pregnant women from research that may be of benefit to both them and their fetuses? In other words, here is a case where the regulations, though well-intended, seem to come into stark conflict with ethical considerations of beneficence and justice.

Should we be worried that the regulations don’t always “cover the ethical bases” adequately, or even sometimes clash with them? After attending AER, I believe we might not need to worry too much about this issue, because so many of those who work on the ground in the research protections field view substantive ethical review as part of their everyday work. In fact, I wonder if making more of this fact might help mitigate some of the misconceptions out there about the purpose of, and place for, research oversight. What do you think?

Staying in the know about education research

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad about the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad wrote every day from the conference, and will continue to blog about how AER is affecting their lives.

While attending the 2010 Advancing Ethical Research Conference last week, I went to various sessions on education research. I was hoping to be able to better understand education research and have the opportunity to share some information with my colleagues when I returned home.

I am happy to report that I was able to bring not some, but a whole lot of information back to Minnesota! Not only did I get new ideas out of these sessions, but also validation that our institutional review board (IRB) is not alone in some of the common issues it faces in education research. Here are some session highlights; I challenge you to think about them as well:

Issues with research data

• Is the data collected valid?
• If data is invalid, how will research findings impose risk on educational outcomes?
• Can the data really be deidentified?
• Should we implement a data safety management board in education research studies that are studying student behavior through records?

Questions on policies and regulations

• How does the Protection of Pupil Rights Act (PPRA) overrule the Common Rule (45 CFR 46) in education research? What does this mean for IRBs and researchers?
• If a school district does not have a policy about parent notifications or permissions for research, what should you do?
• How do IRBs and researchers balance and stay in the know about the differences in local, state, and federal guidelines?
• How will potential changes to FERPA affect IRBs and researchers?
• What Department of Education-funded education research cannot be exempt under the Common Rule, even though the Common Rule says it can be?

Issues with permissions to conduct research

• Who decides what research is allowed within the school?
• Who is right when it comes to parental permission requirements?

Uncertainty surrounding consent and assent to participate

• Who should assent potential human subjects?
• Should we allow passive consent? (Yes, this is taboo for IRBs, but it’s language is used in education research.)
• Who can assent or consent to research?
• What does it really mean when we say subjects can opt-out?

There are even more areas for discussion, and I strongly encourage my fellow conference attendees, researchers, and human protections staff to take a look at the resources and handouts that are available in the AER Online Conference Portal.

Here are a few of the many research studies, journal articles, and tools that I found especially helpful; if you have additional resources that you love, please share them here!

Session resources to look at in the AER Online Conference Portal:

A15: The Assent Process and Assessing Children’s Competence to Understand a Proposed Research Project

D21: Challenges of Research with Adolescent Populations

D26: School-Based Research and the Common Rule: The How-Tos

E25: Beyond the Basics in Education Research: Difficult Issues from Pre-School to Grad School

45 CFR 46 Subpart B regulations need updating

By: Wendy R. Tate, PSM, CIP, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad has blogged every day from the conference, and these are the final onsite posts. Continue to check back for more updates from the Blog Squad.

For me, Subpart B of the Heath and Human Services (HHS) regulations always raises more questions than it answers. It’s not that I don’t understand this portion of HHS regulations. I have read them several times and feel that I understand them quite well. My questions are brought up because I feel they are no longer applicable to today’s society.

Question 1: Why must the consent of the father be obtained?

Subpart D regulations allow a waiver of one parental signature if there is a prospect of direct benefit to the child. Subpart B requires the consent of the father if there is potentially direct benefit only to the fetus. Why the discrepancy? Consent of both the mother and father should not be necessary if there is prospect of direct benefit. A waiver, similar to the one described in Subpart D, should be included into regulations affecting pregnant women.

Question 2: Why require that “the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means?”

This one sentence in the regulations makes almost all social behavioral research with pregnant women impossible to conduct. The majority of social behavioral research is minimal risk, especially when it comes to interactions that only involve surveys. The inclusion of pregnant women is highly unlikely to affect the pregnant woman or the fetus. There is no justifiable reason to exclude pregnant women from this work, or make the researchers jump through unnecessary hoops to get IRB approval.

Question 3: Why are pregnant women excluded from almost all clinical trials?

This was the topic of a panel on Wednesday titled, Research on Pregnancy: A Necessary Risk? In 1993, the FDA recognized the need for more information on how drugs work in the pregnant body and affect an unborn fetus, so they lifted the ban on the inclusion of women in clinical research. In 1997, the FDA deemed the inclusion of pregnant women in clinical trials as appropriate. The current problem is that most sponsors, researchers, and IRBs do not feel that the inclusion is appropriate. Because of this, we are left with a gaping hole in knowledge on what drugs are effective and safe in pregnant women.

Like any population, the use of pregnant women in research must be justified. This is the Belmont principle of justice. Pregnant women should be enrolled in clinical trials when there is the potential for direct benefit for serious medical conditions.

The FDA (which has not formally adopted Subpart B) has made a bold and necessary move to state that pregnant women should be included in research. Valuable research that does not contribute to important biomedical knowledge (i.e. social behavioral research and some public health research) should not be required to exclude pregnant women because of an outdated regulation. The majority of pregnant women are perfectly able to make informed decisions, and do so for their normal medical care. The current Subpart B needs extensive revision. Experts in the field of obstetrics, maternal health, public health, and pregnancy must be consulted and contribute to the process in order to ensure an applicable, robust set of regulations.

The loneliness of the human subjects protections professional

by Sylvia Baedorf Kassis, MPH, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad has blogged every day from the conference, and these are the final onsite posts. Continue to check back for more updates from the Blog Squad.

If you’ve been in the field of human subjects protections for longer than four days, you have no doubt tried to explain what you do for a living to someone unfamiliar with the topic area, and seen them lose focus on what you are telling them. Similarly, you have no doubt felt like a hurdle to researchers who are frustrated with the whole regulatory system, of which you are but one tiny part.

The field of human subjects protections can be a lonely place.

And while you may feel that you are leaving San Diego with a long to-do list and more questions than when you arrived, please don’t despair. You are a member of a group who is vitally important to the advancement of ethical research and scientific discovery.

I’ve attended the AER Conference four times now, and every year I feel more and more validated and vindicated in my commitment to the field. After hearing such wonderful keynotes, and attending so many thought-provoking sessions, what really strikes me is that everyone I’ve encountered over the past four days is so devoted to advancing ethical research. How inspiring to hear that PRIM&R’s executive director Joan Rachlin has been with the organization for 35 years. How amazing to learn that Rebecca Skloot pursued the Henrietta Lacks story for 10 years of her life. How thrilling to hear of Mozes Kor’s journey to forgiveness of the Nazi doctors.

But how can we stay inspired and invigorated when we get back to the daily grind? How can we wade through the backlogged emails, unanswered voicemails, and meetings, already scheduled and soon to be booked?

Here are three tips to help you cope with the post-AER Conference blues:

1. Make sure to keep in touch with the people you met and connected with at the conference. You never know when you might need their expertise and/or support.
2. As soon as possible, review the program and download the materials from all the sessions you attended and loved, as well as the sessions you wish you could have attended. You might want to refer to that information, and it’ll be helpful to have it all organized in one place.
3. Regularly check out the PRIM&R website, including this blog, to stay connected and up-to-date.

I hope this makes you feel just a little bit better. See you next year!

Looking to the past for lessons learned

by Andy Burman, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad has blogged every day from the conference, and these are the final onsite posts. Continue to check back for more updates from the Blog Squad.

As I wrapped up my first PRIM&R AER Conference yesterday, I thought about the primary lessons learned, and considered what events in particular will have the most affect on me personally and in my role of protecting human subjects. There have been many “A-ha” moments, several humorous instances, and even a dash of disagreement and frustration. However, none of these single moments will stick with me with the veracity of the experience of hearing the keynote addresses of Rebecca Skloot and Eva Mozes Kor.

Some of people outside the research world may recognize the name Rebecca Skloot from her appearance on Oprah. Her book, The Immortal Life of Henrietta Lacks, hit bookstores earlier this year and has been rising in popularity both inside and outside of the research community. The nonfiction story of Henrietta Lacks, a young uneducated woman who developed cervical cancer in her early thirties and died quickly after her diagnoses, exposes many of the injustices that were committed against Lacks and her family after a tissue sample of her cervical cancer was taken, and reproduced exponentially for decades. Now known as the HeLa cell line, this all took place without her or her family’s knowledge.

Ms. Skloot, who is a young woman in her thirties , intrigued me very much during her presentation. She strikes me as the Erin Brockovich of my generation: a young woman working against the odds for many years to uncover an injustice tell the story of someone else. She read moving passages from the book, stark reminders of the world of Jim Crow and the research conducted at that time. I haven’t yet read The Immortal Life of Henrietta Lacks, but it has risen to the top of my reading list for when I return home.

The other most powerful conference experience was listening to the remarks of Eva Mozes Kor. Her speech was appropriate for everyone regardless of their involvement, or lack thereof, in research. Ms. Mozes Kor was a preteen when she and her twin sister, along with the rest of their family was rounded up by the Nazis and sent to Auschwitz. Because they were twins, she and her sister were separated from the rest of the family, none of whom they would ever see again.

The twins were enrolled as subjects of Nazi research. Both of the twins nearly died as result of injections given to them by the Nazis, but they were able to survive until Auschwitz was liberated. Decades later, Ms. Mozes Kor went on to donate an organ to her sister, and to do another amazing and important thing: forgive the Nazi physician, Dr. Mengele, who was the investigator in the project from which she nearly died.

After the address, an attendee asked Ms. Mozes Kor if she had ever been nominated for the Nobel Peace Prize. There was general laughter in the room, but in reality, could there be a candidate more fundamentally qualified for the honor? How many Holocaust research subjects that go on to be an organ donor and forgive the people who harmed them to the point of near-death do you know? It can’t get more selfless than that.

These two moving presentations will stick with me forever. There are so many lessons to be learned from each of these stories that one cannot possibly summarize it concisely, but I’ll try anyway.

Work for justice. Offer forgiveness.

There is no reason to walk alone

By: Wendy R. Tate, PSM, CIP, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

In my introductory blog, I expressed that one of the reasons I love coming to PRIM&R events is the opportunity to network. This year is no different. The people at AER are friendly, intelligent, funny, and willing to discuss and partner with you. I take every opportunity at the conference to meet people from all areas of human subjects protections. Because of this, I meet a lot of really neat people. Here is a taste of the people I have had the privilege to meet in the past three days: IRB chairs, IRB members, clergy, attorneys, PRIM&R members, CIP-certified folks, IRB administrators, OHRP representatives, institutional officials, community members, non-scientists, new IRB staff, first-time attendees, PRIM&R board members, vendors, and AAHRPP representatives. Everyone has something to offer. Even better, only a few have been mildly scared that I might blog about them.

PRIM&R offers excellent opportunities to network. For those 30 years of age or younger, there was the young professionals reception on Monday night. Other after-hours events included the pre-conference reception and the Speed Mentoring event. For PRIM&R members, there was a reception last night. There are also opportunities to network while walking the vendor exhibits and poster sessions, and eating with new people at breakfast or lunch. There have even been special dining sessions for further networking, such as the first-time attendee breakfast, the CIP® breakfast, and the CITI lunch.

And for all you interested in some numbers: This year’s conference has 300 more attendees than last year, and they are from all 50 states and 30 countries. Additionally, David Borasky, chair of the PRIM&R Membership Committee, reported that PRIM&R now has 3,200 members.
Beyond the opportunities to network, sessions stressed the need for creating and maintaining ongoing networks. Starting with my pre-conference program, a culture of networking became an ever-present component of an effective program. No one wants or needs to re-invent the wheel. This was not only discussed, but practiced at the Effective Practices for Reducing Administrative Burden in Human Subject Research workshop. The Federal Demonstration Partnership is setting the bar for collaborative effort in streamlining human protections with a 120-university partnership. Better ideas come from building on other’s work and putting ideas together, rather than trying to come up with a solution alone. After the session, several attendees met with the panelists and exchanged contact information.

The need for networking again was a theme in both the keynote talk by author Rebecca Skloot, and in the panel Making Sense of Community: Responses to Tissue Research. Ms. Skloot and the panelists, Ms. Carletta Tilousi of the Havasupai tribe and Ms. Chris Hempel, all discussed the need for researchers and IRBs to network with the communities in which they are performing research. These true stories gave concrete evidence that networking is a required element in an effective research program that is ethical and protects human subjects. Their experiences are living proof that networking goes beyond one-on-one interactions. Networking includes groups of people from communities, universities, governments and regulatory agencies.

However, don’t just count on PRIM&R and the AER Conference to network for you. Go out, meet people, and collect business cards. Networking does not and should not end when we jump on the airplane home. When you get home, open conversations with other institutions, applicable government agencies, and your local community groups. Together, we will build a global network for protecting human subjects that is stronger than any one link.

Increasing awareness with "Henrietta Lacks"

By Courtney Jarboe, PRIM&R Blog Squad


PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

I'll admit that I have not read Rebecca Skloot's The Immortal Life of Henrietta Lacks.

Yes, I was one of those people at her keynote address quietly raising my hand when that question was posed. However, after her presentation yesterday, I didn't feel ashamed, but curious about the story that opened such massive dialogue within the general public.

As a result, I found myself in line like many other AER attendees, credit card in hand, waiting anxiously to receive a copy. After purchasing the book, I proceeded to stand in line for Ms. Skloot's signature. I've never experienced a book signing, or even met an author in person before. I found though, in this situation, many attendees were impressed by Ms. Skloot's approachability, and her down-to-earth attitude. In addition, her goals and values for the responsible conduct of research were aligned with those shared in many of the sessions that have been held in the past two days.

One point that Ms. Skloot made in her keynote address was that not everyone has basic scientific understanding. We can tell people what a cell is or how it is used, but that doesn't necessarily mean that it is something understandable. More importantly, people outside of science-related fields may not care about some aspects of the science. Ms. Skloot reminds us that the perception of research has been greatly challenged in the past few years, to the point where people are questioning the intentions of researchers and the purpose of research, so it is important to create awareness.

While I was at AER, an article was published in the StarTribune, my local Minneapolis, MN, newspaper. The article indicates that a group of professors from the University of Minnesota Bioethics department sent a letter to the University of Minnesota Board of Regents requesting an investigation into a research study where a participant, Dan Markingson, a schizophrenic, committed suicide.

As the StarTribune article states, the FDA found no fault by the university, and excused both the school and the psychiatry chairman from the lawsuit. While the FDA may have made a determination, bioethicists are still concerned about whether the research team had the ethical capability to enroll and consent Mr. Markingson.

The article also states that this letter included questions about “whether financial incentives from AstraZeneca, the drugmaker funding the study, presented conflicts for the researchers.” While I have my own thoughts about this research study and its issues, the bigger issue is public perception and the future of research participation.

Putting the research study issues aside, we need to think about the general public's awareness of these stories, and how they will affect trust between potential subjects and research. Issues in research ethics shape the public's opinion of research, even if the public does not have a full understanding of facts, or what happens behind the scenes.

If you have a moment, take a look at the StarTribune comments posted by the public. They are all over the spectrum. While some comments need to be taken with a grain of salt, there are others that call out mistrust between the public and research.

So what do we do when the public is questioning intentions of researchers and research? How can we, as a research body, work with journalists, movie directors, or authors to provide examples of how research as a whole has learned from mistakes and has proven worthy of their trust? I wonder if there are better ways for us to work with these professionals to tell stories that not only bring forth the issues, but also provide a more encompassing message. I believe Ms. Skloot did an amazing job of providing this message in both her keynote address, and her bestselling The Immortal Life of Henrietta Lacks.

Got GCP?

By Sylvia Baedorf Kassis, MPH, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

At many institutions, the only required training for anyone conducting research with human subjects is the NIH human subjects protections training. Some professionals may also be required to take an additional training on the responsible conduct of research.

When I hear this, I cringe.

Why aren’t we routinely training investigators on the proper conduct of research? It seems the assumption is that researchers learn how to conduct research in their training, but the reality of audit findings, FDA warning letters, and OHRP determination letters suggest otherwise. Being able to design a scientifically valid study is very different from overseeing the day-to-day conduct of that study. It seems obvious to me that there is not enough training on what it truly means to be a principal investigator (PI), and be responsible for the conduct and oversight of a human research study.

As part of my role as regulatory education manager in Boston University Medical Center’s Clinical Research Resources Office, I co-facilitate an optional training for PIs. This training is particularly aimed at PIs of investigator-initiated studies that do not have a sponsor providing materials and guidance to them.

Using the International Conference on Harmonization Good Clinical Practice (ICH GCP) guidance as a blueprint, we cover key topics such as documentation, informed consent, monitoring and reporting, and self-assessment. Invariably, at the end of each session, I hear from PIs who have “seen the light” and are convinced this session should be mandatory for every PI.

ICH GCP helps to ensure that its two main goals are met: to protect participants enrolled in research, and to ensure the accuracy and credibility of the data and reported results. These are of paramount importance in any clinical research study. Further, certain funders and sponsors (including some centers and institutes within the NIH) have begun emphasizing GCP and even requiring GCP-specific training for all research study staff on clinical trials.

Even if you don’t have the resources to start a formal GCP training at your institution, you can still begin the process of encouraging PIs to adopt ICH GCP. In fact, before I sign off, let me leave you with a tool that has been extremely useful in our investigator trainings.

Since the validity of research data rests in the documentation, the CRRO has developed Regulatory Binder Tabs which are an excellent starting point in facilitating adherence to GCP principles. If such materials have not been provided by the study sponsor, these tabs can be modified to enhance the organization of study documents, and can help create checks and balances to ensure the investigator and study team members are conducting the research per protocol.

For example, one tenet of the program relates to the education of staff and delegation of study-related tasks. Tools such as task delegation/signature logs allow investigators to document their oversight and ensure that that only sufficiently qualified study staff are assigned to perform certain study-related tasks. Training logs and license/certification logs, accompanied by regularly updated CVs and certifications of study personnel, can be kept as further documentation of the qualifications of study team members. Using these tools are cost-effective and important ways to improve your institution’s GCP.

Meaning between the lines

By Andy Burman, PRIM&R Blog Squad


PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

At home when people ask me what about my job title and I reply, "research program coordinator", it is not uncommon for people’s eyes to glaze over. That’s when things get awkward, because the subsequent question becomes, "What does that mean?"

Despite my three years looking at consents with my institution’s IRB, I haven’t been able to develop "clear, concise language" explaining this side effects of my job. Is there language that I could use that most people would easily understand?

It is my job to support a committee of people whose focus is to balance the need to conduct research with the needs of protecting human research participants.

Oh, crud. That has a Flesch Kincaid Grade level score of 13.03. Not below an eighth grade reading level, still too complex. I better try again.

My job is to assist a group of people. These people balance the need to conduct research with the needs of protecting those enrolled in the research.

That’s better, a score of 5.41.

The things we, humans, choose to care about.

An overarching theme of the AER Conference this year has been informed consent.

"Most informed consent reading levels are too high."

"They are too long and legal."

"God save the trees!!"

It seems to me that we are all looking for a magic bullet when it comes to the consent of research subjects. We aren’t happy with the way things are, therefore there must be a better, all-encompassing solution that will work for everyone in all circumstances. But simply to say that informed consent forms are the problem, and to say that verbal consent would more fully inform subjects, is to ignore a huge source of the problem:

Us.

We are human and we don’t all think, act, or behave in the same way. We are different by nature. It is these differences that make the process of informed consent difficult. After all, being "informed" to one person, may not equate to "informed" to the next. Being informed is subjective.

Can we do better consenting? I believe we can. However, as long subjectivity and humans are involved, then we can never expect to reach an all-inclusive solution or perfection of the informed consent process. It just isn’t a reasonable expectation.

Why yes, there are problems with the federal regulations!

by Wendy Tate, PSM, CIP, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

After the release of the PHS Inoculation Study in Guatemala, President Obama issued a press release asking for a nine-month review of human subject regulations. Personally, I welcome a review of regulations. The United States Department of Health and Human Services (HHS) regulations regarding human subjects are now 30 years old. The regulations do not adequately address some current issues, such as cultural/community involvement and consent, low literacy/non-literate subjects, collaborative research, international research, and the definition of a vulnerable population (decisionally impaired, students, employees, patients, etc.).

Yesterday’s general sessions shared a common theme of how to approach reassessing regulations, starting with the keynote address from Dr. Francis Collins, director of the NIH.. Dr. Collins spoke of the need to consider ethics as we proceed into an ever-changing, technologically advanced era. Thirty years ago, having the ability to map all six billion base pairs of human DNA was a dream. Today, not only has it been done, but the cost to do so is exponentially dropping. The NIH is interested in making genomic data available to researchers to do large-scale epidemiologic studies and find causes for disease. They support the transition of information from basic research to bedside, locally and worldwide. This mission alone shows where the current federal regulations are severely lacking.

The Great Debate topic was whether we should keep or abolish informed consent forms. While debating, both sides agreed on one fact: Consent forms are not sufficient. The federal regulations describe the elements that must be in consent forms. Institutions work hard to ensure that we include all of the elements, resulting in 15-, 20-, or even 30-page consent forms that are written in language that is not only at a level higher than subject comprehension, but actually contains no information. How many of you have contemplated the value of saying that a subject may experience benefit, experience no change, or become worse? Has the federal requirement of a written, signed document overtaken the need for study staff to sit down with the potential subject and have a frank, engaging discussion on the study?

Immediately following the debate was a plenary talk given by Ezekiel Emanuel, MD, PhD. Dr. Emanuel touched on many areas where current regulations could be changed, such asthe scope of human subjects regulation, repetitive IRB review, annual review (which is really a misnomer), inconsistent use of the exempt and expedite regulations, uncertainty about what research requires review, information risks, informed consent, inconsistent federal guidelines, and adverse event reporting.

Panel I closed the day’s theme of reassessing the regulations as several researchers who conduct campus-based research discussed innovative research studies involving students as subjects. The panel reminded us that college students are extremely vulnerable, but never considered in the regulations. The IRB side of things is also interesting in these studies. One presenter stated that it took 18 months to gain IRB approval, and it almost cost him his graduate degree. However, the IRB was likely discussing if the project was protecting these students, who were all vulnerable on several levels. The length of approval can impede pertinent, timely research that can help a community or society as a whole.

The audience at AER appears to be enthusiastic that Washington is finally hearing the outcries of the front lines and willing to open the discussion, no holds barred, on reassessing the regulations. I would challenge federal regulators to go a step further and push to consolidate human research regulations. Get all the players at the table. Don’t encourage, but require that OHRP, FDA, OCR, VA, and all other Common Rule agencies to make one set of common regulations. Otherwise, the focus will remain on meeting the regulations and not ensuring that subjects are protected through ethical research.

Hold on, because as Ivor Pritchard and Michele Russell-Einhorn reminded us yesterday morning with a serenade, "the rules, they are-a changin'."

Rethinking the process of informed consent

By Sylvia Baedorf Kassis, MPH, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

Are a good informed consent form and a good informed consent process really mutually exclusive?

Whether you attended yesterday’s Great Debate at the AER Conference, you are undoubtedly aware of the criticisms of informed consent forms used in research. You may have even complained yourself: The forms are too long; the forms have too much legal jargon; the grade level of language is too high; and on and on...

In an effort to address some of these issues, yesterday’s Great Debate was ambitiously titled, Be it Resolved that Consent Forms are an Obstacle to Informed Consent and Should be Abolished. Leonard Glantz, JD, and Jerry Menikoff, MD, JD, took on the topic with gusto and, respectively, debated the pros and cons.

In his arguments supporting abolishment, Mr. Glantz stated that consent forms have nothing to do with ethics or protecting human subjects. Rather, the forms are devised to protect the researchers (and their institutions), and detract from what should be the real focus: the consent process. Mr. Glantz’s argument culminated in the point that consent should involve a discussion that is audio taped, so that meaningful documentation of the process would exist (as opposed to a “meaningless” signature).

In contrast, Dr. Menikoff argued that consent forms are necessary to provide a cheap and efficient method for researchers to cover the key information that subjects should know. The forms should be clear and brief. He closed by stating the consent process is irrelevant if the message isn’t clear.

After listening to rebuttals and audience comments, it seemed to me that the debaters’ arguments had more in common than not. Although the philosophical issue was abolishing the consent form in its entirety, both Mr. Glantz and Dr. Menikoff discussed the need for a meaningful discussion between the person obtaining consent and the potential participant. And really, regardless of whether there is a consent form, both seemed to agree that the entire process of informed consent is what needs to be refined and improved.

I would be surprised if consent forms are abolished any time soon, so I leave you to consider several suggestions of ways to improve the consent process

• Don’t assume that researchers or their staff members are educated in engaging in an appropriate informed consent process. Offer consent training to all members of the research team.
• Administer an assessment of understanding or “teach-back” method to all potential participants before they agree to participate.
• Utilize impartial parties, such as nurses or health educators, to engage in the informed consent process with potential research participants.
• Limit the length of consent forms.
• Permit researchers to decide the key 5-10 points that they want potential participants to know about the research studies, accompanied by a standard research fact sheet that lists the regulatory elements.

Limited resources, unlimited education

by Andy Burman, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

Yesterday afternoon, I attended a session called Developing an Education Program with Limited Resources. This session was hosted by Scott Lipkin, DPM, CIP, associate vice president of research, Lehigh Valley Health Network, and Brenda Ruotolo, CIP, CIM, associate director, Columbia University IRB.

In our current economic environment, it can be difficult for an institution to invest financial resources into an education program. However, it is important to remember that the cost of being noncompliant due to lack of education can be much more expensive to your institution’s financial bottom line, and do significant damage to its brand.

With that being said, there is good news. There are inexpensive ways to educate researchers, institutional officials, IRB members, and IRB support staff. Some of the ideas that the faculty suggested were:

1. Consider forming a consortium with other IRBs in your area so that you can share costs and personnel resources when creating and/or viewing training.
2. Hold monthly workshops for clinical research coordinators to discuss an important topic.
3. Offer regular office hours so researchers can approach you with questions in person.
4. Have a discussion series using an applicable book or movie.
5. Consider making research a formal credential that physicians must earn and maintain at your institution. This way, principal investigators will have to be more involved with your education programs.
6. At your regular IRB meetings, take five minutes to educate IRB members on a given topic. If IRB members can even choose the topics and facilitate the trainings themselves.
7. Host “brown bag” sessions for the research community.
8. No matter what training you offer, consider having food available. If food is available, folks are more likely to come.

The biggest takeaway of the session was, when it comes to training, the only way to do it wrong is not to do it. So go for it. Get educating!

Shaking up the system: Is it what we really want?

by Courtney Jarboe, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

Where should we go? More importantly: How do we get there?

The following recounts my initial reaction to Ezekiel Emanuel, MD, PhD’s plenary session this morning at AER.

As we all know, research regulations can feel a bit outdated, or it can seem as if they are applied differently throughout the world. As our awareness of ethical research increases, we need to rethink what regulations say. We need to, to rethink how they are applied, and to think about “what we can do vs. what we should do,” as stated by Montana Miller, PhD, another speaker at AER.

Dr. Emanuel spoke on these vast issues of research regulations, and ignitinged many different reactions in the PRIM&R audience. While some attendees may have been frustrated, I found the atmosphere of the session to be thrilling.

One idea in particular that I found exciting and a bit nervewracking is the conceptthought of changing IRB requirements for informed consent,, which was the subject of another Monday morning session. The Great Debate plenary focused on whether informed consent forms should be abolished. I spoke with one of my fellow bloggers, Sylvia, and we both agree that there were some interesting points in this debate. It’s true that there are inconsistencies in regulations and reviews, but the issue at hand is institutional buy-in regarding ethics and the IRB.

The amount of work that would be imposed on our office would be difficult to manage, but if it would make subjects more informed, then I’m all for it. I think we as a community support IRBs and researchers. I would be happy to move ethics in the right direction, but if you do not have the resources to make these changes happen, how do we get there?

The bottom line is that we need a change. The first thing that we can improve is our approach to change, and the support we need to make actual changes. We know that there are problems regarding staffing, so how can we become more creative in how we handle these changes andor pursue issues that need to change?

I think of it as creative project management. We have great ideas on how to change, but we too, like many other programs, struggle with prioritizing and managing these changes. I don’t have the solutionss to this either, but would encourage those who have received institutional support and buy-in to comment and share what has worked forrom them. Or, if you have ways to successfully manage initiatives, it’d be great to hear from you as well.

Navigating the AER Conference: Internet Research Sessions

by Courtney Jarboe, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

If you are attending this year’s AER Conference, and missed the pre-conference session Navigating Research Regulations and Research Ethics in the Internet Age, I strongly encourage you to attend one of the several sessions during the regular conference that cover internet research issues.　

Many of the presenters from today’s session will be facilitating similar sessions in a condensed format. If you are interested in conducting internet research, or you are an IRB member reviewing internet-based research protocols, these sessions have a lot to offer on key issues such as informed consent, privacy and confidentiality, data ownership, and data management.　

I would like to highlight the presentation made by Montana Miller, PhD, an assistant professor at Bowling Green State University. Her presentation included the complexities of Facebook surrounding privacy and consent issues, as well as Webkinz regarding validity of research data.

The major point I took from Dr. Miller’s presentation was, "it’s not what you can do, but what you should do." While data may be publicly available, IRBs and researchers cannot make assumptions about any given online environment. Dr. Miller argues, "researchers must evaluate the context, weigh the factors, and come to an ethical stance in each particular case. Ideally, they should discuss and share ethical norms with others in their field and in the field of internet research ethics in general. They must consider (and be prepared to explain to IRB reviewers) the subjects’ experience and expectations."

While there are not regulations or guidance specific to internet activities, Elizabeth Buchanan, PhD, associate professor at UW-Milwaukee, introduced an impressive project, Internet Research Ethics Digital Library, Research Center, and Commons. The mission of this project is to "push the boundaries of traditional research ethics issues, allowing transformative models for managing internet research. It exists to provide sound resources, a solidified research base, and expert advice as more researchers and more IRBs/ethics boards struggle with the complexities of Internet research ethics."

While there were no absolute solutions to some of the issues that were raised, I think this pre-conference program gave me many resources and examples to share with my fellow IRB colleagues. In addition, the course emphasized that there isn’t a right or wrong answer to internet research issues. Instead, it’s about having the discussion and really considering ethics in relation to the population and the method of research.

And for those of you who are onsite at AER, here are some upcoming Internet Research sessions at the conference:

Tuesday December 7
C25: Shifting Ground in the Qualitative Research Fields: Ethnography, Oral Histories, Internet Communities, and More

Wednesday December 8
E10: Facebook, Twitter, and YouTube: Wrangling with New Ethical Ropes, as Internet Research Gallops Forward

The vocabulary of research

By Sylvia Baedorf Kassis, MPH, PRIM&R Blog Squad

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

On my flight from Boston to San Diego for the 2010 AER Conference, I listened to a podcast of the National Public Radio program Being, hosted by Krista Tippett. In October 2009, Tippett interviewed researcher Doris Taylor about her embryonic stem cell research in which she brought the heart of a dead animal back to life. While such an accomplishment could have tremendous implications for the field of human organ transplantation, it also raises questions about the ethics of such research.

Taylor argued that developing a more thoughtful vocabulary related to stem cell research could have minimized the surrounding controversy. In her opinion, embryonic stem cell research has erroneously been linked to abortion. She explained that the fertilized eggs from which the stem cells are derived will never be implanted for in vitro fertilization, and are eventually discarded anyway. The misinterpretation of the definition of embryonic stem cell research, it seems, may be preventing the field from advancing.

Whether you agree with Taylor or not, her plea struck me because so much of what we do in our field is dependent on the existence of definitions. I can’t think of ever having a serious discussion about research that didn’t result in referring to a regulation or a guidance for a specific definition.
But what happens when we don’t all agree?

A fellow conference attendee mentioned how amazing it is that people can assign such different meaning to a given definition. Her comment got me thinking about how vital definitions are to the entire research enterprise.

I can’t count how many times I have found myself in lively discussions about whether a proposal even meets the definition of research. I’ve questioned whether the de-identified specimens in a proposed repository are coded or anonymous. I’ve wondered if a study meets the definition of minimal risk and would be impracticable without a waiver of informed consent. These issues, and issues from your own experience, are all related to the interpretation of definitions.

At face value, different interpretations of a definition can be a fun brain teaser or a minor annoyance. The reality, though, is that such a debate can set off a cascade of delays that affect not only the research study in particular, but scientific advancement at large. By attending AER, I can’t help but think that, at the very least, we’re all in some way united in a four-day quest for a common understanding of the regulations and guidances we uphold every day. That seems like a giant step in the right direction.

“Hot Topics for Institutional Officials” boils over with valuable information

By: Wendy R. Tate, PSM, CIP, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

Institutional interests, conflicts of interest, cooperative agreements, promoting research, minimizing compliance liabilities, accreditation, international research, funding, subject rights, and the federal government. This list of items (plus many more) keeps an institutional official (IO) extremely busy. I am not the IO at my institution; however, part of my job is to provide information to research administration so that the best decisions can be made. And now you know the reason I am attending the Hot Topics for IO pre-conference session at the 2010 Advancing Ethical Research Conference.

I cannot put all of the information from a daylong session into one post , so I decided to capture some short statements of great advice and valuable updates that I took away. Though they were given to an audience of IOs, these “nuggets” are applicable to anyone working in human subjects protections.

• The National Institutes of Health (NIH) has said that in all the cases of high-profile disclosures of conflicts of interest, there has not been a single case of research misconduct.
• Remember that federal funding is granted to the institution, not the investigator. When an investigator fails to disclose required items, it is the institution that is penalized.
  Conflict of interest is about preserving objectivity.
• If your institution has “unchecked the box” on the federalwide assurance, then utilize flexibility in the regulations. The Federal Demonstration Partnership (FDP) is a consortium of agencies and institutions dedicated to reduce regulatory burden and is ready to partner with you.
• We tend to forget how much researchers gain from subject contributions (paraphrase, “Blood Journeys,” The New York Times)
• Opinion: To think that we can de-identify in our increasingly identifiable world is fiction.

There are a lot of guidances and regulations either finalized or proposed; here’s a snapshot of what we discussed:

• The FDA released new regulations regarding investigational drug safety reporting that will be effective on March 28, 2011. These regulations integrate FDA and International Conference on Harmonization reporting rules and guidance.
• The FDA has proposed a regulation on Scientific Misconduct Reporting.
• The FDA has proposed an updated Public Health Service (PHS) policy on conflict of interest.
• There is a proposed change to an OHRP rule, shifting regulatory responsibilities and liabilities to the institution providing IRB review and away from the grant recipient organization.
• The Secretary’s Advisory Committee on Human Research Protections (SACHRP) has given 20 frequently asked questions and answers to OHRP on biobanking. They have feedback from the Office of Civil Rights (OCR) regarding the HIPAA answer to each of the proposed scenarios.
• There is a proposed, and in-use, HIPAA-HITECH rule. Need I say more?

We also had the pleasure of some truthful humor from Ivor Pritchard, senior advisor to the director, OHRP (I have paraphrased some of his quotes):

• OHRP compliance people are dealing with upset people, education people are transmitting information to the regulated, and policy people just don’t get out much.
• Bureaucrats are not very brave. Government feels much better to know that the regulated are behind the rule making. Comment when you think that proposed rules are good.
• Based on an impromptu survey (not performed for research purposes), at least 25% of the room thinks they are a safer driver than they really are.

Finally, if I had to summarize the theme of the day, I would have to say it is harmonization; harmonization between the institution and regulatory committees, among collaborating entities, and among government agencies. In order to reduce regulatory burden, increase compliance with federal and accreditation standards, and have a top-notch research program, harmonization is necessary.

In fact, it will lead to fewer regulations (since we all agree on the same thing) and make all of our jobs easier in the end. Harmonization is not easy. To achieve meaningful harmonization that betters the research process, thoughtful input from people of different disciplines over a significant period of time is required.

Don’t be discouraged: thousands of professionals sharing this desire have gathered in San Diego for the next three days to do this very thing. These professionals will go home to other professionals and discuss these ideas. Collaborations that are formed in San Diego will expand into a global network. Meet, greet, and network. If you aren’t in San Diego, do it virtually. We will all make the process better if we choose to think about the whole research picture like the IO does.

IRB 101: Looking to the future and the past

By: Andy Burman, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

Today I had the pleasure of attending the pre-conference program Institutional Review Board (IRB) 101^sm – Biomedical Research. The course explored a number of topics, including several case studies that produced compelling, thought–provoking, and interesting conversation. However, the discussion of the history of research, while interesting, brought up some disconcerting questions.

“Only a fool learns from his own mistakes. The wise man learns from the mistakes of others.”
– Otto von Bismarck, First Chancellor of the German Empire

It is uncomfortable, and even disgusting, to see images of “research subjects” from the unfortunate events that occurred in Nazi Germany, Guatemala, and Tuskegee. It is tempting, as proponents of research, to hold our hand out and push away that history. After all, many of these events occurred over half a century ago. It is easy to think that such a thing “wouldn’t happen at my institution…” or “in my city…” or “…to me as a research subject.”

Unfortunately, those beliefs of “it can’t happen to me” or “I wouldn’t make an unethical decision” have proven false on too many occasions. As Marcia Angell, MD, former editor-in-chief, New England Journal of Medicine said, “ethical lapses are almost never cases of bad people, bad things, for no good reason. More often they are good people, doing good things, for bad reasons.” Such a statement indicates that, in our pursuit of ethical research we are not bad folks, but from time to time we exhibit bad judgment in our pursuit of great things.

For each of us, as promoters of the day-to-day execution of ethical, the keys to the question of ‘What is ethical?’ are all too often not found in government rules and regulations. Rather, the keys to what is right and ethical will more frequently lie in the past.

It is difficult enough to face our past, but even that will not be enough. The only way to prevent the mistakes of the future is to examine others’ mistakes and change our behaviors.. The study of the history of research, including the dryness, possible uncomfortable results, and lack of general pleasure that accompanies its study, is not something that any research professional can afford to avoid. If we do, we are destined to be the next case in the presentation, a subsequent case of ethicism gone awry.

Learn from the mistakes of others. Don’t let the past be your future.

'Science Times' synthesis

No time to read the New York Times? We can help! Even though we’re one foot out the door to San Diego, we wouldn’t dream of missing our favorite part of the paper. Here’s a sampling of articles we hope you’ll find interesting and maybe even relevant.

Hope to see you in San Diego, and safe travels to those of you who will be joining us there.

November 23, 2010

Radiation worries for children in dentists’ chairs: Some raise concerns about childrens’ vulnerability to radiation at the dentist or orthodontists’ office.

A man from whom viruses can’t hide: Viruses can be difficult to obtain for research purposes, so Dr. W. Ian Lipkin sought another way.

Hazards: work stress raises women’s heart risk, study says: A study examines the possible connection between women who work, and those who have heart problems.

November 30, 2010

An odyssey through the brain: Carl Schoonover, a PhD candidate in neuroscience at Columbia University, explores the brain with colorful images.

A fate that narcissists will hate: being ignored: The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM) has eliminated narcissistic, and a few other previously-included, personality disorders.

Inefficiency hurts U.S. in ranking of health: Researchers claim that the United States’ health care system is to blame for the country’s ranking of 49th in life expectancy.

A nephrologist and patient: Dr. Julian L. Seifter discusses what it’s like to be both a doctor and a patient.

Fuel lines of tumors are new target: There are new, emerging ways to examine tumor cells.

Up with science and up with research, and thanks for your part in keeping them ethical.

Better together: Preparing for the CIP with support

by Andy Burman, PRIM&R Blog Squad member

PRIM&R is pleased to bring you more blog posts from the PRIM&R Blog Squad. The Blog Squad is composed of four PRIM&R members who are devoted to blogging prior to, during, and after the 2010 Advancing Ethical Research Conference.

I have a confession to make.

I took the 2010 Certification Examination for IRB Professionals. I failed the 2010 Certification Examination for IRB Professionals.

The whole process has felt lonely to me. I studied for hours and hours in earnest by myself, I took the pre-test by myself, I freaked out about the poor results on my pre-test by myself, I scrambled to study harder In preparation for the exam by myself, I drove 45 minutes to the nearest testing center by myself, I took the four-hour, 250-question exam, sharing the room with folks coming and going taking their 15-minute examinations on topics like grain bin safety, by myself. It was easy to feel alone, and while I know there are others out there who share similar experiences. I just didn’t know where to look.

I am very much looking forward to meeting many of you next week at the 2010 Advancing Ethical Research Conference. While much of my focus during the conference will be on the Small Research Institutions Track, I am most looking forward to IRB 101sm: Biomedical Research, the pre-conference program that I am scheduled to attend. It is at these workshops that I hope to learn the valuable information that will help me work toward my goal of passing the 2011 exam and gaining the CIP credential.

If there are other folks like me who plan to sit for the exam in the spring, come find me at the conference. You might see me in my red PRIM&R Blog Squad shirt, so feel free to approach me, and we can talk about how we can help each other prepare. Study groups are an exciting and highly encouraged route, but for those of us not in large institutions or metropolitan areas where a number of people locally are taking the exam, this could be difficult. I’d love to discuss study and support groups that we could set up online, or organized via web conference, that would be beneficial to all of us wanting to pass the exam.

The CIP exam should be difficult. The bar should be, and is, high. But the process of success or failure on the exam doesn’t need to be a lonely one.

See you at the conference!

Research in times of disaster: What’s really ethical?

by Courtney Jarboe, PRIM&R Blog Squad member


PRIM&R is pleased to bring you more blog posts from the PRIM&R Blog Squad. The Blog Squad is composed of four PRIM&R members who are devoted to blogging prior to, during, and after the 2010 Advancing Ethical Research Conference.

As I mentioned in my first blog for Ampersand, I am very interested in ethical issues relating to internet research. This is one area of the 2010 Advancing Ethical Research Conference that I can’t wait to explore. However, there are other topics that I’m curious about as well, and one very important one is research and humanitarian disaster settings and war zones.

With the ongoing events in Haiti—earthquakes and aftershocks, cholera outbreaks, and hurricane Tomas, is there enough scientific importance to warrant research? Would conducting research provide benefits that could outweigh the immediate benefits of humanitarian aid? Could conducting research there result in distractions from the directive to rebuild the Haitian community, as well as their mental and physical health? Even if research is allowed, would you obtain fully informed consent from such a vulnerable population? Finally, would the researchers have the ability to conduct the research without harm or additional liability issues to themselves?

What about the Chilean mining incident? During the crisis, Chris MacDonald, PhD, Professor of Ethics at St. Mary's University, wrote a blog article on whether it would be ethical to conduct research on the miners during their entrapment. Dr. MacDonald writes:

Doctors are already monitoring (remotely) the men’s health; why not go
further and study the men, so that we can learn about the effects of prolonged
isolation on the human body and mind? Consent forms could be sent down (and back
up) the newly-drilled access tube. Would doing so be ethical? Informed consent
is certainly possible, but would it be legit? Do trapped miners count as a
"vulnerable population," in the same sense as prisoners and children and people
in mental health institutions?

I’m not sure if research was allowed, but it seems that since the main directive was to rescue the miners, there would not yet be a focus on studying the effects of isolation on the human mind. There are, however, several ethical issues at hand should researchers move forward now. For example, if a researcher wanted to have direct interactions with these men, what measures would have to be in place to protect the men from serious risks of psychological damage (if that is not already occurring)? How could a researcher obtain the miners’ fully informed consent knowing that they’ve been surged with requests from media outlets for interviews, movies, and novels? What should be released in terms of the data (i.e. video and health data) that was gathered during the crisis? And, perhaps most importantly, how could any researcher protect the privacy and confidentiality of the 33 men whose names and general health are already posted all over the internet?

While most of the research I see at my institution is fairly minimal risk, I do see occasional ideas for "after-the-fact" research on environmental disasters or war zones. One of the issues I’ve come across is that of safeguards. What is considered additional versus standard safeguards? For example, is it adequate to provide a data monitoring board and counseling services for participants? Can a researcher get by with conducting survey-based research rather than face-to-face research? Is that as risky, or worse? In addition, while the institutional review board (IRB) is solely charged with protecting the rights and welfare of human participants, who is to safeguard the researcher? What if a researcher is conducting interviews with participants who have experienced devastating catastrophes, or actually is conducting research during these catastrophic events, and there are potential impacts to the health of that researcher?

I’m hoping to take what I learn at AER back to Capella University’s IRB, to provide the IRB members and human research protections program (HRPP) staff with resources, as well as inspiring ideas about some of the ongoing issues with this type of research.

PRIM&R joins the University of Illinois at Urbana-Champaign to create a national center for professional and research ethics

PRIM&R is thrilled to announce that we will be working with the University of Illinois at Urbana-Champaign (UIUC) on a multi-year project designed to make ethics information and training resources readily accessible to those working in the fields of science and engineering. This five-year, $5 million grant was awarded to UIUC by the National Science Foundation (NSF).

The online center, which will be called the National Center for Professional and Research Ethics, will develop, gather, preserve, and provide comprehensive access to resources related to ethics for teachers, students, researchers, administrators, and other audiences. As such, it will provide information and expertise for several populations, including:

• instructors who teach ethics,
• students with questions about research integrity,
• researchers and engineers who encounter ethical challenges in practice, administrators in universities and businesses who oversee ethics and compliance policies,
• scholars who conduct research on professional and research ethics, and
• others with questions or interests in these areas.

"Almost everybody wakes up every day and wants to do the right thing," said Center director C. K. Gunsalus, Coordinated Science Laboratory research professor and professor of business at the University of Illinois at Urbana-Champaign, as well as longtime friend of PRIM&R. "Many people who face ethical dilemmas know the general principles but not necessarily how to apply them in the complexity that real-life professional and research practice present. The Center seeks to create an online environment that encourages the life-long development of ethical practices through materials and interaction with other professionals."

PRIM&R’s role will be small but, we hope, significant, as we will be involved in the development and coordination of human and animal research ethics resources. The planning process has just begun, and we look forward to sharing more details here soon as we begin working on the project. We also look forward to hear more from our community about what resources are missing from the current "cupboard," so that we can more responsively fill the void.

PRIM&R’s executive director, Joan Rachlin, is thilled about our involvement in this project and believes that it will provide a unique opportunity to connect the many ethical and educational threads that already exist, and to at the same time identify and integrate new ones.

PRIM&R is proud to be a member of this team, and we look forward to the development of this exciting Center.

Read more about the grant award in the NSF press release.

'Science Times' synthesis

No time to read the New York Times? No worries! We continue to devour the Tuesday NYT science section at PRIM&R, and are pleased to bring you our bi-monthly blog devoted to a digest of those articles we consider relevant and useful to our community. Enjoy!

November 9, 2010

For edge on Alzheimer’s, testing early treatments: Some Alzheimer’s research will be focusing on earlier stages of what happens to patients’ brains.

Glimpsing a scientific feature as fields heat up: A columnist describes the excitement surrounding unpredictable scientific discoveries.

Behavior: Too much texting is linked to other problems: A study suggests that teens who text are more likely to participate in other risky behaviors.

Genes as mirrors of life experience: How might people’s experience and environment affect the function of their genes?

November 16, 2010

When the mind wanders, happiness also strays: A study examines how focusing may make you happier than letting your mind wander.

MRIs help fight high risk of cancer: Yearly MRIs may help save lives.

Study ties ovarian cancer and hormone therapy: A newly released European study reports that women who take hormones are at significantly increased risk for ovarian cancer, which is rare, but often fatal.

50 years of chimpanzees: An interview with Jane Goodall reviews the past 50 years of her productive and prolific career.

And, in the "little known facts" category, did you know that Joan Rachlin, PRIM&R’s executive director, was one of Grub van Lawick’s (Jane Goodall’s son) pre-school teachers? In a former life, Joan taught at the Bing Nursery School, the lab school at Stanford University, and Grub was a student there while Jane was a visiting professor.

Joan reports that Grub was smart, curious, sweet, and that his play resembled that of the chimps (such as running to trees, hugging them, and looking around from behind the trunks to see who was out there). This was no surprise, though, since he had been raised in Gombe with the chimps, and Bing was his first introduction to school.

Good news and bad from a heart study: A study concerning a heart failure drug yields both positive and negative results.

And even though it’s not really related to research, who can resist an article about serving as the president’s physician? Surely not us!