Archive for Research Resource

ResearchMatch.org

November 13, 2009 at 12:07 pm · Filed under NIH Advice, Research News, Research Resource

No, not an online dating service … ResearchMatch is an NCRR-funded secure registry that allows individuals to sign up to receive alerts about clinical research in which they might be interested and for which they might be eligible — and researchers to sign up to find potentially eligible participants for their studies.

Currently, 40 of the 46 current CTSA sites are participating, and the registry will eventually expand to include non-CTSA institutions. As described in the NIH’s news release:

After an individual has self-registered to become a volunteer, ResearchMatch’s security features ensure that personal information is protected until volunteers authorize the release of their contact information to a specific study that may be of interest to them. Volunteers are notified electronically when they are a possible match and then make the decision regarding the release of their contact information. It also will promote choice as there are no obligations on the volunteer to participate in studies.

According to the ResearchMatch.org participant FAQ, “[approved] researchers will not be given access to begin looking for potential study Volunteers through ResearchMatch until approximately January 2010.” As further explained by the researcher FAQ:

ResearchMatch is a not-for-profit activity and is free for any participating site & their researchers. … Researchers at participating sites will be given access to register through the ResearchMatch system. Upon registration, researchers may request either feasibility or recruitment access … your access to recruit via ResearchMatch will last only as long as your IRB-study approval.

After you have been granted recruitment access, you will be able to search for appropriate matches amongst the non-identifiable ResearchMatch Volunteer profiles in the system. You will enter your study’s criteria in the ResearchMatch Search Builder which will yield a list of these potential matches. You will send out IRB-approved content in your initial recruitment message to these potential matches through ResearchMatch. The secure ResearchMatch clearinghouse will route your message to each of these potential matches and they will have the option of replying yes, no, or no response. Your study’s home page will feature all those Volunteers who say yes and show aggregate figures/charts demonstrating the response rate to your initial recruitment message. Once the Volunteer has authorized ResearchMatch to release their contact information to you, you will be responsible for managing this contact information as called for by your IRB-study protocol.

Vanderbilt, which maintains and whose IRB oversees ResearchMatch.org, also has its own DNA bank called BioVu, which includes leftover blood from all patients seeking treatment unless they opt out when signing the the Vanderbilt Consent for Treatment and Agreement to Pay form.

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ORI Blog

October 8, 2009 at 10:53 pm · Filed under Biomedical Research Ethics, Research News, Research Resource

As I mentioned earlier, ORI has ventured into the blogosphere, and a few recent posts caught my attention, such as the Meaning of RCR by John Galland, PhD, Director pf the Division of Education & Integrity. He concludes with a list of objectives for RCR training:

(a) Protect animal subjects, human participants, research personnel, and the environment
(b) Be honest and transparent, not deceptive (e.g., falsifying, fabricating, or plagiarizing data or deceitful attribution of authorship)
(c) Be fair by not introducing unwanted bias into research results, conclusions, or inferences (e.g., conflicts of interest and commitment, sloppiness)
(d) Be benevolent, not be malicious (e.g., thievery of ideas, unfair criticism during peer review for personal gain; exploitive of others)
(e) Be open to creativity and innovation
(f) Protect the public trust

I like (e) conceptually but cannot for the life of me imagine how typical RCR training would achieve this … hopefully not during lectures about falsification and fabrication.

Today I spotted a new post of personal interest on the Integration of RCR Education and Bioethics Education. Specifically, the question is posed,

What educational programs, what research environment can be fostered, at our institutions to help researchers with such decisions [e.g., fabricate data to secure grant funding needed to sustain research program & staff], or better yet, to help them never have to make such decisions?

Regular visitors will know that I monitor studies and analyses of procedural and distributive justice in the context of the research environment, such as the work of Brian Martinson, Melissa Anderson, et al.. Nice to see ORI giving a little thought to the research environment itself (and its administration) as a means for preventing misbehavior and worse. In discussing grant funding policy here at MWEG, some have suggested that institutions be required to pay the major portion of researcher salaries (hard money), and this would certainly be one way to foster a much more pleasant environment that would likewise be more conducive to the responsible conduct of research. If you have other suggestions, I am quite sure Dr. Galland would appreciate such comments on his blog.

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Science Translational Medicine – Coming Soon to a Newstand Near You

September 28, 2009 at 4:44 pm · Filed under Biomedical Writing/Editing, Research News, Research Resource

And what a shocker … the Chief Scientific Advisor is none other than the Great Zerhouni (Katrina Kelner is the Editor, aided by Senior Editor Kelly LaMarco and an Advisory Board).

So what does the newest AAAS journal, whose “mission is to chronicle the conversion of basic biomedical research into practical applications,” want to publish?

The journal’s editorial team is seeking a variety of research papers, reviews, commentaries and other article formats in the following areas: cancer, cardiovascular disease, metabolism/diabetes/obesity, neuroscience/neurology/psychiatry, immunology/vaccines, infectious diseases, policy, behavior, bioengineering, physics, chemical genomics/drug discovery, imaging, applied physical sciences, medical nanotechnology, drug delivery, biomarkers, gene therapy/regenerative medicine, toxicology and pharmacokinetics, data mining, cell culture, animal and human studies, medical informatics, other interdisciplinary approaches to medicine.

Preference will be given to papers on humans, human tissue, and animal models with proven relevance to human diseases.

Hmmm. Did they leave anything out? We’ll soon see. The first issue of Science Translational Medicine (not to be confused with BMC’s open access Journal of Translational Medicine) is slated to go online on October 7th.

Of course, the Mission Statement & Purpose are pure GZ:

Mission statement: To promote human health by providing a forum for communication and cross-fertilization among basic, translational, and clinical research practitioners and trainees from all relevant established and emerging disciplines.

Purpose: A profound transition is required for the science of translational medicine. Despite 50 years of advances in our fundamental understanding of human biology and the emergence of powerful new technologies, the rapid transformation of this knowledge into effective health measures continues to elude biomedical scientists. This paradox illustrates the daunting complexity of the challenges faced by translational researchers as they apply the basic discoveries and experimental approaches of modern science to the alleviation of human disease. Studies in humans often highlight deep gaps in our fundamental understanding of biology, but the linkages back to basic research to fill these gaps have not been as effective as they could be. Clearly, creative experimental approaches, novel technologies and new ways of conducting scientific explorations at the interface of established and emerging disciplines are now required to an unprecedented degree if real progress is to be made. Nothing short of a true reinvention of the science of translational medicine is likely to suffice. To aid in this reinvention, Science and AAAS have created a new interdisciplinary journal, Science Translational Medicine.

AAAS also kindly defines translational medicine, including specific examples.

Okay folks, go forth and reinvent yourselves (and don’t forget about the National New Biology Initiative as you do so).

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FASEB Congressional Visit Toolbox

September 10, 2009 at 4:29 pm · Filed under Research News, Research Resource

FASEB has launched a new Congressional Visit Toolbox

aimed at empowering, training, and equipping scientists to build relationships with their elected representatives in Congress. The Toolbox contains everything needed to plan and conduct a Congressional visit, including templates for meeting requests and follow-up letters, printable, state-specific ‘leave-behind’ materials, and customizable talking points on the importance of biomedical research. Training materials, such as a slideshow tutorial on advocacy and a video of Congressional visit role-plays, are also linked to the site.

You’ll have a chance to put this resource to use in the coming weeks as the FY10 budget bills come up for debate and votes … not to mention health care reform legislation.

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NSF 2006 Academic Institutional Profiles

July 2, 2009 at 11:35 am · Filed under NSF Info, Research News, Research Resource

The NSF Division of Science Resources Statistics has released its Academic Institutional Profiles for 2006. A convenient upgrade for this year is that you can scroll through alphabetized lists of academic institutions with their various rankings or without any rankings. Clicking on the institution name in either list takes you to their data tables (earned doctorates, federal science & engineering obligations, grad students & postdoctorals, and R&D expenditures). A search engine can also be used to take you to the institution of interest.

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Direct Public Funding of Pilot Research

October 19, 2008 at 2:44 am · Filed under Biomedical Research Ethics, Funding Opportunities, Research News, Research Resource

What a concept: “Our mission is simple: To enable the public to fund pilot research projects.”

Whose concept? Whose mission? Fund Science.

A bit more on their mission …

First we’re providing research funds to a whole new generation of researchers that are our future. Secondly we’re walking the public through the scientific process, from grant writing to funding, all the way to the results. Finally we are creating an ecosystem for scientists to collaborate with each other as well as the public on shaping future research projects. Read the rest of this entry »

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R01s in Decline

October 10, 2008 at 3:58 pm · Filed under Grantsmanship, NIH Advice, Research Resource

A letter in Science from H. George Mandel (GWU) and Elliot Vesell (PSU) starkly lays out data showing the decline of R01 funding.

From 2000 to 2007, the success rate for new Type 1 applications dropped from 20.3% to 7.2%. The average award per R01 looks to have dropped from $3.38M to $2.69M. For individual institutes, they report new application success rates of 5% for NCI and NIAID and 3% for NINDS. Oof.

For Type 2s in this same period, success rate halved from 53.0% to 25.2%, with the award amount declining from $3.03M to $2.44M. The authors note that “For renewal applications, the decline means discontinuation of 75% of ongoing programs.” What a colossal waste of tax-payer investment. Read the rest of this entry »

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Addressing Underpublication of Clinical Trial Results

September 22, 2008 at 6:33 pm · Filed under Biomedical Research Ethics, Biomedical Writing/Editing, Research Resource

In the September issue of The Oncologist, Scott Ramsey and John Scoggins (both from Fred Hutchinson) report that fewer than one in five cancer clinical trials registered with clinicaltrials.gov have been published in the peer-reviewed literature (17.9%). Categories of studies with the lowest rates of publication included industry-sponsored (5.9%), non-randomized (4.4%), and terminated (3.4%) trials.

In examining the 357 trials with published results, the authors could judge whether the results were positive or negative for 341. The majority (64.5%) reported positive results, with Phase I trials most likely to report positive results (89.9%), followed by Phase IV (83.3%), Phase III (63.2%), and Phase II (53.6%). NIH-sponsored trials were most likely to result in positive results (78.8%).

Previously, Richard Johnson and Kay Dickersin (both from Johns Hopkins) also raised the issue of publication bias against negative clinical trials in Nature Clinical Practice Neurology.

Fortunately, the FDA Amendments Act of 2007 has set in motion the expansion of clinicaltrials.gov to include compulsory reporting of basic results. You can check out progress made on the basic results data entry test system, which is designed to capture the following information:

‘‘(i) DEMOGRAPHIC AND BASELINE CHARACTERISTICS OF PATIENT SAMPLE.—A table of the demographic and baseline data collected overall and for each armof the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.‘

(ii) PRIMARY AND SECONDARY OUTCOMES.—The primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures.

(iii) POINT OF CONTACT.—A point of contact for scientific information about the clinicaltrial results.

(iv) CERTAIN AGREEMENTS.—Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial.”

Indeed, in an accompanying commentary, James Doroshow notes that NCI is developing in parallel a complementary clinical trials database to catalogue administrative and outcome data for all studies performed at NCI-supported institutions (perhaps drawing from or building on the NCI’s excellent existing Cancer Research Portfolio database). Unlike the clinicaltrials.gov basic results reporting, the NCI database will include interim reports on accrual and outcomes. Thus, the oncology community will, within the next few years, have rapid access to safety and efficacy data from cancer clinical trials.

Further, the editors of The Oncologist, Gregory Curt and Bruce Chabner, indicate that they are considering whether to “undertake the publication of a peer-reviewed, searchable venue for these trials” in reference to “well-executed trials that fail to meet positive endpoints: ‘negative’ in a sense, but valuable nonetheless.” The editors invite readers to indicate their level of enthusiasm and support for such a venture.

The title of Doroshow’s commentary captures the urgency for action on this front, not only in the oncology community but among all clinical disciplines: Publishing Cancer Clinical Trial Results: A Scientific and Ethical Imperative.

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By JoVE – They’re Indexed!

August 20, 2008 at 12:39 pm · Filed under Biomedical Writing/Editing, Research Resource

The National Library of Medicine will index in PubMed videos from the Journal of Visualized Experiments (JoVE), an online open-access research journal that “publishes” videos of experiments and protocols “to increase reproducibility and transparency in biological sciences.”

Check out the official JoVE blog to learn more about the journal and how you can contribute to their blogging and visualization efforts. The editors also invite you to bring your own blog posts to life with their videos (just ask).

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Olja Finn: Science Goddess

August 17, 2008 at 3:32 pm · Filed under Funding Opportunities, Research News, Research Resource

Nothing put a bigger smile on my face last week than Science’s profile of Olivera Finn, the founding chair of Immunology at Pitt and recent president of AAI. She is a remarkable scientist (cancer immunology), superb mentor, and delightful woman. Her colleagues and trainees are quick and eager to recognize her professional accomplishments in the course of maintaining a rich family life. I like the way Mitch Leslie starts the article:

Take a look at Olivera “Olja” Finn’s life, and you can tick off the actions women are supposed to avoid if they want to advance in science. Get married fresh out of high school. Check. Interrupt your education for your husband’s sake. Check. Allow his career to take precedence over yours. Check. Have children before you have a job and give birth at what seem like inopportune times, such as shortly before you start graduate school. Check.

Yet Finn has, with great success, pursued career and family goals simultaneously. She celebrated her 40th wedding anniversary last month, has raised a daughter and a son, and, at the age of 59, already has grandchildren. Professionally, Finn has prospered. Nearly 20 years ago, she discovered the first cancer antigen, a tumor molecule that elicits a reaction from immune cells. And despite spending her youth in Communist-run Yugoslavia, Finn has climbed the academic ladder in the United States–she is chair of immunology at the University of Pittsburgh in Pennsylvania and has served as president of the American Association of Immunologists. She argues that interweaving career and family is essential. “I don’t think we live long enough to do things sequentially.”

Indeed, programs promoting women in science at the NIH, the AAMC, and FASEB need look no further than Olja for their role model, both in terms of her incredible career and how she manages her own productive yet family-friendly labs.

Of note is the current NIH RFA for “Research on Causal Factors and Interventions that Promote and Support the Careers of Women in Biomedical and Behavioral Science and Engineering.” I know of several applications going in and am not sure “research” will uncover anything more novel than the need for institutions to pony up resources and reward supportive department practices – but we’ll see. Perhaps just having hard rather than anecdotal data will make the difference in justifying policy change and budgeting priorities, especially in terms of enhancing recruitment and retention.

(Those not familiar with allowable grant costs in this regard can check this FAQ on NIH policy on child care and parental leave and should also check with their usual IC for special policies, such as the Primary Caregiver Technical Assistance Supplements for postdocs available through, who else, NIAID … Olja, did you have a hand in this?)

Now if only FASEB would recognize her with an Excellence in Science award….

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