Making a Difference in Real-World Bioethics Dilemmas

New Bioethics Funding Opportunity

New Bioethics Program, Fall 2014

Making a Difference in Real-World Bioethics Dilemmas

 

The Greenwall Foundation will fund a bioethics grants program, Making a Difference in Real-World Bioethics Dilemmas to support research to help resolve an important emerging or unanswered bioethics problem in clinical care, biomedical research, public health practice, or public policy. We hope these grants will have a real-world, practical impact.

 

Under this RFP, we will fund five types of bioethics research grants:

  1. Mentored projects
  2. Senior collaborations,
  3. Normative analyses of implications of empirical research conducted with other funding,
  4. Empirical projects.
  5. Empirical studies of attitudes of clinical trials participants to sharing clinical trials data, which is described in greater depth below. 

The first three types of proposals generally will receive priority if the requested time frame is one-year or less, and the annual budget is below $60,000. Because of the nature of empirical projects, the fourth and fifth types of proposals may have longer timelines and larger annual budgets.

 

1. Mentored research projects. Awards to a senior bioethics researcher to carry out a mentored bioethics research project with a post-doctoral fellow or junior faculty member. The close mentoring will help ensure that the project is completed within a year. The Foundation will provide salary support for the effort of the mentor on the project. Projects where the mentee already has salary support will receive priority. Proposals in which the mentee has other responsibilities that compete with carrying out such a research project, like courses for a degree program and clinical responsibilities by resident physicians or fellows, will be considered only in exceptional circumstances. Mentored research projects may analyze the normative implications of empirical research conducted with other funding (as described in #3).  For projects that involve secondary analysis of existing data sets, the team must include expertise in the obtaining, merging, and analysis of such datasets. For mentored projects, primary data collection will be considered only in exceptional circumstances. Proposals to collect pilot or preliminary data for a larger project will not be considered.

 

2. Senior collaboration projects. Grants to allow innovative biomedical or clinical researchers or leaders of health care organizations or government agencies to partner with an established bioethics scholar to carry out research on the intersection of their primary work with bioethics. For example, a leading researcher in an innovative biomedical field could bring deep knowledge of that field to help analyze important unresolved bioethics problems in it. As another example, a physician-leader in a safety-net hospital or a public health agency could analyze ethical problems she or he had encountered and struggled with. Both collaborating senior scholars are eligible for salary support.

 

3. Analyzing the normative implications of empirical research you are conducting with other funding. Researchers able to obtain funding from other sponsors to carry out empirical research on a bioethics dilemma or issue, may lack support to write about the conceptual or normative implications of the findings of this empirical research. We will fund investigators to write conceptual or normative analyses, providing that the empirical study is well-designed and the findings interesting.

 

          4. Empirical bioethics research involving primary data collection.  We invite projects that involve the collection of primary data, are tightly linked to an active real-world bioethics problem or policy dilemma, and likely to contribute to its resolution. Priority will be given to important bioethics problems or policy questions, particularly those being actively debated by policy makers. The research team must demonstrate the ability to carry out such projects within the proposed time frame. Methodology should be rigorous, (e.g. attention to response rates, representativeness of the sample, and minimizing bias). These projects may have extended time frames and annual budgets larger than $100,000, however, all other things being equal, cost conscious projects will receive priority; for example by adding questions to already-funded survey projects or using cost sharing arrangements such as with existing grants or research trainees whose salary is supported from other sources (provided that trainees do not have conflicting classwork or clinical responsibilities). Proposals to collect pilot or preliminary data for a larger project are discouraged. Partial salary support may be requested for staff to manage the budget/finances and administration as appropriate.  

 

            5. Analyze attitudes of clinical trials participants to sharing clinical trials data (new initiative).  Sharing clinical trial data is an important policy topic that is ripe for empirical bioethics research. The European Medical Agency, the equivalent of the U.S. Food and Drug Administration, will announce requirements for sharing clinical trials data after regulatory decisions, and several major drug companies have committed voluntarily to sharing their data. However, programs for sharing clinical trial data differ in many ways and will evolve over time. There are a number of bioethics issues that need to be addressed:

  • How should data sharing be explained to patients enrolling in clinical trials so that they can give meaningful consent to sharing of de-identified data?
  • Do clinical trial participants have concerns about the benefits and risks of data sharing regarding secondary analyses that do not use valid methodology, which may lead, for example, to inaccurate reports on adverse events?
  • Do clinical trial participants have concerns that much of the data collected in a clinical trial are not analyzed or published, as currently occurs without data sharing?
  • What conditions or restrictions for data sharing, if any, do clinical trial participants support to prevent misuse?
  • What process do clinical trial participants favor for review of requests for access to data?

This would be a several-stage empirical project, starting with qualitative focus groups or deliberative democracy exercises and continuing with a survey of participants enrolled in actual clinical trials. The findings would provide guidance to policy makers, funders of clinical trials, and leaders of clinical trials on how to share data responsibly, while respecting the concerns, values, and preferences of patients who participated in clinical trials.

 

We expect grantees to disseminate their research through practical articles in one or more peer-reviewed journals that reach the appropriate audience for the topic studied, through presentations in relevant national and international professional meetings, and in other ways that will increase real-world impact.

 

Examples of the kinds of real-life bioethics problems grantees might address include:

  • Dilemmas raised by innovative biomedical research and by new communication technologies in clinical medicine.
  • Dilemmas from major changes in the delivery of U.S. health care resulting from the Affordable Care and Patient Protection Acts, changes in the FDA regulatory process, and private initiatives.
  • Dilemmas that are particularly salient -- and particularly ripe for analysis -- in certain cultural and ethnic communities, although they also involve people across the population.

 

In evaluating proposals The Foundation will consider:

  • The real-world importance of the bioethics problem to be studied and the likelihood the project will have a constructive real-world impact.
  • The appropriateness and rigor of the methods, analysis plan, strategy, and approach.
  • The innovative nature of the project's approach and how it goes beyond previous work on the issue.
  • The professional background of the proposed investigators, and their close, practical familiarity with the bioethics problems to be addressed.
  • The previous success of the principal investigator in carrying out similar projects (mentoring, collaboration, normative implication of empirical research, or primary data collection).
  • The success of the investigators publishing practical bioethics articles, similar to what is proposed, in top-tier journals with a broad audience.
  • The value added by interdisciplinary collaboration.
  • The reasonableness of the budget. All things being equal, projects with smaller budgets will receive priority.

 

While we will give strong preference to proposals that meet these criteria, we will also consider exceptional proposals outside these criteria that meet our strategic goal of supporting bioethics research that will have a real-world impact. More than one applicant may apply from each institution and more than one grant per institution may be funded.  However, a primary investigator may submit only one letter of intent per funding cycle. 

 

Projects with the following characteristics will not be funded under this initiative:

  • Projects that implement or make incremental improvements in established approaches to bioethics problems, build institutional infrastructure, or provide bioethics education, training or course work.
  • Projects that simply describe or analyze bioethics issues or provide a conceptual framework, without making practical recommendations for resolving the issues. However, projects that present normative recommendations that are based on previous empirical research are encouraged (project category three).
  • Proposals to gather pilot or preliminary data for a larger project.
  • Projects whose main goal is to convene or enhance a meeting.
  • Projects to support or extend ongoing or core activities of an organization.
  • Applications from unaffiliated individuals and from institutions outside the U.S. The Greenwall Foundation awards grants only to tax-exempt institutions in the U.S.

 

We welcome e-mail inquiries about this initiative to rboxt@greenwall.org. 

 

Application Process

Click on https://www.grantrequest.com/SID_1837?SA=SNA&FID=35006

 

In order to access the online application, you must allow cookies in your browser.  If you have any issues accessing the online application, a common fix is to clear your browsing history. 

 

You will need to create a username and password by clicking on “New Applicant?” under the “email” box on the left side of the page.  Please store your login credentials in a secure place because you will need them to access your application.  If you have applied for a Greenwall grant previously using our online platform, please enter your credentials. 

 

You will need to save your application frequently so that your input is captured; any unsaved information will be lost.  There is no option to save and continue working, so you must select “Save and Finish Later”. You can return to your “In Progress” application by clicking on the blue link on the new page that will appear in your browser.  Upon clicking “Save and Finish Later,” you also will be emailed a link to the application portal and a copy of your application will appear in the body of the email. 

 

To access your application after you have logged out of the online application system, use the link that was emailed to you when you clicked “Save and Finish Later”.  It is important to use the link that is emailed to you to resume work on an application.  If you use the link listed here, you will always be brought to a NEW application, not the one you were previously working on. 

 

If you have any questions or concerns regarding the online application process, please contact Rebekkah Boxt by email at rboxt@greenwall.org or phone at 212-679-7266. We will not accept late applications because of technical issues with the online application portal, so please try logging in and entering your information in advance of the deadline.

 

Letters of intent require the following information be entered into our online application from:

  • PI Contact information
  • Title
  • Type of project: senior collaboration, mentored project, normative implications, primary data collection, and clinical trials data sharing
  • The amount and duration of funding requested (Salaries for investigators are capped at 1.5x the 2014 NIH cap for the basis of the percent effort allocation, fringe rates will be capped at 35%, and 10% indirects will be awarded on salary and benefits only.)
  • A one sentence summary of the project for a lay audience
  • Names of the proposed research team and copies of CV's (no more than 3 pages each, highlighting publications relevant to the application) of the two main investigators (or mentee and mentor).
  • 400-600 word narrative titled “PI Last Name, Institution, Project Title, ” organized under the following headers:
    • The bioethics problem to be addressed
    • The specific aims or research questions of the project
    • How the proposed project is innovative and goes beyond the current work on the problem, particularly in its potential to have a real-world impact
    • The nature of peer-reviewed publication(s) expected from the project and how the target journal audience includes key individuals who can change practice or policy.

 

Letters of intent for this cycle must be submitted online by August 1 at 4:00pm ET.  However we strongly encourage applicants to submit letters of intent earlier, so that they have more time to respond to feedback from reviewers, if invited to submit a full application.  Selected applicants will be invited to submit full applications online by Monday, September 15, with funding to start in early 2015.

 

We will fund another cycle of grants in Spring 2015. The request for proposals and due date for this cycle will be announced in the Winter of 2014.