Documenting our outcomes and publishing our model in the scientific literature is part of our mission of participating in and advancing a global social and scientific movement towards health equity. We must take care, however, to ensure that research only supports our fundamental service obligations to the communities in which we work rather than serving as a distraction. See also Research Ideas, our wiki page where we list some research ideas and projects.
Overview
Mission
To make Nyaya Health a leader in implementation science in rural, resource-limited settings. This research should advance advocacy, service, and policy efforts to reduce health injustices in Nepal, South Asia, and beyond.
Rationale
While Nyaya has a responsibility to the communities we work in, the actions of precedent setting and demonstration of evidence through the formal publication of research can result in more widely effective policy changes. As such, publishing our data and insights, soliciting feedback, and encouraging further discussion and analysis, can have broad-based impacts for persons in similar resource-deprived settings that Nyaya does not immediately work with. Therefore, participating in the larger research discourse is within Nyaya's mandate and achieves three aims:
a) by publishing our data, we solicit feedback and conversation that can enable our own programs to improve through continued critical analysis and peer-review;
b) as with organizations such as PIH or MSF, the publishing of our data provides other organizations, and their own patients, the opportunity to share in Nyaya's evidence-based approach and results, consequently expanding the geographic reach of Nyaya's work; and
c) through publication, we can increase the exposure of Nyaya's work, facilitating further opportunities for future collaborations, volunteers, and funding - all of which can directly benefit the communities in which we work.
Vision and Strategy
Nyaya's vision for our research program:
1) Nyaya's mandate is to provide healthcare resources while simultaneously addressing the structural violence experienced by the communities we work in. As a consequence, any research should necessarily prioritize the benefit of our patients, offering a comparative advantage in both its implementation and results.
2) Our research should stem directly from our ongoing efforts at achieving high-quality health services through our existing strategies, such as critical self-reflection, follow-up of patients, and rigorous data outcomes monitoring.
3) Our research should be action-oriented in the evaluation of the processes and outcomes of interventions.
4) Good research requires commitment, dedication, and rigor over the course of several years; even short-term research should be conceived as part of a long-term vision.
Team and Organizational Structures
Organizational Structures and Financial Arrangements
The Research Team is managed via Nyaya Health Nepal , with parallel support from Nyaya Health International. The administration is wholly distinct from Bayalpata Hospital.
The stipend of the Director of Evaluation and Research will be paid through Nyaya Health International. Grants and other receivables to research be appropriately identified within Nyaya Health International’s accounting system. All local expenses (paying of additional salaries, research material, travel) should be made via Nyaya Health Nepal’s administrative structures in Kathmandu, not via Bayalpata Hospital. These should be appropriately accounted for within Nyaya Health Nepal’s accounting structures.
Contracts will not be beholden to BH policies, so various performance incentives, such as salary withholding in the case of failed communication, can be written into contracts, and also so that the salary itself is on a separate scale.
Research Leadership
The goals of the research team are three-fold: 1) to conduct implementation research; 2) to support, but not implement, the M&E functions of Nyaya Health Nepal; 3) to use research to drive forward advocacy efforts. We aim to create research structures that support and enhance Nyaya Health’s service obligations. Implementation science demands excellent clinical services; in turn, excellent clinical services demand ongoing rigorous data collection and analysis of clinical programs
Please see the appropriate contracts for each of these members as well, to provide specific details to the broad categories below.
- Research Team Lead: Advances the research vision of Nyaya Health; provides overall leadership and management
- Director of Evaluation and Research: Oversees implementation of the research vision and ongoing practical revisions to that vision, and conducts individual research projects
- Individual Research Principle Investigator: Oversee the implementation of specific research projects
Communication Systems and Expectations
Communications is central to the success of this endeavor. As per contractual obligations, the Director of E&R is expected to1 ) Produce monthly evaluation reports of all clinical programs at Bayalpata Hospital; and 2) email biweekly (twice monthly) updates regarding issues and challenges in data collection; these should be prepared as blog or microblog (tumblr) posts
Research@ Listserve
The Research Team Lead serves as the moderator of the research@ listserve. The purpose of the research@ listserve is to provide an update mechanism. These include:
- new research grants possibilities
- data updates (mandated to be sent by the local Director of Evaluation and Research on a monthly basis)
- program updates (mandated to be sent by the local Director of Evaluation and Research on a weekly basis)
- protocol updates-- revisions, IRB submissions, etc.
For the most part, research@ posts should cc appropriate other listserves, e.g., surger@ or communityhealth@ depending upon the subject matter of the research.
Lengthy, bulleted emails that are construed as "organized advice" are not typically a time-efficient use of members' time. Please keep non-update advice/response emails to a minimum unless specifically requested for particular edits or suggestions. There should always be a particular team bottom-lining the research and making decisions. The listserve mechanism is to maintain members' inspiration and engagement, and allow them to participate in the particular tasks for which they are delegated. "Talking through" is best done over the phone or in person. Research can be conducted in many different ways, with many pitfalls and challenges in resource-limited settings; most important for our being able to make efficient use of the listserve is to refrain from engaging in extensive advice-giving for problems/projects that we are not ourselves actively engaged in. If dialogue does need to happen between two members bottom-lining some project or working through a problem together, that discussion is best done individually on phone or over email with pertinent updates then sent to research@.
This is an open listserve; as such members need to be cognizant of engaging in respectful dialogue that doesn't involve personal private information. For example, discussion of research team applications or performance of particular research team members' may not be appropriate. It is very appropriate to discuss the challenges and frustrations in an open manner about doing research in Nepal.
Timeline
The only focus in the first year will be surgical implementation research, including the institutional delivery surveys. Subsequent projects, involving for example malnutrition or laboratory implementation science, will be considered after the successful pilot of surgical implementation research. We will re-evaluate the success of the research endeavor with the surgical research pilot prior to taking on/accepting any additional research. As such, we are not open to any other research projects during this pilot phase, and will re-consider the review process for future research after this phase.
Logistics of Research Implementantion
The remainder of this page provides details on the logistics of carrying out research with Nyaya. An overview of the process is as follows:
1. Identify the research problem
2. Solicit team input
3. Assign roles
4. Solidify the work plan
5. Get ethics review approval
6. Conduct the research (including several interim analyses along the way)
7. Publish results via Nyaya outlets as well as in scientific literature
Note that the timeline for good research is over the course of years, but that planning and role-clarification begins on day one.
Key Roles in a Research Project
It is critical to establish clear roles at the very BEGINNING of a research project.
Principle Investigator: This person will have advanced research training who is responsible for supervising the research and ensuring that the research is conducted in a manner in keeping with scientific ethics and good practice. S/he will typically be the last and corresponding author on any publications.
Project Leader: This person may be the same as the principle investigator. S/he also has significant research background and is capable of independently overseeing research planning, data collection, data analysis, writing up of the piece. S/he is responsible for the initial draft of the piece and for getting the piece through production.
S/he will typically be the first author on any publications.
Implementers: These are the people who conduct the research on the ground, through direct patient care, program coordination and operations management.
Collaborators: These are the people who provide critical insight and guidance on particular scientific or methodological issues.
See a larger discussion about authorship below; implementers and collaborators may or may not be co-authors on the final published piece, depending upon whether they meet the IJCME guidelines. As stated below, the time to start talking about authorship is with the initial role clarifications, NOT when the paper is ready to be written.
Key Pitfalls to Avoid
If you are the scientific lead/principle investigator, be sure that:
-PRIOR to data collection, you have created the database and established the analytic protocol
-Established clear avenues of follow-up and communication with your Project Leader
If you are the Project Leader, be sure that:
-You feel comfortable emailing all members of the team, regularly
-Are ready to meet any challenges that confront the project openly, communicatatively, agressively to avoid letting small problems derail you.
For all members:
-Make sure that if you are collecting clinical data, you have an immediate way, that does not require analysis, to providing clinical care if indicated. One example is that if you are collecting data on malnutrition or HIV, be ready to refer patients who screen positive for treatment IMMEDIATELY. Patient safety and care can not wait for analysis; that is our ethical duty to the communities in which we work.
Collaborative Process
The process of research should be open and efficient. There are many pitfalls to group authorship. A few key principles apply:
Extensive email threads and editing ARE NOT efficient modes of pushing forward big ideas on a paper. As we discuss in our collaboration page, best to have phone (individual or conference) calls early on to establish the vision for the paper and clear roles.
Lead authors should have a clear direction they want the piece to take. The lead authors should have a clear direction to help guide the co-authors and avoid multiple rounds of revisions/re-envisioning.
Avoid the urge to copy-edit. Copy-editing duties rest almost exclusively in the hands of the "primary writer" who may or may not be the first author. This ensures 1) that the piece reads in a single voice; and 2) that In the FINAL pass, select co-authors can suggest copy-edits, but copy-editing should be viewed as a very DOWNSTREAM process. It can be very difficult to separate the big picture from the micro-edits, and the urge to edit is strong, but most co-authors' roles are not to manage the micro-edits.
Identify clear tasks and timelines. The first author should delegate clear tasks, such as finding this or that reference, adding a particular methodology, etc.
Communicate openly about authorship and contributions. See below.
Authorship
We are open within our team about authorship. Prior to submission of any piece that involves Nyaya's work, the first author will email the submission to our team list. Any member who would like to comment on the piece may do so. If a member feels that the research is unethical, misleading, or otherwise misrepresents Nyaya's work, s/he may initiate an open dialogue as to whether the paper should even be submitted at all.
Members will also discuss openly if they feel that they should be included as a co-author. Only those members who meet international standards for authorship will be co-authors on the piece, as stated by the ICMJE (International Committee of Medical Journal Editors):
1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data;
2) drafting the article or revising it critically for important intellectual content; and
3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.
See: http://www.icmje.org/index.html#author
It is the job of the first author (together, as needed and if applicable, with the senior author) to be the arbiter of authorship. The first author will decide whether someone who has requested authorship should be a co-author and the order of all the co-authors. Order of authors is often difficult to navigate and be completely unbiased or just. Order, as with authorship itself, notably does not go simply according to who put the most time or effort into the piece but rather also must take into account the substantive intellectual contributions made by the co-author. The first author will be courteous and respectful and open in dealing with all potential co-authors, including those who have requested to be co-authors but who the first author has decided does not meet criteria. This is not always easy; from the co-authors end, we ask that they be open about their feelings and also be open to listening to where the first author is coming from. In the end, the most important thing is that the piece gets published and honestly a slight difference in the order of the author will not be too important in the grand scheme of things.
Touchy or sensitive discussions should be done in person or over the phone; email is not an appropriate communicative medium for potentially emotional issues. The first author is also responsible for ensuring that all authors declare any potential conflicts of interests BEFORE submission, which is critical to avoid editorial/acceptance problems subsequently.
It is important to note that while this seems somewhat bureaucratic, it really will increase the work load of the first author only minimally, since for the most part members are understanding and saavy and honest about these things. The key to efficiency is openness and communication from the beginning.
Ethics and Organizational Review
At the outset of planning of the research proposal, the researcher must submit the idea to the grants team at grants(AT) to start the dialogue with our grants managerst (see guidelines at Grants). Subsequently, all research must be approved by submission to team(AT) as above. Finally, all research must be approved by the appropriate institutional review boards at the home institution of the Principal Investigator, with the Nepali Health Research Council in Nepal, and with other IRB's as appropriate (which will be under the jurisdiction of the PI and senior author to determine).
Nepal Health Research Council Approval Process
These are guidelines for IRB approval from Nepal
1. Start as early in advance as possible. Delays are highly likely. Also, the proposal is rather extensive.
2. Go to http://www.nhrc.org.np/ and download the "Approval Proposal Format". See SharedNyaya (2)\Research&Pubs\Ethics Review Board Issues for examples.
3. You will need at least one Nepali citizen as a co-investigator.
4. A passport size photograph is required for the PI.
5. Need the signature from the head of department of the PI.
6. After completing the application, contact a Nyaya Kathmandu-based contact to submit a paper copy. You can also try emailing them but best to submit a paper copy. As noted in the instructions, submit an electronic copy as well: either in a CD or floppy disk or via email. Again, CD and paper copy in Kathmandu is best.
7. Follow up by calling them (see contact info below) regarding status of the application.
CONTACT (check website for current info)
http://www.nhrc.org.np/contactus.php
External Researchers
*NOTE IN THE PRESENT TIME NYAYA HEALTH IS NOT OPEN TO NEW RESEARCH PROPOSALS, INTERNAL OR EXTERNAL, WHILE WE PILOT SURGICAL IMPLEMENTATION RESEARCH*
While Nyaya is continually interested in expanding our social network, and involving as many new volunteers as we can accomodate, we must adhere to strict principles in considering research collaborations. Nyaya's priority is first and foremost to our patients, and secondly to the global health delivery community and other stakeholders. There is a significant amount of research that falls under this purview, and in acknowledging this, Nyaya is happy to pariticipate and involve external researchers who are interested in research priorities that offer a particular benefit to the organization and its stakeholders. Nyaya does not have the capacity to offer research opportunities that will not directly benefit the community of Achham or other Nyaya stakeholders, and as such encourage any volunteer interested in collaborating in formal research with Nyaya to contact us ahead of beginning any significant planning. In this vein, Nyaya is usually unable to offer opportunities to fulfill educational requirements, but is willing to discuss on a case-by-case basis.
Given that proposed research is in line with Nyaya's priorities, Nyaya is open to research collaborations with both students and/or external researchers. The following expectations must be met by investigators for research to take place:
- the investigator takes upon him/herself all responsibilities of proposal and study instrument development;
- Nyaya staff will not be responsible for providing mentorship in the development of research proposals, however expect that any investigator have the support of a formal research institution and mentor;
- all proposals and instruments developed externally are subject to revision and/or rejection by the Nyaya team, and should be submitted for formal review before finalizing any plans for travel/funding;
- all follow-up of research conducted is the responsibility of the investigator and will be agreeed upon ahead of study commencement.
Publication Charges
In keeping with our overall open-source mission, we prefer to have publish our work in open-access journals. This often carries publication fees. Upon acceptance of our piece, we should request a waiver on the publication fees on the basis of the fact that we work in a resource-denied setting. This is true for grant-supported research as well, since research dollars are best spent in Nepal. In very uncommon circumstances, where for example a very high impact journal has accepted our piece but refuses to waive the fees and there is grant money that cannot be spent in Nepal, then we can consider using those specific, earmarked grant funds to cover publication fees. Otherwise, we are better off publishing in a different journal; in such cases, our open-access objective would be secondary to our fundamental service and resource redistribution mission within Nepal.
Post-Publication Dissemination
A critical component of the research and advocacy process is post-publication dissemination of the piece via email, blogs, and listserves. Our theory of change in doing research is: do innovative work-->collect, document, analyze, and publish our processes and outcomes-->share results with others-->leverage the work to advocate for policy change. A published piece as such is only the beginning of the global health delivery improvement and advocacy process, and does not represent an end in itself. We cannot allow our work to not be heard and read and effect change; it is in fact our ethical obligation to the folks participating in the research to make sure that the fruits of the research actually reach those individuals in the greatest need. Another perspective is that any successful creative endeavor, from fiction novels to new designs for cars to a medical technology, requires two things: 1) a great product and 2) an effective marketing strategy.
Here's the strategy:
1) Immediately AFTER the embargo period is over, email out to the relevant blogs, listserves, academics, activists, and implementers
2) Document these contacts on the sheet (is private because has contact information):
https://spreadsheets.google.com/a/nyayahealth.org/spreadsheet/ccc?key=0AtZQBHyI2oBYdEZ0VE1sZ3JidGZQNy1kTkJGbTZDd1E&hl=en_US
3) Post on the Nyaya Health blog, email out over the Nyaya Health team list, add to tumblr, facebook
With respect to emailing colleagues, to avoid having all co-authors cc'd on twenty emails, and to encourage personal-ness of these collaborations, we recommend:
1) emailing out an initial private email to colleagues; the ASK here is "please check this out, let me know if you have any interest, send it around".
2) if there is a positive response from that initial email, goal in many cases is to meet that person in person; at this point, it is appropriate to bring other co-authors in, to see if any or all can meet up or discuss further; the ASK here is "let's deepen the dialogue, engage other colleagues"
The point is, that it is critical that we foster our networks, since many of our colleagues share overlapping in their networks, and it is important to be on the same page. At the same time, we should also foster personal (in addition to group) relationships, and respect each others' (overflowing) inboxes).
Additional Notes
Note on General Interest Pieces, Abstracts, and Commentaries
In contradistinction to research studies, general pieces, commentaries, and abstracts can be drafted in near-final form and then sent to the team list. This is because such pieces are typically driven by the first author's time and efforts. The first author is encouraged to send along ideas early on in any stage of development, and to use the ResearchIdeas page collaboratively. Inclusive in these pieces are brief abstracts based on analysis of already collected data that have been open-sourced by Nyaya Health and do not require IRB review. Typically, however, research projects, even involving retrospective open-sourced data, should follow the protocol below in "Note on Research Studies".
The first author will request co-authorship at that time, for example:
All of us have contributed to making this happen, and I want to encourage anyone who feels that s/he would like to be a coauthor and would meet the criteria on our research page to email me personally to let me know (just email me to avoid cluttering the team list).
Note on Research Studies
Prior to conducting the research, the principal investigator must email the team list (this is also for ethical clearance). It is at that time that the principal investigator will offer co-authorship, since, unlike commentaries, much of the work of the research is done prior to the writing of the piece. Members will understand that authorship is assigned at that time, at the onset of the research. Again, while it is important for the principal investigator to do so, for the most part members will understand what their roles are and will only request authorship/participation if they know they will make a meaningful contribution. So for the most part this single email is the only added work on the part of the principal investigator, and it will do significant good in maintaining the open and collaborative spirit of the organization.
Note on Protocols Submissions
Some open-access journals are publishing protocols. On the one hand, these are nice opportunities to engage in transparency and dialogue in an academic setting. On the other hand, it requires work to get these published, and they are not particularly valued by many academic departments or funding agencies. The primary downside is the time involved given the uncertain benefits. The potential benefits of publishing are:
Transparency: Publishing our protocols forces us to put our protocols in a public, peer-reviewed format. However, for transparency, we can certainly publish all our protocols on the wiki.
Dialogue: Protocol publication facilitates dialogue in academic circles, reaching out to groups that may not read our wiki or blog or otherwise be privy to our protocols. Again, however, we can share these protocols with our colleagues via the wiki and blog.
Legitimacy: While many agencies and academics do not value protocols as bonafide publications per se, some colleagues may, and be more likely to comment or provide meaningful feedback if the protocol is already published in a peer reviewed venue.
Given this is a relatively new phenomenon in academic publishing, it is unclear exactly our protocol publishing will pan out. Given this uncertainty, it is worth evaluating individual protocols for the relative merits and de-merits of publishing protocols in a peer-reviewed format. It is unlikely that publication charges would ever be worth it if these are not waived.
Note on Non-Intellectual Contributions
The ICMJE recommends and most Principal Investigators practice that they not include research assistants or other staff UNLESS they made substantive intellectual contributions. This certainly values cognitive contributions over time or physical ones, but that is what professionally the research community has come up with. We should of course work to engage staff members so they can make such contributions. Research is a hugely collaborative effort, and the fact that someone is not a co-author does not mean their work is not valued or that it is not meaningful, simply that their contributions do not merit authorship.
Note on Healthcare Delivery Staff Involvement in Research
In implementation research in particular, the implementation itself, driven by the efforts and professionalism of the healthcare delivery team (both clinical and non-clinical), is critical. However, healthcare staff have clear roles and contracts directed at patient care. They as such should not be co-Investigators, program managers, or research assistants on research projects, unless they have revised contracts that stipulate XX% clinical/XX% research or some other arrangement. Healthcare delivery taff buy-in, cooperation, collaboration, and input are all important, and they can be expected to participate in research debriefs and in research explorations, and they should be allowed to express their concerns about the ethics or logistics or feasibility of research projects, but they should not have specific jobs/tasks/roles in research projects.
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