Research

Standard Operating Procedure of Research Committee

Introduction

The purpose of developing Standard Operating Procedure (SOP) of the Research Committee at Sri Manakula Vinayagar Medical College and Hospital is to give a clear idea to undergraduate/post-graduate/faculty researchers about its proposal processing pathway. The Research Committee at Sri Manakula Vinayagar Medical College and Hospital consists of faculties from pre-clinical, Para-clinical and clinical disciplines. The Research Committee aims to offer timely and complete critical appraisal to the submitted research proposals and offer technical guidance to those who submit their proposals for its review. The review of the submitted research proposals is an in-house exercise, where an attempt is made to assess its feasibility, to improve relevance to the local context, technical quality and ethical aspects of proposed research. We encourage Good Clinical Practice and Good Authorship Practices at Sri Manakula Vinayagar Medical College and Hospital. Hence, SOP is developed with a following objective –

To ensure that the proposed research has relevance in the present context and that it is technically sound and meets ethical standards.

In order to achieve the above mentioned objective, following activities are done to -

Develop the procedures for processing the submitted research proposals
  1. To offer guidance to RC members and investigators as how to review and receive comments respectively
  2. Conduct periodic research methodology trainings to empower students and faculty on relevance, technical quality and ethical aspect of the research.
  3. Define a policy for funding institutional research at Sri Manakula Vinayagar Medical College and Hospital
  4. Workout authorship guidelines for researchers at Sri Manakula Vinayagar Medical College and Hospital
Composition of the Research Committee

The committee consist of members from various clinical, pre and para clinical departments, who have the qualification and experience to review and evaluate the scientific, ethical and legal aspects of research projects. We have members who are professionally trained in quantitative and qualitative research methods. Members are also trained to review the ethical issues and offer guidance to the researchers.

The Committee will ensure that their members receive initial and continued education in research ethics and science, and are kept aware of current issues and developments in the broad area of ethics and science.

Meeting and quorum requirement

The meetings are flexible depending on the number of projects submitted or the need to review post-graduate thesis proposals.

Recording of the discussion

The minutes of the meetings are recorded. The members are given a template to note down their comments. Later on, comments for each proposal are compiled and communicated to the concerned investigators.

Guidance for the Investigators: How to develop the research proposal?

The investigators are advised to develop their proposals as per the pre-specified checklist (see Annexure 1). The proposal should be developed under the following titles

Introduction

The proposal should have an “Introduction’ section which states the ‘need’ for the present study. It should have a brief note on what is known to the science on the given topic and what ‘new’ will be added by doing the present study. It should state as how this study is going to benefit the current state of practice/medical care/education etc.

A brief review of literature

It should include some known facts and some existing gaps in the knowledge. It is better to review the recent articles from the indexed journals. An attempt should be made to know as what is happening at international level, national level and regional level. It should also explore the strengths and limitations in the previously reported studies.

Objectives

‘Objectives (Primary and Secondary) of the students’ should be clearly defined.

Material and Methods

In the ‘Methods’ section, please define the setting (Laboratory/hospital/community/college) in which the present study will be done. Also, specify under which Department the proposed study will be done.

Study design

Please specify the study design

Study participants/subjects

Human/Animals/Laboratory samples/Secondary data

Sample size

In quantitative research, sample size should be worked out on the basis of a ‘primary outcome’ of the study and justified. It is better to avoid feasible sample/convenient sample in quantitative research as it affects its external validity. In qualitative research, type of sample and sampling should be worked out and described.

Sampling procedure

Once the sample size is decided, then that sample should be selected from a suitable ‘sampling frame’ by using some random selection methods, where every study participant has equal probability of getting into the study. Sampling procedures and the study period should be defined. In case of clinical trials, the details related to ‘Phase’ of the trial, randomization and blinding should be given.

Measurement

Develop a tool which is reliable and valid i.e. It measures what you want to measure more accurately. Follow standard questionnaire development practices. Please check copyright/permission issues if you are using a standard questionnaire. The details of study participants such as age, gender etc. should be mentioned.

Ethical issues

Please mention the ethical issues you are expected to face and your strategy to minimize any potential harm. Please follow guidelines on Good Clinical Practice (GCP) while conducting clinical trials and CPCSEA guidelines in the conduct of animal experiments. The consent forms for research on human subjects should have an informed consent form as per given template (see Annexure 2). Please follow Consolidated Criteria for Reporting Qualitative Research for conducting and reporting qualitative researches (Tong A, 2007). We encourage researchers to anticipate ethical issues in the proposed research and try to address it in its design and data collection.

Analysis

The details of the study variables to be measured and the appropriate statistics (test of significance, level of significance) should be given. Analysis plan should be clearly worked out at the time of proposal development. Please mention the name of statistical software to be used for analysis of proposed study data. Please consult and acknowledge the biostatistician or epidemiologist during the phase of proposal development.

How to submit the research proposals?
  • Please submit one hard copy of research proposal with the completed checklist and a covering letter (Annexure 4) to the member secretary of Research Committee.
  • Please check the content of proposals as per points in the checklist and then check the box.
  • Also, submit a soft copy of the proposal as a single file to email ID - smvmchresearch@gmail.com.
  • Please make sure that a soft copy of the proposal is submitted before the submission of hard copy to the member secretary of Research Committee..
Presentation of proposal at RC committee meeting

Investigators are invited to present their proposed research work at a scheduled RC meeting. Investigators are advised to make a PowerPoint presentation of not more than seven minutes as per the template prescribed by the RC. It is mailed to the concerned presenters once they submit a soft copy to the above mentioned email ID. There will be three minutes time for questions and clarifications. The RC members will receive the soft copies of all research proposals on their respective email IDs. In the RC meeting, the members will have to review the proposals as per review template given for the research on humans (Annexure 5) and animals (Annexure 6).

There are separate review templates for research based on humans and animals. Once the presentation of the Investigator is over, the members can write their comments in the respective review templates. The members may obtain these templates from the RC member secretary quite before the RC meeting if they wish to finish the review before attending the meeting.

Comments by the RC members

Investigators are encouraged to note down the comments of the RC members during the presentation. However, all the presenters will receive the complied comments in a written communication within a week after the presentation at RC meeting is over.

How to submit the revised proposals?

Investigators have to revise their proposals in the light of comments given by the RC members. Apart from this, investigators have to respond to each comment point wise as per the given response template (Annexure 7) and make the corresponding changes in the proposal.

StepsResearch

Fig-1:Processing of Research Proposal by Research Committee, SMVMCH

Policy for Research Scholarships at SMVMCH, Pondicherry

Purpose of the Research Funding

The purpose of research scholarships is to promote research leading to publication of original research papers by students and faculties in indexed scientific bio-medical/health journals. However, we encourage students, post-graduates and faculties to apply for funding at various regional, national and international level.

Research by the undergraduate students
  1. Undergraduate investigators who have obtained clearance from the research committee, SMVMCH and the ethics committee and those who did not get funding under ICMR- STS program may apply for funding.
  2. The maximum funding amount will be 5000 INR
  3. Projects will be shortlisted depending on its scientific merit and publication potential
  4. Investigators will have to submit their completed project report and publications related to work done to coordinator of the Research Committee.
Research by the postgraduate
  1. No scholarship for mandatory assignments such post-graduate dissertation will be offered
  2. Any research project, apart from thesis work and mandatory requirements will be considered for a scholarship which is subject to clearance from the Research committee and the ethics committee.
  3. The maximum funding amount will be 25,000 INR where 20% amount will be released after the publication of the article (based on work done) in an indexed Journal.
  4. Projects will be shortlisted for funding based on its scientific merit, compliance to comments given by research committee members and its publication potential.
  5. Investigators have to submit their completed project report and related publications to coordinator of Research Committee. Standard Operating Procedure of Research Committee, SMVMCH, Pondicherry
Research by the teaching Faculties
  1. The maximum funding amount will be 30,000 INR where 20 % amount will be released after the publication of the article (based on work done) in an indexed Journal.
  2. Scholarship is subject to clearance from the research committee and the ethics committee.
  3. Projects will be shortlisted for funding based on its scientific merit, national or regional, or local relevance of topics, compliance to comments given by research committee members and its publication potential.
  4. Investigators have to submit their completed project report and related publications to coordinator of the Research Committee.
Decision-making body

The sub-committee for research at SMVMCH will recommend the shortlisted projects for funding approval by Management of SMVMCH. Acknowledgement for funding should be mentioned in all the publications. Refer to Annexure 8 for application to seek funding.

Authorship Guidelines for Researchers at SMVMCH, Pondicherry

The reason for this authorship guideline is to –

Offer technical information and promote good authorship practices among researchers at SMVMCH and avoid duplication of efforts

It is based on the recommendations of the International Committee of Journal Editors, Journal of American Medical Association and FAIMER guideline for authorship.

International Committee of Medical Journal Editors (ICMJE), also known as Vancouver group, 2001, states that – Authorship credit should be based on:

  1. Substantial contributions to conception and design, or 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

Conditions 1, 2, 3 must all be met. Acquisition of funding, the collection of data, or general supervision of the research group, by themselves, do not justify authorship.

To reduce the incidence of authorship problem, we encourage following tips for all the researchers at SMVMCH (COPE report, 2003).

  1. Encourage a culture of ethical authorship – Good authorship practices should reduce the incidence of such dilemmas. Each department library should have a book on publication ethics and there should one post-graduate seminar on publication ethics.
  2. Start discussion on authorship when you plan your research – It is better to decide the team to begin with and gather views of all team members and if possible discuss authorship at a face-to-face meeting. Continue to discuss ideas about authorship as research work progresses, especially if new people get involved. Keep a written record of your discussion and decision.
  3. Decide authorship before you start writing each article/case report – Ensure good communication to avoid misplaced expectations and poor communications. Ideally there should be a face-to-face meeting where it is confirmed who will do what – and by when. Keep everyone informed of changes, if any.
  4. Review by Research and Ethics Committee – Please ensure the clearance of your research proposals from the Research Committee and the Ethics Committee of SMVMCH. It is expected to strengthen technical and ethical dimensions of your research proposals.
  5. Informed consent Please obtain informed consent and retain its details. In a case report, consent for publication in print and electronically must be obtained from the patients. Please prepare your consent forms in the prescribed format as recommended by the Research and Ethics Committee of SMVMCH.
  6. Consider author contribution All authors must have made an individual contribution to the writing of the article and not just been involved with the patient's care.
  7. Individuals just involved in the patient's care (including diagnosis and management) should be listed in the acknowledgements.
Authorship disputes – how to handle it?

The team should have a written authorship agreement before the article is written. We recommend authors to follow authorship criteria followed by The Journal of American Medical Association, July 2007 to decide authorship. We also recommend to follow a rubric provided by Francois Cilliers, 2007 to decide the order of co-authorship. Disagreement about authorship can be classified into two types: those that do not break ICMJE guidelines (disputes) and those that do (misconduct).

(a) Disputes – It is a question of interpretation. In this case, you may discuss with the people involved and the supervisor/any senior person involved in the study/Head of the Department. Consider or support your discussion or opinion with the evidences such as laboratory notebooks, manuscripts, ICMJE statement, Instructions to Authors etc. If you remain unhappy with the supervisor’s decision, you may approach to the Research coordinator of the Research Committee at SMVMCH. But you should do this in exceptional circumstances only and other researchers are well informed about what you're intending to do.

(b) Misconduct – If you notice or experience some scientific misconduct, please bring it to the notice of the Research Committee of SMVMCH.

Authorship Criteria

Rubric provided by Francois Cilliers, 2007

Authorship of any work resulting from this research will be determined by means of the following authorship index

Co-authorship scoring system: Each coauthor (s) completes a self-assessment form indicating individual contribution and is encouragedto complete a form for each member of the team.

Intellectual Input

(Planning/designing/interpretation)

Literary Input

(Contribution to first complete draft of manuscript)

No contribution 0 No contribution 0
One detailed discussion/correspondence 5 Edited others’ material 5
Several detailed discussions/correspondence 10 Contributed small sections 10
Longer meeting/ correspondence 15 Contributed moderate proportion 15
Substantial liaisons 20 Contributed majority 20
Closest possible involvement 25 Contributed virtually all 25
Practical Input

(setting up/observing/recoding/abstracting)

Specialist Input From Related Fields
No contribution 0 No contribution 0
Small contribution 5 Brief or routine advice 5
Moderate indirect contribution 10 Specially-tailored assistance 10
Moderate direct contribution 15 Whole basis of approach 15
Major indirect contribution 20
Major direct contribution 25
Practical Input: Beyond DataCapture

(data processing/organization)

No contribution 0
Minor or brief assistance 5
Substantial or prolonged assistance 10

Whoever achieves a total of 25 points will be offered joint authorship in rank order of total score. In the event of ties, recent near misses will be considered. If none exists, alphabetical order may be used.

Note for authorship in case report: In the past, it was acceptable to include as authors those contributing to the management of the patient, but this is no longer true. Currently, it is expected that the authors contribute significantly to the intellectual content of the case report. Keep in mind that the best case report abstracts are those that make a small number of teaching points (even just one) in clear and succinct language. (American College of Physician, Personal Communication with Dr Gitanjali, JIPMER, Pondicherry 2013)

Criteria for Authorship used by the Journal of American Medical Association, July 2007

Each author should meet all criteria below (A, B, C, D) and should indicate general and specific contributions by checking the appropriate boxes.

I certify that Agree

A1. The manuscript represents original and valid work and that neither this manuscript nor one with substantially similar content under my authorship has been published or is being considered for publication elsewhere, except as described in an attachment, and copies of closely related manuscripts are provided:

A2. If requested, I will provide the data or co-operate fully in obtaining and providing the data on which the manuscript is based for examination by the editors or their assignees;

A3. For papers with more than one author, I agree to allow the corresponding author to serve as the primary correspondent with the editorial office, to review the edited transcript and proof, and to make decisions regarding the release of information in the manuscript to the media. If I am the only author, I will be the corresponding author and agree to serve in these roles

B.I have given final approval of the submitted manuscript.

C.I have participated sufficiently in the work to take public responsibility for (Check one)

Part of the content............... b. All of the content............

To qualify for authorship, you must check at least 1 box for each of the 3 categories of contributions listed below

D1. Conception and design....................... 
Acquisition of data....................... 
Analysis and interpretation of data....................... 

D 2. Drafting of the manuscript....................... 
Critical revision of the manuscript....................... 
D3. Statistical analysis....................... 
Obtaining funding....................... 
Administrative, technical or material support....................... 
Supervision....................... 
No additional contributions....................... 
Other (specify)....................... 
Acknowledgement

We are grateful to the faculty members of the research committee for giving their valuable comments to improve these guidelines. We are especially thankful to Dr. Gitanjali, Professor in Pharmacology JIPMER, Pondicherry and Shital Bhandari, Patan Academy of Medical Sciences, Nepal for their critical review and inputs.

References
  1. International Committee of Medical Journal editors. Uniform requirements for manuscripts submitted to Biomedical journals: Writing and editing for Biomedical Publication. [online] Accessed on 7 March 2013 ; URL: www.icmje.org
  2. Cillers F.Authorship criteria, references and copyright issues. 2007 [obtained from a colleague at a meeting number of years ago] . The table in FAIMER Educationl Scholarship Toolkit, Alpha Version , p.51
  3. Journal of American Medical Association. The pertinent table is in FAIMER Educational Scholarship Tolkit, Alpha Version, and p.52.
  4. Albert T. How to handle Authorship disputes: a guide for new researches. COPE Report 2003. [online] [Accessed on 7 march 2013] ; URL: publicationethics.org/files/2003pdf12.pdf
  5. Writing a clinical vignette abstract. ACP [online] [Accessed on march 7 2013]; URL: http://www.acponline.org/residents_fellows/cometitions/abstract/prepare/clinvin_abs.htm
  6. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ) 32 item checklists for interviews and focus groups. International Journal for quality in health care. 2007; 19:349-357.
Annexure