research protocol By Sandeep.pptx

Medical Research Protocol
Thesis Protocol

1. Developing Research Protocols Dr. Sandeep Singh Jadon G.R.Medical College,Gwalior,M.P.

2. Learning Objectives ❖Definition of Research ❖What is Clinical Research Protocol ❖Why Protocol is required ❖Parts of Protocol ❖What is protocol violation

3. Definition of Research Research is a systematic collection, analysis and interpretation of data to answer a certain question or solve a problem. What is Clinical Research Protocol A research protocol is a formal written record that one prepares BEFORE research fieldwork is undertaken.

4. Why a Protocol To clarify the research question To compile existing knowledge To formulate a hypothesis and objectives To decide about a study design To clarify ethical considerations To apply for funding

5. Parts of Protocol Study Title • Should be concise and descriptive. • Must be informative and catchy. • The hypothesis to be studied can be included. 2) Introduction Problem statements Background Rationale Aims and objectives of the study

6. 3) Methodology Research design Data sources Sampling procedures – size and technique Data gathering instruments to include validity testing and pilot study Procedures Data analysis Ethical considerations 4) Study time frames and budget 5)References 6)Appendices

7. Ethical framework for Health Research Any research involving human participants should follow international standards of ethics. Indian national standards are not less exacting and Indian ethical guidelines are on par with international guidelines. Ethics review is also expected in situations involving no risk when available data are used or minimal risk such as when only questions are asked, no samples/ other specimens are collected

8. I nd ia n C ou n ci l o f M e d ica l R e s ea r c h i n t r o d uce d E thica l G ui d e l i n e s f o r R e s ea r c h o n H u m a n P a r t icipa nt s NATIONAL GUIDELINES 2000, ICMR guidelines All institutions in the country which carry out any form of biomedical research involving human beings should follow these guidelines in letter and spirit to protect safety and well being of all individuals. 2006, Revised ICMR guidelines There are several other national guidelines available Genome Policy and Genetic Research [2000], Indian GCP [2001], Amendment of Drugs and Cosmetics Act [2002], Assisted Reproductive Technology [2005], Stem Cell Research and Bio-banking [2006]

9. R a ng e o f e th i c a l iss u e s tha t nee d t o b e a dd r e ss e d i n he alt h r e s e a r c h Competence of the researchers and the research team Provisions for protection of human rights and ethical issues: vulnerable populations , women and children Measures for protecting confidentiality and non-discriminatory practices Appropriateness of Informed consent and study specific educational material

10. R a ng e o f e th i c a l iss u e s tha t nee d t o b e a dd r e ss e d i n he alt h r e s e a r c h Mechanisms for reporting and management of adverse events and serious adverse events Care and support for research participants - standard of care, long-term care, post -trial access to care . Reimbursement and compensation Continuing review of progress of the study

11. C h e c k li s t f o r P ub li c a t i o n E t h ic s Approval and consent Pla g i a r i sm and Self- Pla g i a r i sm Approval of the regulatory authorities, Institutional Review Board and Ethics Committee Registration of clinical trial Documentation of Informed Consent Data Accuracy F a l s i f i c a t i o n Fabrication Any manipulation of material, equipment, process or data Any lurking fake data Double check for data accuracy Use of your own prior work or others work Have written permission for reproduced material, figures or tables If so addition of citation

12. C h e c k li s t f o r P ub li c a t i o n E t h ic s Submission Fraud Ethics of A u t ho r sh i p Conflict of Interest Simultaneous submission to two journals Previous publication of entire work or part of content(s) Excessive citation of own publication Inclusion of all authors in a specific pre- agreed order Agreement & awareness of co-authors of contents Inclusion of any ghost or guest author Declaration of relevant interests and relationships could be seen as influencing the research findings both financial and scientific

13. Plagiarism Use of previously published manuscript by someone for his/ her manuscript or unreferenced use of other’s published and unpublished ideas without consent, credit, or acknowledgement Most common form of plagiarism is copying text word-for-word Considered as serious publication misconduct

14. Types of Plagiarism Direct Plagiarism Complete or partial copying without acknowledging the original author Self-Plagiarism Duplicates of previous works or sentences Redundant publications ('salami' publications) Publishing similar manuscripts/reports based on the same experiments

15. How to avoid plagiarism? Avoid “copy-paste” Write the concept in own words-spend more time Acknowledge original sources (Even unpublished works) Cite references accurately Avoid writing several articles of the same type Use anti-plagiarism software tools like ‘ URKUND’, ‘ Ithenticate ’ or ‘ Turnitin ’ etc. (as per University norms)

16. Penalties in case of plagiarism in submission of thesis Institutional Academic Integrity Panel (IAIP) shall impose penalty considering the severity of the Plagiarism. i ) Level 0 : Similarities upto 10% - Minor Similarities, no penalty. ii) Level 1 : Similarities above 10% to 40% - Such student shall be asked to submit a revised script within a stipulated time period not exceeding 6 months. iii) Level 2 : Similarities above 40% to 60% - Such student shall be debarred from submitting a revised script for a period of one year. iv) Level 3 : Similarities above 60% -Such student registration for that programme shall be cancelled.