Basic Principle of All Medical Research[1].pptx

Principles
Risk, Burden and benefits
Vulnerable group/individual
Scientific require and research protocols
Research Ethical Committee
Privacy and Confidentially
Informed Consent
Result

Risk, Burden and benefits

Objective of the study to overcome risk.
Risk > modify/stop study
Monitored, assessed, documented, managed

Vulnerable group/individual
Increase chance additional harm- protection should be done
Assent should be obtained from minors, if child able to do so
Vulnerable group - (pregnancy, sensitive, children, elderly, psychological issues)
Scientific require and research protocols
Before human study-scientific literature, lab and animal experiment
Statement-regarding funding, sponsors, institutional afflation's, potential conflict of interest - submitted
Research involving humans must confirm to generally accepted scientific principles and thorough knowledge of scientific literature and methods
Literature review and animal exp prior conducting human research provide scientific evidence, base

�Research Ethical Committee�
Before study (faced prior) - designs, no bias. follow National/International ethical norms
Research submit- final report with study findings and conclusion in end of the study
Research protocols should be reviewed by an independent committee and conduct by medically/ scientifically qualified individuals
Main aim is the participant health, Introduction of ethical committee, responsibility to check again and again (follow adherence), increase revolutionary decision.
If not they have a reason to stop/declared invalid


�Privacy and Confidentially�
Human subjects and information
Dignity, privacy, confidentiality and life of participants should be protected.
Every precaution should be taken to respect privacy, confidentiality and participant's physical and mental integrity

�Informed Consent�
Inform the human subjects (Aim/method/conflict of interest/function/general outcome of study/ voluntary (freely agrees),legally authorative representative.
Participants must be volunteers and informed in research project.
Informed consent in writing and participant should be informed about each intervention.

�Result�
Investigators are obliged to preserve the accuracy of results, negative and positive results should be publically available

1. Basic Principle of All Medical Research Priyadarshini J.L. College of Pharmacy, Electronic Zone Building, M.I.D.C., Hingna Road, Nagpur-440016 2022-23 Presented By Swapnil S. Tirmanwar Dept. of Pharmacognosy

2. Principles Risk, Burden and benefits Vulnerable group/individual Scientific require and research protocols Research Ethical Committee Privacy and Confidentially Informed Consent Result

3. Risk, Burden and benefits Objective of the study to overcome risk. Risk > modify/stop study Monitored, assessed, documented, managed

4. Vulnerable group/individual Increase chance additional harm- protection should be done Assent should be obtained from minors, if child able to do so Vulnerable group - (pregnancy, sensitive, children, elderly, psychological issues)

5. Scientific require and research protocols Before human study-scientific literature, lab and animal experiment Statement-regarding funding, sponsors, institutional afflation's, potential conflict of interest - submitted Research involving humans must confirm to generally accepted scientific principles and thorough knowledge of scientific literature and methods Literature review and animal exp prior conducting human research provide scientific evidence, base

6. Research Ethical Committee Before study (faced prior) - designs, no bias. follow National/International ethical norms Research submit- final report with study findings and conclusion in end of the study Research protocols should be reviewed by an independent committee and conduct by medically/ scientifically qualified individuals Main aim is the participant health, Introduction of ethical committee, responsibility to check again and again (follow adherence), increase revolutionary decision. If not they have a reason to stop/declared invalid

7. Privacy and Confidentially Human subjects and information Dignity, privacy, confidentiality and life of participants should be protected. Every precaution should be taken to respect privacy, confidentiality and participant's physical and mental integrity

8. Informed Consent Inform the human subjects (Aim/method/conflict of interest/function/general outcome of study/ voluntary (freely agrees),legally authorative representative. Participants must be volunteers and informed in research project. Informed consent in writing and participant should be informed about each intervention.

9. Result Investigators are obliged to preserve the accuracy of results, negative and positive results should be publically available

10. Thank You