Anticipated Start Date (The work will start after completion of all necessary approvals)
Duration of the study:
Submission Type:
This protocol is for:
The protocol was reviewed by scientific reviewing committee:
Literature Search for Duplication:
What is the time period covered by the search:
Funding Agent:
Fund amount:
Keywords in the search and Acronyms or abbreviations used:
Research Team Information and the process he/ she is responsible
Subject Area:
Primary Objective (s)
Secondary Objectives
Hypothesis, Rationale and Scientific Validity
Background
Procedure in Details
Sample size and groups
Explain how did you calculate the sample size?
Gantt and Flowcharts
N/A
N/A
Does this protocol involve the use of substances that may pose any health risk (infectious, carcinogenic, toxic, bacteria, viruses, fungi, parasites, cell lines, primary cells, tissue, fluids, blood, recombinant DNA, chemicals, laser or radiation) to humans?
List of References
Application for Research Studies using Medicinal Plants (Wild or Cultivated)
what is the social value of this research
what is the scientific validity
what is the environmental advantage in the future
what is the economic benefits
How to conserve the plant, if it is rare and possesses a valuable biological importance
In case of biotechnological plant researches, you should clarify the difference between the biological activity of natural plant fractions or compounds versus the genetically modified plant
In the event of important new findings, to whom the Intellectual Property Rights will belong to
Acute toxicity
LD50
Effective dose
Side effects
The site and date of collection of plants
The taxonomical identification of plants by specialized Taxonomist
Which part of the plant will be used (i.e., plant organ(s) used in the research)
The safety procedures taken to protect or mitigate the side effects of herbal extracts, fractions or compounds
The efficacy of herbal samples
Consent form
Purpose of the Waiver Request: Briefly state or summarize the purpose of this waiver
Type of Waiver of Informed Consent Request
List of identifying information you plan to collect or keep a link to
Explain why the research could not practicably be conducted without the waiver or alteration
Please detail your reasons for a waiver to consent below
Explain why the research and privacy risk of the research are no more than minimal
Describe the measures you will take to ensure the waiver or alteration will not adversely affect the rights and welfare of the subjects
Explain how you will, if applicable and appropriate, provide the participants with additional pertinent information after they have participated in the study, or indicate "Not Applicable"
