Write Ethical Considerations, including how you will obtain consent and ensure anonymity .

Description

Title:

Exercise programme using telemedicine to improve glycaemic control in patients living with T2M

Method:

Randomised Controlled Trial

Research Proposal: Write Ethical Considerations, including how you will obtain consent and ensure anonymity (300 words max)

In response to a particular call from a grant awarding organisation (e.g. NIHR), you are a group of academic researchers who have come together to produce a grant application to undertake an investigation into the effectiveness of an intervention for the treatment and/or prevention of a particular disease/condition.

Specific Tasks

1. Identify a Principal Investigator (PI) from within the Group. The PI should be responsible for coordinating the completion of the protocol for your investigation.

2. Agree on the disease or condition that you plan on investigating and whether you are going to apply an intervention for treatment and/or prevention.

3. Agree on the population that you are going to target.

4. Agree on your intervention. This can be a simple, single intervention (e.g. a drug), a multi-component intervention (e.g. diet, exercise & CBT) or a complex intervention (e.g. several components that act along the same or different causal pathways).

5. Complete your study protocol. As a minimum this should include the following sections but you can add additional sections as required:

i. An introduction to your project. What is the context for your investigation? Why is it important that your study is funded?

ii. A detailed methodology, including but not limited to the following:

a. An investigative plan, study design and justification for this design

b. Your study population, inclusion and exclusion criteria

c. Methods of recruitment and sample size

d. Your intervention, including any plans for intervention development (e.g. literature reviewing, public/patient involvement, logic modelling)

e. Methods of randomisation and other procedures for minimising the risk of bias (e.g. blinding, allocation concealment). You may also need to consider any emergency procedures for unblinding

f. Justification of primary and secondary outcome measures and a description of how these will be measured

g. A statistical analysis plan, including details of descriptive and main analysis and any exploratory analysis

h. The monitoring, recording and reporting of side effects, adverse events and serious adverse events

i. Ethical considerations, including how you will obtain consent and ensure anonymity (Your task, 300 words max)

j. Plans for dissemination and public communication

k. References

l. Appendices, including your participant information sheet, a consent form and the completion of a high risk ethics application*

Below is the decided topic:

Title: Exercise programme using telemedicine to improve glycaemic control in patients living with T2M

Method: Randomised Controlled Trial

Research Proposal: Write Ethical Considerations, including how you will obtain consent and ensure anonymity (300 words max) (You Part)

Further Guidance

Protocols should be presented using Arial, font size 12 and double spaced. The word limit for this protocol is 3000, excluding references and any tables or figures.

Protocols should be presented using Arial, font size 12 and double spaced. The word limit for this protocol is 3000, excluding references and any tables or figures.

Wherever possible, your protocol should be supported by the use of guidelines that ensure consistency with regard to reporting

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