Clinical Research: Participant Information Sheet, Consent Form, and Procedures

Clinical Research
Clinical Research
Name of the Student
Name of the University
Author Note

1Clinical Research
Contents
Participant Information Sheet:...................................................................................................3
Introduction:...........................................................................................................................3
Purpose of the research:.........................................................................................................3
Type of Research Intervention:..............................................................................................4
Participant Selection:.............................................................................................................4
Voluntary Participation:.........................................................................................................4
Information on Trial Drug......................................................................................................5
Procedures and Protocol:........................................................................................................5
A. Unfamiliar Procedures:.................................................................................................5
B. Description of the Process:............................................................................................6
Duration:................................................................................................................................6
Side Effects:...........................................................................................................................7
Risks:......................................................................................................................................7
Benefits:.................................................................................................................................7
Reimbursements:....................................................................................................................7
Confidentiality:......................................................................................................................7
Sharing the results:.................................................................................................................8
Right to refuse or withdraw:..................................................................................................8
Alternatives to participating:..................................................................................................8
Who to contact:......................................................................................................................8
Certificate of Consent:.............................................................................................................10

2Clinical Research
Consent Form...........................................................................................................................12
References:...............................................................................................................................14

3Clinical Research
Participant Information Sheet:
Introduction:
I am the lead researcher of a research team, working for _________. We are
conducting a Randomized Control Trial that is aimed to study and compare the efficacies of
two forms of treatment for depression, viz. Cognitive Behavior Therapy and administration of
Anti-Depressants. The trial will consist of 200 participants, and will continue for 3 months, to
analyse which treatment shows as being more effective. We would like you hereby invited to
participate in this study. Please note that you may contact me or anyone from the research
team if you have any questions regarding the research, and you can go through the details
provided in this information sheet to decide if you would like to participate in this. You do
not have to make your decision today whether you would like to participate, and your
correspondence is always welcome, if you have any doubts regarding the trial. There might
be certain technical aspects you might have difficulty understanding, in which care I you are
more than welcome to revert to me, and I shall try my best to explain it to you.
Purpose of the research:
Depression is a common mental health condition that affects more than 300 million
people from all age groups around the world. It is one of the leading causes of disability
globally and a major contributor to the overall burden of the disease (who.int, 2018).
Different treatments exists for depression such as psychological and pharmacological
interventions (Li, 2018). The aim of our study is to compare one psychological intervention
(Cognitive Behavior Therapy) with a pharmacological intervention (Anti-depressants) to find
out which strategy is more effective. Results from this trial can be used to inform clinical
decisions in the treatment of Depression.