Question

Draft a sample consent form using the following assumptions: Hytril is an investigational antihypertensive agent being studied as a once a day agent (10mg) in patients with mild hypertension. The study is 8 weeks long and is placebo controlled. Enrollment will be approximately 150 patients over 6 months. Side effects include: headache, nausea, and skin rashes. This agent can lower blood pressure 15% and has been approved for use in Europe. The investigator is Dr. Pressure and the IRB is called Quantus. Subjects will receive no compensation for this trial. All other data required may be made up by the student. The format, which you chose is up to you. You may use paragraph form or question and answer style. Make sure the elements of informed consent are contained in the draft.

No plagiarism please

Answer 1

This form will give to required information about this study, reason for conducting this study and possible risks and benefits. Read it carefully and discuss your doubts and ask questions to the researchers.

If you decide to take part in this study, you have to sign this form and will be given copy of this form.

Title - Study to establish the effectiveness of Hytril in patients with mild hypertension.

Background - This study is sponsored by IRB. There is no specific guarantee that this study will control your hypertension. Outcome of this study may help to improve the life of others depending on the results of study.

You can ask questions or leave the study - All participants can ask questions clear the doubts. As participation in this study is voluntary, you can leave the study anytime by informing the researchers.

Method of study - once you sign the consent to participate in study, all participants will be divided into two groups.

Group 1 - will be given table Hytril 10 mg per day for 8 weeks.

Group 2 - second group will receive the placebo.

Member of our team will meet you and explain all the details regarding the group you included.

Scheduled visits and taking of medicine -

You will be required to take medicine for 8 weeks daily one tablet. In between your blood pressure will be monitored routinely. You can also be contacted via phone to know about any side effects you are having or any other concerns you have during the study.

Study evaluation -

At every follow-up visit will include several surveys for you to
complete that may be on paper or asked by the study staff. The surveys will help our team evaluate the
different effects of drug on blood pressure each group at the end of the study.
The surveys for this study will ask questions about:

1. Any improvement you have noticed in your health.

2. Any side effects you have faced during the study.

Risk and side effects-

There are few side effects of the drug like headache, nausea, and skin rashes. If you notice anything unusual, you must inform the research team as soon as possible.

Possible benefits-

Participation in this study may lead to better control of your blood pressure. Although there is a chance that you may not get any benefit form the study.

Privacy and confidentiality-

Your confidentiality is one of our main concerns. We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy.

Ending you participation-

If you fail to follow the directions or suffer nay side effects our team may ask to leave you from study.

Compensation-

You will not be paid for participating in study, neither you will be reimbursed for any expenses you do for participating in this study.