Informed Consent form for men and women who attend eye clinic , and who we are inviting to participate in research. The title of our research project is “Comparison of Antibiotic-only and Antibiotic-steroid Combination Treatment in Bacterial Keratitis Patients: Double-blinded Randomized Clinical Trial.”
Name of Principal Investigator : Silvia Fransisca
Name of Organization : Department of Ophthalmology, First Affiliated Hospital Nanjing Medical University
This Informed Consent Form has two parts:
• Information Sheet (to share information about the research with you)
• Certificate of Consent (for signatures if you agree to take part)
You will be given a copy of the full Informed Consent Form
PART I: Information Sheet
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Voluntary Participation
Your participation in this research is wholly voluntary. It is your choice whether to participate or not. Whether you choose to participate or not, all the services you receive at this clinic will continue and nothing will change. You may change your mind later and stop participating even if you agreed earlier.
Information on the Trial Drug [gatifloxacin (Zymar) and dexamethasone 0.1% (Maxidex)]
The drug we are testing in this research is called gatifloxacin (Zymar) and dexamethasone 0.1% (Maxidex). Maxidex is usually given or being combined after patiens use Zymar for 2-3 weeks. This second research is called a "phase 2" trial.
The drug Maxidex is used to treat certain eye conditions due to inflammation or injury, it works by relieving symptoms such as swelling, redness, and itching. Rarely, stinging/burning of the eyes for 1 to 2 minutes may occur when you apply this medication. We know of no other problem or risks.
Some participants in the research will not be given the drug which we are testing. Instead, they will be given only the drug Zymar, the drug which is most commonly used in this region with no combination with the drug Maxidex. There is no risk associated with that drug and no known problems.
Procedures and Protocol
A. Unfamiliar Procedures
Because we do not
Every patient has a right to decide on their own course of treatment and freely consent to that treatment. In order to make an educated decision they must be provided with the proper information to make an informed choice (Opinion 8.08 - Informed Consent, 2006). It is the physician’s legal and ethical obligation to provide this information when making their recommendation on treatment. The choices given must be in accordance with good medical practice (Opinion 8.08 - Informed Consent, 2006). The informed consent is the legal policy, either written or verbal, that gives full disclosure of all the information including potential risks that is applicable to the patient’s condition and treatment being offered (Kazmier, 2008).
Explain how and why the concept of informed consent is critical to issues of euthanasia (active and passive) as well as physician-assisted suicide. Informed consent is a process for getting permission before conducting a healthcare intervention on a person, autonomy at its best. In physician assisted suicide we have the informed consent of the patient requesting the help to die. In this instance the patient is the direct cause or their own death, they just require the physician to help them get the medicine needed to end their life, they decide where and when to do it, and they are competent when making this decision. This is important when it comes to the law and the physician possibly being sued. In active euthanasia the physician gives
No clinical interaction studies have been performed, so caution is advised when ceftobiprole is administered together with drugs with narrow therapeutic indices.
3) Compared two drugs of interest. 4) Have similar groups, allocation concealment, baseline validity and reliability of measures in order to eliminate bias of studies 5) Have low risk of bias. 6) Patients that receive medication treatment within twelve months after diagnosis. The strength of evidence was graded as high, moderate, low or insufficient based on established guidelines on four criteria: a) Risk of bias b) Consistency c) Directness d) Precision
INFORMED CONSENT : Valid consent is impossible. To date, foetal tissue transplants have been handled as any other organ transplants under the UAGA, thus requiring consent of next of kin. The mother cannot give morally legitimate consent, since she initiated the termination of the pregnancy. Elimination of consent, however, would further turn the unborn child into an object; it would be inconsistent with the fact that, biologically, the developing foetus does not interpret the woman’s tissue. The UAGA and the NIH Panel both fail to discern the conflict between normal organ transplants and the function of foetal tissue. In the instance of foetal tissue, the mother is presumed to be the one who gives consent to the use of the tissue for the transplant (or for some other kind of experimentation). Granting to the normal understanding of proxy consent, her role assumes that she is working in the best interest of the unborn child. However, she is also the one who has initiated the final termination of pregnancy. Just quoting the part of the act dealing with informed consent stated in the NewZealand legislation
Note: No consent was necessary because we reviewed only the patients' records and no patient personal data was taken. This study approved in accord with IRB standards.
Patients who are eligible for the study and provide written informed consent will randomized to one of two groups, 90 mg dose of Dextromethorphan (twice a day) or the placebo on a 1:1:1 basis. The trial will utilize Clinstat, a free, statistical software, to perform randomization of patients. The random number generation will assign all the participants to the treatment or placebo group by generating a number that corresponds with Dextromethorphan or the placebo. An outside committee that has no interest in the study and is not connected to anyone conducting the study will be responsible for the allocation of participants. This will limit the risk of introducing bias into analyses and results.
The notable similarities among the two different types of informed consent forms are that they include the provisions of services, fees, benefits/risks, and confidentiality between client/counselor. The dissimilarities include the counselor’s qualifications, credentials, relevant experience, and approach to counseling or psychotherapy.
The nature of their study was a prospective double blind randomized clinical trial study. Double blind studies are ‘experiments designed to test the effect of a treatment or substance by using groups of experimental and control subjects in which neither the subjects nor the investigators know which treatment or substance is being administered to which group’ (Farlex Partner Medical Dictionary, 2008). The aim of the study was to compare the effects of glucosamine alone and combination of glucosamine and alendronate administration to treat knee osteoarthritis. Arti and Azemi aimed to test the hypothesis that combination
“Researchers refer to populations which have low autonomy as "vulnerable populations"; these are groups which may not be able to fairly decide for themselves whether to participate in clinical trials. Vulnerable populations include…the incarcerated/detained, children, women, prisoners, soldiers, migrants, mentally insane or any other condition which precludes their autonomy, and to a lesser
Informed consent is the basis for all legal and moral aspects of a patient’s autonomy. Implied consent is when you and your physician interact in which the consent is assumed, such as in a physical exam by your doctor. Written consent is a more extensive form in which it mostly applies when there is testing or experiments involved over a period of time. The long process is making sure the patient properly understands the risk and benefits that could possible happen during and after the treatment. As a physician, he must respect the patient’s autonomy. For a patient to be an autonomous agent, he must have legitimate moral values. The patient has all the rights to his medical health and conditions that arise. When considering informed
The next step is we should Set up and implement the SOP. Prior to submission of the protocol to the IRB and/or to an external funding agency, the investigator should meet with the clinical research pharmacist or designee to review the feasibility of the proposed protocol. (prep course#14 advanced good clinical practice)The study protocol, as well as all requirements for study drug preparation should be reviewed. Because the consent and assent documents are highly dependent on the content of the protocol, their development will begin as soon as the protocol procedures and study-associated risks are well described. A quality assurance unit does the systematic and independent examination of all trial-related activities and documents which determines whether the evaluated activities were appropriately conducted and that the data were generated, recorded, analyzed, and accurately reported according to protocol, standard operating procedures and good clinical practices. (Advanced good clinical practice). A safety oversight review is to be conducted to independently assess the safety data (e.g., adverse events and unanticipated problems) as well as study progress (e.g., recruitment and enrollment), study conduct (e.g., protocol deviations), and key data elements determined on an individual study basis. (national institute of dental and craniofacial
However, should you find any part of this experiment objectionable for any reason; it is your right to discontinue participation and to withdraw from the study. Participation in this research project is completely voluntary. You have the right to say no. You may change your mind at any time and withdraw. You may choose not to answer specific questions or to stop participating at any time. If you choose to withdraw at any time from this study you will not receive extra credit.
Many patients need not only a preventive or reactive drug, but adapted a combination of both types of drugs in order to allow maximum relief of their disease. Most doctors agree that the result for maximum relief of the minimum amount of medication
It is now accepted worldwide that before a drug is brought into routine use its efficacy, safety, and the balance between two need to be formally demonstrated. The efficacy of new drugs nowadays is almost invariably established with a technique known as ‘randomized controlled trial’.