INFORMED CONSENT
The patient informed consent document is a vital part of your submission to the Ethics Committee as well as vital to ethical research in general. The type of informed consent will vary dependent on the type of study you are doing. Here are different study scenarios with examples of valid informed consent documents.
1. Drug trial or intervention study (self initiated or initiated by pharmaceutical company)
(PIC 1 ± PIC 4)
2. Study involving volunteers or patients that does not involve a study drug or intervention. (PIC 2 ± PIC 4)
3. Study using anonymous questionnaires
Note that this is seldom appropriate when dealing with very young, elderly or sick people. In these instances it would be better to get informed consent as in Example 2. If appropriate to use anonymous questionnaires then make use of them (PIC 3).
4. In all cases of above 1 - 2 and 5 it might be appropriate to add a special paragraph for people who are illiterate (PIC 4).
5. Retrospective clinical audits involving patients data
Auditing in general is an accepted management function. It may however also be used to formulate new hypotheses. The researcher must ensure strict confidentiality of all data collected. In the protocol / letter of intent the researcher must state why a retrospective audit is the evaluation of choice and must state how confidentiality will be ensured. Informed consent would then not be needed. Please note that this is not a given. If the research is of a very sensitive nature the Ethics Committee may advise a prospective study with full informed consent.
6. Prospective auditing
Many have defined a need in future retrospective auditing for patient information regarding clinical tests and outcome to be available for research (or clinical audits). This need can be met if all patients attending as outpatients or as inpatients complete an informed consent letter in this regard (PIC 5).
7. Studies in emergency medicine and Intensive Care. These are important studies to conduct but often informed consent cannot be obtained because of the severity of illness and because next of kin are not readily available. In the instances where routine diagnostic and therapeutic practices are used for studying research questions this could be dealt with as a retrospective audit. If the patient however is exposed to a non-routine invasive procedure or experimental form of therapy then informed consent would be needed.
Voorbeeld
Pro Forma
PATIENT INFORMATION LEAFLET AND INFORMED CONSENT
(Each patient must receive, read and understand this document before the start of the study)
TRIAL TITLE
Clinical trial number ………..: a (multi center, double blind, randomised placebo controlled?)…… trial in patients with………. to investigate efficacy and tolerability of ………
INTRODUCTION
You are invited to volunteer for a research study. This information leaflet is to help you to decide if you would like to participate. Before you agree to take part in this study you should fully understand what is involved. If you have any questions, which are not fully explained in this leaflet, do not hesitate to ask the investigator. You should not agree to take part unless you are completely happy about all the procedures involved. In the best interests of your health, it is strongly recommended that you discuss with or inform your personal doctor of your possible participation in this study, wherever possible. (The Company) will be notifying your personal doctor in this regard.
WHAT IS THE PURPOSE OF THIS TRIAL?
You have been diagnosed as suffering from ……………… and the investigator would like you to consider taking part in the research of a new drug, called …………………. . (Where possible include the trade name and/or examples of the drug in brackets after the word)
(Furnish details of the study population)
During the study you will receive either the active agent or a placebo. A placebo is an inactive substance, it does not contain any of the drug.
WHAT IS THE DURATION OF THIS TRIAL?
If you decide to take part you will be one of approximately …….patients. The study will last for up to ……….(days/weeks/months). You will be asked to visit the investigator…………….times as per the following schedule:……………………. At such visit you will undergo the following:
Visit 1 – (week ??) : Visit 2 – (week ??) :
(Kindly note that the exact reasons for the blood and urine test, ECG, and all other tests must be stated)
It is important that you let the investigator know of any medicines (both prescriptions
or over-the-counter medicines), alcohol or other substances that you are currently taking.
HAS THE TRIAL RECEIVED ETHICAL APPROVAL?
This clinical trial Protocol was submitted to the Faculty of Health Sciences Research Ethics Committee, University of Pretoria and written approval has been granted by that committee. The study has been structured in accordance with the Declaration of Helsinki (last update: October 2000), which deals with the recommendations guiding doctors in biomedical research involving human/subjects. A copy of the Declaration may be obtained from the investigator should you wish to review it.
WHAT ARE MY RIGHTS AS A PARTICIPANT IN THIS TRIAL?
Your participation in this trial is entirely voluntary and you can refuse to participate or stop at any time without stating any reason. Your withdrawal will not affect your access to other medical care. The investigator retains the right to withdraw you from the study if it is considered to be in your best interest. If it is detected that you did not give an accurate history or did nor follow the guidelines of the trial and the regulations of the trial facility, you may be withdrawn from the trial at any time.
IS ALTERNATIVE TREATMENT AVAILABLE?
Alternative treatment in the form of ……………… is often used to treat (this condition)…………… If you decide not to take park in this study it is possible that your doctor may treat you with this, or other suitable medication.
MAY ANY OF THESE TRIAL PROCEDURES RESULT IN DISCOMFORT OR INCONVENIENCE?
(Example): Venipunctures (i.e. drawing blood) are normally done as part of routine medical care and present a slight risk of discomfort. Drawing blood may result in a bruise at the puncture site, or less commonly fainting or swelling of the vein, infection and bleeding from the site. Your protection is that the procedures are performed under sterile conditions by experienced personnel. A total of ……..ml of blood (i.e. 1 tablespoon) will be collected over the course of the entire study.
WHAT ARE THE RISKS INVOLVED IN THIS TRIAL?
All medicines carry some risk, however small. In previous studies some patients have reported experiencing side effects, which included………, ……….. and …………. .
ARE THERE ANY WARNINGS OR RESTRICTIONS CONCERNING MY PARTICIPATION IN THIS TRIAL?
(Example): If you are a female who can become pregnant you must use suitable contraceptive measures during the trial, as the safety of this medicine during pregnancy has not been established.
DISCONTINUATION OF TRIAL TREATMENT
Uncontrolled discontinuation of trial medication is inadvisable. Special care needs to be taken for the discontinuation of this trial medication. The investigator will supervise any discontinuation with your health as first priority.
INSURANCE AND FINANCIAL ARRANGEMENTS
(The Company) will provide payment for all trial procedures and reasonable medical expenses which you may incur as a direct result of this trial as determined by (the Company) and the investigator. Neither you nor your medical scheme will be expected to pay for any study medication or trial procedures.
(The Company) has obtained insurance for you and the investigator in the event of such trial related injury. A trial-related injury is……… . (The Company) assumes no obligation to pay for the medical treatment of other injuries or illnesses. Further detailed information on the payment of medical treatment and compensation due to injury can be obtained from the investigator should you desire to review it.
N.B. Most of the SA Ethics Committees have agreed that the ABPI (Association of the British Pharmaceutical Industry) Guidelines adequately cover the compensation aspects relating to clinical trials. Kindly confirm whether your coverage meets the standard of the ABPI guideline and, if not, to what extent does it deviate.
Investigator initiated study or studies where the patient(s) medical scheme may be paying for certain cost:
Your medical scheme should receive pre-notification on the cost to be borne by them and you should, preferably, obtain clarification as well. Kindly note that a sentence to the effect that, in the event of the patient who is not a member of any medical scheme participating in this study, or where the patient’s medical scheme refuses to pay for the trial procedures, then the cost of all trial-related procedures would be paid by the sponsor company, should also be included.
You must notify the investigator immediately of any research or other related complications, side effects and/or injuries during the trial and the nature of the expenses to be covered.
If a research related injury occurs, you have not waived any of the legal rights which you otherwise would have as a participant in this trial by signing this form.
(Except for phase one trials) You will not be paid to participate in this trial. The investigator will determine if you are eligible to receive reimbursement for out-of-pocket and/or travel expenses.
Please note that if you have a life insurance policy you should enquire whether your insurance company requires notification of your intention to participate in a clinical trial.
Our information to date is that it should not affect any life insurance policy taken out. Nevertheless you are strongly advised to clarify same with the company concerned.
SOURCE OF ADDITIONAL INFORMATION
For the duration of the trial, you will be under the care of Dr ………… . If at any time between your visits you feel that any of your symptoms are causing you any problems, or you have any questions during the trial, please do not hesitate to contact him/her. The telephone number is ………., through which you can reach him/her or another authorized person.
CONFIDENTIALITY
All information obtained during the course of this trial is strictly confidential. Data that may be reported in scientific journals will not include any information which identifies you as a patient in this trial. In connection with this trial, it might be important for domestic and foreign regulatory health authorities and the Faculty of Health Sciences Research Ethics Committee, University of Pretoria , as well as your personal doctor, to be able to review your medical records pertaining to this trial.
Any information uncovered regarding your test results or state of health as a result of your participation in this trial will be held in strict confidence. You will be informed of any finding of importance to your health or continued participation in this trial but this information will not be disclosed to any third party in addition to the ones mentioned above without your written permission. The only exception to this rule will be cases in which a law exists compelling us to report individuals infected with communicable diseases. In this case, you will be informed of our intent to disclose such information to the authorized state agency.
INFORMED CONSENT
I hereby confirm that I have been informed by the investigator, Dr ……….……about the nature, conduct, benefits and risks of clinical trial ……… I have also received, read and understood the above written information (Patient Information Leaflet and Informed Consent) regarding the clinical trial.
I am aware that the results of the trial, including personal details regarding my sex, age, date of birth, initials and diagnosis will be anonymously processed into a trial report.
I may, at any stage, without prejudice, withdraw my consent and participation in the trial. I have had sufficient opportunity to ask questions and (of my own free will) declare myself prepared to participate in the trial.
Patient's name
(Please print)
Patient's signature Date
I, Dr ………………. herewith confirm that the above patient has been informed fully about the nature, conduct and risks of the above trial.
Investigator's name
(Please print)
Investigator's signature Date
Witness's name* Witness's signature Date
(Please print)
*Consent procedure should be witnessed whenever possible.
INFORMED CONSENT FOR PARENTS / GUARDIANS (on behalf of minors under 18 years old)
Dr …………………. has provided me with a copy of the Patient Information Leaflet and Consent Form regarding clinical trial number ………… and has fully explained to me the nature, risks, benefits and purpose of the trial. He/she has given me the opportunity to ask any questions concerning both the drug and the trial. It has been explained to me that I will be free to withdraw my child from the trial at any time, without any disadvantage to future care. I have understood everything that has been explained to me and I consent to my child to participating in this clinical trial.
Parent/Guardian(s) Name
(Please print)
Parent/Guardian(s) Signature Date
Patient's Name
(Please print)
Patient's Signature * Date (*Minors competent to understand must participate as fully as possible in the entire procedure.)
Investigator's Name
(Please print)
Investigator's Signature Date
Witness's Name Witness's Signature Date
(Please print)
VERBAL PATIENT INFORMED CONSENT (applicable when patients cannot read or write)
I, the undersigned, Dr ………………, have read and have explained fully to the patient, named ……………….. and/or is/her relative, the patient information leaflet, which has indicated the nature and purpose of the trial in which I have asked the patient to participate. The explanation I have given has mentioned both the possible risks and benefits of the trial and the alternative treatments available for his/her illness. The patient indicated that he/she understands that he/she will be free to withdraw from the trial at any time for any reason and without jeopardizing his/her subsequent injury attributable to the drug(s) used in the clinical trial, to which he/she agrees.
I hereby certify that the patient has agreed to participate in this trial.
Patient's Name