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By Adam Landsman, DPM, PhD, FACFAS
Frequently, private practitioners who conduct clinical research will simply use a "consent to treat" form or "surgical consent" form for research purposes. However, this is not appropriate in most cases.
An informed consent form used for research must deal with several peculiarities not normally associated with standard clinical practices. For example, you probably will not know what treatment you are going to give a clinical trial patient when they consent to participate. Furthermore, if they end up in a control group, they may receive no treatment whatsoever for their ailment. Therefore, an informed consent form must have several elements included.
In the spirit of an informed consent, it is appropriate for me to insert the following disclosure before I go any further: Please note that there are specific items that must be included in any informed consent, and that the following list is not meant to be comprehensive. Also, please be sure to consult with your Institutional Review Board to confirm that this consent meets their standards. Having stated these limitations, following are some of the most common elements essential to a good research consent form.
Time commitment - Informed consents must describe the time commitment required of the study subject. This should include any time that you anticipate they will need to spend at the clinic and the number of visits required, but does not have to include time getting to and from the clinic (unless that is an integral part of the study).
Compensation - You must indicate what, if anything the subject will receive of value. If nothing other then free medical care will be provided, then this should be stated as well. You are not required to disclose what you as an investigator are receiving.
Risks and Dangers - You must indicate what dangers, and risks if any, may be associated with treatment in each group.
Alternatives - Describe what alternative treatments are commonly used, rather then the ones being used in the study. If you are the subject's normal caregiver, you should also state that if they choose not to participate in this study, you will continue to provide the same level of care as you have in the past.
Treatments - If you will be drawing blood, taking urine, taking x-rays, or performing any sort of tests, these should be listed, along with any notable risks associated with each test.
Severance - It must be clearly stated that the subject may leave a study at any time, without any penalty imposed whatsoever. Furthermore, it may indicate whether or not the subject can keep study materials, or may be required to return study materials in the event that they choose to not participate.
Remedies - In the event that a subject experiences complications during the course of a study, it must be clearly stated how those complications will be dealt with. This must include how they will receive medical treatment, and usually indicates that the study sponsor will fund the treatment of complications directly associated with the use of a test drug or product. It should also clearly state if this is not the case. For example, if you expect that the patient who has complications will not receive free medical care, you must state this as well.
Releases - If you anticipate photographing your test subjects, it is a good idea to inform them of this, and get their permission up front. This may also save you a great deal of trouble if you want to use their images for publication at a much later date, when it may be more difficult to contact them.
Confidentiality - You must take steps to insure the confidentiality of all test subjects. This typically involves assignment of code numbers to test subjects which may consist of their initials plus a number (i.e., initials + enrollment date). You must also disclose who will have access to these records, such as the FDA, other investigators, or site monitors.
Approvals -The top of the first page should state the name of the Institutional Review Board (IRB) which approved the consent document, with a telephone number to which questions or complaints pertaining to the protocol can be directed.
Emergency Contacts - In the event of an emergency or adverse event, the study subject should be given a telephone number to reach the principal or co-investigator, 24 hours a day, 7 days per week. If a research nurse is used, that number can be given as well.
Understanding - Subjects participating in studies must indicate that they understand the nature of the study, and must indicate that all of their current questions have been answered prior to study initiation. If the study subject is a minor, then their parent or guardian must sign on their behalf. A witness must sign the document as well, to insure that the signature is genuine. In addition, it is a good idea to provide all test subjects with a copy of the document that they have signed.
Keep in mind that the Informed Consent is just a part of Good Clinical Practices in research. For most prospective clinical trials, you must also seek Institutional Review Board (IRB) approval for both your protocol and your consent form. University or hospital-based projects are typically reviewed by internal IRBs. However, there are several private IRBs which can also review your projects as needed, on a fee-per-service basis (typically about $1,000 for a project which is moderate in size and complexity). Also, you are required to report any complications that occur during the course of a study to the certifying IRB. In some cases, the IRB may recommend termination of the study, as well as informing patients of potential dangers.
Study enrollment requires patients to make compromises in their lives, to be available for participation, and may not even provide them with a functional treatment. Therefore, pick your subjects wisely. It is important for them to understand what they are getting involved in, and that their expectations are within reason. Be careful not to promise something that you cannot deliver without jeopardizing the study, such as a guarantee that they will not be in a control group. Also, it is critical that you do not rely on your patient's trust in you as their primary care giver to coerce them into participation in your study. Let them decide for themselves, and all will benefit in the long run.
Source: ACFAS Bulletin July/Aug 2000 |