Consent forms

Please provide an appropriate patient information leaflet providing a full explanation of the nature, purpose, procedures and risks associated with the study and consent form. 

Glycolic acid peeling is a medical procedure that requires the informed consent of the patient. The medical doctor must obtain from the patient a well-standardized formal consent that shows that all information about the medical procedure performed was explained to the patient. We include below the formal consent form submitted to the patient before the glycolic acid peeling procedure. 

Standard photography and a consent form are always obtained before the procedure. 

Coordinating centers that prefer this approach use it because first, they feel they can ensure the validity of the subject-consenting process before randomizing, and second, they feel they can exert full control over the randomization processes to ensure their validity. This is achieved by requiring participating sites to fax signed informed consent forms to the coordinating center to enable review for completeness and validity before randomization. 

The consent form is a document to be used to acquire the consent of worker volunteers to become a part of a worker exposure study or re-entry exposure study and is an integral part of ensuring the ethical integrity of the research project. This form is normally in English but should be translated into Spanish or any other language... 

Review of the consent form by ethical review boards... 

Most consent forms that have been developed have at some time been reviewed by standing ethical review boards, usually associated with a university. The format of the consent form described above has been reviewed over time by more than one ethical review board and would be acceptable in most States for the purpose of acquiring the consent of potential volunteers in a worker exposure or re-entry study. If performing worker exposure studies in California, the researcher is advised to contact the State regulatory agencies and submit the draft consent form and study protocol to the State-appointed ethical review board for review and approval prior to initiation of the field phase of the study. Of course, if the researcher has any doubt about the acceptability of the proposed consent form, he/she should contact the appropriate state agencies where they plan to perform the study. 

Communication with the potential volunteers prior to the study is essential. Prior to the initiation of the field phase of the study, a meeting should be held with the potential volunteers to explain the details of the procedures of the study, present the consent form, and inform the potential volunteers of the risks and benefits (including any monetary compensation to the worker) of participating in the study. At this meeting, consent in writing should be obtained from the worker. If there is any language barrier between the researcher and the potential volunteers, an interpreter should be present at the meeting. 

Because alosetron has been associated with ischemic colitis, it may be prescribed only under strict guidelines, including signing of a consent form by both patient and physician. Patients selected for therapy should exhibit chronic IBS symptoms and have failed to respond to conventional therapy. 

Looks like you ll be busy for a while, I say, as the couple pay for a ram s head pendant for him and a lightning-bolt brooch for her, and their place is taken by a round-eyed girl still clutching the consent form for ear-piercing and fingering her own bright pink lobes with awe. She starts to inspect the stars. 

Empirical Investigation , Psychological Science 7, no. 3 (1996) 174-76 Moseley, J. Bruce, K. O Malley, N. J. Petersen, T. J. Menke, B. A. Brody, D. H. Kuykendall, J. C. Hollingsworth, C. M. Ashton and Nelda P. Wray, A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee , New England Journal of Medicine 347 (2002) 81-88 Myers, M. G., J. A. Calms andj. Singer, The Consent Form as a Possible Cause of Side Effects , Clinical Pharmacology dr Therapeutics 42 (1987) ... 

The mobility of samples and data means that samples or data provided by research subjects could be used by people they never met—and hence with whom they never developed a relationship of trust. They may also be used for purposes different from those for which the samples were collected and possibly purposes that the research subject does not like. Research subjects will rarely learn of these secondary users and uses of their samples and data. When they do, the collecting researcher may be able to point to broad language in a consent form authorizing their sharing of samples or broader research aims. Nonetheless, participants may feel misled and harmed. For example, at least one band of Canadian native peoples alleged publicly that it had been mistreated when samples it claimed it had given for purely medical research were put to anthropological uses (Kleiner, 2000 They Need Your DNA, 2000). 

Research subjects may want to limit the research use of their materials and data to scientists they trust and ends of which they approve. It currently may take a lawyer s reading of the consent form to determine whether the materials and data may be shared or used for other purposes. Even if the form does limit who can use the research materials and data and for what purposes, the extent to which those forms can and will be enforced is limited. Minority groups with special concerns about the use of samples and data from their groups need to reach clear and enforceable understandings with researchers. Groups may want to limit the research use of their samples and data to the questions initially posed or further questions expressly approved by the group. Similarly, they may wish to limit to whom the samples and data can be transferred. 

Netherlands Organization. Subjects signed an informed consent form. 

In addition to the elements enumerated in the federal regulations, IRBs must consider whether consent forms should include the fact of randomization in the case of prospective randomized clinical trials. 

The written informed consent form should be presented to potential participants in a language that they understand and written in terms that they can comprehend. This is one of the important functions of an IRB. The IRB members review every informed consent form to determine if it contains all of the required elements and any additional required elements of an informed consent form as sef forth in the governing regulations. The informed consent form is also reviewed to determine that complete, accurate, and pertinent study-related information is being provided to the potential participants and that medical terms are clearly defined, in simple language at the study population can understand. 

Human participant protection is a shared responsibility between the sponsor, the investigator, and the IRB. It is their responsibility as a team to ensure that the participants remain well informed and that their rights and welfare are protected. It is important that all members of the research team understand the informed consent form regulations, their part of the informed consenf process, and apply this knowledge to each informed consenf form that is reviewed, presented, and distributed to a potential participant. 

In addition to the required elements of an informed consent form, an IRB can and may require other standard information or signatures be added to all informed consenf forms being reviewed by the board. 

Written informed consent document and consent form updates (which include aU of the required elements of an informed consent — asee Section 22.6)... 

A third consent form was required if we planned to document drug effects on film or on videotape. 

As I have eommented during media interviews, real guinea pigs do not volunteer freely or sign consent forms. Nevertheless, many persist in the use of this shop-worn eliehe. I would say just the opposite - that our volunteers performed a patriotic service, and almost invariably felt good about it ... 

The report then turns to the volunteer consent form ... 

The IG report criticizes this consent form for not guaranteeing adequate discussion of the nature and hazards of the experiment. This was particularly true for the early volunteer records. Establishment of trust, however, was always a priority. No one can predict all the symptoms or mishaps that might conceivably occur. Ultimately, the volunteer s confidence in the physician s integrity and concern for his well-being is paramount. The concept of informed consenf remains as slippery today as it was in the sixties. Honest communication remains more important than fine print in a contract. 

Is the manner in which the technician will draw blood samples quite clear Does the consent form adequately emphasize the freedom to refuse the test if the volunteer has a change of heart after signing the form Should we allow three days for the volunteer to cancel his consent, just as with other contracts Will we be able terminate the test at any point if he requests it What do we do to stop the action of a drug if, after taking effect, it is causing discomfort and the subject wants to discontinue ... 

Detailed written information, which generally constitutes part of the consent form, should not be provided to potential volunteers until ethics approval has been obtained. A checklist of the items that should be covered in the volunteer information is given in Box 4.8. Most importantly, the information should be provided in clear non-technical language. ... 

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