Safety, Efficacy, and Complexities in ART Practice
Safety, Efficacy, and Complexities in ART Practice
An integral part of the evolution of a program is an effort to perform research. Although research can mean extended quality control procedures within the clinical and laboratory setting, clear communication and input from all members of the program should be part of the decision to critically evaluate discrete parts of the ART system. The threshold between research and quality control (of established procedures) can be indistinct. Institutional review boards (IRBs) set a low threshold and even require that they review and approve projects exclusively involving chart reviews. The use of normally discarded tissue and the need for IRB approval can vary between institutions and is less extensively observed in private clinics where external IRBs may contribute added expense. Even without an IRB protocol, the informed consent process should indicate what is being done with patient material to preclude legal action. The laboratory needs to know what the patient has agreed to. An accurate foolproof method is needed for transmission of this information to the embryology laboratory. This is even more difficult if the clinic and laboratory are separate corporate entities. Still, the critical evaluation of clinical and laboratory techniques within each program's differing environments is associated with progress and continuous quality improvement for a clinic's patient population and the ART community in general.
Does the decision to alternate ovulation induction medications (i.e., with or without added luteinizing hormone activity) of FDA-approved medications reach the level of need for an IRB protocol or patient consent? Some would argue that any structured change in clinical management should result in an informed consent process, whereas many will argue that attempting to maximize response with different patient populations with differing ovarian reserves, and so on, evolving from the literature or from meetings is part of the clinical practice of medicine. However, physicians have the responsibility to report any change to the embryology team who can evaluate laboratory functions such as oocyte quality beyond clinical pregnancy rates. The same argument can be made for reporting comparison of culture media or culture conditions back to clinicians. However, the issue of specific breakpoints for IRB approval and/or informed consent is beyond the scope of this article. Programs with sufficient volume to evaluate clinical and laboratory perturbations should be encouraged to do so.
True research projects, such as the evaluation of new experimental procedures, require informed consent and the patient protection offered by IRBs. Many large programs based within private practices (nonacademic based) comply with these ethical practices, and nonacademic affiliation should not be a crutch for noncompliance. The decision to pursue research that will advance the field is to be supported. Again, such decisions require the ethical interaction of the entire team.
When should a procedure within a program be extended from research to standard clinical practice? Some guidelines for this change are provided by practice and ethics committee documents of our professional organizations. The disagreement between programs and ASRM are well documented. The sustaining criteria should be the safe and ethical provision of care.
Research
An integral part of the evolution of a program is an effort to perform research. Although research can mean extended quality control procedures within the clinical and laboratory setting, clear communication and input from all members of the program should be part of the decision to critically evaluate discrete parts of the ART system. The threshold between research and quality control (of established procedures) can be indistinct. Institutional review boards (IRBs) set a low threshold and even require that they review and approve projects exclusively involving chart reviews. The use of normally discarded tissue and the need for IRB approval can vary between institutions and is less extensively observed in private clinics where external IRBs may contribute added expense. Even without an IRB protocol, the informed consent process should indicate what is being done with patient material to preclude legal action. The laboratory needs to know what the patient has agreed to. An accurate foolproof method is needed for transmission of this information to the embryology laboratory. This is even more difficult if the clinic and laboratory are separate corporate entities. Still, the critical evaluation of clinical and laboratory techniques within each program's differing environments is associated with progress and continuous quality improvement for a clinic's patient population and the ART community in general.
Does the decision to alternate ovulation induction medications (i.e., with or without added luteinizing hormone activity) of FDA-approved medications reach the level of need for an IRB protocol or patient consent? Some would argue that any structured change in clinical management should result in an informed consent process, whereas many will argue that attempting to maximize response with different patient populations with differing ovarian reserves, and so on, evolving from the literature or from meetings is part of the clinical practice of medicine. However, physicians have the responsibility to report any change to the embryology team who can evaluate laboratory functions such as oocyte quality beyond clinical pregnancy rates. The same argument can be made for reporting comparison of culture media or culture conditions back to clinicians. However, the issue of specific breakpoints for IRB approval and/or informed consent is beyond the scope of this article. Programs with sufficient volume to evaluate clinical and laboratory perturbations should be encouraged to do so.
True research projects, such as the evaluation of new experimental procedures, require informed consent and the patient protection offered by IRBs. Many large programs based within private practices (nonacademic based) comply with these ethical practices, and nonacademic affiliation should not be a crutch for noncompliance. The decision to pursue research that will advance the field is to be supported. Again, such decisions require the ethical interaction of the entire team.
When should a procedure within a program be extended from research to standard clinical practice? Some guidelines for this change are provided by practice and ethics committee documents of our professional organizations. The disagreement between programs and ASRM are well documented. The sustaining criteria should be the safe and ethical provision of care.
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