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Section 125341 Of Chapter 2. Procuring Of Oocytes For Research From California Health And Safety Code >> Division 106. >> Part 5.5. >> Chapter 2.
125341
. An institutional review board (IRB) that reviews and
approves medical and scientific research shall require all of the
following of any research program or project that comes under its
review that involves AOP or any alternative method of oocyte
retrieval:
(a) That it include a written summary as required under Section 125335 that would include information on health risks and potential adverse consequences of the procedure and describe the manner in which the subject will receive and review this written summary.
(b) That it obtain informed consent in compliance with the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20), including informed consent for information obtained pursuant to Section 125342.
(c) That it provide the subject with an objective and accurate statement about the existing state of the research for which the subject is providing oocytes.
(d) That it perform psychological and physical screening, in accordance with the appropriate standard of care, for all subjects prior to the oocyte retrieval procedure.
(e) That it ensure that after conducting AOP or any alternative method of oocyte retrieval on a subject, the subject be given a postprocedure medical examination at a time within the standard of care to determine if the subject has experienced an adverse health effect that is a result of the procedure. The subject shall be informed that she has the right to a second opinion if she has any medical concerns.
(f) That it ensure that the subject has access to and coverage for medically appropriate medical care that is required as a direct result of the procedure for research purposes. The research program or project shall ensure that payment or coverage of resulting medical expenses be provided at no cost to the subject and that a summary of the arrangements the procuring entity has made for coverage or payment for medical care related to AOP or any alternative method of oocyte retrieval is provided to the subject prior to the procedure.
(g) That it provide a summary informing the subject that oocytes may not be sold or transferred for valuable consideration except as set forth in Section 125350.
(h) That it provide disclosure if the physician and surgeon and his or her immediate family members have any professional interest in the outcome of the research or of the oocyte retrieval procedure and, if so, that it provide disclosure that he or she carries the interest of both the subject and the success of the research.
(a) That it include a written summary as required under Section 125335 that would include information on health risks and potential adverse consequences of the procedure and describe the manner in which the subject will receive and review this written summary.
(b) That it obtain informed consent in compliance with the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20), including informed consent for information obtained pursuant to Section 125342.
(c) That it provide the subject with an objective and accurate statement about the existing state of the research for which the subject is providing oocytes.
(d) That it perform psychological and physical screening, in accordance with the appropriate standard of care, for all subjects prior to the oocyte retrieval procedure.
(e) That it ensure that after conducting AOP or any alternative method of oocyte retrieval on a subject, the subject be given a postprocedure medical examination at a time within the standard of care to determine if the subject has experienced an adverse health effect that is a result of the procedure. The subject shall be informed that she has the right to a second opinion if she has any medical concerns.
(f) That it ensure that the subject has access to and coverage for medically appropriate medical care that is required as a direct result of the procedure for research purposes. The research program or project shall ensure that payment or coverage of resulting medical expenses be provided at no cost to the subject and that a summary of the arrangements the procuring entity has made for coverage or payment for medical care related to AOP or any alternative method of oocyte retrieval is provided to the subject prior to the procedure.
(g) That it provide a summary informing the subject that oocytes may not be sold or transferred for valuable consideration except as set forth in Section 125350.
(h) That it provide disclosure if the physician and surgeon and his or her immediate family members have any professional interest in the outcome of the research or of the oocyte retrieval procedure and, if so, that it provide disclosure that he or she carries the interest of both the subject and the success of the research.
