Copernicus Group Independent Review Board (CGIRB) may have access to your PHI in relation to its responsibilities as an Institutional Review Board. The Study Doctor or Sponsor may disclose your PHI to the United States Food and Drug Administration (“FDA”) or similar regulatory agencies or health authorities in the United States and/or foreign countries and Sponsor’s related companies in the US and in other countries. These disclosures also help ensure that the information related to the Study is available to all parties who may need it for research purposes. Except for the disclosures described above, your PHI will not be shared with others unless required by law. If your PHI is given to the parties listed above and/or to others who are not required to comply with the federal law, your PHI will no longer be protected by this law and could possibly be used or disclosed in ways other than those listed here, although other safeguards apply. Please refer to the and Confidentiality” section “Privacy in the informed consent form to see how Sponsor will treat your PHI confidentially. If you have questions about how your PHI will be protected, you can ask the Study Doctor. You have a right to see and make copies of your PHI. You are agreeing, however, by signing this document, not to see or copy some or your entire PHI until the Sponsor has completed all work related to this Study in order to protect the integrity of the Study. At that time, you may ask to see your records. If you do not withdraw this Authorization, it will remain in effect. If the research site is located in California, Delaware, Indiana, Washington, or Wisconsin, this authorization will expire on 31Dec2060. There is no expiration of this authorization except for research conducted in the states listed above. You have a right to withdraw your Authorization at any time. If you withdraw it, your PHI will no longer be used for this Study, except to the extent the parties to the Study have already taken action based upon your Authorization or need the information to complete analysis and reports for
Copernicus Group Independent Review Board (CGIRB) may have access to your PHI in relation to its responsibilities as an Institutional Review Board. The Study Doctor or Sponsor may disclose your PHI to the United States Food and Drug Administration (“FDA”) or similar regulatory agencies or health authorities in the United States and/or foreign countries and Sponsor’s related companies in the US and in other countries. These disclosures also help ensure that the information related to the Study is available to all parties who may need it for research purposes. Except for the disclosures described above, your PHI will not be shared with others unless required by law. If your PHI is given to the parties listed above and/or to others who are not required to comply with the federal law, your PHI will no longer be protected by this law and could possibly be used or disclosed in ways other than those listed here, although other safeguards apply. Please refer to the “Privacy and Confidentiality” section in the informed consent form to see how Sponsor will treat your PHI confidentially. If you have questions about how your PHI will be protected, you can ask the Study Doctor. You have a right to see and make copies of your PHI. You are agreeing, however, by signing this document, not to see or copy some or your entire PHI until the Sponsor has completed all work related to this Study in order to protect the integrity of the Study. At that time, you may ask to see your records. If you do not withdraw this Authorization, it will remain in effect. If the research site is located in California, Delaware, Indiana, Washington, or Wisconsin, this authorization will expire on 31Dec2060. There is no expiration of this authorization except for research conducted in the states listed above. You have a right to withdraw your Authorization at any time. If you withdraw it, your PHI will no longer be used for this Study, except to the extent the parties to the Study have already taken action based upon your Authorization or need the information to complete analysis and reports for
Bacterial-Vaginosis-Study-Information-and-Consent-Form.2.15.17.docx