Montefiore Medical Center蒙特非奥里医疗中心.doc

MONTEFIORE MEDICAL CENTER ALBERT EINSTEIN COLLEGE OF MEDICINE INSTITUTIONAL REVIEW BOARD COMMITTEE ON CLINICAL INVESTIGATIONS ADDENDUM TO GENERAL APPLICATION FOR APPROVAL OF RESEARCH PROJECT REQUEST FOR WAIVER/ALTERATION OR EXEMPTION FROM HIPAA AUTHORIZATION AND INFORMED CONSENT Principal Investigator Name: Protocol Title: Which of the following are you requesting (select all that apply): HIPAA Authorization Waiver/Alteration (Complete Page 1) Informed Consent Waiver (Complete Page 2) HIPAA Authorization Exemption (Complete Page 3) Oral Informed Consent (Complete Page 2) WAIVER/ALTERATION OF THE REQUIREMENT FOR USE OF A HIPAA AUTHORIZATION FORM This form permits investigators to request a waiver or alteration of individual authorization to use and disclose protected health information for study related purposes (required under the Privacy Regulations of the Health Insurance Portability and Accountability Act (HIPAA), or for a more limited purpose such as the recruitment of potential study subjects (known as a “partial waiver”). SECTION 1. (Complete if requesting HIPAA Authorization Waiver/Alteration, Informed Consent Waiver, and/or Oral Informed Consent.) 1. Does the research present more than minimal risk of harm to the subject? (Minimal risk is defined as the probability and magnitude of harm or discomfort are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological tests). The risk of subject privacy should be deliberated when considering risks. Please see the AECOM/MMC Policy entitled Policy for the Use of Patient Medical Record Information in Research and Recruitment of Research Participants Yes No 2. Will the waiver/alteration adversely affect the rights and welfare of the subjects? Yes No 3. Can the research be practicably carried out without the waiver/alteration? *If it is impracticable to obtain individual authorization,