Montefiore Medical Center蒙特非奥里医疗中心

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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 (lect all that apply):
HIPAA Authorization Waiver/Alteration (Complete Page 1)	Informed Connt Waiver (Complete Page 2)
HIPAA Authorization Exemption (Complete Page 3)	Oral Informed Connt (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 u and disclo protected health information for study related purpos (required under the Privacy Regulations of the Health Insurance Portability and Accountability Act (HIPAA), or for a more limited purpo such as the recruitment of potential study subjects (known as a “partial waiver”).


SECTION 1. (Complete if requesting HIPAA Authorization Waiver/Alteration, Informed Connt Waiver, and/or Oral Informed Connt.)

1. Does the rearch prent 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 tho 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. Plea e the AECOM/MMC Policy entitled Policy for the U of Patient Medical Record Information in Rearch and Recruitment of Rearch Participants		Yes No

2. Will the waiver/alteration adverly affect the rights and welfare of the subjects?		Yes No

3. Can the rearch be practicably carried out without the waiver/alteration? *If it is impracticable to obtain individual authorization, plea describe why?		Yes No*

4. 超凡脱俗的近义词Can the rearch be practicably carried out without access to and u of protected health information? If it is impracticable to conduct this rearch without access to identified health information, plea describe why:		Yes No*



5. What is your plan to protect identifiers from improper u and disclosure?

6. Will the patient identifiers be destroyed at the earliest opportunity? If yes, describe the plan for destroying identifiers (e.g. how, by whom, and when identifiers will be destroyed): lol领取中心 If no, indicate the health or rearch justification for retaining the identifiers.


SECTION 2. (Complete if requesting Informed Connt Waiver or Oral Informed Connt.)
Per the code of Federal Regulations Title 45, Part 46.116 (d), an IRB is ONLY permitted to approve a connt procedure which does not include, or which alters, some or all of the elements of informed connt (i.e. a waiver of informed connt ) if four very specific criteria are met.

1. Does the rearch prent 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 tho 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 risk.		Yes No
2. Will the subjects be provided with additional pertinent information after participation, whenever appropriate?		Yes No

3. Would the connt document be the ONLY identifiable link between the subject and the rearch, AND would there be potential harm to the subject if the confidentiality of the connt document were breached?	Yes* No

*If you indicated ‘YES’ above, Indicate below how a breach of confidentiality would be harmful to the subject:

4. Does the rearch involve any procedures for which written connt is normally required outside of the rearch context? 八年级上册数学补充习题答案	Yes No

Include a copy of the narrative that will be ud in obtaining Oral Informed Connt and/or HIPAA Authorization.

By signing this form, you provide an assurance that the protected health information will not be reud or disclod to any other person or entity, except as required by law, for authorized oversight of the rearch project, or for other rearch for which the u or disclosure of protected health information would be permitted.
Principal Investigator Signature	Date

For Institutional Review Board u only Montefiore Medical Center FWA: 00002558

Yeshiva University FWA: 00000140

HIPAA Authorization Waiver/Alteration

Approved

Not Approved – Plea provide explanation for disapproval.

Informed Connt Waiver/Alteration

Approved

Not Approved – Plea provide explanation for disapproval.

Reviewer’s Signature		Date

聆听拼音

MONTEFIORE MEDICAL CENTER ALBERT EINSTEIN COLLEGE OF MEDICINE INSTITUTIONAL REVIEW BOARD COMMITTEE ON CLINICAL INVESTIGATIONS REQUEST FOR EXEMPTIONS TO THE REQUIREMENT FOR USE OF A HIPAA AUTHORIZATION FORM Per the Code of Federal Regulations Title 45, Parts 160 and 164 a rearch participant’s authorization for u/disclosure of protected health information for rearch purpos is not required under the circumstances listed below.

USE OF DE-IDENTIFIED DATA

U or disclosure for rearch purpos of protected health information is permissible if the health information has been de-identified. The de-identifiers consist of the following Data Elements: Name, Address, Employer, Relatives’ Names, Date of Birth, Telephone and Fax numbers, E-mail Address, Social Security Number. Member or Account Number, Certificate/licen Number, Voice/fingerprints, photos, or other number, code or characteristics.

Will all of the above listed Data Elements be removed?				Yes No
1If no, complete ction on rearch using LIMITED DATA SET.

USE OF PROTECTED HEALTH INFORMATION PREPARATORY TO RESEARCH (Complete only if applicable)

Idea/Hypothesis:

What records will be accesd:

Is the u or disclosure of the protected health information solely to prepare a rearch protocol or for similar purpos preparatory to rearch?				Yes No

Will the rearcher remove any protected health information from the covered entity?				Yes No 红烧肉烧腐竹

Is the protected health information for which access is sought necessary for the rearch purpo?				Yes No


I understand that it is my obligation and responsibility to maintain the confidentiality of all patient information. Improper disclosure or misu of patient information, whether intentional or due to neglect on my part, is a breach of patient confidentiality, which can result in the loss of access to clinical information for my employer and mylf and may result in disciplinary action by my employer. Improper access, disclosure or misu of patient information may result in action being taken, which may result in revocation of my appointment or dismissal.

RESEARCH ON PROTECTED HEALTH INFORMATION OF DECEDENTS Complete only if applicable

What records will be accesd:

Is the u and disclosure sought solely for rearch on the PHI of decedents?			Yes No

Is the PHI for which u or disclosure is sought necessary for the rearch purpos?			Yes No

RESEARCH UTILIZING A LIMITED DATA SET Complete only if applicable

A limited data t is the same as a de-identified data t (e above ction) except that the following data elements are allowed: zip code, city, state, date of birth, and other dates. If a limited data t is to be ud, a data u agreement is required. Refer to the U of Patient Medical Record Information & Recruitment of Rearch Participants Policy and Appended Sample Data U Agreement

By signing this form, you provide an assurance that the protected health information will not be reud or disclod to any other person or entity, except as required by law, for authorized oversight of the rearch project, or for other rearch for which the u or disclosure of protected health information would be permitted.
	Principal Investigator’s Signature	养老保险可以取出来吗Date

Include a copy of the narrative that will be ud in obtaining Oral Informed Connt and/or HIPAA Authorization.

For Institutional Review Board u only Montefiore Medical Center FWA: 00002558

Yeshiva University FWA: 00000140

Informed Connt Waiver/Alteration

Approved

Not Approved – Plea provide explanation for disapproval.

Note to Institutional Review Board reviewer(s): Plea complete the recommendations above. If necessary, plea contact the Institutional Review Board office with comments or for follow-up on other options.

Reviewed on an expedited basis by an IRB member designated by the Chair: