Attachment F IRB approval continuation

Attachment F: CDC #2010-03 IRB Approval for Continuation of Protocol

Date: December 23, 2010

From: Anjani Chandra, Ph.D.

Vice Chair, NCHS Research ERB

To: David Woodwell, M.P.H.

Re: Protocol #2010-03 National Hospital Ambulatory Medical Care Survey

The NCHS Research Ethics Review Board reviewed the request for approval of Continuation of Protocol #2010-03 National Hospital Ambulatory Medical Care Survey on December 21, 2010, using the review process, based on 45 CFR 46. In addition, the Board considered the protocol as affected by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Protocol #2010-03 is approved for the maximum allowable period of one year.

In addition, the convened Board agreed to grant the following waivers to Protocol #2010-03 National Hospital Ambulatory Medical Care Survey under normal review procedures:

1. In accordance with 45 CFR 46.116(d), the Board voted to approve a waiver of the requirements to obtain informed consent of patients. The Board determined that the study would pose no greater than minimal risk to participants and that omission of the consent process would not adversely affect the rights or welfare of the subjects. The Board noted that the data are already collected and contained in the medical records and no directly identifying data are collected. The Board also agreed that it would not be practicable for the investigators to contact patients, the next of kin, or their legal guardians before obtaining the data. The Board decided the fourth criterion did not apply to this situation. The Board recognized that information about the research is available from a number of sources.

2. In accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Regulation (45 CFR 164.512), the Board voted to approve a waiver of patient authorization for release of patient medical record data by health care providers. The Board determined that the disclosure of protected health information involves no more than a minimal risk to privacy of individuals. The Board determined that:

   1. There was an adequate plan to protect the identifiers from improper use and disclosure,

   2. There was an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, and that an adequate research justification was provided for retaining the following identifiers: date of birth, date of health care visit, and zip code, and

   3. There were adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart. The Board also agreed that the research could not practicably be conducted without the waiver. The Board agreed that the research could not practicably be conducted without access to and use of the protected health information.

IRB approval of protocol #2010-03 will expire on 12/21/2011.

If it is necessary to continue the study beyond the expiration date, a request for continuation approval should be submitted about 6 weeks prior to 12/21/2011.

There is no grace period beyond one year from the last approval date. In order to avoid lapses in approval of your research and the possible suspension of subject enrollment, please submit your continuation request at least six (6) weeks before the protocol's expiration date of 12/21/2011. It is your responsibility to submit your research protocol for continuing review.

Any problems of a serious nature resulting from implementation of these changes should be brought to the attention of the Research ERB, and any additional proposed changes should be submitted for IRB approval before they are implemented.

Please submit "clean" copies of the revised protocol, consent forms, and any other revised materials to this office for the official protocol file.

Please call me or Verita Buie, DrPH, if you have any questions.

Anjani Chandra, Ph.D.

Vice Chair, NCHS Research ERB

__________________________________________________________________________________

Date: May 31, 2011

From: Stephen Blumberg, Ph.D.

Chair, NCHS Research ERB

Anjani Chandra, Ph.D.

Vice Chair, NCHS Research ERB

To: David A. Woodwell, M.P.H.

Subject: Protocol #2010-03 National Hospital Ambulatory Medical Care Survey (NHAMCS), Amendment #4 Pretest for automation of survey materials

The NCHS Research Ethics Review Board reviewed the request for amendment of Protocol #2010-03 National Hospital Ambulatory Medical Care Survey (NHAMCS), Amendment #4 Pretest for automation of survey materials, using the expedited review process, based on 46.110 of 45 CFR 46(b)(2), minor change to previously approved research protocol.

Description of proposed modification:

Amendment #4 Pretest for automation of survey materials

Protocol #2010-03 Amendment #4 is approved.

Of Note: Approval is not granted for pretesting the asthma supplement in the NHAMCS. Because physicians report their knowledge and attitudes as part of the asthma supplement, these physicians would be considered human subjects. At present, there are no physician consent procedures for this research, nor a waiver of consent. Per an e-mail from Paul Beatty on May 27, 2011, the investigators agreed to withdraw the request to test the asthma supplement as part of NHAMCS.

IRB approval of protocol #2010-02 will expire on 12/21/11.

If it is necessary to continue the study beyond the expiration date, a request for continuation approval should be submitted about 6 weeks prior to 12/21/11.

There is no grace period beyond one year from the last approval date. In order to avoid lapses in approval of your research and the possible suspension of subject enrollment, please submit your continuation request at least six (6) weeks before the protocol's expiration date of 12/21/11. It is your responsibility to submit your research protocol for continuing review.

Any problems of a serious nature resulting from implementation of these changes should be brought to the attention of the Research ERB, and any additional proposed changes should be submitted for IRB approval before they are implemented.

Please submit "clean" copies of the revised protocol, consent forms, and any other revised materials to this office for the official protocol file.

Please call me or Verita Buie, Dr.P.H., if you have any questions.

Stephen Blumberg, Ph.D.

Chair, NCHS Research ERB

Anjani Chandra, Ph.D.

Vice Chair, NCHS Research ERB