MEG Users Meeting 4/11/03

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MEG Users Meeting 4/11/03

• HIPAA Compliance
• Acquiring and Saving MEG Data

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Main problem
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Saving data main problems
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HIPAA methods Step 1

• Each group will now have its own login name and
  pswd for sinuhe
• Group names are created as acqxxxx
• e.g. megclin, meghalg, megmbar, etc
• The same group will also be created on the linux
  sidethis group will own your data files

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HIPAA methods Step 2

• Subject Type
• Default is Volunteers, instead select Patients
• Registered and MEG data will now be available
  only to your group

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HIPAA methods Step 3

• Accessible to group
• Change to your labs group name, e.g. acqwest

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HIPAA methods Step 4

• HIS ID west001
• HIS ID can be any code of your choosing
• Use unique names
• e.g. west001 vs 001
• Directories will now be named as
• /subj_ltHISgt/ltdategt/

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HIPAA methods Step 5

• Data files should be saved with this code as well
  (rather than initials)

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HIPAA methods Step 6

• In addition to logging out of the Acquisition
  program, you also need to log off the computer
• Simply hit Exit on the task bar at the bottom of
  any window

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PIs responsibility To do list

• http//www.healthcare.partners.org/phsirb/hipaa2do
  .htm

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Approved/ongoing protocols (prior to 4/14)

• Subjects enrolled prior to 4/14
• Authorizations not required (unless subject
  re-consented after 4/14)
• Subjects enrolled on or after 4/14
• Subject must sign both a consent form and an
  authorization form
• Must be given a copy of the Privacy Notice, and
  obtain written acknowledgement of receipt

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Authorization form

• Downloadable from website
• Fulfills specific elements of Privacy Rule
  without requiring you to rewrite/resubmit
  existing consent form
• Must provide a copy to the Human Research Office
  to document compliance with the Privacy Rule
• Authorization will not be reviewed by the PHRC -
  you are responsible for the accuracy of the
  information in the document
• Signed Authorization should be kept with signed
  consent form
• Free-standing Authorization should be used until
  your PHRC-approved consent form includes the
  authorization language (ie, merge consent with
  Authorization)

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Privacy Notice

• Privacy Notice can be downloaded from previously
  mentioned site, and does not need to be
  approved by Human Research Office
• Signed acknowledgement forms must be returned to
  the Privacy Officer at your institution
• Although not required, recommended that you keep
  a copy of the signed receipt of Privacy Notice
  for your records