As a result of your valuable feedback the following changes have been made to the HIPAA Privacy Rule Research Guide. Please continue to contact us with any questions and comments you may have.

-2005-

May 26

• Combined HIPAA Research Authorization and Common Rule Informed Consent Form: An interactive program for the development of a combined form that contains the required elements for authorization under HIPAA and informed consent under the Common Rule.

-2004-

December 15

• Application for IRB Waiver of Authorization or Altered Authorization Under the HIPAA Privacy Rule: this document has been revisedÝto require the Investigator to add his/her printed name, title of the study, and IRB Protocol Number (if assigned) to assist IRB staff in matching this document to the appropriate study.

April 26

• Certification for Use of a Limited Data Set Within the UW Health Care Component or Within the UW Affiliated Covered Entity: this form, which is required when a limited data set is used within the UW HCC or UW ACE, has been added.

 
February 23

• Research Authorization Form and Research Authorization Form for Children:  Revisions (deletion of section G. question) have been made to these forms to reflect that research records are not part of the designated record set (and therefore copies of these records are not available to subjects).  In addition, a clarifying sentence has been added to section C. regarding the disclosure of PHI to non UW researchers.

-2003-

September 16

• Certification for PHI of Decedents: A form used to properly certify the protected health information (PHI) of decedents' has been added.

• HIPAA Privacy Rule: WHAT? – Decedents' PHI: Greater detail has been provided regarding the purposes and necessary actions associated with decedents' PHI.

September 11

• Frequently Asked Questions: Questions and answers to some commonly posed questions regarding application of the HIPAA Privacy Rule.

August 26

• HIPAA Privacy Rule: WHAT? – Limited Data Sets: City, State, and zip code
  have been added as three examples of information that can be included in a
  Limited Data Set.

August 5

• Data Use Agreement: A data use agreement has been added to fulfill Privacy Rule requirements for the use or disclosure of a limited data set.

• Responding to a Data Use Agreement for Use of a Limited Data Set: this form has been added to provide a checklist of the required elements of a Data Use Agreement.

July 31

• HIPAA Privacy Rule: WHAT? – Limited Data Sets: Greater detail has been provided regarding the purposes and necessary actions associated with a disclosure of a Limited Data Set. Also added is a list of the identifiers that must be absent for a valid Limited Data Set.

• Definitions: A number of terms used in the Data Use Agreement have been revised or added to the list of general definitions. The revised or added definitions are for Limited Data Set, Health Care Provider, Research, Health Care Operations, and Public Health.

• Veterans' Administration (VA) Research Authorization Form: An authorization to use and disclose Protected Health Information for research participants of studies at the VA Hospital has been added.

• Veterans' Administration (VA) Addendum for Sponsor-Specific Language: An addendum to the VA Research Authorization Form for the addition of language proposed by a sponsor about the sponsor's use of PHI from a VA study has been added.

July 23

• Instructions for Research Authorization: Links have been added to the general instructions of this form. In particular, a link to the Veterans' Administration (VA) research authorization and addendum for sponsor-specific language are up and running.

July 17

• Research Authorization Form for Children: A signature line for the person obtaining the authorization has been added.

July 14

• Disclosures Log: This form has been added to provide a standardized procedure to record disclosures of a research subject's PHI.

• Information on Accounting for Disclosures: More detailed information on who does and does not need to account for disclosures of PHI, in addition to a step-by-step procedure detailing how an accounting should be handled.

July 7

• Waiver of Authorization: This form was revised to further clarify the required information necessary for an IRB-approved waiver of or alteration of authorization. A list of identifiers has also been added for ease of reference.

June 30

• Elements of a Valid Research Authorization: Additional requirements for a valid research authorization have been added, including a statement requiring a copy of the signed authorization be given to the research participant, and a statement about the potential for re-disclosure of PHI and resultant loss of Privacy Rule protection.

June 27

• Psychotherapy Notes definition: Psychotherapy notes have been added to the list of defined HIPAA terms.

June 19

• Database Decision Tool: Databases that contain health information from only a single study do not need to be registered with the University’s Privacy Officer. The Database decision tool has been updated to reflect this change.

• Database Registration Form: Examples clarifying possible sources of health information have been added to the database registration form, as has an instruction identifying who should sign the registration form when the custodian is an entity.

• HIPAA Privacy Rule: WHAT? – Databases: Databases that contain health information from only a single study do not need to be registered with the University’s Privacy Officer. The database guidance has been updated to reflect this change.

• Preparatory to Research Activities: Eligibility screening is now considered a Preparatory to Research activity. The instructions and preparatory to research activities certification form have been revised accordingly.

• Research Authorization Form: Widespread revisions of the Research Authorization form have been made to simplify the text.

• Research Authorization Form for Children: A newly created form is now available for use when research participants are children.

• Instructions for Research Authorization Form: Instructions for filling out theResearch Authorization form have been clarified and include suggestions for standardized terms and expressions. The instructions are applicable to the Research Authorization Form for Children as well.