Research Request Privacy Principles

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					                       HARRIS COUNTY HOSPITAL Policy No:                         3.05
                               DISTRICT       Page Number:                       1 of 6

                       POLICY AND REGULATIONS Effective Date:  09-27-01
                               MANUAL         Board Motion No: 01.9-370

The purpose of this document is to establish the policy for the approval of research to
be conducted at/in conjunction with the Harris County Hospital District. This policy
replaces HCHD Policy #2550 and supersedes all previous policies. [Key Words:
Research, Institutional Review Board/Committee for Protection of Human Subjects,
Principal Investigator.]
        The Harris County Hospital District values the search for new knowledge and
        uses new knowledge to improve patient care. The District is guided by the
        principles and guidelines of the Belmont Report (reference #1), the District’s
        statements of ethical principles (reference #2), and the Patient’s Rights and
        Responsibilities statement (reference #3). The research approval process requires
        a rigorous review for each research protocol to protect the rights of the
        patients and staff, insures compensation to the District for the use of resources,
        and delineates the methods by which principal investigators can access the
        District facilities, staff, patients, and information. All research to be conducted
        at/in conjunction with any District facility must be approved by the
        President/CEO (or designee) prior to data collection or subject recruitment.
        The District supports well-designed and properly executed research and is
        committed as an institution to comply with Federal regulations and maintain
        adequate processes for the protection of human subjects.
           A. Research is defined as a systematic investigation (i.e., the gathering and
              analysis of information) designed to develop or contribute to generalized
           B. Quality Assurance/Performance Improvement is defined as a
              systematic investigation designed to improve health care delivery or
              outcomes using known technology. Some investigations may be
              classified as both research and Performance Improvement.
             HARRIS COUNTY HOSPITAL Policy No:                       3.05
                     DISTRICT       Page Number:                     2 of 6

            POLICY AND REGULATIONS Effective Date:  09-27-01
                    MANUAL         Board Motion No: 01.9-370

  C. Protocol refers to the formal design or plan of an experiment or
     research activity; specifically, the plan submitted to an Institutional
     Review Board (IRB) for review and to an agency for research support.
  D. Publication is defined as the public availability of results including
     institutional printing or circulation.
  E. Belmont Report is a statement which sets forth three basic ethical
     principles that should be followed in research: respect for persons
     (respect individual autonomy and protect individuals with reduced
     autonomy), beneficence (maximize benefits and minimize harms), and
     justice (equitable distribution of research burdens and benefits). These
     principles are operationalized as informed consent, privacy &
     confidentiality, risk/benefit analysis, scientific merit, and review of
     subject selection.
  F. Informed Consent is the voluntary choice of an individual or an
     individual’s legal representative, if diminished capacity is present, to
     participate in research based on an accurate and complete
     understanding of its purposes, procedures, risks, benefits, alternatives,
     and any other factors that may affect an individual’s decision to
  G. HCHD Research Office is the office responsible for coordinating the
     administrative review of proposed research studies within the District
     and serves as a liaison between the District and investigators wishing to
     conduct studies within its facilities. The HCHD Research Office is the
     primary contact for the IRBs.

           A. For all studies, the following approvals must be documented
              prior to sending the protocol to the President/CEO or
              designee for approval (see attached procedure):
                   1. Hospital and/or Health Center Chief(s) of Staff
                   2. Hospital and/or Health Center Administrator(s)
               HARRIS COUNTY HOSPITAL Policy No:                        3.05
                       DISTRICT       Page Number:                      3 of 6

               POLICY AND REGULATIONS Effective Date:  09-27-01
                       MANUAL         Board Motion No: 01.9-370

                      3. HCHD Research Office
                      4. HCHD Research Finance Panel
             B. Studies which involve obtaining data through interventions or
                interaction with human subjects or identifies private
                information, must additionally have the approval of a
                recognized University or Organization Institutional Review
                Board (IRB) or Committee for Protection of Human Subjects
                (CPHS) as defined in the District’s Federal Wide Assurance
             C. The President/CEO or Designee must approve all research
                conducted at/in conjunction with any facility of the Harris
                County Hospital District.
             D. Review and approval of continuance of a project is required at
                least annually and whenever changes are made to the protocol.
             E. Risks to human safety or violations of federal policy in
                relation to research are to be reported by the principal
                investigator to the Chief(s) of Staff, Hospital/Health Center
                Administrator(s), and the HCHD Research Office
                immediately upon discovery.
             F. Research conducted for quality assurance processes should be
                specifically requested through the Quality Review Council.
       A. The principal investigator is responsible for the performance of all
          research performed at/in conjunction with the District, including
          complying with Federal, state, and local laws as they may relate to
          research and adhering to the established policies of the District. The
          principal investigator is responsible for submitting to the District
          Research Office annually a brief summary of the study
          purpose/procedures/interim results and a one page abstract of the
          study findings upon completion/termination of the study
       B. Prior to approval of a research study, the District will assure that the
          IRB has considered the following:
               HARRIS COUNTY HOSPITAL Policy No:                          3.05
                       DISTRICT       Page Number:                        4 of 6

               POLICY AND REGULATIONS Effective Date:  09-27-01
                       MANUAL         Board Motion No: 01.9-370

                    1. The risks to the subject,
                    2. The anticipated benefits to the subjects and others,
                    3. The importance of the knowledge that may result,
                    4. The informed consent process to be employed,
                    5. The provisions to protect the privacy of subjects,
                    6. The additional safeguards for vulnerable populations.
Patients, District staff, contractual employees, and physicians may decline to
participate as subjects in research projects, investigational studies, and clinical
trials and are assured that their decision will not affect their care or District
      A. The District recognizes and names in its Federal wide Assurance the
         IRBs of universities and organizations who will serve as IRBs for
         research conducted at/in conjunction with the District.
      B. All Human Subject Research or research involving personalized
         information must be reviewed at least annually by an IRB recognized
         by the District prior to approval of initial study or continuance. The
         principal investigator is responsible for obtaining IRB approval,
         complying with all IRB regulations and stipulations, and providing
         written IRB approval to the District.
      A. Legally effective informed consent must be obtained from each
         research participant or his or her legally authorized representative.
         The informed consent, whether oral or written, may not include any
         exculpatory language wherein the subject or the legally authorized
         representative is made to waive or appear to waive any of the
         subject’s legal rights, or releases or appears to release the investigator,
         the sponsor, the institution or its agents from liability for negligence.
           HARRIS COUNTY HOSPITAL Policy No:                             3.05
                   DISTRICT       Page Number:                           5 of 6

           POLICY AND REGULATIONS Effective Date:  09-27-01
                   MANUAL         Board Motion No: 01.9-370

   B. Written consent forms will be in English and Spanish and conform
      to the elements identified in Title 45, Code of Federal Regulations, Part 46:
      Federal Policy for the Protection of Human Subjects.
   C. Consent must be discussed in a language that the patient or his/her
      legally authorized representative understands. If an interpreter is
      used, the interpreter must sign the consent form indicating his/her
      role in the consent process.
   D. Investigator shall assure that a properly executed IRB-approved
      consent form is filed in the appropriate medical record of each
      District research subject, unless the research has been classified as
      Exempt Research by the IRB pursuant to 45 CFR 46, Protection of
      Human Subjects and the requirement for a consent form has been
      waived by the District and the IRB.
   A. Approval for research is terminated after one year; or less if specified
      by the principal investigator’s protocol or approving IRB/CPHS,
      from the date of the initial approval unless a revision or request for
      continuation is submitted and approved by the initial approval
      documentation path.
   B. Research may be terminated at any time upon a written request from
      the District to the principal investigator. Termination of research
      that is not being conducted in accordance with the federal or IRB
      requirements will be reported in writing to the approving IRB.
                       HARRIS COUNTY HOSPITAL Policy No:                      3.05
                               DISTRICT       Page Number:                    6 of 6

                       POLICY AND REGULATIONS Effective Date:  09-27-01
                               MANUAL         Board Motion No: 01.9-370

         Protocols approved by the District should identify the District and/or its
         Hospital/Health Center in publications, unless otherwise specified in the
         District’s approval letter or informed consent form. Copies of publications of
         research performed at the District should be provided to the HCHD Research

  I.        Belmont Report: Ethical Principles and Guidelines for the Protection of
            Human Subjects of Biomedical and Behavioral Research, 1979.
  II.       HCHD Ethics Policy and Procedure
  III.      HCHD Patients Rights and Responsibilities, 2000.
  IV.       HCHD Assurance of Compliance with DHHS Regulations for Protection
            of Human Research Subject, 2001.

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