{"id":790,"date":"2011-06-03T10:45:13","date_gmt":"2011-06-03T14:45:13","guid":{"rendered":"http:\/\/www.marshall.edu\/ori\/?page_id=790"},"modified":"2024-05-01T10:36:39","modified_gmt":"2024-05-01T14:36:39","slug":"purpose-of-the-human-research-protection-program","status":"publish","type":"page","link":"https:\/\/www.marshall.edu\/ori\/office-of-research-integrity\/human-subject-research\/purpose-of-the-human-research-protection-program\/","title":{"rendered":"Purpose of the Human Research Protection Program"},"content":{"rendered":"

The Marshall University Human Research Protection Program (HRPP) is a comprehensive and organized system to ensure the protection of human volunteers participating in research.\u00a0The objective of this system is to assist the institution in meeting ethical principles and regulatory requirements for the protection of human subjects in research.<\/p>\n \n \n \n \n

\n Ethical Principles Concerning the Protection of Human Research Participants\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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The ethical principles described in the\u00a0Belmont Report<\/a>\u00a0(April 18, 1979) include 1) respect for persons, 2) beneficence, and 3) justice. These are the basic underlying ethical principles that Marshall University Institutional Review Boards consider when reviewing research protocols involving human subjects.<\/p>\n

Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s). (ICH-GCP)<\/p>\n

A system with procedures that assure the quality of every aspect of a clinical trial should be implemented.\u00a0 (ICH-GCP)<\/p>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n

\n Written Assurance\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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Marshall University stringently adheres to the assurance prescribed in its Federal Wide Assurance (FWA #00002704).<\/p>\n<\/div>\n<\/article>\n<\/div>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n

\n Types of Activities Under HRPP\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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The Human Research Protection Program has the authority and responsibility to oversee all human research conducted by any employee, student or other agent of Marshall University (or affiliate by means of a Memorandum Of Agreement) conducting research as part of their assigned duties. Marshall University IRBs have sole authority to review, approve, disapprove or require changes in research or related activities involving human subjects conducted by Marshall University or affiliated investigators.<\/p>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n

\n What Constitutes Research\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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Research is defined as:\u00a0 A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.<\/p>\n

Under FDA regulations, research is defined as any experiment that involves a test article and one or more human subjects, and that either is subject to requirements for prior submission to the Food and Drug Administration.<\/p>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n

\n Components of HRPP\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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The components of the Human Research Protection program include the IRB, the participants, the investigators who design, oversee and conduct the research, and the research staff who support them and carry out all necessary protection functions for a particular protocol.<\/p>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n

\n Responsible Institutional Official\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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The responsible Institutional Official for the Marshall University\u00a0IRBs is the vice president for research.\u00a0He\/she is responsible for ensuring the independence of\u00a0each IRB, its support and standing within the institution.\u00a0He\/she has the responsibility for the implementation and operation of the Human Research Protection Program.\u00a0The director\/staff of the Office of Research Integrity assist in the day-to-day operations of the program.<\/p>\n

The Institutional Official is authorized to review and sign a Department of Defense Addendum.<\/p>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n

\n Organizational Structure\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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The president of Marshall University serves as the chief executive officer of the institution. The senior vice president\/provost serves as the chief academic officer. The vice president for research, who also serves as the Human Research Protection Program\u2019s Institutional Official, reports to the provost. The director of the Office of Research Integrity (ORI) reports to the vice president for research and serves on the university\u2019s IRBs (as a non-voting member). The IRB chairmen and IRB members are appointed by the director of the ORI. The staff of the ORI report to the director and assist with all administrative duties involved with the Human Research Protection Program.<\/p>\n<\/div>\n<\/article>\n<\/div>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n

\n Responsible Individual for Implementation of HRPP\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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The director of the Office of Research Integrity is responsible for: \u00a0<\/strong><\/p>\n

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  1. Implementation of the institution\u2019s Human Research Protection Program policy;<\/li>\n
  2. Review and evaluation of reports and results of compliance assessment and quality improvement activities;<\/li>\n
  3. Implementation of needed improvements and follow-up on\u00a0actions, as appropriate; and<\/li>\n
  4. Monitoring changes in federal and state regulations and\u00a0policies that relate to human research protections.<\/li>\n<\/ol>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n
    \n Institutional Review Board (IRB)\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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    Marshall University has two IRBs of record registered with the U.S. Department of Health and Human Services\u2019 Office for Human Research Protections (IRB#1 Medical: 00002205 and IRB#2 SBER: 00003206).\u00a0<\/strong><\/p>\n

    The university\u2019s Human Research Protection Program\u00a0Standard Operating Procedures Manual\u00a0(see the IRB Membership Chapter) details the membership composition, and their roles and responsibilities in evaluating the scientific and ethical integrity of proposed research, including conflict of interest issues. An active IRB membership roster is available on the ORI website under each individual board.<\/p>\n

    The accurate maintenance of records for each active protocol is a responsibility of the IRB coordinator.<\/p>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n

    \n Safety Monitoring\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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    When reviewing research that is more than minimal risk, the IRBs are responsible for determining the protocol includes adequate provisions for monitoring the data collected to ensure the safety of participants.<\/p>\n

    For U.S. Department of Defense-sponsored research:<\/p>\n

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    • Appointment of a research monitor.\n
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      • Required for research involving greater than minimal risk, although the IRB can require for a portion of the project or for studies involving no more than minimal risk if appropriate.<\/li>\n
      • Independent research monitor must be appointed by name.<\/li>\n
      • The research monitor has the authority to:\n
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        • Stop a research study in progress.<\/li>\n
        • Remove individuals from a study.<\/li>\n
        • Take any steps to protect the safety and well being of participants until the IRB can make an assessment.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n
          \n Systemic Budgeting for HRPP\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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          A\u00a0systematic budgeting process for the Marshall University Human Research Protection Program, including its IRBs, is described in the\u00a0Standard Operating Procedures Manual.<\/p>\n

          The Director of the Office of Research Integrity (ORI) is responsible for the budgetary functions of the Human Research Protection Program. The Director is responsible for identifying and reporting budgetary needs, appropriations, disbursements, and discrepancies to the Vice President for Research.<\/p>\n

          The Marshall University Research Corporation (MURC) is responsible for maintaining the daily budget, receiving funds, disbursing funds and invoicing for applicable study fees.<\/p>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n

          \n Conflict of Interest\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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          The policies to identify and manage institutional, IRB member and investigator conflict of interest with research conducted at Marshall University are described in the Human Research Protection Program\u00a0Standard Operating Procedures Manual\u00a0(see the Conflict of Interest Chapter).<\/p>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n

          \n Participant Involvement\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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          The Marshall University institutional policies to address complaints and non-compliance\u00a0are listed in the Human Research Protection Program\u00a0Standard Operating Procedures Manual\u00a0(see the Complaints, Non-Compliance, and Regulatory Improprieties Chapter). In addition, the Office of Research Integrity welcomes feedback and complaints from research participants, and then engages those research subjects in resolving issues.<\/p>\n<\/div>\n<\/article>\n<\/div>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n

          \n Investigational Product Management\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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          The Marshall University institutional policies for the management of investigational drugs (IND) [including investigational pharmacy, IND log, IND dispensing, pharmacy evaluation and reporting, and pharmacy corrective action], and investigational devices is specified in the Human Research Protection Program\u00a0Standard Operating Procedures Manual\u00a0(see the Investigational Drugs\/Devices Chapter).<\/p>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n

          \n Quality Improvement Program\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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          The procedures that the Marshall University Human Research Protection Program (HRPP)\u00a0is using for its continuous quality improvement process to measure investigator\u00a0and\u00a0HRPP\u00a0performance and take corrective actions to improve these activities as appropriate are described in the\u00a0Standard Operating Procedures Manual\u00a0(see the Quality Assurance\/Quality Improvement Chapter).<\/p>\n

          The Office of Research Integrity conducts monthly random study and record audits to ensure that research studies are in compliance with IRB approval and that regulatory issues are being met.<\/p>\n\n\n <\/div>\n <\/div>\n <\/div>\n \n \n \n

          \n Education and Training Program\n <\/div>\n\n \n \n <\/path>\n <\/svg>\n <\/span>\n <\/button>\n\n \n
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          An ongoing education and training program that meets federal requirements\u00a0and provides guidance to investigators on informed consent documents and processes is described in the Human Research Protection Program\u00a0Standard Operating Procedures Manual\u00a0(see the Education and Training Chapter). Marshall University has adopted the Collaborative Institutional Training Initiative (CITI) Program as\u00a0its required educational training course.<\/p>\n\n\n <\/div>\n <\/div>\n <\/div>\n\n

           <\/p>\n

          \n","protected":false},"excerpt":{"rendered":"

          The Marshall University Human Research Protection Program (HRPP) is a comprehensive and organized system to ensure the protection of human volunteers participating in research.\u00a0The objective of this system is to assist the institution in meeting ethical principles and regulatory requirements for the protection of human subjects in research.  <\/p>\n","protected":false},"author":15,"featured_media":2776,"parent":14,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"page-sidebar-right.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-790","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/pages\/790","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/users\/15"}],"replies":[{"embeddable":true,"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/comments?post=790"}],"version-history":[{"count":6,"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/pages\/790\/revisions"}],"predecessor-version":[{"id":3000,"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/pages\/790\/revisions\/3000"}],"up":[{"embeddable":true,"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/pages\/14"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/media\/2776"}],"wp:attachment":[{"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/media?parent=790"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}