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INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptx

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INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptx

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The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).

An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.

Per the FDA, an IRB/IEC should have:

At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.

The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).

An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.

Per the FDA, an IRB/IEC should have:

At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.

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INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptx

  1. 1. INSTITUTIONAL REVIEW BOARD/INDEPEDENT ETHICS COMMITTEE (IRB/IEC) SU BM ITTED BY: R A HU L PA L SU BM ITTED TO : D R . S. BHA R AT REGULATORY AFFAIRS
  2. 2. CONTENT IRB/IEC 2  INTRODUCTION  BACKGROUND  COMPOSITION  RESPONSIBILITIES OF IRB/IEC  PROCEDURE OF IRB/IEC  MAINTENANCE OF RECORD OF IRB/IEC
  3. 3. INTRODUCTION 3 IRB/IEC serves as an independent body that reviews, evaluate, approves and decides on the scientific and ethical aspects of the clinical trial protocol as well as the benefits and risks to the study participants.  Main purpose of IRB/IEC is to protect the rights, safety and well being of the subjects who participate in a trial.
  4. 4. BACKGROUND • National research act passed by congress on July 12, 1974, mandated establishment of IRB/IEC. • Act provide national commission for protection of human subjects of biomedical and behavioral research and lead to publication of The Belmont Report in 1979. • The amended regulation on July 27, 1981. • Submission of NDA’S approval of IRB is necessary. 4
  5. 5. COMPOSITION IRB Consists of members, who • Collectively have the qualifications and experience to review and evaluate the science, medical aspects and ethics of the proposed trials. • Include at least five members, of which at least one members whose primary area of interest is nonscientific discipline and at least one member who is independent of the institutional/trial site. 5 IRB/IEC
  6. 6. IRB/IEC MEMBERSHIP Members of ICE: • Chair person. • 1-2 basic medical scientists. • 1-2 clinicians from various institutes. • One legal exert or retired judge. • One social scientist, One philosopher/ethicist. • One lay person. • Member secretary. 6 IRB/IEC
  7. 7. RESPONSIBILITIES OF IRB/IEC The Committee has been designated to- • Approve • Monitor • Review biomedical and behavioral research, involving humans with the aim to protect the rights, safety and welfare of the research subjects. • Safeguard the rights, safety and well-being of all trial subjects. • Reviews a proposed clinical trial within a reasonable time and documents its view s in writing. • Conducts continuing review of each ongoing trails at least once per year. 7 PRESENTATION TITLE
  8. 8. PROCEDURE OF IRB/IEC • Determines its composition and authority under which it is established. • Schedules, notifies its members of, and conducts its meetings. • Conducts initial and continuing review of trials. • Specifies that no subjects should be admitted to atrial before the IRB/IEC issues its written approval/favorable opinion of the trail. • Specifies the information that the investigator should promptly report to the IRB/IEC (like deviations from the protocol, adverse drug reactions etc) 8 PRESENTATION TITLE
  9. 9. 9 PROCESS OF IRB OVERVIEW
  10. 10. MAINTENANCE OF RECORD OF IRB/IEC • IRB/IEC retains all relevant records (e.g. written procedures, lists of occupations/affiliations of members, submitted document, minutes of meeting etc.) for period of at least 3 years after completion of the trial and makes them available upon request from the regulatory authorities. • IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide copies of its written procedures and membership lists. 1 0 PRESENTATION TITLE

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