INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)

regulatory affairs

1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) By Sagar Trivedi SKB college of pharmacy kamptee

2. Introduction IRB/IEC serves as an independent body that reviews, evaluates, 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

3. Background National research Act passed by congress on July 12, 1974, mandated establishment of IRB/IEC. Act provided national commission for protection of human subjects of Biomedical and behavioral research and lead to publication of The Belmont Report in 1979. Private practitioners conducting trials were exmpted from IRB and informed consent regulation required.

4. The amended regulation on july 27,1981 requires IRB review and approval of all research increased need of establishing IRB that would review and approve research proposal tha might affilited with major research centre , hospital , universities Submissions of NDA’s approval of IRB is necessary.

5. IRB/IEC Duties The goal of IRB/IRC is protection of the rights , safety and welfare oh human subjects involved in clinical research investigations. Reviews a proposed clinical trial within a reasonable time and document its views in writing Conducts continuing review of each ongoing trial at least once per year

6. Provide advice to the researchers on all aspects of welfare and safety of research participants Responsibilities of IRB/IEC Ensures that information regarding payment to subjects (including the methods, amounts, schedule of payment) is set forth in the written informed consent form and any other written information is provided to the subjects If the all the things are not sufficient may either dissapprove the investigation or may suggest modifications The sponsor must secure the investigator’s agreement to fulfill obligations by obtaining signed and dated before initiating a trial

7. IRB/IEC Membership & Responsibilties Consists of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trials Includes at least five members, of which at least one member whose primary area of interest is nonscientific, and at least one member who is independent of the institution/trial site MEMBERS OF IEC

8. Chair person 1-2 basic medical scientists 1-2 clinicians from various institutes One legal expert or retired judge One social scientist One philosopher/ethicist One lay person Member Secretary

9. IRB/IEC Documentations & Operations IRB’s must maintain written procedures of all operations. All activities associated with the following operations must be recorded. Conducting initial review and conducting review/ approval of research Conducting expedited review/ approval of research Ensuring that changes in research activites are reported

10. Ensuring that changes in previously approved research are not implemented without review and approval Reporting of serious risk Reporting of serious findings All IRB’s are required to maintain records of meetings and documents for at least three years after completion of study IRB’s are responsible for reporting's investigators noncompliance

11. Information required for IRB/IEC review All information submitted to an IRB review of a research protocol is provided by clinical investigator The standard document provided are research protocol , sample of intended informed consents , Investigators Brochure. It has become important to provide patient information or instruction guidelines.

12. FDA information sheets suggesting that they be provided has served as guidelines / refrences for common practices that facilitate regulated activites In ICH GCP guidelines its specially stated that certain document be obtained for review as part of responsibility of IRB/IEC Review of the protocol ensures adequate selection criteria and procedure to protect vulnerable study population

13. The Informed Consent Form The informed consent regulations (21 CFR, part 50) apply to all clinical investigations regulated by FDA that include applications for research or marketing permits for products the FDA regulates. General requirements for informed consent (IF) are Subject participating in trial should not only inform about project but procedures n followed by risks and benefits associated with it. The IF requires written contest from each participant that they are satisfied with all terms and conditions.

14. FDA implemented regulation in regarding case histories to specify that case histories must document that IF was obtained before a subject participated in study . According to IF clinical investigators should allot sufficient time for patients to review and ask questions regarding it IF overall documentations must be done in simple and easy language that is easily understood by layperson . All technical, medical , legal terminology should be explained to a prospective subject.

15. Basic elements of Informed Consent Statement should be prepared which shall involve purpose of research ,expected duration ,schedule and events to be followed. Descriptions of any reasonable risk or discomfort. Descriptions of benefits that may be expected as result of research. Disclosure of appropriate procedures or course of treatment

16. Additional Elements of Informed Consent form A statement that the particular treatment or procedure involve currently risk Circumstances under which subjects involvement may be terminated by investigator. Consequences that may result from the subjects decision to withdraw from research. The approximate no. Of subjects involved in study

17. Oral Consent It's a short-form written consent document starting that the elements of IF have been presented orally to the subject or authorized representative . Following are requirements necessarily implemented to use oral consent A witness to oral presentation must be present.

18. The IRB must approve written summary of what will be said to subject. The oral consent must be signed by subject/representative and by witness

19. Informed Consent During Emergency use In an emergency use situation where an investigator has determined that there is not sufficient time to obtain IF from subject but he or she is required to have determination reviewed by physician but a written certification of following IF requirements before use which are as follows

20. The subject is confronted by a life threatening situation necessitating use of test article Time is not sufficient to obtain effective consent from subject No alternative method of therapy is available.

21. THANK YOU