IRB / IEC

Detailed constitution and functions of IRB

1. INSTITUTIONAL REVIEW BOARD, INDEPENDENT ETHICS COMMITTEE Submitted by: San jay gandh Department – Pharmaceutics

2. IRB/EC in Clinical Trials The International Council on Harmonization (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 risks in relation to any benefits that might result from the research.

3. An IRB/IEC: Reviews all study-related materials before and during the trial Must operate in accordance with national and/or local regulations, as well as with ICH go o d c l i n i c a l pr a c t i c e s ( GC P s ) gu i de l i n e s IRB/IEC Membe r s h ip IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial. A n I RB/ I E C s h o u l d h a v e : A t l e a s t f i v e memb e rs M e mb e rs w it h v a r y i n g b a c k gr o u n ds At least one member must represent a non-scientific area (a lay member) At least one member must not be affiliated with the institution or the trial site (an independent member) Competent members who are able to review and evaluate the science, medical a s p e ct a n d e t h i cs of t h e p r o p o s e d t r i a l

4. IRB/IEC Responsibilities Before, During and After a Trial Before a site is allowed to start enrolling patients in a clinical trial, the IRB/IEC must review all study-related materials in an initial re v i ew. T he I RB / I E C al s o p erforms per i odi c re v i ews – called continuing reviews – throughout the trial’s duration. Continuing reviews may take place at least once a year and include the ent i re tr i al , not j u s t changes . The IRB/IEC may also ask for additional information regarding payments and compensation to study participants, as well as the informed consent process . Investigator Responsibilities for Ensuring Compliance The principal investigator (PI) is responsible for ensuring compliance with any IRB/IEC procedures or requirements. He or she may deviate from the study protocol without prior IRB/IEC app r o v al only to el i m i n at e i m m e d i a te s afety haz a rd to a st u dy participant.

5. INSTITUTIONAL R E V I E W B O A R D

6. What is the Ins t itution a l Revie w Bo a rd (IRB)? The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy. The IRB shall have at least five members of varying backgrounds in order to provide complete and adequate review of human research and its institutional, legal, scientific, and social implications. The Board will also include at least one member who is not affiliated with the institution and one member who is not a scientist. The IRB has several consultants who advise the Board and are periodically involved in protocol review.

7. FDA Guidance for Institutional Review Boards Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

8. FDA Guidance for Institutional Review Boards (CONTD) As published in the Federal Register on January 15, 2009, (74 FR 2358), 21 CFR Part 56, Institutional Review Boards, was amended with regard to IRB registration (21 CFR 56.106). This amendment requires each IRB in the United States (U.S.) that reviews FDA- regulated studies to register. IRB registration information is entered into an Internet- based registration system maintained by the Department of Health and Human Services (HHS) The fundamental purpose of IRB review of informed consent is to assure that the rights and welfare of subjects are protected. A signed informed consent document is evidence that the document has been provided to a prospective subject (and presumably, explained) and that the subject has agreed to participate in the research. IRB review of informed consent documents also ensures that the institution has complied with applicable regulations.

9. Indian IRB The Central Drug Standards and Control Organization (CDSCO), amended the Schedule Y, by issuing three amendments to introduce new compensation rules and registration of IRBs functioning in the country. Central Drug Standards and Control Organization (CDSCO) has granted registration to 565 IRBs in the country, this means that at least on paper these IRBs are compliant to the norms as of 2013. IRBs in India must have at least seven members in place of five members required in the International Conference on Harmonization (ICH) region.

10. INDEPENDENT ETHICS COMMITTEE

11. Four Basi c Ethica l Principles Respect for Persons Application : Informed Consent Beneficenc e Applicatio n : A ss e s s m e nt of Ha r ms and Benefits Ju s tice Applicatio n : Select i on of P art i c i pant s i n Research Res p ec t for Com m uni t ies Applicat i o n : C omm un i ty involvement and participation

12. RESPONSIBILITIE S OF IEC 1.To protect the dignity , rights & well being of patients. Ensur e a competent review of t he p r otocol. Advise on a l l a spect s of welfa r e & safet y . Ensur e scien t i fic soundnes s of t he p r oposal.

13. IE C MUM B AI DATA S r. N o. IEC assigned No. T i t l e Name of PI L o cati o n 1. I E C /1/2000 A phase II study of Gemitabine, Paclitaxel and cisplatin in chemotherapy naïve FIGO stage III B and IV ovarian cancer Dr. Purvish M. Parikh T ata M emor i al Hospital, Mumbai 2. I E C /2/2000 An open non comparative study of efficacy and safety of ketoprofen IV in the treatment of cancer pain Dr. Purvish M. Parikh Dr. L.J.D'Souza T ata M emor i al Hospital, Mumbai 3. I E C /4/2001 A study of gynaecological morbidity and common mental disorders in Goa Dr. Vikram Patel G oa

14. REFERENCE https://hub.ucsf.edu/protocol-development http://www.ct-toolkit.ac.uk/routemap/protocol-development/ https: //w ww .uth.edu/ctrc/trial-conduct/protocol-development.htm https://grants.nih.gov/policy/clinical-trials/protocol-template.htm https://blogs.fda.gov/fdavoice/index.php/2016/03/fda-and-nih-release-a-draft-clinical-trial- protocol-template-for-public-comment/ http://www.cdsco.nic.in/writereaddata/Guidance_for_New_Drug_Approval-23.07.2011.pdf http://ctep.cancer.gov/handbook/index.html https: //w ww .fda.gov/RegulatoryInformation/Guidances/ucm126420.htm http://research.oregonstate.edu/irb/frequently-asked-questions/what-institutional-review-board-irb http://www.ppdi.com/Participate-In-Clinical-Trials/Become-an-Investigator/Institutional-Review- Board https: //w ww .ncbi.nlm.nih.gov/pmc/articles/PMC3980545/ http://www.iecindia.org/project.htm