IRB Review and Aproval Process and ongoing mointoring of safety data.pptx

IRB REVIEW

1. IRB/IEC review and approval process and ongoing monitoring of safety data -AARTI VATSA

2. TABLE OF CONTENT: Introduction Background Review Process Procedure Conclusion

3. 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 .

4. 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 exempted from IRB and informed consent regulation required. Submissions of NDA’s approval of IRB is necessary.

5. REVIEW PROCESS Researchers are required to submit a request for review to the IRB if their research involves human participants or their data. The IRB will determine if the research meets the requirements for oversight, according to the Code of federal regulations (45CFR46). The request must be reviewed by the IRB prior to collecting data or contacting participants. For continuing or modifying a current protocol, use the appropriate form located on the IRB Forms page.

6. REVIEW PROCESS… IRB Decision is Required Prior to Contacting Participants or Collecting data

7. 1. PROTOCOL COMPLETION Complete the Request for Review, Continuation, or Modification form, with an expected start date at least 10 business days in the future. Attach your Human Research CITI Completion for all persons involved with the research and other supporting documentation (consent/assent forms, site letter of permission or support, recruiting materials, questionnaire/ survey, flyers, email or phone scripts, etc.)

8. 2. SUBMIT PROTOCOL TO IRB Submit ONE PDF ATTACHMENT of your completed protocol to [email protected] . Please do not sent multiple attachments or a hard copy. Also, do not send your protocol to the IRB Chair. When your protocol has been forwarded for review, you should receive an email stating that your protocol has been submitted for review with the estimated decision date.

9. 3. ESTIMATED DECISION DATE The IRB should have feedback or a decision back to you within 10 days from the date your protocol was accepted and issued a protocol number. And in case you do not receive feedback or a decision within 10 business days, please contact at [email protected]

10. 4. DECISIONS Decisions are based on the definition provided by the 45CFR46. The decisions reached could be- 1. Approved 2. NHPR (Not Human Participant Research) 3. Further Review (need to provide clarifications or corrections to your submitted materials) 4. Needs Full Board Review

11. The IEC’s member secretary shall screen the proposals for their completeness and depending on the risk involved categorize them into: Expedited review- Those with no more than minimal risk to research participants may be subjected to this review Ex: clinical studies of drugs and medical devices. T he research involves already approved drugs. W hen a adverse event or unexpected adverse reaction is reported. F ull review- All research proposals presenting with more than minimal risk. Projects that involve vulnerable population (children, psychiatric patients etc.,) Full review is carried out in cases involving: (a) collection of blood samples (b) Prospective collection of biological specimens eg. Skin appendages, excreta saliva, placenta, amniotic fluid, sputum etc. Exempted from review- P roposals with less than minimal risk Ex: research on educational practice, instructional technics, curricula, classroom management methods

12.   Following parameters are considered for ethical review: Scientific design and conduct of study Recruitment of Research Participants Care and Protection of Research Participants Protection of research participant confidentiality Informed Consent Process

13. The IRB should review a proposed clinical trial within a reasonable time and document its views in writing, clearly identifying the trial, the documents reviewed and the dates for the following : Approval / favorable opinion M odifications required prior to its approval / favorable opinion; disapproval / negative opinion Termination / suspension of any prior approval / favorable opinion The IRB should consider the qualifications of the investigator for the proposed trial, as documented by a current curriculum vitae and / or by any other relevant documentation the IRB requests

14. TYPES OF REVIEW Periodic Review : Ongoing research may be reviewed at regular intervals of six months to one year Continuing Review : The IEC has the responsibility to continue reviewing approved projects for continuation, new information, adverse event monitoring, follow up. Interim Review: Interim Review decide special circumstances for review by sub-committee – re-examination of proposal already examined by IEC.

15. STEPS IN IEC REVIEW IEC date fixed Submission made by researchers Decide primary and secondary reviewers Review The IEC meeting The Discussions The Decision Documenting the discussions and decisions Communicate the decisions to researchers Revisions/ Resubmissions/ Cleared.

16. PROCEDURES The IRB/IEC should establish, document in writing, and follow its procedures, which should include: Determining its composition (names and qualifications of the members) and the authority under which it is established. Scheduling, notifying its members of, and conducting its meetings. Conducting initial and continuing review of trials. Determining the frequency of continuing review, as appropriate.

17. Providing, according to the applicable regulatory requirements, expedited review and approval/favorable opinion of minor change(s) in ongoing trials that have the approval/favorable opinion of the IRB/IEC. Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written approval/favorable opinion of the trial. Specifying that no deviations from, or changes of, the protocol should be initiated without prior written IRB/IEC approval/favorable opinion of an appropriate amendment, except when necessary to eliminate immediate hazards to the subjects or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change of monitor(s), telephone number(s).

18. Specifying that the investigator should promptly report to the IRB/IEC: Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial All adverse drug reactions (ADRs) that are both serious and unexpected. New information that may affect adversely the safety of the subjects or the conduct of the trial

19.   Ensuring that the IRB/IEC promptly notify in writing the investigator/institution concerning: (a) Its trial-related decisions/opinions. (b) The reasons for its decisions/opinions. (c) Procedures for appeal of its decisions/opinions.

20. RECORDS The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 3-years after completion of the trial and make them available upon request from the regulatory authority( ies ). The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists.

21. CONCLUSION  An Institutional Ethics Committee is a mandatory requirement as per the ICMR which is the over–seeing body of medical research in India. It is an Independent body constituted of medical, non- medical, scientific and non-scientific members whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in the trial.

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