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e. a recusal may not be counted as an abstention) Requiring Changes or Disapproving Research: The Draft Guidance provides that minutes of IRB meetings must be sufficient in detail to show the basis for requiring changes in approving or disapproving research If an investigator is required to make changes to the research protocol or informed consent documents and to resubmit such documents to the convened IRB for subsequent review these IRB decisions must be documented in the minutes If the IRB disapproves of a research activity the minutes should summarize the IRB’s discussion and deliberations for its decision to disapprove proposed research and clearly indicate the IRB’s reasoning for disapproval Controverted Issues and Their Resolution: For issues that cause controversy and dispute among IRB members the minutes must summarize the IRB’s discussion and plans for seeking resolution if resolution is not reached during a convened meeting When resolution of a controverted issue is reached the minutes must summarize the IRB’s discussion and how they were resolved If there were no controverted issues this should also be noted in the minutes The Agencies recommend that institutions and IRBs decide who is responsible for preparing and maintaining minutes and outline the process in the IRB’s written procedures Institutions and IRBs may consider creating a standard template to assist in the preparation of their minutes The Agencies also note that while recordings of IRB meetings are acceptable to help in the preparation of meeting minutes this does not relieve the IRB of its obligation to keep written minutes in accordance with regulatory requirements Practical Takeaways Meeting minutes must be retained for at least three years after completion of the reviewed research and must be accessible for inspection and copying by authorized representatives of the Agencies It is important to understand that IRB minutes from meetings during which multiple studies were reviewed must be retained until all of the studies that were reviewed at that meeting have been completed for at least three years The Draft Guidance emphasizes that failing to prepare and maintain adequate minutes could result in IRBs being cited in OHRP determination letters and FDA warning letters Continued noncompliance can eventually lead to debarment from participation in research or even civil monetary penalties Examples of noncompliance related to minutes include: The Draft Guidance makes clear that the Agencies and their representatives will review IRB minutes and other appropriate IRB records very closely to assess compliance with all applicable regulations Therefore it is recommended that institutions and IRBs begin to review their procedures in anticipation of the release of final guidance to ensure that their documentation includes the required elements and a sufficient level of detail If you are interested in submitting a comment or would like additional information about the Draft Guidance or the requirements for maintaining adequate IRB minutes please contact: Please visit the Hall Render Blog at http://s.blogshallrendercom/ or click here to sign up to receive Hall Render alerts on topics related to health care law 1See 45 CFR § 46115(a)(2) and 21 CFR § 56115(a)(2)Written by PTI | New Delhi | Updated: February 18 2014 12:50 pm Related News With an aim of enhancing transparency in functioning of the judiciarythe government is pushing for video recording of court proceedings as part of reforms in the legal system Law Minister Kapil Sibal said the issue was discussed recently at a meeting of an advisory committee of his ministry and it unanimously made the recommendation in this regard “The Advisory Council met here Unanimously the council believed that court proceedings must be videographed and that the technology (for the same) must be put in place now” he told PTI here Explaining the reason behind the moveSibal said the processes of the law must be “as transparent” like the processes of the government Sibal said the plan is to begin with video recording of the proceedings of the trial court “…start with the trial courts as it is the foundation of the justice system” he said The Minister said the judiciary will be taken on board on the issue “We’ll have to discuss it with the judiciary as this is not something on which the government can decide on its own” he said The Advisory Council of the National Committee for Justice Delivery and Legal Reformschaired by Sibaldecided to seek the views of the higher judiciary as trial courts fall under High Courts and it cannot be implemented without their consent Members of the Council discussed the case in other countries where the facility is available to record what the judgeswitnesses and the prosecutors say during a court proceeding The Advisory Council includes Planning Commission Deputy Chairman Montek Singh AhluwaliaAttorney General G E VahanvatiNational Innovation Council chief Sam Pitroda and chairman of Parliamentary Committee on Law and Personnel Shantaram Naik During the meetingthe issue of pendency in subordinate courts also came up with members expressing concern over the annual rising trend in pendency The meeting was told that since the last two years the increasing trend has been reversedand the total pendency has come down to 268 crore cases Referring to the use of modern technology and IT in judiciary and legal systemSibal said there was a need to put in place a “comprehensive technical plan” for the future He said technology should not remain limited to videographing court proceedings and “we should integrate it with the jails and the investigating process” Sibal said the process would not be an “very expensive” affair with the availability of fiber optic connectivity For all the latest India News download Indian Express App More Related NewsBy: Express News Service | Jalandhar | Published: August 31 2017 12:51 am Related News Punjab’s Technical Education Minister Charanjeet Singh Channi on Wednesday blamed the contemporary Sikh leadership/organisations patronised by the Shiromani Akali Dal leadership for promotion of “dera culture” in the state? Disapprove. However the plane with a high-end black box will be at least Rs 60 lakh to Rs 1 crore costlier than the set of planes with a traditional black box. I was complacent. he is a Congress candidate with all the baggage and legacy of that party, The government on its part is busy making announcements but they are not reaching people at the grassroot level.



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