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University of Puerto RicoMedical Sciences CampusHuman Research Subjects Protection OfficeEffective:9/1/2008Rev.07/01/2014INITIAL REVIEW – FULL IRB REVIEWPurpose:To describe the process of full IRB review at the UPR/MSC.Introduction:During the initial review of research, the IRB assesses the proposedprotections of the rights and welfare of human subjects participating inresearch. In order for a project to be approved, it must meet the DHHSCriteria for IRB approval of research as defined at 45 CFR 46.111, 21 CFR56.111 and receive the approval of a majority of the quorum.Source:45 CFR 46.111; 45 CFR 46 Sub parts B, C and D21 CFR 56.111; 21 CFR 50 Sub part DApplicability:IRB Staff, IRB MembersPolicy:To ensure a thorough review and to provide the greatest protection to ourresearch participants, initial review of research is conducted at a convened

meeting where quorum is present, except where expedited review isallowable under the Federal Regulations.The IRB chair or a designated member shall determine if a research activitymeets the criteria for expedite review.Procedure:Reviewer systemThe UPR MSC IRB utilizes a primary reviewer system. The protocols onagenda for full board evaluations are distributed among the memberstaking in consideration their expertise, so that each protocol will have aprimary and secondary reviewer. The secondary reviewer will substitute theprimary reviewer if the latter is absent at the meeting, and will otherwiseprovide an additional level of review and discussion. Treatment protocolswill have a physician, nurse or other qualified healthcare professional as theprimary reviewer.Documents distributed to IRB Members before a meetingEach member will receive an electronic version of the complete agendaand protocols to be reviewed through the IRBWISE system. Each reviewerwill be provided an IRB evaluation worksheet to be used as a guide forpresenting the protocol during the meeting and given to the office staffafter the meeting finalizes.All the IRB members have special access privileges to the IRBWISE system;therefore they can review all the documents for each study on agenda.At least one week prior to the IRB meeting, each primary reviewer willreceive an agenda packet containing paper copies of the application andprotocol (refer to policy for IRB submission).Primary reviewer may request additional information from the PrincipalInvestigator. This can be accomplished directly or through the IRB Officestaff. The primary reviewers will present the research project to theconvened board at the IRB meeting and address all of the following issues:(a)Research design and methods(b)Risk identification and assessment

(c)Benefits identification and assessment(d)Disclosure of risks and benefits(e)Plan for data collection storage and analysis(f)Privacy and confidentiality issues(g)Equitable selection of subjects(h)Adequacy of provisions for monitoring and observation ofresearch participants(i)Adequacy of content, expression and process of informedconsent(j)Requirements for assentAfter the primary and secondary reviewers have presented their comments,all Board members discuss the documents received for review and add theircomments.Research or clinical investigations involving pregnanthuman fetuses and/or neonateswomen,For research involving pregnant women, human fetuses and/or neonates,the committee will determine compliance with additional protections ofCFR sub- part B.Research or clinical investigations involving childrenIn the case of research or clinical investigations involving children assubjects, IRB will assess the risk category that applies to the study (asdefined on 45 CFR 46 subpart D and if applicable 21 CFR 50 subpart D) andthe requirement for parental permission and child assent as follows: Studies not involving greater than minimal risk to the children orstudies involving greater than minimal risk but presenting theprospect of direct benefit to the individual child subjects involvedin the research: Parental permission (one parent maybe sufficient)and child assent according to age guidelines described on

“Informed Consent and Child Assent” section of this manual. Studies involving greater than minimal risk and no prospect ofdirect benefit to the individual child subjects involved in theresearch, but likely to yield generalizable knowledge about thesubject's disorder or condition: Parental permission (both parentsunless one is deceased, unknown, incompetent or not reasonablyavailable and child assent according to age guidelines described on“Informed Consent and Child Assent” section of this manual. Studies that the IRB believes does not meet the conditionsdescribed above, but finds that the research presents a reasonableopportunity to further the understanding, prevention, or alleviationof a serious problem affecting the health or welfare of childrenThis special cases may not be approved by local IRB and must bereferred to DHHS if DHHS funded and/ or to the Commissioner ofFood and Drugs, for review.Research involving prisoners as subjectsFor research involving prisoners, a special checklist will be utilized toassure compliance with CFR sub-part C of CFR.Determination of Quorum & VotingPlease refer to “IRB Meetings Policies and Procedures” section.Criteria for IRB approval of ResearchThe IRB reviews research in accordance with current Department of Healthand Human Services (DHHS) and Food and Drug Administration (FDA)regulations. The main purpose of the IRB is to protect the rights andwelfare of human subjects who take part in research. More specifically, theIRB assures that:(1)Risks to subjects are minimized.(2)Risks to subjects are reasonable in relation to any benefits thatmightbe expected from taking part in a research study and tothe importance of the knowledge that may result.

(3)Selection of subjects is fair and equitable.(4)Participation is voluntary and informed consent is obtained fromeach prospective subject or where appropriate, from the subject'slegally authorized representative.(5)The research plan provides for monitoring the data collected toensure the safety of subjects.(6)There are adequate provisions to protect the privacy of subjectsand to maintain the confidentiality of data.Determining frequency of continuing reviewWhen IRB votes to approve a protocol, they decide the period for whichIRB approval is to be granted. This determination is based on theirassessment of the degree of risk to participants, as defined in 45CFR46.103(b) and 109 (e). When the risk is significantly higher in relation tothe risk of alternative procedures, IRB will consider requiring morefrequent continuing review (periods shorter than a year), or one year withcase by case reporting. The approval period begins the day that either thefull committee approves the study, or the day the Chair or designatedreviewer approves the response to stipulations and must not be longer than ayear.Determining which studies need verification from sources other thanthe investigatorsInvestigators are expectedconduct of the researchbetween the investigatorsSafety Monitoring Boards’ provide all relevant information regarding theto the IRB. This system is based on trustand the IRB. The IRB also relies on Data and(DSMB) reports as an external source of dataIn order to assure that the research is conducted in compliance with allregulations for human subject’s protection, IRB may require at theirdiscretion verification of information from other sources. Verification ofinformation provided to the IRB may be requested by the convenedcommittee or by the IRB chairpersons during the process of carrying outreviews.

Independent verification may include request and verification ofcorrespondence between sponsor and or FDA and the investigator;including sponsor’s audit reports, or direct audits by an IRB-delegatedteam. This may be considered in the following situations: Projects involving unusual levels or types of risk to subjectsStudies conducted by investigators who had previous non-compliancewith regulationsUnclear or contradictory information noticed during continuing reviewComplaints from subjects or whistleblowers

Criteria for IRB approval of research as defined at 45 CFR 46.111, 21 CFR 56.111 and receive the approval of a majority of the quorum. Source: 45 CFR 46.111; 45 CFR 46 Sub parts B, C and D 21 CFR 56.111; 21 CFR 50 Sub part D Applicability: IRB Staff, IRB Members Policy: To ensure a thor

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