Training in theResponsibleConduct ofResearch
NOTE: This information was adapted from a training grant RCR training plan, and should be customized, revised, and/or condensed as you and your mentor see fit needed for your individual fellowship application. Some portions are adapted from . Be sure to document your past instruction, as wellas current and/or planned instruction. You should also briefly describe your mentor's role inyour RCR instruction. You can’t fit everything in the one page limit for this section of your proposal, so select the activities that are most appropriate for your research training.
The NIH hasstringentguidelinesfortraininginthe Responsible ConductofResearch(RCR)andthistraining plan gives thesethe highestpriority.The University of Florida has takenmanysteps to ensurethatinstitutional and individual training programs proactivelyprovideboth formal and informal trainingandsupervision needed to develop and maintain good RCR practicesby traineesandmentorsthroughoutthe trainingperiod.MultimodalRCR training is provided for all PhD students, regardless of funding source, and emphasizes:(i)training in theprotection ofthewelfareofhuman subjectsthrough coursework, Institutional ReviewBoard visitationand/orservice,researchteammeetingdiscussionswith thementor,University initiatives,and at traineemeetingsand(ii)responsible scientificconductinthegathering andreportingof scientificdatathroughrequiredcourse work,researchteammeetings,discussion with thementor,and trainee meetings.
Formal Training. As a (PhD student / postdoctoral fellow) in the (___ PhD program / Dept. of ___) in the College of ___ I participated in the following RCR training activities. (select those that apply)
I will continue RCR training during my fellowship by participating in the following activities. (select those that apply)
UFrequires HIPAAtrainingannually(“HIPAA &Privacy– Research”). Possible additional online courses, depending on your research roles: “IRB01 MandatoryLocalTraining”, “Animal Awareness Seminar”,“Human Subject Payments”,“Administratorsand RCR”,“CTSIInformed ConsentTraining”,“PIResponsibilityfor Informed Consent”,“Study CoordinatorRoles inResearch”,“FinancialConflictofInterest”,“Billing forDevice Studies”,“FERPA Basics”, “FERPAforFaculty”.
Requiredreading forall trainees andmentorsavailable online includes the BelmontReportand45 CFR46. The OfficeofHuman Research Protections(OHRP)considersitunethicalforanyone involved in human subjectresearchnotto have read theBelmontReport,which describestheethicalprinciples thatshould be followed by investigators:respectforpersons,beneficence andjustice. Via Multiple ProjectAssurance,UFhas a contractwith OHRP assuring thatinvestigatorsconductinghumanresearch will followthe ethicalprinciples outlined in the Code ofFederal Regulations. All trainees mustread andbepreparedto discuss45CFR46, which describesauthorityand responsibilityofInstitutional ReviewBoards (IRBs)in protecting human subjects.
I completed/will complete the graduate course “Responsible ConductofBiomedicalResearch”(GMS 7877,1 credit,21 contacthours),arequired/elective course inthe ___curriculum.The course isdesignedto introducekey issuesin RCR followingtheresearch processfrominception toplanning,conducting,reporting,andreviewing biomedicalresearch,and providesa practical overviewoftherules,regulations,andprofessionalpracticesthat define RCR.Ten2-hourteam-based learning sessionsinclude ethicaldecision-making,defining researchmisconduct,human subjects,animalwelfare,conflictsofinterest& commitment,datamanagement,mentor-traineerelationships, collaboration,authorship & publication,andpeerreview.Each session entailsassigned pre- readings,individualand teamreadinessassurance tests,andapplication exercisesin which student teamspractice and discuss making decisions based on research on researchscenariosposingreal-lifeethicaldilemmas.
I completed/will complete the graduate course “EthicalandPolicyIssuesin ClinicalResearch(GMS 6931,2 credits,30 contacthours), arequired/elective course inthe ___curriculum. This course coversethicaland policy issues relating toconductofclinicalresearchand providesa basicunderstanding ofregulationsgoverning research on humansubjectsandan introductiontothetopicofresearch with animals.Inadditionto didactictraining, case-basedpresentationsand discussionsareused tofacilitateactive learning.
Additionalelectivegraduate courses: Ethicsin Genetics (GMS 6221,1credit); Ethicsin Population Science(PHC 7427,2credits).
Informal Training. In my mentor Dr. ___’s lab, I am receiving training in the responsible conduct of research through individual meetings with my mentor and collaborators (Drs. ___) on a (weekly, biweekly, monthly) basis (mention any special training your mentors have had in RCR). Additionally, the members of the lab have group meetings, which provide consistent forums to evaluate and critique experimental data. These discussions also offer the opportunity to address ethical issues such as responsible authorship, sharing of data and reagents, and data management. We are also provided informal instruction from various faculty and scientists in the responsible conduct of research in laboratory interactions and other situations. (Possible additional details for this section are shown below)
(Department/center/institute) seminarpresentersare encouragedto incorporateresearchethicsissues encountered intheirresearch,includingdiscussion ofethicaldilemmasinvolving IRB policies,authorship guidelines,conflictsofinterest,mentoring, and/or responsible reportingofresearchfindings.
Our (weekly/monthly) (Dept. of Pathology Works in Progress / Dept. of Epidemiology All Hands / lab / other) meetings include an “ethical moment” discussion that highlights a timely issue related to authorship, data management, data analysis, conflicts of interest, research funding, or other matters that affect research integrity.
I am required by the ___ program to have atleast(weekly, biweekly, monthly)meetingswith my mentorstoreviewprogressandsetgoals.RCR issuesarereviewed and documented in thesemeetings.
Inthe developmentofmy dissertationresearch project,I (prepared and submitted my own protocol / will prepare and submit my own protocol / assisted or will assist in the preparation and submission of my mentor’s protocol) for the Institutional Review Board (IRB) / Institutional Animal Care & Use Committee (IACUC)to learnmore aboutprotection ofhuman andnon-human research participants.Aspartofthisexperience,I attended/will attendtheIRB/IACUC meetingatwhich theprotocolis/wasreviewed,in ordertobetterunderstandtheIRB/IACUCreviewprocesses.
(If you or your lab have other activities that you believe would be of interest to and benefit other students and/or postdocs, please share them with Dr. McCormack so they can be included in this document. Thank you.)