WORKSHEET: HUA Harvard Policies
The purpose of this worksheet is to provide support for IRB staff conducting screening of submission materials. The completion of many of the below items may be accomplished through the ESTR Ancillary Review process. The ESTR Ancillary Review Guide may be found in the ESTR Library. INITIAL REVIEW OR MODIFICATION (when the modification affects one of the following) OR CONTINUING REVIEW (when not documented)Ancillary Review: At Harvard, the Manage Ancillary Review (available from pre through post review) activity is only available to IRB staff and reviewers. Ancillary approvals not recorded in the system (for example, obtained via email or as an attachment) must be added via Manage Ancillary Review. Track Harvard Determinations (THD): Additionally, a custom Track Harvard Determinations (available from pre-review to determination) activity allows for recording metrics about particular study features that require reporting which may or may not separately require ancillary review. Track Harvard Determinations must be recorded on every submission (even if features of the study remain unchanged).ItemAction Needed / Additional InformationRequired for Approval/ Determination?Ancillary Review TypeTHDWorking with Other Institutions FORMCHECKBOX Reviewing IRB Reliance Agreement Eligibility – Master AgreementWhen a reliance agreement involves only Harvard institutions, the Harvard Master Agreement is used.Refer to HRP-085-Cede Review for more information.Instructions:When HUA IRB is the Reviewing IRB and a reliance request is received, the IRB Reviewer will notify the HUA IRB Reliance Administrator and the HLC Reliance Administrator through Ancillary Review.Include a brief description of engagement as a note in the Ancillary Review.If “NO” from either party, reliance will not occur. Decision for “NO” will be included in response. A “YES” decision from HLC confirms that reliance has been reached.Yes<Reliance Eligibility Check>Assign to Person rather than OrganizationHUA: Meghan PronovostHLC: Julie ChamberlinNo FORMCHECKBOX Reviewing IRB Reliance Agreement Eligibility – Outside InstitutionsWhen a reliance agreement involves outside institutions.Refer to HRP-085-Cede Review for more information.Instructions:1. When HUA IRB is the Reviewing IRB and a reliance request is received, the IRB Reviewer will notify the HUA IRB Reliance Administrator through Ancillary Review.2. Include a brief description of engagement as a note in the Ancillary Review.3. If “NO” from HUA Reliance Administrator, reliance will not occur. Decision for “NO” will be included in response. A “YES” decision from HUA confirms only that the project is eligible for reliance; not that a reliance has been reached.Yes<Reliance Eligibility Check>Assign to Person rather than OrganizationHUA: Meghan PronovostNo FORMCHECKBOX Relying IRB Reliance Agreement Eligibility – Master AgreementWhen a reliance agreement involves only Harvard institutions, the Harvard Master Agreement is used.Refer to HRP-085-Cede Review for more information.Instructions:1. When HUA IRB is the Relying IRB and a reliance request is received as an External IRB submission, the HUA IRB Reliance Administrator will notify the HLC Reliance Administrator through Ancillary Review.2. Include a brief description of engagement as a note in the Ancillary Review.3. If “NO”, reliance will not occur. Decision for “NO” will be included in response. A “YES” decision from HLC confirms that reliance has been reached.Yes<Reliance Eligibility Check>Assign to Person rather than OrganizationHLC: Julie ChamberlinNoPrincipal Investigator Eligibility: FORMCHECKBOX Harvard Principal Investigator (PI) EligibilityThose listed as a Principal Investigator (PI) must meet certain eligibility requirements. Instructions: Staff to verify that PI is eligible. If not, a waiver of PI requirement or Faculty Sponsor ancillary review and attestation is required via ESTR (see below).YesN/AException PI FORMCHECKBOX Waiver of PI requirement obtainedCertain criteria have been established for the Waiver of PI status. This option may not be available at all schools. Instructions: If the PI does not meet the Waiver requirements, a Faculty Sponsor ancillary review and attestation is required via ESTR. See PI eligibility folder for reference.Manage Ancillary Review to record determination.Yes<Dean>IRB Staff to complete. If assigning in ESTR, assign to a Person (you) rather than an Organization. This can be yourself if completed on behalf of Reviewer.No FORMCHECKBOX Faculty Sponsor Ancillary Review Process for non-PI eligible individuals (e.g. student, fellows, etc.) Instructions: If the PI does not meet the eligibility requirements, the faculty sponsor ancillary review and attestation is required via ESTR. IRB Staff must also add a comment with instructions for the faculty Sponsor.The Faculty Sponsor is named on the Study Team Members page of the SmartForm.Yes<Faculty Sponsor Review> Assign to Person rather than OrganizationNoTraining in the Ethical Conduct of Human Subjects Research FORMCHECKBOX Harvard Training RequirementInstructions:If training has not been completed or is not current, refer the researcher(s) to the HUA IRB website that lists the training requirements and instructions on how to complete the training - Security Policy FORMCHECKBOX Data Security Policy for Harvard maintained dataA data security level (DSL) must be designated for each human subjects research study in ESTR. Instructions: For projects designated as SENSITIVE the IRB will complete its approval process upon receipt of HUIT review and approval.HUIT review/approval is managed through the Safety system. See note below. Staff should initiate Ancillary Review to receive a notice that the review is complete by the IT Security Reviewer.When submitting the Ancillary Review, leave a comment for the Reviewer to indicate why the submission has been determined to include SENSITIVE data. For example, “The study is collecting SSN” or “The data is subject to GDPR”, etc.This is especially important for data that may be DSL-5For assistance in determining data security level, refer to HRP-336-WORKSHEET-Harvard Research Data Security Level Decision Aid<NOTE>If a PI has not yet submitted a submission in the Safety System, the following language should be used to inform them of this requirement:A Data Safety review is required for data involved in this study. Please visit to create and submit your Data Safety project for review, and use the "Manage Related Projects" activity to link your IRB and Safety studies. For more information, including a Data Safety Study Submission Guide to help you get started and a schedule of information sessions about the new Data Safety System, see here: Please contact rshelp@harvard.edu with any questions about the Data Safety submission.Yes, If SENSITIVE<IT Security Review>See Appendix 1Harvard Research DSL DeterminationData/Biospecimen Concerns FORMCHECKBOX Genomic Data Sharing (GDS) to a national repository (dbGaP, GEO, etc.) that requires Institutional Certification.Review must follow the NIH GDS policy and Harvard GDS policy.See HRP-064-NIH GDS Institutional CertificationInstructions: Contact IRB Director about GDS data sharing, dbGaP, or any other national repository before proceeding.Signature on the GDS certification letter is handled through email.Documentation is managed through Ancillary Review. Yes<Genomic Data Sharing Institutional Certification> IRB Staff to complete. Assign to Person (Ara Tahmassian) rather than OrganizationNo FORMCHECKBOX Human embryonic stem cells, induced pluripotent stem cells, or derivatives obtained from such cellsResearch involving human embryonic stem cells must also be reviewed by the Harvard ESCRO Committee. See Instructions:PI or ESCRO to submit ESCRO approval.Manage Ancillary Review to record ESCRO determination.No<Embryonic Stem Cell Research Oversight Committee (ESCRO)>Assign to Person (Melissa Lopes) rather than Organization.No FORMCHECKBOX Use of Human Fresh Fetal Tissue in Research and M.G.L. ch 112, §12JMA State Law has requirements for the use of Fresh Human Fetal Tissue Reference:MA Biotechnology Law - “Section 12J”: Follow SOP: HRP-045: Use of Human Fresh Fetal Tissue in Research and M.G.L. ch 112, §12JContact IRB Director for any research involving use of fresh fetal tissue. All fresh fetal tissue research must be reviewed by the convened IRB. 12-J materials are sent to OGC for submission to the MA AG.Documentation of receipt of these materials by the MA AG is managed through Ancillary Review. Yes <Other Scientific>IRB Staff to complete. Assign to a Person (you) rather than an Organization. This can be yourself if completed on behalf of Reviewer.Use of Fetal Tissue FORMCHECKBOX Transfer of materials (incoming or outgoing) (E.g., blood, tissue, other biological material)Incoming or outgoing materials require a Material Transfer Agreement (MTA)Instructions: Refer researcher to the?Office of Technology Development?(OTD). See: Manage Ancillary Review to record any related Agreements.No<OTD> IRB Staff to complete. If assigning in ESTR, assign to a Person (you) rather than an Organization. This can be yourself if completed on behalf of Reviewer.None FORMCHECKBOX Transfer of data (incoming or outgoing)Incoming or outgoing data require a Data Use Agreement (DUA). Instructions: Refer researcher to the DUA portal – dua.harvard.edu DUAs are managed using the Agreements-DUA system.NoN/ANone FORMCHECKBOX Recombinant DNA / work involving biohazardsCommittee on Microbiological Safety (COMS) registration is needed for all research involving recombinant DNA as well as work involving biohazards (e.g., Recombinant DNA; Synthetic Nucleic Acids; Infectious Agents; Select Agents; Biological Toxins; Human Blood and Tissues; Non-Human Primate Blood and Tissues; Prions; Dual Use Agents; Clinical Gene Transfer; Clinical Xenotransplantation; Clinical Trials that use potentially biohazards materials (i.e., vector, viable micro-organisms as vaccines). COMS has indicated that they permit researchers to have one COMS approval to cover related work. If not related, a new COMS approval is required.Instructions: IRB Staff to direct researcher to COMS registration website. Manage COMS Review through Ancillary Review process. Yes< COMS>Assign to COMS [HMS] Organization rather than PersonNone FORMCHECKBOX Radioactive materials, lasers, X-rays, etc.Radiation Safety Committee (RSC) approval is required for all research involving radioactive materials, lasers, x-rays, etc.Radiation sources include: ionizing and non-ionizingradiation sources or devices; radioactive materials; lasers; x-rays, etc. Instructions: Obtain Radiation Safety Form from researcher via SmartForm and forward to RSC for review – radiation_protection@harvard.edu IRB Staff to upload any applicable documentation via Manage Ancillary ReviewYes<Radiation Safety>IRB Staff to complete. If assigning in ESTR, assign to a Person (you) rather than an Organization. This can be yourself if completed on behalf of Reviewer.None FORMCHECKBOX Genetic data collected in ChinaCertain restrictions apply to genetic data collected in China: Harvard researchers collaborating with Chinese Scientists should inquire whether these scientists have complied with applicable Chinese law in conducting the study; Any research involving human subjects in China must show that a local Ethics Committee covering the collaborator or collaborating institution has approved the project. The approval letter (original and translation) and any supporting documentation such as consent forms (original and translation) should be included in the ESTR submission. Registration and Permitting is required for “genetic resources” taken out of China regardless if the materials or data have been deidentified, or if the research project is “exempt”.Instructions:IRB Staff to upload any applicable documentation via Manage Ancillary Review.Yes<Provostial Review>Assign to the Office of the President and Provost Organization rather than PersonNone FORMCHECKBOX General Data Protection Regulation (GDPR)If data is being collected from individuals who reside in the EEA, the GDPR may apply. See HRP-098 - SOP - HUA – GDPR as well as HRP-325-WORKSHEET-GDPR.docx for more information. Instructions:Should it be determined that a Data Protection Impact Assessment might be needed (DPIA), IRB Staff are to upload any applicable documentation via Manage Ancillary Review.DPIA review and recommended changes are managed through Ancillary Review. Please refer to HRP-098 - SOP - HUA – GDPR for additional GDPR requirements when Harvard researchers are working with vendors or there is a data transfer involved.Yes<GDPR-Based Evaluation>Assign to Person <Rachel Talentino> rather than OrganizationNoneTarget Populations (as a focus of the study; population under investigation) FORMCHECKBOX Harvard UndergraduatesIf Harvard Undergraduates are a focus study population, review by the Office of Undergraduate Education (OUE) must occur using the ESTR ancillary review process Instructions: Manage approval through ancillary review. Note. A separate email to the OUE may be needed that includes a summary of the study and why there may or may not be concern for participation.OUE contact – Elisabeth (Lisa) Laskin (elaskin@fas.harvard.edu) Manage Ancillary Review to record the approval received from the OUE if approval received outside the system. Yes<Dean>A member of this office must complete. Assign to Elisabeth (Lisa) Laskin rather than Organization. Response is required. For separately received approval, this can be yourself if completed on behalf of Reviewer.Harvard Undergraduate Students FORMCHECKBOX Harvard Law School (institution or students)HLS has requested that they receive notification of research that includes HLS or HLS students as a focus study population. Instructions:A separate email to the HLS is needed that includes a summary of the study and why there may or may not be concern for HLS and/or HLS students.HLS contact - Catherine Claypoole (claypool@law.harvard.edu) Manage Ancillary Review to record the acknowledgement received via email from the HLS.Yes<Department Chair Review>IRB Staff to complete. If assigning an ancillary office contact in ESTR, assign to a Person rather than an Organization. This can be yourself if completed on behalf of Reviewer.Harvard Graduate Students FORMCHECKBOX Other Harvard Graduate Students and/or employeesInstructions: Inform researcher to request documented permission from the department/school to which the subjects are affiliated.Manage Ancillary Review to record the permission received.Yes<Department Chair Review>IRB Staff to complete. If assigning an ancillary office contact in ESTR, assign to a Person rather than an Organization. This can be yourself if completed on behalf of Reviewer.Harvard Graduate Students (“Employees” is listed on Pre-Review) FORMCHECKBOX Native Americans See “Provostial Review”Yes<Provostial Review>Assign to the Office of the President and Provost Organization rather than PersonNoneHarvard Subject Study Pools FORMCHECKBOX Psychology Department Study PoolInstructions:For all studies that use this study pool, the text “Harvard Psychology Department Study Pool” must be listed in the IRB approval letter under the heading “The IRB made the following determinations:” Refer researcher to the restrictions that may apply, if applicable: NoN/APsych Dept. Study Pool FORMCHECKBOX Harvard Decision Science Laboratory (HDSL)Instructions: Refer researcher to the restrictions that may apply, if applicable: NoN/ANone FORMCHECKBOX Harvard Business School Computer Lab for Experimental Research (CLER)Instructions: Refer researcher to the restrictions that may apply, if applicable: NoN/ANone FORMCHECKBOX Harvard Digital Lab for the Social Sciences (DLABSS)Instructions: Refer researcher to the restrictions that may apply, if applicable: Locations FORMCHECKBOX Brazil Approval from the Brazilian Government may be needed. CONEP (National Commission for Ethics Research) is the branch of the Brazilian Government (or one of its official designees) that provides ethical oversight for research studies that take place in Brazil. Preference is given to the University of Sao Paolo to provide ethical review. Other acceptable institutions to provide ethical review are the Funda??o Getúlio Vargas (FGV), Federal University of Roraima (UFFR), or any Brazilian institution with a CONEP-certified “IRB” however this should only be for those studies that are benign in nature and determined to be exempt or expedited. Should a study involve indigenous populations, be sensitive, or be reviewed by the Convened IRB, please contact the IRB Director. Instructions:Ensure proper ethical review is obtained and documented in the ESTR study record. Manage Provostial Review through Ancillary Review process.Yes<Provostial Review>Assign to the Office of the President and Provost Organization rather than PersonNone FORMCHECKBOX ChinaSee “Genetic data collected in China” under the heading “Type of Data/Biospecimen Concerns” above.Instructions:Ensure project complies with the indicated policy.Manage Provostial Review through Ancillary Review process.Yes<Provostial Review>Assign to the Office of the President and Provost Organization rather than PersonNoneProvostial Review FORMCHECKBOX International Site with Expedited level of review FORMCHECKBOX Provision of clinical or medical services FORMCHECKBOX Reputational risk to the University FORMCHECKBOX Involvement of Native Americans as a target population or research taking place on Sovereign Lands FORMCHECKBOX Possible Foreign Component* pertaining to federally funded study FORMCHECKBOX Other institutional review such as suspension or terminationThe Provostial Review process provides review and oversight of major projects and programs or studies that pose management challenges and/or reputational risk. Those that pertain to human subjects research are found to in the left column. For more information see: Note. Italicized items extend beyond the scope of the Provostial Review policy however have been flagged as areas of concern from an institutional perspective.* A Foreign Component may consist of financial interests, relationships, or affiliations with foreign entities, including foreign institutions of higher education or the government of another country, including: 1) Collaborations with investigators at a foreign site anticipated to result in co-authorship; 2) Use of facilities or instrumentation at a foreign site; or 3) Receipt of financial support or resources from a foreign entity including a financial conflict of interest that pertains to a foreign entity or foreign activities.Instructions:Please see HRP-335-WORKSHEET-Provost Review.Manage Provostial Review through Ancillary Review process.Yes<Provostial Review>Assign to the Office of the President and Provost Organization rather than PersonNoneSpecial Policies FORMCHECKBOX Use of the Harvard Name PolicySpecific restrictions apply to the use of the name “Harvard University”. See Instructions: Ensure project complies with the indicated policy.YesN/ANone FORMCHECKBOX Human Subject Payment PolicyThere are certain requirements for method of subject payment that require obtaining subject contact information as well as additional IRS reporting requirements. See: Instructions: Ensure project complies with the indicated policy.YesN/ANone FORMCHECKBOX Harvard Conflict of Interest PolicyResearchers will indicate in their IRB submission whether there is a financial conflict of interest. See HRP-055 - SOP - Financial Conflicts of InterestsSee: Instructions: IRB Staff to send to appropriate interest reviewer via Manage Ancillary Review.Yes<Financial Interest>Assign to Person rather than Organization See Appendix 2NoneAppendix 1: IT Security Review ContactsSchool“Sensitive” DeterminationCADMOrganization: Information Security, HUITFASOrganization: Information Security, HUITGSDPerson: Hal Gould (Local)GSEPerson: Sarah Pruski (Local)GSASOrganization: Information Security, HUITHBSOrganization: Information Security, HBSHDSPerson: Dan Hawkins (Local)HKSPerson: Ty Smith (Local)HLSPerson: Christopher Wood (Local) cwood@lawRadcliffe InstituteOrganization: Information Security, HUITSEASPerson: Judit Flo Gaya (Local)Wyss (SEAS)Organization: Information Security, HUITAppendix 2: Financial Interest Review ContactsSchool?ContactSystem or Email OptionHMS/HSDMKim LincolnSystem (assign to contact person)HSPHInternally ReviewedAssigned to convened IRB agenda and reviewed at the meetingFASMegan MooreSystem (assign to contact person)FAS SCRB*Megan Moore, however, if researcher has a primary affiliation with HMS, the contact is Kim LincolnSystem (assign to contact person)GSEEric D HultmarkSystem (assign to contact person)HKSMatthew AlperSystem (assign to contact person AND send a separate email)HBSJean CunninghamAlain BonacossaSystem (assign in system, but may receive response via external email; add ancillary twice, once to each person – only one confirmation in the system is required)SEASKristen HardingSystem (assign to contact person)HLSCatherine ClaypooleSystem (assign to contact person AND send a separate email)GSDAnne MathewSystem (assign to contact person AND send a separate email)HDSKarin Grundler-WhitacreKristen AndersonA. Jody BlackwellSystem (assign to each contact person, only one recorded review is required in ESTR)WyssKatrin DuevelSystem (assign to contact person)Radcliffe InstituteKristen HardingSystem (assign to contact person) ................
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