Understanding IRB Review for Research Projects

Working with Data: How to determine if you need IRB review 10/13/2020 Alma Castro Senior IRB Review Specialist acastro@hsph.harvard.edu

Is your Project Human Subjects Research? Research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge A Human Subject is a living individual about whom an investigator conducting research obtains: Data through intervention/interaction with the individual, or Identifiable private information Reference: Glossary of Key Regulatory Definitions (last slide)

Is Your Data Identifiable? Term As defined by the IRB Research with Human Subjects? No; no collection of identifiable data/specimens. Anonymized/ De-identified Samples or data where no identifiers were ever collected or where identifiers/codes have since been removed and destroyed. Coded/ Indirectly Identifiable Samples or data labeled with a code (e.g., a number), rather than a person s name or other personal identifier. This code can be traced or linked back to sample donor/data provider by an investigator, who retains key, e.g., coding system/crosswalk. Yes, unless.. Data is de-identified, or Data provider can provide PI with attestation that s/he will not release identifiers or key.

Not Human Subjects Research If your project does not fit the definition of research and/or does not fit the definition of human subjects (e.g. private identifiable information), then it would considered Not Human Subjects Research and would not require IRB review. You are free to do your research without coming to us. You can use the IRB Decision Tool and if you get a NHSR result, you are free to continue doing your research without coming to us. If you want or need an official IRB determination of NHSR, then you will have to submit an application in ESTR.

Caveats to NHSR Collaborating with the data provider And data provider has access to identifiable information And/or analyses being done is primary analysis or primary use NIH, study sponsor, data provider consider your project human subjects research and require an Exempt determination from the IRB. Data are coming from the EU/EEA and GDPR is invoked

Exempt #4 Determination If your project does not fit the NHSR determination, it is possible that it will fit an Exempt 4 determination This will require an IRB application submitted in ESTR. You will have to complete the Research Protocol and attach to your IRB application in ESTR. IRB review will need to be completed and the Exempt determination letter sent out in ESTR before you can start your research.

Expedited #5 If your project does not fit the NHSR determination or the Exempt determination, then it could be reviewed under an Expedited 5 categorization This will require an IRB application submitted in ESTR. The PI listed in ESTR will have to be a faculty member. The submission will require ancillary reviews (e.g. Dept. Chair review). You cannot start your research until IRB approval has been granted.

Case Study #1 A Harvard investigator is obtaining BRFSS data from the CDC website.

Case study #2 A Harvard investigator is obtaining coded data from an NIH repository (e.g. dbGaP data).

Case study #3 A Harvard investigator is analyzing de-identified data & specimens obtained from a colleague at BWH

Case Study #3b A Harvard investigator is analyzing de-identified data & specimens obtained from a colleague at BWH. The Harvard investigator is collaborating with the BWH colleague on a research project. The data/specimens were originally collected by the BWH colleague for a separate research project in which the BWH colleague served as the PI and has access to identifiable information.

Case Study #3c A Harvard investigator is analyzing de-identified data & specimens obtained from a colleague at BWH. The Harvard investigator is collaborating with the BWH colleague on a research project. The data/specimens are being collected by the BWH colleague who is the PI on a grant. The Harvard investigator is a co-PI on the grant and is involved in the design, analysis, and reporting on this research project.

Case Study #3d A Harvard investigator is analyzing de-identified data & specimens obtained from a colleague at BWH. The Harvard investigator is working with the BWH colleague on a research project. The data/specimens are being collected by the BWH colleague who is the PI on a grant. The Harvard investigator is conducting the analyses only as a subcontract on the grant.

Reference & Resources HLMA IRB Website: https://www.hsph.harvard.edu/regulatory-affairs-and- research-compliance/ IRB Review Specialist Department Assignments: https://www.hsph.harvard.edu/regulatory-affairs-and- research-compliance/department-assignments/ Investigator Manual: www.hsph.harvard.edu/ohra/ IRB Decision Tool: http://bit.ly/2LBTcYx IRB Tip Sheets: https://www.hsph.harvard.edu/regulatory- affairs-and-research-compliance/irb-tip-sheets/ QIP Service Request Form: https://harvard.az1.qualtrics.com/SE/?SID=SV_9Hx4AQ5p9 74GvMF QUESTIONS?

Glossary of Key Regulatory Definitions Research - a systematic investigation designed to develop or contribute to generalizable knowledge Human subject - a living individual about whom an investigator conducting research obtains: Data through intervention or interaction with the individual, or o Identifiable private information o Intervention - both physical procedures by which data are gathered (e.g. blood draw) and manipulations of the subject/subject's environment performed for research purposes Interaction - communication/contact between investigator and subject Private information - information about behavior that occurs in a context in which an individual can reasonably expect that no observation/recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g. a medical record) Minimal risk - the probability and magnitude of harm/discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical/psychological exams or tests