Alyssa Speier, MS, CIP QIP Student Education Session Common Questions Answered: What every (Harvard LMA) Student Investigator Should know Alyssa Speier, MS, CIP QIP Student Education Session

Agenda Office of Human Research Administration FAQs Answered Case Studies Question/Answer

OHRA Office of Human Research Administration Harvard Longwood Medical Area (Harvard Chan School, HMS, HSDM) Managing Director - Leslie Howes Institutional Review Board Assistant Director, Kim Serpico Department-assigned IRB Review Specialists: Grace Bullock Alma Castro Jada Dixon Keren-Nicole Insalaco Quality Improvement Program Assistant Director, Alyssa Speier QA/QI Specialists: Lisa Gabel Scott Meyers

IRB’s Primary Function To Ensure: - Participant Protection: Rights and Welfare Safety Privacy and Confidentiality - Compliance with IRB-approved protocol, Institutional policies, and federal regulations

Types of IRB Reviews & Determinations Non-Full Board Review – on a rolling basis Not Human Subjects Research determination Exemption determination Expedited approval Full Board (Convened IRB) Review - monthly Most common for student protocols

Am I conducting Research with Human Subjects Research is defined as a… “systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” Human Subject is a “living individual about whom an investigator (whether professional or student) conducting research obtains Data through intervention/interaction with the individual, or Identifiable private information”

DE-identified vs. Coded Term As defined by the IRB… Research with Human Subjects? Anonymized/ De-identified Samples or data that may have identified human subjects at one time, but all identifiers or codes have since been removed and destroyed No; no collection of identifiable data/specimens Coded/ Indirectly Identifiable Samples or data labeled with a code (e.g., a number), rather than a person’s name or other personal identifier. Such 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 gives PI attestation that s/he will not release identifiers or key

What should I submit to the IRB? When activities don’t meet the definitions of research with human subjects… IRB review & approval is not required but recommended Investigators may obtain a formal NHSR determination To do so, prepare a Not Human Subjects Research Request Form available in ESTR and on our website at http://www.hsph.harvard.edu/ohra/formsinstructions /new-submissions/

Is my human subjects Research Exempt from IRB approval? Research conducted in established or commonly accepted educational settings, involving normal educational practices Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior Surveys, interviews, observation of public behavior if participants are public officials Collection of existing data, documents, specimens If publicly available OR If no identifiers are recorded Evaluation of public benefit or service programs, etc. subject to approval of Department or Agency heads Taste and food quality evaluation and consumer acceptance

Category #2 Up Close Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior Caveats: Sensitive information collected must be anonymous Doesn’t apply to research with minors unless activities are limited to observation of public behavior and investigator doesn’t manipulate the environment Doesn’t apply to research with prisoners Examples: You survey a group of patients at a primary care office and their family members to determine their basic understanding of available health services. You keep track of who attended, so you can contact them later. You then hold focus groups of some of the people you surveyed to identify their most common concerns regarding access to care.

Category #4 Up Close Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Caveats: Data must be existing, on the shelf, at the time of submission to the IRB “Publicly available” means anyone could access it Identifiers cannot be recorded if not publicly available Example: You are going to search a medical records database for all subjects who had an allergic response to an anesthetic used in the OR from January 2011 through December 2011. You are going to record gender, age, type of surgery, and treatment.

What should I submit to the IRB? When conducting human research activities that are exempt-eligible… IRB review (& determination) is required A consent process must be in place, when applicable. It should disclose That the activities involve “research” The research procedures That participation is “voluntary” The PI’s name & contact information Prepare Exemption Request Form obtained through QIP consultation

Expedited and Full Board Review Non-exempt human research is reviewed either… Expedited basis Rolling basis, first come-first served Activities pose minimal risk and fit into one or more Expedited Review Categories Convened IRB aka “Full Board” Monthly meeting (submit at least 30 days prior) Activities pose greater than minimal risk and/or don’t fit into Expedited Review Categories Note: A faculty member must serve as PI. Students are not eligible to be PI for Non-Exempt Human Research

How do I submit My IRB Application? ESTR: Electronic Submission, Tracking, & Reporting Harvard’s IRB electronic submission system, available at irb.harvard.edu Login using HarvardKey, HUID, or eCommons log-in Click “Create New Study” and follow system prompts to complete electronic Smartform Upload relevant study materials where prompted, e.g., Not Human Subjects Research Request form; Exemption Request form (consult with QIP to get a copy); Research Protocol; local IRB approval, etc. Available ESTR Support IRB Pop-up Clinics One-on-one support, contact QIP ESTR helpdesk: estrhelp@harvard.edu

Do I need IRB Training? OHRA policy requires human research training of the following: Any PI, Co-Investigator, Key Personnel as defined by NIH, and Anyone with direct contact with human subjects or access to their identifiable data Ways to satisfy the requirement for training CITI: https://www.citiprogram.org/ Attend 3 OHRA Education series offerings/academic year

Type of Determination or Review Average review turnaround times When will I Hear back? Type of Determination or Review Average review turnaround times Not Human Subjects Research Determination 1 week Exemption Determination Expedited 2-3 weeks Full Board 1 month

Considerations/Tips Are you being added to an existing HLMA or Non-HLMA protocol that already has IRB approval? Contact QIP, we may be able to help streamline your process. Conducting research abroad? Discuss project with local collaborators Obtain local review and approval If your plans change, submit modifications/clarifications to the IRB before implementation in the field Plan Ahead – things always take longer than anticipated Obtain QIP consultation prior to IRB submission Examples for last bullet If extending analysis to add a dataset not mentioned in your previous submission Substantive changes to interview guides, etc.

Additional Resources Office of Human Research Administration website www.hsph.harvard.edu/ohra Investigator Manual https://cdn1.sph.harvard.edu/wp-content/uploads/sites/43/2012/10/HRP-103-Investigator-Manual_10-9-2015.pdf ESTR Submission Guide http://estrsupport.fss.harvard.edu/study-submission-guide Department-Assignments http://www.hsph.harvard.edu/ohra/department-assignments/ Quality Improvement Program staff Lisa Gabel ∙ 617-432-5842 ∙ lgabel@hsph.harvard.edu Scott Meyers∙ 617-432-2143 ∙ smeyers@hsph.harvard.edu Alyssa Speier ∙ 617-432-2140 ∙ aspeier@hsph.harvard.edu

CASe Study #1 Dr. Kim plans to analyze SAT scores from 2006 to 2015 from 10 Boston-area schools. The schools will provide Dr. Kim with a de-identified data set and neither Dr. Kim nor the schools will be able to link the scores back to the students. She will collect basic demographics about the school from their websites. What should Dr. Kim submit to the IRB?

Case Study #2 Dr. Smith has a freezer of blood samples that were originally collected for a research study which ended several years ago. Patient codes (which can be linked to patient medical records) remain on the samples. The consent form originally signed by the subjects indicated whether or not their stored blood could be used for future research. A student advisee of Dr. Smith has requested access to the samples to conduct his own secondary data analyses. Dr. Smith agrees. What next?