1. 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

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

3. 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

4. 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

5. 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

6. 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”

7. 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

8. 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 /new-submissions/

9. 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

10. 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.

11. 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 You are going to record gender, age, type of surgery, and treatment.

12. 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

13. 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

14. 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:

15. 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:
Attend 3 OHRA Education series offerings/academic year

16. 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

17. 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.

18. Additional Resources Office of Human Research Administration website
Investigator Manual
ESTR Submission Guide
Department-Assignments
Quality Improvement Program staff
Lisa Gabel ∙ ∙
Scott Meyers∙ ∙
Alyssa Speier ∙ ∙

19. CASe Study #1
Dr. Kim plans to analyze SAT scores from 2006 to 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?

20. 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?