This document discusses considerations for human subjects research for teaching and scholarship. It provides an overview of federal regulations and policies governing human subjects research, including activities that require Institutional Review Board (IRB) approval. It discusses the differences between quality improvement projects and human subjects research, and provides examples to help determine if an activity would be considered human subjects research. It also outlines the different levels of IRB review, including exempt, expedited, and full board review. Key areas like assessing risks, obtaining consent, and criteria for IRB approval are summarized.

1. CONSIDERATIONSIN HUMAN SUBJECTS
RESEARCHFOR TEACHINGSCHOLARSHIP
Betsy Ripley
April 7, 2014

2. Federal Regulations and Policy stemming
from Belmont Principles
45 CFR 46 – DHHS Policy for Protection of Human
Research Subjects
21CFR50, 56, etc. – drugs, devices, biologics
Common Rule, DOD, DOE ……

3. ActivitiesrequiringIRBapproval
45 CFR 46.102(f)
RESEARCH
A systematic investigation designed to develop or
contribute to generalizable knowledge.
45 CFR 46.102(d)
AND
HUMAN SUBJECT
A living individual about whom an investigator conducting
research obtains
1) data through intervention or interaction with the
individual, or
2) identifiable private information

4. Quality Improvement
• OHRP FAQ’s http://answers.hhs.gov/ohrp/categories/1569
• To determine whether these regulations apply to a particular quality
improvement activity, the following questions should be addressed in
order:
• (1) does the activity involve research(45 CFR 46.102(d));
• (2) does the research activity involve human subjects (45 CFR 46.102(f));
• (3) does the human subjects research qualify for an exemption (45 CFR
46.101(b)); and
• (4) is the non-exempt human subjects research conducted or supported by
HHS or otherwise covered by an applicable FWA approved by OHRP.

5. QI as HSR
Goals
Purpose
Methods
Publication is not the main determinant
Is it Research??
A systematic investigation designed to develop or contribute to generalizable
knowledge.

6. Is this HSR?
• A weekly survey to determine work hours by all housestaff.
• A survey of housestaff regarding concentration, motor skill and sleep
patterns to be tied to work hours.
• Using “clickers” for a pre and post test as part of a TBL and obtaining
ward scores to correlate with knowledge as determined by pre and post
scores.
• Implementation of a discharge summary template to improve adequacy
of summary. Training half of the housestaff on the template and
providing it to the other half. Did the template and/or the training
improve the adequacy.
• Receiving a dataset with MCAT scores and board pass rates and
comparing by age, gender, and year of enrollment for past 5 years. Data
set contains age, gender, year of MCAT, MCAT score, year of board exam
and board score.
• Beginning a pilot project to train third year residents to teach fourth
year medical students how to convey bad news to a patient. The
program will involve role play, video, and writing. A survey will be
conducted with the residents, students and with the students again at
the end of their internship.

7. Document your decision!
• If you determine that it is not HSR then make a note to your
study file with an explanation of how you determined that.
• If you determine it is HSR then you will need to submit to the
IRB.

8. IRB ReviewContinuum
Exempt Expedited Full
Low Risk High
Level of potential risk determines
route of review

9. Minimal risk
The probability and magnitude of harm or
discomfort anticipated in the research are
not greater in and of themselves than those
ordinarily encountered in daily life or during
the performance of routine physical or
psychological examination or tests.
45 CFR 46.102(i) and 21 CFR 56.102(i)

10. “Risk Assessment”
Not just physical risks!
Consider:
- Emotional distress
- Embarrassment/ stigma
- Risk to financial status
- Risk to social status
- Risk to employment
- Risk to criminal/ civil
liability
- Invasion of privacy
- Etc.

11. Vulnerable Populations
• Children (less than 18 in VA)
• Pregnant women and neonates
• Prisoners
• Students
• Employees
• Trainees
• Adults with decisional challenges

12. Mechanisms for Initial IRB Review
•Exemption*
•Expedited Review
•Full Review (Convened)
*FDA requirements differ from the 45 CFR 46 and Common Rule

13. Exemption Categories:
45 CFR 46 101 (b)
1. *Typical educational practices
2. *Anonymous surveys, interviews, or
observation of public behavior (generally not
applicable to children)
3. Research with elected public officials,
appointed public officials, candidate for
public office)
4. *Existing data, documents, pathological
specimens, if publicly available or
unidentifiable (no identifiers retained)
5. Evaluation of public benefit service
programs
6. Taste and food quality evaluation and
consumer acceptance studies

14. Exempt [46.101(b)]
1. Research conducted in established or
commonly accepted educational
settings, involving normal educational
practices

15. Exempt [46.101(b)]
2. Survey, interviews or observations of public behavior,
unless
- information obtained is recorded in such a manner that
human subjects can be identified, directly or through
identifiers linked to the subjects; and
- any disclosure of the human subjects’ responses
outside the research could reasonably place the
subjects at risk of criminal or civil liability or be
damaging to the subjects’ financial standing,
employability, or reputation

16. Exempt [46.101(b)]
4. Research involving the collection or study
of existing data, if the data 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

17. Categories for Expedited Review:
No greater than minimal risk!
Clinical studies: IND/IDE
NOT required
Blood sample collection
(routine methods –small
amounts)
Prospective collection of
biological samples—
noninvasive means
Data collected though
noninvasive means
(routinely practiced in
clinical settings)
Materials (data, documents,
specimens etc.) have been
collected or will be collected
for non-research purposes
Collection of voice, video or
digital data for research
purposes
Individual or group behavior,
surveys, interviews, oral
histories

18. Exempt<<< Review >>>Expedited
(1)
Minimal risk
One IRB or Qualified
Exempt reviewer
Fits one of 6 categories of
research
Usually no recorded
identifiers, with some
exception
Topic generally not
sensitive
Minimal risk research
One IRB reviewer outside of
convened meeting
Fits one of 7 expedited
categories (for initial review)
May include identifiers (direct
or indirect)
Topics not sensitive OR may
include some sensitive topics,
but confidentiality securely
protected

19. Exempt <<< Review >>>Expedited (2)
• Non-vulnerable
populations, with some
exception
• Exempt from formal
informed consent
requirement (but subjects
deserve to know about
the research if possible)
• Exempt from continuing
IRB review
• Populations may include
regulated vulnerable &
others with adequate
protections
• Required formal informed
consent process OR justify a
waiver of consent
• Requires IRB continuing
review at least annually

20. Full IRB Review
Does not qualify for exempt or expedited review
based on risk assessment by PI and/or IRB…….
Greater than minimal risk!
(some non-HSR requires IRB approval per regs)
2 reviewers present the study at a convened meeting
IRB majority finds all Criteria for Approval are
satisfied

21. Additional Review Requirements
• Type of Review Categories for Exempt and Expedited
• Documents: Surveys, Questionnaires, Ads
• Engagement of outside investigators or institutions
• GWAS criteria
• HIPAA
• COI as relates to human subjects
• Congruence of grants
• IRB office: CITI training, COI resolution, other review groups
(ex. investigational drug plan, biohazards)

22. 8CriteriaforIRBApproval
45CFR46.111(a)
Select One or More IRB_Approval_Conditions
Filter by Number
Total Selected: 8 1-8 of 8
Number Long Name
1 Risks to subjects are minimized (i) by using procedures consistent with sound research
design and do not unnecessarily expose subjects to risk and (ii) if appropriate, by using
procedures already being performed for diagnostic or treatment purposes
2 Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects,
and the importance of the knowledge that may reasonably result
3 Selection of subjects is equitable
4 Informed consent will be sought from each prospective subject or the subject's LAR to
the extent required by 45 CFR 46.116 / 21 CFR 50.20
5 Informed consent will be appropriately documented in accordance with 45 CFR 46.117
/ 21 CFR 50.27
6 When appropriate, the research plan makes adequate provision for monitoring the data
collected to ensure the safety of subjects
7 The research plan includes adequate provisions to protect the privacy of subjects and
to maintain the confidentiality of data
8 When some or all of the subjects are likely to be vulnerable to coercion or undue
influence, additional safeguards have been included in the study to protect the rights
and welfare of these subjects.(46.111 (b))
Total Selected: 8 1-8 of 8

23. Duty to Report
• VCU Policy goes beyond traditional mandatory reporters
• Should be in your consent if appropriate

24. Consent
• Not formally required for Exempt
• Required for Full board or Expedited unless waived with required and if applicable
information
• Waiver of Consent: Waiver of some or all elements of informed consent/permission
may be appropriate:
- research is no greater than minimal risk
- no impact on rights or dignity of participants
- not practicable to obtain informed consent
- provide debrief after the research, as appropriate
• Waiver of Documentation of Consent
• Research presents no more than minimal risk*
• AND
• Research involves procedures that do not require written consent when performed
outside of a research setting
• Consent Templates on VCU IRB website
• RAMSIRB Consent Groups: This is the types of folks you will be consenting. For
instance if you are consenting medical residents for one survey, nursing staff for
another then that would be two groups.

25. Once Approved the Fun Starts
• Regulatory Binder
• Data Security
• Continuing Review
• Amendments
• Study Closure
• Prompt reports: Unanticipated Problems and SAEs
• Non prompt reports

26. RAMSIRB
• Main VCU IRB website
http://www.research.vcu.edu/human_research/conducting.htm
• RAMSIRB
• Must have VPN on computer if not at VCU/VCUHS
• Sign in with eid
• What you need to get started: CITI, FIR, PI CV, Consents,
Surveys, your plan.
• Student Trainee research
• Determine what type of research it is

27. Helpful hints to RAMSIRB
• Add editors
• Conversion Amendments
• Have to answer questions with *
• Help text
• You have to upload one document when you get to the personnel
screen. PI CV is usually it. This will then appear anytime a document is
requested. This is a running list of documents. Do not delete a
document unless you really want it gone from the system.
• Create a dummy study if want to see what happens with different
choices or know what you will be asked.
• Once submitted reviewer makes comments to you in the review section
on each page. If changes required before approval or need clarifications
they will send it back to you (electronically). You need to respond to
every reviewer comment even if to say OK or done or changes made.
Then submit again. Only those on the side with current access can work
on it. You can however look to see progress on the first screen
• If you have a question about a submitted study you can send a public
comment in the system.

28. HELP!
• Email or talk to me
• Send public comment in an already submitted protocol
• Other reviewers, IRB panel coordinators
• Michelle Stickler, Christine Davison, Susan Kimbrough
• ORSP@vcu.edu for questions about the content of the study
forms
• ERAHELP@vcu.edu for technical issues