1. Regulations of Human Subject
Research
Assessing Risk and Navigating through IRB
Review
Heather Park-May, IRB Administrator
October 12, 2016

4. Agenda:
» Discuss Ethical considerations when doing research,
and the Belmont Report
» Getting started with an idea, question, or identified
knowledge gap.
» Distinguishing Research from QA/QI
» Elements and requirements of a consent form

5. » While the focus of this talk is on the IRB piece of the
research regulatory pie, keep in mind that there are
other things to consider that may apply to your
research project such as:
 Budget
 Coverage Analysis
 Material Transfer Agreement
 Contracts…

6. Researchers are Change Agents for the
Healthcare Industry
» Research is the path to innovation and can empower
all caregivers to discover ways to improve the care
we provide in a way that is driven by data.
» Changes made to support our Researchers:
1. Research Workshop Education Program
2. New streamlined MSU/Sparrow Reliance Process
3. Research Merit Review Committee
4. Efforts to centralize research at Sparrow to create a
gateway for Sparrow and MSU researchers currently
underway

7. Human Subjects Protection
A Shared Responsibility:

8. 1932-1972 Syphilis Study at Tuskegee
1939-1945 Nazi Medical War Crimes
1944-1974 Cold War Human Radiation Experiments
1946- Nuremberg Doctors’ Trial
1947- Nuremberg Code
1948- United Nations adopted Universal Declaration
1953- First US Federal Policy for Protection of Human subjects
1963- Jewish Chronic Disease Hospital Study
1963-1966- Willowbrook Study
1974- Federal Protections for Human Subject
1979- Publication of the Belmont Report
1980- Publication of FDA Regulations
1991- Publication of Common Rule
1996- Health Insurance Portability and Accountability Act
1999- Death of Jesse Gelsinger
2000- The Office of Human Research Protections Split from NIH.
Human Subjects Historical Timeline

9. Tuskegee Syphilis Study
“ Sometimes, with the best of intentions, scientists and public
officials…working for the benefit of us all, forget that people are
people. They concentrate so totally on plans and programs,
experiments, statistics- on abstractions- that people become
objects, symbols on paper, figures in a mathematical formula…”
- Atlanta Constitution, July 27 1972

10. Belmont Report:
3 Ethical Principles
•Respect For Persons
•Beneficence
•Justice

11. Respect For Persons (1785)
Idea began with Immanuel Kant:
Leading Philosopher of Deontology and the categorical imperative of treating
every rational being as a free rational agent, and as ends in themselves.
Principle:
•Subjects are respected as
Autonomous Beings
•Protection of Subjects with
Limited Autonomy (Minors,
cognitively impaired)
Applications:
•Informed Consent
• Informed
• Competent
• Voluntary
•Subjects’ Assent and Third
Party Consent

12. Beneficence (1789)
Beneficence is a concept in research ethics which states that researchers
should have the welfare of the research participant as a goal of any clinical
trial or other research study.
•The antonym of this term, maleficence, describes a practice which opposes
the welfare of any research participant.
Jeremy Bentham: Philosopher of Utilitarianism and the Principle
of Utility of the Greatest Happiness of the Greatest Number
Principle:
•Do No Harm
•Maximize Benefits and
Minimize Possible Harms
Principle:
•Do No Harm
•Maximize Benefits and
Minimize Possible Harms
Applications:
•Favorable Risk/Benefit
Assessment
•Systematic Analysis and
Minimization of Acceptable Risks
of Harm
Applications:
•Favorable Risk/Benefit
Assessment
•Systematic Analysis and
Minimization of Acceptable Risks
of Harm

13. Justice (350 BCE)
Aristotle: Leading philosopher of Aristotelian Philosophy and
of the principle of distributive justice, distributing goods,
rights, burdens, etc, according to what people deserve.
Principle:
•Distribute Burdens and
Benefits Equitably
•Don’t Exploit Vulnerable
Populations
Applications:
•Select Individuals and Classes
of Subjects Equitably
•Link burdens to benefits.

14. The history of unethical research practices
shaped the regulations we follow today.
Refer to the Quality or Research Guidance Form Provided

15. » Step 1. Set up a good research project
» Identify a knowledge gap in your area of interest
» Conduct a literature review. Library!
» Step 2: Determine if your idea/hypothesis will
involve research to test.
» Definition of Research: Research means a systematic investigation, including
research development, testing and evaluation, designed to develop or contribute
to generalizable knowledge. Activities which meet this definition constitute
research for purposes of this policy, whether or not they are conducted or
supported under a program which is considered research for other purposes. For
example, some demonstration and service programs may include research
activities.
Getting Started:

16. So to be research you must have:
1. Systematic investigation
2. Research development
3. Testing and evaluation
4. Intent of contributing to
generalizable knowledge

17. Your Study Is Research If:
» You are testing a hypothesis
» Your activity is outside of the standard of care
» You are doing a group comparison to test your hypothesis
» Your study seeks to test an intervention which is beyond
current science and experience
Most resident studies take the form of retrospective or
prospective record reviews. If your testing a hypothesis with
the data you are gathering and you intend to develop or
contribute to generalizable knowledge your study is research.

18. QI Study Aim’s
If there is NO intention of using the data for research
purposes and…
»improve a process or delivery of care with established
or accepted quality standards
»to implement change mandated by sparrow clinical
quality improvement program
»to improve performance on a service or program in
the hospital and is part of the normal standard of care

19. MSU Reliance Agreement
» MSU affiliated Investigators conducting research at Sparrow Facilities and/or with
Sparrow Patients or Sparrow data will require the use of the Reliance process. This
means you go through the MSU IRB as the IRB of record.
» Your requirements for the Sparrow IRB are minimal.
» We ask that you submit your reliance application (Simple 3 page application) along
with the completed protocol impact statement to the MSU online submission
system. The MSU IRB and the Sparrow IRB communicate through the MSU IRB
review process.
Keep in mind Sparrow Patients need to receive a Sparrow template Consent
Form, and HIPAA Authorization to Release PHI for Purposes of Research
form. Available on IRBNet and on the Website. www.sparrow.org/irb
» You may begin research when you have approval letters from both IRB’s.

20. When does the Reliance process apply?
» You are an MSU individual and your research:
• Involves any intervention for research purposes with Sparrow
patients as human subjects of the research by performing
invasive or noninvasive procedures.
• Examples of invasive procedures:
• Collecting buccal mucosa cells using a cotton swab
• Administering individual or group counseling or
psychotherapy
• Administering drugs or other treatments
• Surgically implanting medical devices
• Utilizing physical sensors
• Utilizing other measurement procedures

21. When does the Reliance Process Apply
Cont.
• Involves the collection of protected health information about the
Sparrow patients as subjects of the research.
• Any intervention for research purposes with any Sparrow patients as
human subjects by manipulating the environment
Examples: Controlling environmental light, sound, temperature,
presenting sensory stimuli, orchestrating environmental events or
social interactions.
» And others! See HRPP Manual 4-1 for more information about when
MSU review is required
If it is not clear whether your study falls within these descriptions,
contact the Sparrow OHRA, or MSU IRB staff. We are here to help!

22. What the reliance process
actually involves:
MSU IRB

23. IRB Submission Requirements
» Complete Initial Application
» Abstract
» Protocol
» Completed Protocol Impact Statement
» Other applicable study documents: Consent form, Investigator’s brochure…
» An Attending Physician to lead the study as PI for resident studies.
» Nursing Research Council approval for nursing studies.
» Curriculum Vitae or Resume of all researchers
All forms and templates are available on the website: sparrow.org/irb,
IRBnet (forms and templates) and on New Innovations

24. Elements of the Consent Form
» Study Title
» Researcher’s information department, and contact info
» Introduction
» Why is this study being done?
» How many people will participate?
» What will happen if I participate?
» How long will I be in the study?
» What are the side effects, or risks to my participation?
» What are the benefits of participating?

25. Elements of the Consent Form
» What choices do I have if I chose not to participate?
» What are the costs to me ?
» What happens if I am injured as a result of participating?
» Termination of the Study
» What are my rights if I participate?
» Will my medical information be kept confidential?
» Who can answer my questions about the study?

26. The research process and
medical terminology is
confusing for most
subjects, which is why
we ask that you limit
your medical jargon, and
spell out all acronyms
used, and write the
document at an 8th
grade
reading level.

27. HIPAA Authorization Documentation

28. HIPAA Authorization Documentation and Covered
Entities
 Individuals engaged in human subject
research are responsible for complying with
all requirements regarding use or disclosure of
PHI, including those set forth in HIPAA and
implemented by the covered entity(ies).

29. What HIPAA form template should I use?
» MSU: If the PHI will be obtained from a clinic that is part of the MSU covered
entity, use of the template “MSU Health Team Research Authorization Form”
is required.
» If your research requires subjects to sign a consent form and you will be using
Sparrow PHI, you will use the Sparrow HIPAA Authorization Form Template
» If your research only involves a retrospective record review of Sparrow PHI,
and/or it is not practicable to obtain authorization from the patient to use
their PHI for research, you will complete the Sparrow Request for Waiver of
Authorization form.
» If you will need to obtain Sparrow PHI before you are able to meet with your
subject and discuss the study for enrollment purposes, you will complete the
Partial Waiver of Authorization

30. HIPAA Documentation By Study Type
» Research designed in a way where it is not
practicable to obtain signed HIPAA Authorization:
HIPAA Waiver of
Authorization» Research designed in a way where it IS possible to
obtain signed HIPAA Authorization:
HIPAA Authorization to Disclose PHI for Research
» Access to limited PHI such as name and address for
recruitment purposes:
HIPAA Partial Waiver of Authorization

31. * CITI Training
What is it?
»An internet based system that provides and tracks human subjects research (HST)
training required by OHRP to conduct research
Who does it apply to?
»All individuals engaged in research activities. This includes anyone delegated to
collect or analyze data.
How long does it take?
»Everyone works at a different pace, however it can take anywhere from 4-8 hours. It
can be completed in more than one sitting. The program saves your progress. So be
sure to calculate this time into your research project plan
Does it expire?
»Yes. The CITI program training is good for 3 years, so it is important to be aware of
when it expires.

32. How Do I Complete My CITI Training
» Go to www.citiprogram.com
» Register as a new user (or sign in)
» When prompted, select “Sparrow
Health System” under “Participating
Institutions” then continue to Step 2.
» Complete the required fields in steps
2 thru 6
» For Step 7, question 1, select the
learner group that best represents
you. In most cases it will be the
Biomedical Researcher learner
group.

33. Learner Modules
» Biomedical Researcher
» Chose this group if your research does not fall within any of the other
categories below
» Sparrow Clinical Research Institute Researchers
» Chose this group if you are involved in research through the Sparrow Clinical research institute
» Cancer Center Researchers
» Chose this group if you are involved in research through the Sparrow Cancer Center
» Humanitarian Use Device (HUD) Investigators
» Chose this group if you are involved in HUD Studies
» Nursing Research Council Members
» Chose this group if you are a member of the Nursing Research Council
» IRB Members
» IRB Community/Non-Scientific Member

34. Optional Modules
» For researchers working with a sponsor, you may
find that the Sponsor has specific requirements for
HST training modules. In order to comply with
additional sponsor requirements, we have several
optional modules.
» There are modules on hot topics such as stem cell
research and Social Behavioral Methodologies in
Biomedical Research.
» Our newest module is on Clinical Trial Billing
Compliance.

35. Using IRBNet
To begin the registration process, go to www.irbnet.org and click
on the New User Registration link.
Users that are not
registered on IRBNet
may click here to self-
register
If you have forgotten
your password, click
here.

36. New Project Submission
As a Researcher, Research Manager, or Research
Coordinator you should know how to:
Log In to IRBNet
• Access My Projects
• Build Your First Electronic Project Package
• Share with Your Research Team
• Communicate with Your Team
• Sign Your Project Package
• Submit Your Project Package for Review
• Revise Incomplete Submissions
• Access Review Decisions and Board Documentation

37. Continuing Review; Amendments
Continuing Review:
Pay close attention to the expiration date of the study on the approval letter.
 Be sure to submit your continuing review application to renew your
study well in advance of the expiration date to avoid a lapse in IRB
approval.
 60 day IRBNet e-mail reminder
 Exempt studies are not required to be renewed yearly, however it is
Sparrow’s procedure to touch base with researchers of exempt status
studies to see if the study is still ongoing, or if it has been closed.
Amendments:
 Any changes to protocol, IRB approved forms, documentation, data
collection procedures or researchers involved need to be submitted to
the IRB through an amendment application.

38. PI Responsibilities
The term Principal Investigator (PI) defined as the individual under whose
immediate direction the research activities (i.e., focus group, survey, and
drug or device trial) occur.
The protection of human research subjects is a shared responsibility between
the PI, the institutional review boards and the sponsor (as applicable). The PI
must acknowledge that regulations governing human subjects’ research are
an additional area of expertise and that the Sparrow OHRA staff are available
to provide guidance as needed.

39. The PI is ultimately responsible for:
» Submitting proposed research for approval by the IRB
» All actions that take place during a clinical study to ensure patient safety at all
times by abiding by and promoting Good Clinical Practices guidelines. The PI may
delegate some tasks and responsibilities but retains ultimate responsibility for the
ethical conduct of the research.
» Training and communicating with research team members.
» Requesting continuing review of the research and ensuring the IRB that the
research is proceeding according to all applicable regulations
» Notifying the IRB of any upcoming audits (Sponsor, FDA, OHRP, etc) and then
providing the IRB with a copy of the audit report. (Notification of routine
monitoring visits not required.)
» Reporting to the IRB any findings and allegations of non-compliance
» Notifying the IRB in writing prior to leaving the institution. (Sparrow, or MSU) with
a plan to either terminate ongoing studies, or designate a new PI.

40. In order to fulfil these responsibilities the PI should:
» Be aware of the resources available :
» Department of Health and Human Services, Office for Human Research Protections, and the Food and Drug
Administration
» Have realistic expectations of research team members and understanding their positions and
time commitments
» Have access to the internet
» Understand and follow institutional policies, SOP’s and guidance concerning human subject
research.
» Understand and follow FDA, DHHS and OHRP rules and regulations for human subject research
» Have access to and read/respond to email
» Obtain informed consent and continuing consent from subjects if applicable.
» Carefully review lab reports and subjects history/physical findings noting any abnormalities
while reviewing in the context of known effects of drug/device under study.
» Delegate Duties of research team in writing
» Complete required HST training (CITI or MSU’s HST training modules)
» Ask questions when needed and encourage other research team members to do the same

41. New Project Submission
As a Researcher, Research Manager, or Research
Coordinator you should know how to:
Log In to IRBNet
• Access My Projects
• Build Your First Electronic Project Package
• Share with Your Research Team
• Communicate with Your Team
• Sign Your Project Package
• Submit Your Project Package for Review
• Revise Incomplete Submissions
• Access Review Decisions and Board Documentation

42. Additional Technical Guidance
»www.sparrow.org/researchers

43. Tips for a Smooth Review
• Assess the feasibility of your protocol
• Literature Review!: Check out the Sparrow Library!
• Is there enough data available
• Do you have a well defined research plan
• Does your study address a valid need
• Do you have appropriate resources and funding
• Obtain appropriate Sparrow departmental approval prior to IRB submission.
• Discuss ALL resources that will be required to follow the protocol
• Be as detailed as possible when responding to questions in the IRB application
• Submit all required documents:
• Read all instructional material provided
MSU Researchers:
• Check the comments in the MSU online review system frequently
• Contact the MSU IRB if you have any questions.

44. More information available on websites
» Sparrow: www.sparrow.org/researchers
» http://www.sparrow.org/?id=2365&sid=1
» http://www.sparrow.org/sparrowlibrary
» MSU: http://hrpp.msu.edu/
» http://hrpp.msu.edu/forms

45. The Sparrow Way
» In order to address the challenges of increasing prevalence of chronic disease
and an aging population, to improve the quality of care and the Patient
experience while also ensuring greater affordability, Sparrow needs to
implement profound changes in how care is provided.
The work of the brilliant minds in this room is how we get there!
» This change starts with the system-wide adoption of the Sparrow Way. In
partnership with our Caregivers and Physicians, the Sparrow Way is a
commitment to ensuring that the Patient care delivered at Sparrow adheres to
Patient-centered, evidence-based best practices.
http://www.sparrow.org/?id=1540&sid=1

46. Thank You!