Office of Research
& Sponsored Programs
Laura Ann Camlet Houser, Ph.D.
Director of Research Compliance
Courene M. Loftus, MPA, CIP
Director of Human Participants Protection

Overview
• Who Protects Human Subjects
• Historical Developments
• Regulations
• Review System and requirements
• How to Prepare and submit (IRBNet)
• What to Submit
•
Post Submission Requirements
• Resources for Information

Office of Research & Sponsored Programs (ORSP )
Located in Keith J. O’Neill Center for Healthy Families
• Responsible for oversight, compliance management and the appropriate conduct of sponsored activities (federal, internal & program grants)
• Ensures adherence to federal, state or local regulations
• Ensures protection of humans or animals in research
• Minimizes risks
• Ensures ethical practices in research

Institution
IRB or ERC Investigator
Faculty
Sponsor/Advisor
Government
Research Team Public
Funder Family
Advocates

Historical Developments
• During the Nuremburg Trials at the end of World War II, it became clear that no accepted standards existed regarding the conduct of human research.
• Final judgment included 10 points describing required elements for conducting research with humans. These points became known as the
Nuremberg Code .
• Some points of Code were:
• Voluntary informed consent of the human subject is essential.
• Experiment should be designed to yield fruitful results for the good of society.
• Physical suffering, mental suffering and injury should be avoided.
• Degree of risk should never exceed that determined by the humanitarian importance of the problem to be solved.

Historical Developments
•
Researchers in the United States thought ethical principles were implicit in their work (not so).
• Code applied only to non-therapeutic human research.
•
Code had no strength of law.
More was needed to protect humans in research.

Historical Developments
• In 1964 the World Medical Association developed a code of research ethics, a reinterpretation of the Nuremberg Code, that came to be known as the Declaration of Helsinki .
• Focused on medical research with therapeutic intent.
• Not legally binding, but journal editors began requiring adherence to Declaration.
• In principle, this document set the stage for the implementation of the Institutional Review Board (IRB) process. However, unethical studies continued to surface.

Historical Developments
Study Examples
HEALTH
Public Health
Service Syphilis
Study
(1932-1971)
Ethical Issues
 Began on African American men when treatment was not available.
 After penicillin was found to be effective, participants were denied antibiotics and prevented from receiving further treatment.
 Resulted in 28 deaths, 100 cases of disability, 19 cases of congenital disease.
 Example of lack of informed consent, deception, withholding new information, withholding available treatment, putting men and families at serious risk, and exploitation of a vulnerable group who would never benefit from participation.
PSYCHOLOGY
Milgram
“Obedience to
Authority” Studies
(1963)
 Authority study where each participant was told to teach a
"student" and to punish the student’s errors by administering increasing levels of electric shock.
 “Students” were in on it; mimicked pain and/or unconsciousness.
 63% of the participants administered what they thought were lethal shocks, some even after the "student" claimed to have heart disease. Even after being debriefed, some participants experienced serious emotional crises.
 Example of serious deception, unanticipated psychological harms
Other examples: Syphilis Experiments in Guatemala (1946-48),
Stanford Prison Experiment (1971), etc.

Federal Regulations
National Research Act (1974) – Passed and established Nat’l
Commission for the Protection of Human Subjects
Belmont Report (1979) – 3 Basic Ethical Principles
Principles
Respect for
Persons
Beneficence
Justice
Applications
Informed Consent Process
Provide necessary information; ensure participant comprehension; communicate voluntary nature
Assessment of Risks & Benefits
Design study to maximize the probability and magnitude of benefits
Equitable Participant Selection
Fairness in overall distribution of the burdens and benefits of research
Institutions Accepting Federal Funds: Obtain Federalwide Assurance
An agreement where an institution commits that it will comply with the requirements of the human subject regulations published by the US Dept. of Health and Human Services.

Federal Regulations
(Continued)
United States Department of
Health and Human Services
Office of Human Research
Protections
• 45 CFR Part 46: Subpart A
(Common Rule) – 17 federal agencies adhere
• 45 CFR Part 46 Subparts B,
C, & D – Pregnant Women,
Fetuses & Neonates,
Prisoners, Children
Food & Drug Administration
• 21 CFR Parts 50 and 56 –
Covers drugs, devices & biologics w/ humans
Office for Civil Rights
• Public Law 104-191: Health
Insurance Portability &
Accountability Act (HIPAA)
– privacy and security rules for covered entities
United States Department of Education
• 34 CFR Part 99: The Family
Educational Rights and Privacy
Act (FERPA)
United States Department of Agriculture
• Animal Welfare Act & Regulations

Federal Regulations
(Continued)
• Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
• Human subject (participant): a living individual about whom an investigator (whether professional or student) conducting research obtains:
• Data through intervention or interaction with the individual (Note: online surveys are considered interaction)
• Identifiable private information
• 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 examinations or tests.

Federal Regulations
(Continued)
• Physical
• Emotional
• Social
• Financial
• Legal
• Situation based (e.g., breach of confidentiality)

At Marywood University
3 RESEARCH BOARDS/COMMITTEES
Human Research
Institutional Review Board (IRB)
• Full reviews
• Expedited reviews
Exempt Review Committee (ERC)
• Exempt Reviews
Animal Research
Institutional Animal Care & Use
Committee (IACUC)

Reviewed By Examples Review
Category
Exempt Review
Expedited Review
Full Review
ERC
IRB
IRB
Risk to
Participants
No greater than minimal risk (risk of everyday life or activities)
No greater than minimal risk
Greater than minimal risk
Research w/ adults involving non-sensitive surveys, interviews, cognitive tests, as long as disclosure wouldn’t place participants at risk
(physical, social, psychological, legal, etc.); no video/audio taping
Interview w/ video or audio taping of participants; sensors on skin; body composition assessment, etc.
Studies collecting identifiable data which may be harmful if breached; involving drugs; medical procedures, etc.
Research w/ prisoners can never be exempt. Research w/ children cannot be exempt if involving surveys, interviews or observation of behavior where the researcher participates in the observation. Research w/ pregnant women may be exempt if the activities qualify.

• Research by faculty, staff, or students of Marywood University involving human participants, conducted at Marywood University or under its sponsorship at another location, must comply with applicable policies, procedures and guidelines for the protection of human subjects.
• All research that can be defined as "a systematic investigation designed to develop or contribute to generalizable knowledge" (45 CFR 46) must be reviewed and approved by the Institutional Review Board for the
Protection of Human Participants (IRB) or submitted as an exemption request for review to the Marywood Exempt Review Committee (ERC).
• IRB/ERC review is also required of research carried out under the sponsorship of an institution other than Marywood University but which is performed on the premises (includes email) of Marywood University, even if the research has already been approved by the IRB at the sponsoring institution or elsewhere.

All research team members must complete research ethics education (principal investigator, co-investigators, sponsor/advisor, research assistants, etc.). Where a thesis/dissertation committee is involved, it only needs to be the sponsor, unless others are engaged in research activities (actively recruiting, answering questions, obtaining informed consent, data collection or analysis of identifiable data).
• Completed online through the Collaborative Institutional Training Initiative
(CITI) at www.citiprogram.org
•
Each member of team must earn 2 completion certificates:
1.
Human Research Course (HRC) or Animal Course
• Covers history, ethics, regulatory requirements, harm to participants, breach of confidentiality, etc.
• Can choose from social/behavioral, biomedical, clinical trial, or IRB members and staff (investigators don’t take this one)
2.
Responsible Conduct of Research (RCR)
• Covers prevention of false data, misrepresentation of data, plagiarism, etc.
• Can choose from social/behavioral, biomedical, humanities or physical sciences

1.
Read our policies and procedures on our websites.
2.
Complete CITI online training. Also make sure all members of research team complete training.
3.
Determine under which category your research falls. Decision charts are linked on the IRB’s website: www.marywood.edu/irb/regulations.html
4.
Use templates and forms.
5.
Prepare your documents (spellcheck/proofread).
6.
Understand that no research activities, including recruitment or data collection, may begin until approval is granted.

• Online submission and management system
• Register for an account online at www.irbnet.org
.
• Make sure members of the research team (coinvestigators, sponsor/advisor, etc.) are registered as well.
IRBNet Instructional Tools
• Written IRBNet Instructions for Researchers
• Short training tutorial videos
• Assistance provided by Research Graduate Assistant
• Several IRBNet workshops with open labs per semester

• Two research training certificates (upload to user profile on IRBNet or in submission package)
• All project documents
Exempt Review
1. ERC Application
2. Participant Letter
3. Recruitment Permission Letter
Expedited or Full Review
1. IRB Application
2. Consent/Parental Consent Form (s)
Child Assent Form or Script
3. Recruitment Permission Letter
4. Recruitment Materials
5. Instruments
6. 1 Professional Review of
Instrument Letters (for researcherdeveloped instruments only)
4. Recruitment Materials
5. Instruments
6. 1 Professional Review of Instrument
Letters (for researcher-developed instruments only)

• Informed consent is not just a form, but a process.
•
Process begins with recruitment.
• Principal Investigator (PI) must provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate.
•
PI must minimize the possibility of coercion or undue influence.
• Information given shall be in language understandable to the subject or the representative (readability).
• No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
• Regulations define elements which must be present. Use our templates:
• Exempt – Participant Letter
•
Expedited or Full
– Informed Consent Form, Parental Consent Form,
Assent Form (minors 7+) or Assent Script (minors under age 7).

• Watch your email account. You’ll receive a notice when a decision letter has been uploaded electronically to IRBNet.
• Decisions:
• Not approved
• Deferred
• Modifications required
• Approved
• Any modifications requested need to be tracked in word processing software (written instructions, short video tutorial, OIT workshops available).
• Once approved, stamped documents will be uploaded to IRBNet with the approval letter (i.e., anything part of the consent process consent form/participant letter, advertisements, scripts, etc.).
Stamped versions of informed consent/participant letter, assent, advertisements must be used (exception: online documents)
• A status report is due 6 months from approval date (IRB only).
• Approval is good for one year only. A final report is due by expiration date, unless a renewal/continuing review application is submitted (IRB and ERC).

All student investigators must identify a full-time campus sponsor/advisor. This person:
• Shares responsibility for the ethical conduct of research with the student
• Completes required CITI training
• Guides student through design and process
• Reviews application materials before submission (proofreading)
• Applies esignature to the project before it’s submitted
• Ensures that student submits reports in a timely manner
•
Six-month Status Report (IRB only)
• Closure Report (before 1 year expiration)
•
Continuing Review/Renewal Application (if going beyond 1 year)
•
Adverse Event or Deviation/Violation

http://www.marywood.edu/research-office/
Exempt Review Committee http://www.marywood.edu/research-office/research-at-marywood/erc.html
Institutional Review Board www.marywood.edu/irb

TBD
– Research Graduate Assistant
570-348-6211, x. 2233 irbhelp@marywood.edu
DIRECTORS
Institutional Review Board (IRB)
Courene M. Loftus, MPA, CIP
Director of Human Participants Protection
O'Neill Center for Healthy Families
Room 211
Phone: (570) 961-4782, Fax: (570) 340-
6068 cloftus@marywood.edu
Exempt Review Committee (ERC)
Laura Ann Camlet Houser, Ph.D.
Director of Research Compliance
O'Neill Center for Healthy Families
Room 218
Phone: (570) 340-6031, Fax: (570) 340-
6068 lacamlet@marywood.edu