1. Long Island University Institutional Review Board:
An Overview

2. Purpose of the IRB Protect human subjects during research
Definitions:
Research: A systematic investigation designed to develop or contribute to generalizable knowledge
Human Subjects: Living individuals who participate in research

3. Belmont Report
Created the basic ethical principles underlying the acceptable conduct of research involving human subjects
3 Principles
Respect for Persons
Beneficence
Justice
More info: policy/belmont-report/index.html

4. Respect for Persons
Involves recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy
Informed Consent requires that:
Participants are provided with sufficient information about the research
Participants comprehend the research and study requirements
Participation is voluntary
Sufficient information includes information on:
Research procedures
Purpose of research
Risks and benefits of participating
Alternative procedures (where therapy is involved)
Statement offering opportunity to ask questions and withdraw from research at any time

5. Informed Consent Essential components of informed consent are:
The consent is given in the absence of coercion or duress;
The potential participant is provided with all information (in language understandable to him or her) relevant to making a meaningful decision regarding participation (initial or continuous) and;
The potential participant has decision-making capacity needed to make a meaningful choice about whether to participate in the study.

6. Informed Consent and Children
Parental Permission: parental permission for child to participate in research
Assent: a child’s affirmative agreement to participate in research
Mere failure to object should not, absent affirmative agreement, be construed as assent. This means the child must actively show his or her willingness to participate in the research, rather than just complying with directions to participate and not resisting in any way. This gives a child authority to say “No” to participating in research. 45 CFR (b), 21 CFR 50.3(n)

7. Beneficence
An obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm (Involves risk/benefit assessment)
Individual benefits and harms
Ex: psychological and physical
Societal benefits and harms
Minimizing risk is essential, including avoiding the use of human subjects when possible

8. Justice
Requires that the benefits and burdens of research be distributed fairly
Fair or “just” selection of research subjects
Selection should not be based on investigator favoritism or disdain (e.g., involving “undesirable” persons in risky research)
Subject should not be chosen simply because they are readily available or easily manipulated due to illness or socioeconomic condition
Non-random sampling must be justified
“Justness” refers to subject selection as an individual and to the subject as a member of social, racial, sexual, or ethnic groups.
The rigor of a study design is important consideration of the IRB. A well-designed study will help protect the rights of participants. Proper sampling ensures both validity and ethical justice.

9. Risk
RISK: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study.
MINIMAL RISK: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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
What are some examples of the different types of harm (physical, psychological, social, economic)?

10. Institutional Review Board
Comprised of professors from LIU and outside members
Reviews and discusses human subject research proposals
Ensures the rights of human subjects in research are protected according to the three principles of the Belmont Report

11. LIU Post’s IRB Members 2017-2018
IRB Human Subjects Administrator : Dr. Lacey Sischo
Chair: Dr. Kathleen Feeley
Members:
Dr. Selenay Aytac
Dr. Tejas Bouklas
Dr. Jennifer Brown
Dr. Jerrilynn Burrowes
Dr. Orly Calderon
Dr. Arthur Freidman
Dr. SeungYeon Lee

12. LIU Brooklyn’s IRB Members 2017-2018
IRB Human Subjects Administrator : Dr. Lacey Sischo
Chair: Dr. David Taft (Interim Chair)
Dr. Paul Ramirez (Chair)
Members:
Dr. Cristiana Kahl
Dr. Diane Reynolds
Dr. Elizabeth Kudadjie-Gyamfi
Dr. John Sannuto
Dr. Anait Levensen
Dr. Benjamin Saunders
Dr. Kevin Meehan
Dr. Jay Shuttleworth
Dr. Karina Moreno-Saldivar

13. Types of Applications Exempt (no risk)
Expedited (no more than minimal risk)
Full Board (more than minimal risk)
The type of review will be decided by the IRB and will depend on the level of risk involved in the study and the subjects being studied. The decision will also depend on the extent to which the participants remain anonymous and the location of the study.

14. Exempt Applications
Research activities that involve no risk to human subjects AND
Fall into specific categories:
Research conducted in established or commonly accepted educational settings, involving normal educational practices.
Research using anonymous or no-risk tests, surveys, interviews, or observations.
Most research involving public officials.
Research involving the collection or study of existing data if they are publicly available or if subjects cannot be identified.
Research examining public benefit or service programs.
Taste and food quality evaluation and consumer acceptance studies.
Examples:
b.1: research on regular and special education instructions strategies; research on the effectiveness of or the comparison among existing instructional techniques, curricula, or classroom management methods
b.2: UNLESS information is obtained in a way that participants can be identified AND disclosure of the participants’ responses could result in damage or criminal liability
b.3: human subjects are elected or candidates for office OR federal statutes requires without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter (e.g., with Certificate of Confidentiality)
b.4: as long as sources are publicly available OR information is recorded in such a manner that human subjects cannot be identified
These applications will be reviewed by IRB administrator and either approved or rejected. If rejected, the research activity doesn’t meet the exempt requirements and therefore the applicant will be asked to fill out an Expedited or Full Board application.

15. Examples of Exempt Applications
Having participants fill out a questionnaire on quality of life without obtaining any identifying information
A study of health beliefs, agency detection, and prosocial behavior that utilizes anonymous online survey data

16. Expedited Applications
Research activities that present no more than minimal risk to human research participants
In general, research may qualify for expedited review if it is judged to involve only minimal risk, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate informed consent procedures.
For example, the collection of physical data through non- invasive procedures is eligible for an expedited review, including:
Height and weight
ECG, MRI, Ultrasound
Moderate exercise
Blood or other bodily fluids (within limits as specified in expedited categories)
We don’t officially have this yet at LIU, but hopefully will soon. In an expedited application, a few designated members of the IRB will review the application and either approve it or determine that it requires full board approval. A full list of categories can be found here:

17. Examples of Expedited Applications
Survey of parents of child with a chronic condition that includes measures of psychological distress as long as the study includes adequate provisions for confidentiality and informed consent
Study that includes collection of baby teeth after they have naturally fallen out or if routine patient care indicates a need for extraction
More info: policy/regulations/45-cfr-46/index.html#46.110

18. Full Board Applications
Required for research not eligible for Exempt or Expedited review
Involves more than minimal risk
Involves protected subjects (e.g., children, prisoners, individuals with disabilities)
Involves procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial, or legal)
Are reviewed by the IRB at a monthly scheduled meeting
Full board applications are the most complex and time consuming. Getting materials in early is crucial!

19. Examples of Full Board Applications
Study of incarcerated women’s mental health (protected population)
Study of drug use among ER nurses (could jeopardize participants’ employment)

20. Human Subjects Training
All LIU personnel (including students and staff) involved in projects using human research subjects are required to complete an online training program before beginning their research
Protecting Human Research Participants (PHRP) through National Institutes of Health
Soon we will move to CITI (Collaborative Institutional Training Initiative) training and possibly training in the Responsible Conduct of Research

21. How to submit any type of application
Obtain an application from the Office of Sponsored Research - Sponsored Programs website LIU/Administrative- Departments/Academic-Affairs/Office-of- Sponsored-Research
Submit IRB materials via to: irb- (Post) or (Brooklyn)

22. Post Deadlines (for Full Board review)
Meeting Date
Submission Deadline
February 21, 2018
February 12, 2018
March 21, 2018
March 5, 2018
April 4, 2018
March 26, 2018
May 2, 2018
April 23, 2018
**Please remember to allow sufficient time to secure the appropriate signatures BEFORE the submission deadlines!

23. Brooklyn Deadlines (for Full Board review)
Meeting Date
Submission Deadline
February 15, 2018
February 5, 2018
March 22, 2018
March 12, 2018
April 19, 2018
April 9, 2018
May 3, 2018
April 23, 2018
**Please remember to allow sufficient time to secure the appropriate signatures BEFORE the submission deadlines!

24. Timeline for Approval
Applications are initially reviewed by IRB Administrator
Identify any missing components
Request clarifications to facilitate approval
Exempt Applications
Are reviewed by IRB Administrator
Decision in ~2 weeks
Expedited
Are reviewed by IRB chair and 1-2 other Board members
Decision in ~3 weeks
Full Board
Reviewed by all IRB members
Decision timeline dependent on Board review, meetings once a month

25. The ideal application…
Has addressed each of the components outlined on the application form – this is essential!
Is written for a lay audience (most IRB members are not from your discipline)
Has been edited in its entirety for grammar, typos, formatting issues, etc.
Has been reviewed by faculty sponsor and department chair to ensure all necessary information, documents, materials, and signatures are included.

26. The Review Process
Keep in mind for full board reviews, there are multiple individuals reviewing all of your materials. If each has 2 or 3 comments/questions/requests, that means you will receive a list of at least 14 points to change or clarify. So, please expect this amount of feedback and do not be surprised when you receive it.

27. DECISION STATUS FOR FULL REVIEW CATEGORY
Approval
Approval with Stipulations
requires some minor revisions- can be submitted via to administrator for final review and approval
Deferred
requires major revisions and another review by the board
Disappoval

28. Annual Reporting
All studies that received an expedited or full review require an annual re-review.
Complete the “IRB Annual Renewal Form” prior to study expiration date
Will get a reminder ~3 months before expiration
Departments/Academic-Affairs/Office-of- Sponsored-Research

29. Common Challenges Items on the application are not addressed.
The consent forms are not adequate or fail to include necessary information.
There is not enough information to determine what it is the researcher is doing and thus the procedures cannot be approved.
There are missing documents:
Required human subjects training certificate
Letters from collaborators
Measurement tools
Recruitment materials
The application has not been proofread and/or signed by the appropriate individuals

30. If you have questions….. Contact Dr. Lacey Sischo, IRB Administrator:
Phone:
Office: 211 Bush Brown Hall