Office of the Vice President for Research

UB HRPP Required Training:
- Who must complete the CITI training?
- What is CITI training?
- What are the initial training requirements?
- What if I completed equivalent CITI training at another institution?
- What are the continuing training requirements?
- How do I access CITI training courses?
CITI Optional Courses and Optional Modules
- What are CITI Optional “Courses” and Optional “Modules”?
HRPP and IRB Training Workshops available for researchers

Exemption Requests

FDA REGULATED PRODUCTS: RESEARCH INVOLVING INVESTIGATIONAL DRUGS, AGENTS, BIOLOGICS, AND DEVICES

Overview
Investigational new drug (IND)
- B-1. Overview
- B-2. Types of IND Applications
- B-3. Phases of a Clinical Trial
- B-4. Requirements for Submission of an IND Application to the FDA for Research Involving Drug or Biologics that Have Not Yet Reached the Market
- B-5. Clinical Investigations of Marketed Drugs Not Requiring Submission of an IND Application
- B-6. Research Involving Combinations of FDA Approved Drugs, Agents or Biologics
- B-7. Investigator Responsibilities for Research Involving Investigational Drugs, Agents and Biologics
- B-8. Investigator Responsibilities for Storage, Handling, and Dispensing of Investigational Drugs, Agents, and/or Biologics
- B-9. Emergency Use of an Investigational Drug or Biologic
- B-10. Emergency Exemption from Prospective IRB Approval
- B-11. Exception from Informed Consent Requirement
- B-12. Expanded Access to Investigational Drugs
- B-13. Communication with Hospital-Based Pharmacies
Investigational Device Exemption (IDE)
- C-1. Overview
- C-2. Investigational Device Exemption (IDE)
- C-3. Exemptions from Obtaining an IDE
- C-4. Significant Risk vs. Non-Significant Risk Devices
- C-5. Investigator Responsibilities for Studies Involving Investigational Devices
- C-6. Responsibilities of Investigators Who Also Sponsor the Research
- C-7. Investigator Responsibilities Involving Unanticipated Adverse Device Effects
- C-8. IRB Review of Investigational Devices in Determining SR/NSR
- C-9.Investigator Responsibility for Maintaining the Distinction Between Research and Therapy
- C-10.Concurrence of FDA, Sponsor and IRB Determinations for SR/NSR
Humanitarian Use Devices (HUDs)
- D-1. Overview
- D-2. Investigator Responsibilities for HUDs
- D-3. Additional Reporting Requirements for Serious Events/Problems (SEPs) Involving HUDs
- D-4. IRB Review of HUD Use
Emergency Use of Unapproved Medical Devices
- E-1. Overview
- E-2. Requirements for Emergency Use
- E-3. After-use Procedures
- E-4. Exception from Informed Consent Requirement for Medical Devices
- E-5. Exception from Informed Consent for Planned Emergency Research
- E-6. Investigator Responsibilities for Conducting Planned Emergency Research
- E-7. IRB Review of Planned Emergency Research
IRB Responsibilities for Emergency Use of FDA Regulated Products

Fees Associated with IRB Review of a Commercially Sponsored Research Project

Forms and Templates (All HSIRB Forms and Templates)

HIPAA (Health Insurance Portability and Accountability Act): Guidelines/Forms/Templates

HIPAA Guidelines
HIPAA Forms
- Worksheet
- Authorization
- De-Identification
- Full Waiver
- Partial Waiver

Informed Consent Process

Overview
Requirements for Informed Consent

B1. Elements of consent: What must be said about the research

Basic Elements
Additional Elements
Specific FDA requirements

B2. Providing enrolled subjects with new information

Who may obtain consent, permission, and assent?
How and where to obtain consent
Documentation of consent

E1. Overview
E2. Signature Requirements

The Subject or LAR
Person Obtaining consent
A Witness
Time of Consent
PI Signature

Who Gets a Copy of the Signed Consent Document(s)?
What Consent Documents Must be Retained in the Study Files
Reporting Missing Signatures or Dates and Other Consent Irregularities
Waivers of Consent and Waivers of Documentation of Consent

I1. Waiver of consent
I2. Waiver of written documentation of consent

Parental Permission and Child Assent

J1. Definitions
J2. Overview
J3. Documentation of permission of parents/guardians
J4. Assent of the child
J5. Documentation of child assent
J6. Waiver of parental/guardian permission
J7. Waiver of child assent
J8. LARs for minors in New York State
J9. Minors in NYS who may be able to give legally effective informed consent
J10. When a child reaches the legal age of consent while enrolled in a study
J11. Research involving wards of the State

Which consent document formats/templates to use

K1. HSIRB formats/templates
K2. Sponsor-prepared templates

Special consenting situations

L1. Non-English consents
L2. Illiterate English-speaking individuals
L3. Physically incapacitated individuals
L4. Adult decisionally incapacitated individuals
- Capacity assessment
- Legally authorized representatives (LAR)
- Documentation of LAR consent
- Assent by decisionally incapacitated adult subjects
- Consent of adult subjects who regain capacity
- Anticipated loss of decisional capacity by adult subjects enrolled in research
L5. Genetic research
L6. Pregnant women or fetuses prior to delivery
L7. Neonates
L8. Students, employees, and others in subordinate positions

Leaving the Institution (When Principal Investigators Leave)

New/Initial Submissions:

Expedited Review

Overview
What to submit
How to submit

Full Board Review

Overview
What to submit
How to submit

(See also Exemption Requests)

Privacy and Confidentiality

Privacy vs. Confidentiality – What is the difference?
Protecting Participant Privacy Interests

Protocol Requirements

Quality Control Projects

Reportable Events and Problems

"On-Site" events/problems

Determining "Serious" or "Non-Serious"
Reporting "Serious" Events/Problems (SEPs)
Requirements for follow-up reports
Reporting "Non-Serious" events/problems

"Off-Site" SEPs

Safety Reports
Other types of off-site SEP notifications
How to report an off-site SEP

PI responsibilities at the time of continuing review
PI responsibilities for further reporting of events/problems

Retrospective Chart Reviews

Roswell Park Cancer Institute (RPCI) - Research Agreement

Survey Research

Veteran's Administration WNY (VAWNY) – Research Agreement

Vulnerable Subject Populations

Overview
Research involving Pregnant Women, Human Fetuses and Neonates
- B1. Overview
- B2. IRB Requirements for Approval of Biomedical Research Involving Pregnant Women and Fetuses
Research Involving Prisoners
- C1. Overview
- C2. If an enrolled subject becomes a “prisoner”
Research Involving Children
- D1. Overview
- D2. Wards of the State
Other Groups and Research Situations Requiring Special Consideration
- E1. Overview
- E2. Adults Unable to Provide Consent
- E3. Research in Schools
- E4. Students, Employees, and Others in Subordinate Positions
- E5. Economically or Educationally Disadvantaged Persons and Other Groups Requiring Special Consideration
- E6. Minors in New York State Who May Consent for Themselves

TopSECTION 3: FORMS and TEMPLATES (all HSIRB forms and templates)

Amendment Form
Annual Disclosure of Significant Financial Interest and Significant Obligations
Authorization of Fee Collection for IRB Review of a Commercially Sponsored Research Protocol
Closed/Completed Notification Form
Continuing Review Application
Exempt Status Request Form
Expedited Review Form
HIPAA Forms

Worksheet
Authorization
De-Identification
Full Waiver
Partial Waiver

HS-1A Application Form
HS-1A Multi-Site Addendum Form
Informed Consent Templates

Consent Document Template
Consent Document Template with HIPAA Incorporated
Parental Permission Template (includes alternative signature page for participants 14-17 yrs of age)
Parental Permission Template with HIPAA Incorporated (includes alternative signature page for participants 14-17 yrs of age)
Assent Document Template (for children 7-13 yrs of age)

Serious Events And Problems (SEPs)- Initial Report Form
Serious Events And Problems (SEPs) - Follow-Up Report Form

TopSECTION 4: USEFUL RESOURCES AND LINKS

General Resources

Other UB IRBs that Review Human Subjects Research

Children & Youth IRB
Social & Behavioral Sciences IRB

Office of the Vice President for Research
CITI Human Subjects Protection Tutorial
Lay Terms for Use in Consent Forms
NIH (National Institutes of Health)
Tips for Writing an Understandable Consent Document
UB HIPAA Web Site
UB HRPP Standard Operating Procedures (SOP)
UB Sponsored Projects Services (SPS)

Ethical Principles and Guidelines

Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
Nuremburg Code

Regulations

DHHS Regulations (Department of Health & Human Resources)

DHHS 45 CFR Part 46 - Protection of Human Subjects/ Institutional Review Boards
OHRP Site (Office for Human Research Protections)

FDA Regulations (Federal Drug Administration)

FDA 21 CFR Part 50 - Protection of Human Subjects
FDA 21 CFR Part 56 - Institutional Review Boards
FDA 21 CFR Part 312 – Investigational New Drug Application
FDA 21 CFR Part 812 – Investigational Device Exemptions
FDA Site (Food and Drug Administration)

TopSECTION 5: FOR HSIRB MEMBERS ONLY

HSIRB Meeting Dates

Reviewer Evaluation and Guidesheets

Initial Review
Continuing Review
Amendment
Exempt Status
Children
Pregnant Women
Prisoners
Serious Events and Problems (SEPs)
Short Form Consent Process
Waiver of Consent and Waiver of Documentation of Consent

Health Sciences Institutional Review Board (HSIRB)

HSIRB Site Index

TopSECTION 1: GENERAL INFORMATION

TopSECTION 2: GUIDELINES/ REQUIREMENTS

HSIRB Quick Links

UB HRPP Resources