PowerPoint Presentation

Human Research Protection Program

Yale Research

Community Training

New Yale HRPP/IRB Manuals &

related research topics.

• This manual is the “go to” document

for referencing federal, state, and Yale

HRPP policies, procedures, and

guidance information related to

human research protections and

research requirements.

Human Research Protection Program

Yale HRPP Policy and Standard Operating Procedure

Manual – Part I

Yale HRPP Policy & Standard Operating Procedure Manual Sections (Part I)

1 Human Research Protection Program 25 Conflict of Interest in Research

2 Quality Assurance 26 Participant Outreach

3 Education & Training 27 Health Insurance Portability and Accountability Act (HIPAA)

4 “Human Subjects” and “Research” Determinations 28 IRB and HRPP Billing

5 Exempt Determinations 29 Select State Statues Related to Human Subjects Research

6 IRB Reliance 30 ICH-GCP E6

7 Research Previously Approved by Another IRB 31 Databases, Registries, & Repositories

8 HRPP Business Continuity 32 Research Involving or Generating Genetic Information

9 Yale Institutional Review Board 33 Incidental Findings with Possible Health and Safety Significance for

Research Participants

10 IRB Actions, Failure to Respond, Appeals 34 NIH Data Management and Sharing

11 IRB Review Process 35 Genomic Data Sharing (GDS)

12 Suspensions, Terminations, and Investigator Holds 36 Certificates of Confidentiality

13 Documentation and Records 37 Self-Experimentation

14 Obtaining Informed Consent from Research Subjects 38 Student Research

15 Vulnerable Subjects in Research 39 Community Based Research

16 FDA-Regulated Research 40 Transnational Research

17 Unanticipated Problems Involving Risks to Subjects or Others 41 Lead Investigator/Coordinating Center

18 Noncompliance 42 Research Involving the VA Connecticut Healthcare System

19 Complaints 43 Department of Defense

20 Other Reportable Information 44 Department of Justice

21 Reporting to Federal Agencies, Departments, and Organizational Officials 45 Department of Energy

22 Reporting to AAHRPP 46 Environmental Protection Agency

23 Investigator Responsibilities 47 Department of Education

24 Sponsored Research

Human Research Protection Program

Yale HRPP Policy and Standard Operating Procedure

Manual – Part I: NEW or REVISED Content

New Content or Areas of Heavily Revised Content/Layout

• Section 6 – IRB Reliance

• Section 8 – HRPP Business Continuity

• Section 10 – IRB Actions, Failure to Respond, Appeals

• Section 37 – Self-Experimentation

• Section 39 – Community Based Research

Streamlined Navigation for Study Team Regarding Reporting

Requirements/Guidance (content has not changed)

•

Section 12 – Suspensions, Terminations, and Investigator Holds

•

Section 17 – Unanticipated Problems Involving Risks to Subjects or Others

•

Section 18 – Noncompliance

•

Section 19 – Complaints

•

Section 20 – Other Reportable Information

Human Research Protection Program

Yale HRPP Policy and Standard Operating Procedure

Manual – Part II

• Part II of the of the Yale HRPP Policy

and Standard Operating Procedure

Manual contains links to additional

standalone HRPP policies,

procedures, and guidelines relevant

to the conduct of human subjects

research under the purview of the

Yale HRPP (Section A).

• Additional relevant Yale policies,

procedures, and guidelines under

the authority of other University

departments, offices, or programs

reside elsewhere. However, links to

key policies, procedures, and

guidelines are included in Part II

(Section B)

Human Research Protection Program

Yale HRPP Policy and Standard Operating Procedure

Manual – Part II

Yale HRPP Policy & Procedure Manual Sections (Part II)

Section A: Yale Human Research Protection Program Standalone Policies, Procedures, and Guidelines

HRPP Policy on Oversight of Yale Sponsor-Investigator held Investigational New Drug (IND) Applications, Investigational Device Exemptions

(IDE) or Emergency Use or Emergency Use Authorizations (EUA)

HRPP Policy on Institutional Conflicts of Interest In Human Research

Research Recruitment at Yale and Yale New Haven Hospital

Guidance on Committee Reviews Required for Human Subjects Research Protocols Using Radiation

Clinical Trial Registration and Reporting Requirements

Guideline - Quality Improvement Projects (Clinical Setting)

Yale Human Research Protection Program Business Continuity Plan

Section B: Yale University and Other University Schools, Departments, Offices, or Programs Standalone Policies, Procedures,

and Guidelines

University Policy 1360, Human Research Protection

University Policies & Procedures

Researchers: Policy guidelines for Yale Faculty, Students, and Staff governing Research at Yale

Research Administration University-Wide Policy Documents

Yale Research Support

Yale Faculty Handbook

Yale University Policy on Conflict of Interest

Human Research Protection Program

UPDATED INVESTIGATOR MANUAL

Yale Research Community Training

Human Research Protection Program

Investigator Manual – Overview of Changes

• Added new sections:

 Working with External IRBs;

 Instructions on requesting Yale IRB to serve as the sIRB for a multi-site research

project;

 Data Sharing Plans for federal grant applications; and

 Description of ancillary committees.

• Revised format – sections were streamlined (topics grouped accordingly) and

the question-and-answer format was removed.

• Updated the information regarding regulatory requirements for research

subject to federal agencies’ oversight.

• Added instructions that previously lived as standalone documents (e.g.,

obtaining Certificates of Confidentiality, adding Unaffiliated Investigators,

submitting RNI vs. MODs, etc.).

Human Research Protection Program

Investigator Manual – Format

Old format

Revised format

Human Research Protection Program

Investigator Manual – How to Use this Resource

• Think about the Investigator Manual as the “how-to” manual for

investigators and research staff. The information contained in the document

may need to be supplemented with additional regulations and agency

guidance.

• If a question arises during the conduct of research, look for guidance in the

Investigator Manual first. You may also review the HRPP Policy and Standard

Operating Procedure Manual to understand any relevant regulatory

frameworks.

– For example, the HRPP Policy and Standard Operating Procedure Manual will include

information about Certificates of Confidentiality with instructions for the IRB

regarding when one should be required, while the Investigator Manual will include

instructions for the investigator on how to obtain one.

• Located in the IRES IRB Library (Handbooks and Manuals tab) - Same

location as the HRPP Policy and Standard Operating Procedure Manual.

Human Research Protection Program

UPDATED CHECKLISTS,

WORKSHEETS, AND OTHER FORMS

Yale Research Community Training

Human Research Protection Program

Yale HRPP/IRB Checklists – Summary and Location

Checklists are used by the IRB reviewers to document required IRB determinations.

Investigators may consult the checklists to understand the regulatory requirements related

to research – however Investigators are not required to complete the checklists. They will

continue to be posted in the Checklists tab of the IRES IRB Library.

Human Research Protection Program

Yale HRPP/IRB Checklists – Changes to Documents

The following checklists were recently revised for clarity or new regulatory

requirements. The effective date for these checklists is January 30, 2023:

• HRP-414 – CHECKLIST – Neonates of Uncertain Viability

• HRP-412 – CHECKLIST – Pregnant Women

• HRP-411 – CHECKLIST – Waiver of Written Documentation of Consent

• HRP-417 – CHECKLIST – Cognitively Impaired Adults

 PLEASE NOTE: The revisions made to the checklists are not substantial and will

not impact study teams or the conduct of research. The changes have been

made to better assist Yale IRB staff with reviewing research applications

involving the above topics.

Human Research Protection Program

Yale HRPP/IRB Worksheets – Summary and Location

Worksheets provide the IRB reviewers with additional information about regulatory

requirements and guidance related to the IRB review and approval of research. Investigators

may consult the worksheets to understand the regulatory landscape related to human

subjects research - however Investigators are not required to complete the worksheets. They

will continue to be posted in the Worksheets tab of the IRES IRB Library.

Human Research Protection Program

Yale HRPP/IRB Worksheets – Changes to Documents

The following worksheets were revised for clarity or new regulatory requirements.

The effective date for these worksheets is January 30, 2023:

• HRP-332 – WORKSHEET – NIH GDS Institutional Certification

• HRP-307 – WORKSHEET – Devices

• HRP-311 – WORKSHEET – Engagement Determination

• HRP-331 – WORKSHEET – FERPA Compliance

• HRP-306 – WORKSHEET – Drugs and Biologics

• HRP-312 – WORKSHEET – Exemption Determination

• HRP-317 – WORKSHEET – Short Form of Consent Documentation

• HRP-318 – WORKSHEET – Additional Federal Criteria

• IRB Member Review Worksheet – Initial

 PLEASE NOTE: Most revisions made to the worksheets are not substantial and will

not impact study teams or the conduct of research. The biggest change was the

revision of HRP-312 (Exemption Determination), which was updated to reflect the

updated 2018 Common Rule exemption categories.

Human Research Protection Program

Yale IRB Submission Form – Overview of Changes

Two types of changes:

• Addition of new sections (required only for certain types of studies).

• Addition of new questions/reminders to existing sections.

What the changes mean for the research community:

• Use of the revised submission form is only applicable to new submissions of initial

studies.

• Initial submissions of protocols using older version of the form will be rejected as of

March 1, 2023.

• The IRB may request that the investigator add any of the applicable new

sections/questions to the existing IRB Submission Form at the time of a specific

modification (e.g., submission of modification to add a new federal grant that includes a

data sharing plan may mean that the new supplement on data sharing be added to the

existing IRB Submission Form*)

*This is consistent with the current practice (e.g., Supplement on Multicenter Management must be

completed at the time of a modification to add new sites to the protocol and where the Yale site becomes

the coordinating center).

Human Research Protection Program

Yale IRB Submission Form – New Sections

Section Description

Supplement V: Research

with Tobacco Products

Complete only when the research includes the

use of tobacco products.

Supplement IX: Research

Under an IND or IDE Held by

a Yale Investigator

Complete only if the research involves use of a

drug conducted under an IND held by a Yale

investigator or a device study conducted under an

IDE held by the Yale investigator; currently this

supplement exists as a stand-alone document;

the information is used by the YCCI IND/IDE

Management Office.

Supplement X: Ancillary

Committees

Investigators should review this section to

identify any ancillary committees applicable to

the research.

Supplement XI: Data Sharing

and Management Policy

Complete if the study is subject to the NIH Data

Sharing and Management Policy.

Human Research Protection Program

Yale IRB Submission Form – Supplement V – Tobacco

Products

The supplement is

only for studies that

involve tobacco

products as the

Drugs page in IRES

IRB does not

include specific

questions relevant

to tobacco products

Human Research Protection Program

Yale IRB Submission Form – Supplement X - Ancillary

Committees

Instructions on how and

when to obtain approval

from the committee

Name of the ancillary

committee

Description of

when the

ancillary review

applies; if the

scenario applies

to your research,

check off the box

in the second

column

Human Research Protection Program

Yale IRB Submission Form – Supplement XI – Data

Management and Sharing

Applies to federally

funded studies with the

grant application dated

January 25, 2023 or later;

additional information is

available in the

Investigator Manual and

on the OSP website:

https://tst.your.yale.edu/r

esearch-support/office-

sponsored-projects/data-

management-and-

sharing-dms

Human Research Protection Program

Yale IRB Submission Form – Revised Sections

Section Description

Section 4.

Confidentiality and

Privacy

Questions added regarding:

• Cloud data storage

• Data Use Agreements

• Material Transfer Agreements

• Privacy of research participants

Guidance added regarding:

• Business Associate Agreements

• Data classification

SUPPLEMENT VIII:

Special Populations

Question added regarding:

• The consent process for non-English speaking individuals to

ensure the process is conducted in the language understood

by the potential participant

Guidance added regarding:

• FDA expectations regarding translation of the consent

document if a short form is used for enrollment

Human Research Protection Program

Request to Use External IRB Form – Overview of

Changes

• Form that must be completed at the time of the initial request to use an

external IRB (with the exception of NCI CIRB studies).

• Will be required for submissions on January 30, 2023.

• Must be uploaded as the category ‘Request to Use External IRB’ in the

Local Site Documents page (Other attachments [Item #3]).

Human Research Protection Program

Request to Use External IRB Form – Summary

• The Request to Use External IRB form asks questions relevant to

the institutional review of local context:

• Recruitment of participants

• Storage of data

• HRPP billing instructions

• Data Use Agreements and Material Transfer Agreements

• Review by Ancillary Committees

• Research under an IND or IDE held by a Yale Investigator

• Data Management and Sharing for NIH funded studies

• Most of the questions and guidance are identical to the IRB

Submission Form (used for initial submission to Yale IRB).

Human Research Protection Program

COA Form for Billable Protocol Charge Information –

Overview

• This is a new document that must be submitted for all CRs and MODs/MODCRs

for billable protocols for which the study specific COA (chart of account) has not

been provided.*

• The COA form must be uploaded in IRES IRB as follows:

– For CRs and MOD/CRs, upload in the “Attach supporting documents” section of the

“Continuing Review/ Study Closure Information” page of the application.

– For MODs, upload in the “Other attachments” section of the “Local Site Documents”

page of the application.

• For information about the billing process, see the HRPP announcement dated

July 12, 2022, on the HRPP website

*IRB Submission Form includes charging instructions for invoicing the IRB review fees,

however, when the study specific COA is not available at the time of the initial review, the

investigator must provide a general departmental account.

Human Research Protection Program

Location of New/Revised Forms

Location of IRB Submission Form, Request

to Use External IRB Form, and COA Form

Human Research Protection Program

Training Summary

• The Yale HRPP has streamlined our policies, procedures, guidance documents,

worksheets, checklists, and other related documents and we have reimagined

some of the ways in which we educate our research community and HRPP

team.

• The majority of Yale HRPP/IRB policies and processes are not changing. The

manuals are simply new ways of providing information to our research

community, with some minor regulatory changes included.

• The effective date for all new/revised documents is January 30, 2023.

• All new/revised documents will be posted in the IRES IRB Library.

• The Yale HRPP is committed to a partnership with the research community in

the promotion of safe and ethical research. Yale HRPP/IRB staff are available to

the research community for consultation, education, and guidance.

Human Research Protection Program

Reference: HRPP and IRB Leadership

HRPP Main

Office Number

and Helpline

Access:

25 Science Park, 150 Munson St., 3

Floor 203-785-4688 or

[email protected]

HRPP

Leadership

Linda Coleman, Director, HRPP

Jessica Rowe, Associate Director, HRPP/YCCI

Monika Lau, Assistant Director, HRPP & Deputy

HIPAA Privacy Office, HIPAA Data Privacy Office

Cathi Montano, Assistant Director, HRPP

Matt Stafford, Assistant Director, HRPP

Alan Teller, Assistant Director, HRPP

Michele Antisdel, Manager, HRPP - Institutional

Review

Brandy Lagner, Manager, HRPP - Operations

Gina Larsen, Senior Manager, HRPP

Amanda Liss, Manager, HRPP - Yale IRBs

Dawn Pedevillano, Senior Manager, HRPP -

Yale IRBs

Meriam Worzella, Manager, HRPP

linda.coleman@yale.edu

jessica.rowe@yale.edu

monika.lau@yale.edu

cathleen.montano@yale.edu

m.stafford@yale.edu

alan.teller@yale.edu

michele.antisdel@yale.edu

brandy.lagner@yale.edu

gina.larsen@yale.edu

amanda.liss@yale.edu

dawn.pedevillano@yale.edu

[email protected]

Human Research Protection Program

Questions?

Thank you for your dedication to

protecting research participants and for

conducting ethical research at Yale!

Please Document Your

Attendance Here: