aahrpp re-accreditation changes new and improved forms and sops human subjects forms &...

AAHRPP RE-ACCREDITATION CHANGESNEW AND IMPROVED FORMS AND SOPS

Human Subjects Forms & Procedures Update

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AAHRPP Accreditation Overview

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) offers accreditation to research organizations that provide comprehensive protections to research participants.

Process Voluntary, Peer-driven, and educational Renews every three years Application process to address AAHRPP requirements Site-visit

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Changes to Forms and Procedures

Why are changes being made? Comply with AAHRPP accreditation standards and

requests Consolidation of the Indianapolis and Bloomington

Human Subjects Office To un-complicate forms Revisions/updates haven’t been done since May 2009

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Major Changes

Merger of the HRPP IUPUI and IUB merged IUPUI/Clarian changed to IU on forms PI’s can use any IRB, no longer campus specific

New office name: IU Human Subjects Office Research Compliance Administration changed to Human

Subjects IU Human Subjects Office – Biomedical (Indy) IU Human Subjects Office – Behavioral (IUB)

All forms and SOPs updated See Summary of Changes for abbreviated list on HSO website:

http://researchadmin.iu.edu/HumanSubjects/hsdocs/Summary+of+Changes+-+All+Documents.pdf

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New Human Subjects Website

Vision Single HRPP website

Updates Instruction Packet no longer exists See website pages and guidance documents for information

Timeline “Live” on January 15th with new forms and new SOPs

New Links Human Subjects Home:

http://researchadmin.iu.edu/HumanSubjects Human Subjects Forms:

http://researchadmin.iu.edu/HumanSubjects /hs_forms.html

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Dates to Know6

January 15th New forms are available for use on the Human

Subjects website

March 15th New forms are required for applicable submissions

New Studies Continuing Reviews – Open to Enrollment Amendments, as applicable

Summary Safeguard Statement

Important changes: Section I –

Clarified instruction on the form; reminder: lay language Section II – HIPAA

Covered Entity Checklist is not automatically required Refer to HIPAA form

Section III – Performance Site Reworked to include IUB, IUPUI, etc. Read the section for familiarity with changes

Section IV – Subject Population Subjects Outside of US - Transnational Research – will be

prompted to complete separate request form New SOP coming soon

Clarified Number of Subjects to be involved in the research

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Important changes continued: Section V – Recruitment

If subject to HIPAA, go straight to the HIPAA & Recruitment Checklist

Clarified what competing studies means and how to handle More guidance coming from Executive Committee

Section VI – Study Procedures Describe frequency and duration Attach ancillary materials

Section VII - Risk and Benefit sections now combined to Risk/Benefit Ratio Section

Section VIII – Protection Procedures Is PI lead on Multi-Center Clinical Trial

Doesn’t mean conducting at multiple locations locally Section IX – Data Safety Monitoring Plan

No Changes Section X – Payment

No Changes

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Important changes continued: Confidentiality and Safeguards section (was Section X

prior) has been removed from all forms Misleading, caused confusion and inconsistency; raised

potential for noncompliance Section XI – Informed Consent Process

Minor Updates – review form Section XVI and XVII – Additional Reviews

Revised – review form Section XVIII – Federal Funding

Condensed Ensure copies of proposal and sample consent are sent

with submission

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Important changes continued: Section XIV – Investigational Test Articles

Added - If you think the device/drug does not require an IDE/IND, fill out the checklist to confirm, or submit the FDA confirmation of status

Question whether IU-affiliated investigator holds the IND/IDE

Complete risk assessment for NSR devices NSR devices are still investigational

Section XV – Co-investigator section and COI section are REMOVED Separate form now

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Investigator List

New form, required for ALL submissions Regardless of level of review (exempt, expedited, full Board) Not required for non-human subjects research or student

projects

This information removed from SSS SSS won’t be connected to co-investigator list or updates

Includes COI section Additional question added to form (discussed during COI

section)

When submitting Co-investigator updates, include: Co-investigator update form Investigator list (updated with track changes)

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HIPAA & Recruitment Checklist

New form Moved from SSS to new form Formerly the Recruitment Checklist and supplemented with

other HIPAA information and considerations Intended to reduce redundancy: all HIPAA/recruitment

information located on one form Section I – Recruitment Section

Competing Studies section • More guidance coming from Executive Committee

Section II – Same Section III – Authorization section

Previously in SSS Waivers of authorization:

• Recruitment vs. Participation

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HIPAA & Recruitment Checklist

Template language for VA Waivers for Recruitment and Informed Consent available from VA R&D office

When you will receive a signed Checklist back from HSO office: At initial review: if a waiver of authorization is

approved by the IRB With amendments: if ANY changes are made to the

HIPAA & Recruitment Checklist With CR: no.

Authorizations for recruitment: Only one authorization form is necessary Subject should sign prior to recruitment Additional signature at time of consent not necessary

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Child Request Form

New process for requesting waivers of assent Based on capability Waivers not required for children incapable of assent Also see SOP on Vulnerable Populations

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Waiver of Assent for Children

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Informed Consent Statement

New Informed Consent template includes new stamp template Will start to see new stamp on word version of forms

New IU IRB Guidance on Informed Consent Statement Templates are now embedded in the guidance form Found on HSO website:

http://researchadmin.iu.edu/HumanSubjects /hs_forms.html Template includes required language and optional sections as

needed SOP separates what is required on consent and what is not

Example: Compensation for Injury section Study number included on consent is helpful for reviewers

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Authorization Form(s)17

Healthy Subjects Use when medical charts will not be accessed; will

only be collecting research data directly from subject

Non-Healthy Subjects Use when collecting information from some or all of

subject’s health records

VA Specific VA Template

Transnational Research Form

For use when enrolling subjects outside of the US.

Requires information on Local IRB review where the research will be

conducted Local context (social, economic, political, etc.) that

may impact research Communication between PI and local investigators,

community leaders, etc.

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Other Updates 19

Exempt Studies Documentation of Review and Approval now required

with submissionAmendment form

Now required for exempt, expedited, and full Board submissions

Noncompliance, Prompt Reporting, and Misc. General Information form Signed upon approval of the item

Continuing Review form Category 9

Minutes Template

New format for IRB Board minutes Updated to reflect new assent processMinimal risk vs. greater than minimal risk

determination: For ALL full Board new studies For all full Board CRs

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SOP Updates

Overarching changes Added SOP Intro Added new sections to each SOP

VA FDA HIPAA And other including DOD, DOJ and DOE, BOP

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SOPs with Minor Changes

Introduction to SOPs New Section: Mission Statement, Charter, Scope

IRB Operations Continuing Review expiration date

The study expires at 11:59pm on the IRB approved expiration date

EXAMPLE: If the study was approved on July 20, 2010, the investigator can conduct study activities through 11:59pm on July 19, 2011

Approval stamp: continuing review date is now expiration date

Confidentiality and Privacy HIPAA is reorganized to be independent section

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SOPs with Minor Changes

Definitions Changes and Additions made, review for updates.

Exempt and Expedited New Study Process Added IRB staff can grant exemptions Amendment form is required for all exempt changes now

Investigator Responsibilities – New SOP Combined PI, Research Personnel, Investigator Qualifications

SOPs NOW Applies to all investigators (Co and Principle) Updates: CITI, DOD, DOJ

Planned Emergency Research Separated from Research with Investigational Test Articles

SOP No changes to communicate

Emergency Use of Investigational Test Articles VA – can’t do emergency research at the VA, can receive the

intervention as a patient but not as a research subject

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Auditing

Auditing SOP updated to more accurately reflect the current process Now includes language regarding more than one auditor Updated to IU language from IUPUI/Clarian and other new

SOP format changesSOP Covers Three Major Areas Regarding

Auditing How PIs/studies are chosen for audit

Directed and Scheduled Changed to require approval from Shelley for Scheduled

Audit List instead of the Executive Committee Describes the general audit process from notification, to site

visit, to audit report, response to findings, and then IRB Review Changed the requirement that noncompliance noted during an

audit must be reported by the PI Responsibilities related to external audits

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Genetic Information Nondiscrimination Act (GINA)

New SOP Guidance for studies involving testing or tracking of a

particular disease or disorder in an individual’s family Includes what needs to be on consent document and

considerations to be made by Board for approval (what protections need to be in place when using genetic information)

Consent language (applies to VA as well):This research follows the Genetic Information Nondiscrimination Act (GINA), a federal law which generally makes it illegal for health insurance companies, group health plans, and most employers to request the genetic information we get from this research and discriminate against you based on your genetic information

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Genome-Wide Association Study (GWAS)

New SOP Provides guidance on studies that intend to identify

common genetic factors that influence health and disease

New form What it is, when to use it, when to submit

These studies will be identified as GWAS studies – our office fills in before issuing approval

Prospective asking to submit to GWAS or Retrospective we’ve already collected and now we want to submit to study• Specific determinations the IRB must make associated with this

now• On form – text boxes: IRB Certification and Institutional

Certification• Say appropriate use and explicit use of specimens

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Humanitarian Use Devices (HUD )

New, separate SSS for HDE (HDE SSS) FDA guidance included Need to include product information and FDA

letter of approval with submission Two directions

Clinical purposes only Submit HUD Application Clinical Consent only (no separate research consent) Can go Expedited on continuing review, but not initial

review Clinical + investigation

If data is to be collected, study needs “regular” IRB documents (SSS, research consent, etc.)

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Informed Consent

SOP Reorganized Additional VA guidance (not new, additions have been

required) FERPA

Guidance on when you can access student records; IRB review is only concerned when using student records for research

If researcher has legitimate access to student records, consent not needed Academic researchers do have legitimate access If intent is for IU purposes to improve, report, etc. it is

consistent with FERPA School official definition

IRB can make determination regarding whether the researcher has legitimate access

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Informed Consent – Short Form

Document that provides basic elements of informed consent: non study-specific information, includes info that is relevant to all research Languages available at IU : English, Arabic, Chinese,

French, Russian, Spanish, Vietnamese When they can be used:

Study participant or LAR does not speak English Speak only a language not anticipated for study

population Appropriate consent form in their language has not been

approved by the IRB There is not enough time or demand for IRB to approve

a consent in their language

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Informed Consent – Short Form

How they are used Short Form consent document should be translated in

a language understandable and given to subject with study summary document (e.g. English consent document)

Signatures Has to be a witness Subject signs the short form Witness signs short form and copy of study summary English

version (e.g. English consent) Study team member signs English version

IRB Approval Requirements Report use of short form at time of continuing review Board will determine trends and whether a translated

consent form is required

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Transnational Research31

New SOPProvides procedures on conducting research

outside of the US and enrolling populations outside of the US.

Guidance document and Transnational Research form are also available

Vulnerable Populations

If study population includes a vulnerable population, but members of the vulnerable population cannot be explicitly identified, then the Request form does not need to be completed.

Research with Children (review) Request for waiver of assent is not necessary if the

population of children is not capable of assent PI provides justification as to why requested population of

children are not capable of assent Any questions, please contact our office.

Research with Prisoners When using prisoners as a study population, the research

has to meet one of the four categories of prisoner research Expedited review of research involving prisoners is allowed

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COMPLIANCE ADMINISTRATIONCOMPLIANCE ADMINISTRATIONANDAND

RESEARCH ETHICS, EDUCATION, AND POLICYRESEARCH ETHICS, EDUCATION, AND POLICYOFFICE OF RESEARCH ADMINISTRATIONOFFICE OF RESEARCH ADMINISTRATION

Conflict of Interest and IRB: Principles and

Processes33

Table of Contents

Individual Conflict of Interest Principles/Mission Process: Flow Chart

Institutional Conflict of Interest

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Principles /Mission

CoI: Objectivity in Research PHS: CFR 42 Part 50 Subpart F. Responsibility of

Applicants for Promoting Objectivity in Research for which PHS Funding is sought.

FDA: CFR 21 Part 54. Financial Disclosure by Clinical Investigators.

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Principles /Mission

IRB: Protection of Human Research Subjects PHS: CFR 45 Part 46. Protection of Human Subjects

FDA: CFR 21 Part 50. Protection of Human Subjects.

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Point of Intersection:

Protecting human subjects when there is a

conflict of interest

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AAHRPP Standards

Standard I-6. Organization has and follows written policies/procedures to ensure that research is conducted so that financial CoIs are identified, managed and minimized or eliminated I.6.A. … to identify, manage, and minimize or eliminate

financial CoIs of the Organization that could influence the conduct of the research or integrity of HRPP

I.6.B. … to identify, manage, and minimize or eliminate financial CoIs of researchers and research staff that could influence the conduct of the research or integrity of HRPP. Organization works with IRB

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Process: Flow Chart39

Process: Flow Chart

Disclosures Annual Disclosure

All faculty and other researchers Disclosure based on IU policy

Based on PHS/NSF standards Updates as appropriate ORA routing sheet ask for disclosure of any

potential CoI’s All Key Personnel As per specific project

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Process: Flow Chart

IRB CoI Disclosure All Researchers conducting human subjects research

must complete IRB protocol with questions regarding CoI.

Disclosure Based on FDA standards For all Key Personnel Asks for interests related to a specific project

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Process: Flow Chart

CoI Management CoI Committee reviews:

To determine if financial interest constitutes CoI If no, process stops If yes, next step

If management plan is necessary If no, process stops If yes, management plan developed and shared with

IRB

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Process: Flow Chart

IRB reviews management plan Accepts as sufficient to protect human subjects Adds additional restrictions to protect human subjects

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Process: Flow Chart

Common elements of management plan Public disclosure of financial interests Monitoring of research by independent reviewers Modification of research plan Disqualification from participating in all or portion of

research Severance of relationship that create conflict

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Definition: Conflicts of interest based on either the financial interests of the institution itself or of its officials acting in leadership or supervisory positions, are of special concern in the conduct of human subjects research (AAMC).

Specifically relevant to: Intellectual Property (IP) and Institutional

Investments Gifts Financial interests of Senior Administrative Officials

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Intellectual Property (IP) and Institutional Investments All IU IP and investments of IURTC held by and

managed by IURTC IURTC

Committed in principle and practice to respecting and maintaining autonomy of IU’s research integrity and operations, in general, and to its human research protection program and processes, in particular.

Passed resolution committing itself to non-interference with IU’s program and processes for protecting human subjects in research.

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Major Gifts and investments All major gifts to IU and investments of IUF are held

by and managed by the IUF IUF

Committed in principle and practice to respecting and maintaining autonomy of IU’s research integrity and operations, in general, and to its human research protection program and processes, in particular

Passed resolution committing itself to non-interference with IU’s program and processes for protecting human subjects in research.

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Financial interests of Senior Administrative Officials Such officials must comply with:

IU Financial Conflict of Interest Policy Indiana State Law on Conflict of Interest (35-44-1-3)

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Disclosure of I-CoI Investigators identify, to the best of their knowledge,

if a proposed project involves IU IP or IU gifts IURTC and IUF provide relevant information as

requested by IRB and CoI Committee

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Review of I-CoI IRB staff and IRB evaluate and review institutional

significant financial interests related to conduct of human subjects research as they do individual significant financial interests.

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Questions? 51

Biomedical Human Subjects OfficeOffice of Research AdministrationIndiana [email protected]

Behavioral/Social Sciences Human Subjects OfficeOffice of Research AdministrationIndiana University812.856.4242 [email protected]

Research Ethics, Education, & Policy OfficeOffice of Research AdministrationIndiana University812.855.0656 [email protected]

aahrpp re-accreditation changes new and improved forms and sops human subjects forms &...

Documents

new forms

summary of changes

number of subjects

hipaa form section

changes section x payment

improved forms

forms pis

subject population subjects