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Human Subjects Forms & Procedures Update

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Presentation on theme: "Human Subjects Forms & Procedures Update"— Presentation transcript:

1 Human Subjects Forms & Procedures Update
AAHRPP Re-accreditation changes New and improved forms and sops

2 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 HSO

3 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 HSO

4 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: Shelley

5 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: Human Subjects Forms: /hs_forms.html HSO

6 Dates to Know January 15th March 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

7 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

8 Summary Safeguard Statement
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

9 Summary Safeguard Statement
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 amy

10 Summary Safeguard Statement
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 amy

11 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) amy

12 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

13 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 amy

14 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

15 Waiver of Assent for Children
Capable of Assent Requires Assent of Child or Waiver of Assent* Waiver Justification: 1. Minimal Risk or 2. Holds Prospect of Direct Benefit *Requires IRB approval of Waiver request Not Capable of Assent** Does not require Waiver or Assent from Child PI needs to justify why Children are not capable of Assent - Ex: Age, Limited Capacity, etc. **Requires IRB concurrence with the justification

16 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: /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

17 Authorization Form(s)
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

18 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.

19 Other Updates Exempt Studies Amendment form
Documentation of Review and Approval now required with submission Amendment 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

20 Minutes Template New format for IRB Board minutes
Updated to reflect new assent process Minimal risk vs. greater than minimal risk determination: For ALL full Board new studies For all full Board CRs Human Subjects Office

21 SOP Updates Overarching changes Added SOP Intro
Added new sections to each SOP VA FDA HIPAA And other including DOD, DOJ and DOE, BOP Human Subjects Office

22 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 Human Subjects Office

23 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 Human Subjects Office

24 Auditing SOP Covers Three Major Areas Regarding Auditing
24 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 changes SOP 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 Human Subjects Office

25 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 Human Subjects Office

26 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 Human Subjects Office

27 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.) Human Subjects Office

28 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 HSO

29 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 Human Subjects Office

30 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 Human Subjects Office

31 Transnational Research
New SOP Provides procedures on conducting research outside of the US and enrolling populations outside of the US. Guidance document and Transnational Research form are also available

32 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 Human Subjects Office

33 Conflict of Interest and IRB: Principles and Processes
Compliance Administration and Research Ethics, Education, and Policy Office of Research Administration John B.

34 Table of Contents Individual Conflict of Interest
Principles/Mission Process: Flow Chart Institutional Conflict of Interest John B.

35 CoI: Objectivity in Research
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. John B.

36 IRB: Protection of Human Research Subjects
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. John B.

37 Point of Intersection:
Protecting human subjects when there is a conflict of interest John B.

38 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 John B.

39 Process: Flow Chart John B.

40 Process: Flow Chart Disclosures All faculty and other researchers
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 John B.

41 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 John B.

42 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 yes, management plan developed and shared with IRB John B.

43 Process: Flow Chart IRB reviews management plan
Accepts as sufficient to protect human subjects Adds additional restrictions to protect human subjects John B.

44 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

45 Institutional Conflict of Interest
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 John B.

46 Institutional Conflict of Interest
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. John B.

47 Institutional Conflict of Interest
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. John B.

48 Institutional Conflict of Interest
Financial interests of Senior Administrative Officials Such officials must comply with: IU Financial Conflict of Interest Policy Indiana State Law on Conflict of Interest ( ) John B.

49 Institutional Conflict of Interest
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 John B.

50 Institutional Conflict of Interest
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. John B.

51 Questions? Biomedical Human Subjects Office
Office of Research Administration Indiana University Behavioral/Social Sciences Human Subjects Office Research Ethics, Education, & Policy Office


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