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INVESTIGATOR'S GUIDE

By Gregory Perez,2014-07-06 14:00
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THE INVESTIGATOR'S GUIDE TO PROTECTING HUMAN SUBJECTS IN RESEARCH WAS CREATED BY THE HUMAN RESEARCH PROTECTION OFFICE. ADDITIONAL RESOURCES, USEFUL LINKS, ...

Investigator’s Guide

Protecting Human Subjects in Research

Human Research Protection Office

    The IRB Review Process at a Glance

     Click CTRL and the

     task for more details

Complete required training

Request access to iRIS software program

Submit application to IRB for Initial Review

Respond to all IRB requests for clarification

    and/or revisions

Conduct study in accordance with GCP

    Implement recruitment methods as approved by the IRB

Obtain and document Informed Consent

    Report unanticipated/adverse events to the IRB, federal agencies, and sponsor

    Notify the IRB of any changes in the study PRIOR to implementation

    Submit study for IRB Continuing Review by the established deadline

Submit study for Final Closure

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Table of Contents

    The IRB Review Process at a Glance.......................................................................................1 Introduction ...............................................................................................................................3 Contact Information ..................................................................................................................3 What is subject to review? .......................................................................................................4 TTUHSC IRBs ............................................................................................................................6 Who can be a Principal Investigator? ......................................................................................8 Training Requirements .............................................................................................................9 Preparing for IRB Review .......................................................................................................11 IRB Review & Approval ..........................................................................................................12 Other Requirements................................................................................................................15

     Good Clinical Practice (GCP) ...........................................................................................15

     International Research ......................................................................................................15

     IRB Fees for Commercially Sponsored Research ...........................................................15

     IRB Relation to Other Committees ...................................................................................15 Amendments and Continuing Review ...................................................................................16 Study Closure & Suspension/Termination ............................................................................18 Recruitment and Advertising .................................................................................................20 Informed Consent A Process ..............................................................................................22 Unanticipated Problems/Adverse Events ..............................................................................25 Vulnerable Populations ..........................................................................................................26 Investigational Drugs/Devices………………………………………………………………………………………………….27 Genetic Research ....................................................................................................................28 Packaging & Shipment of Infectious Materials .....................................................................29 HIPAA ......................................................................................................................................30 Recordkeeping & Confidentiality ...........................................................................................31 Monitoring ...............................................................................................................................33 Glossary ..................................................................................................................................34 Appendix (Useful Tools) .........................................................................................................40 I. PI Responsibilities ..............................................................................................................41 II. Documentation of the Consent Process...........................................................................44 III. Designation of Authorized Personnel ..............................................................................45 IV. Regulatory Files Checklist ...............................................................................................46

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Introduction

    The primary concern of investigators is the protection of the rights and welfare of research participants. The purpose of this manual is to provide guidance to research investigators and personnel on the protection of human research participants in accordance with applicable laws, regulations and Texas Tech University Health Sciences Center (TTUHSC) policies and procedures.

    All research involving human subjects conducted at or in affiliation with TTUHSC must be reviewed and approved by a TTUHSC Institutional Review Board (IRB) prior to beginning the study.

    The Human Research Protection Office (HRPO) provides administrative support to the TTUHSC IRBs, educates on the protection of human research participants, and monitors human research approved by the IRB through routine and for-cause audits.

Contact Information

The Investigator’s Guide to Protecting Human Subjects in Research was created by the

    Human Research Protection Office. Additional resources, useful links, and current announcements are available at our website: www.ttuhsc.edu/research/hrpo

     Ann McGlynn, PhD, Director, Human Research Protection Office

    (806) 743-4753 / fax: (806) 743-4746

    ann.mcglynn@ttuhsc.edu

    IRB ADMINISTRATION LUBBOCK / ODESSA Beth Taraban, MA, IRB Administrator

    (806) 743-4566 / fax: (806) 743-4746

    Beth.Taraban@ttuhsc.edu AMARILLO Katherine Thomas, BSN, RN, CCRP, IRB Administrator

    (806) 354-5419 / fax: (806) 354-5549

    Kathy.Thomas@ttuhsc.edu Angelia Heare, BA, IRB Research Project Coordinator

    (806) 354-5419 / fax: (806) 354-5549

    Angelia.Heare@ttuhsc.edu EL PASO Myrna Arvizo, IRB Coordinator

    (915) 783-6200 / fax: (915) 783-6216

    Myrna.Arvizo@ttuhsc.edu

    QUALITY ASSURANCE / COMPLIANCE

    Victoria Rivera, MPA, Research Compliance Officer

    (806) 743-4754 / fax: (806) 743-4746

    Victoria.Rivera@ttuhsc.edu Chad Copeland, MPA, Research Compliance Analyst

    (806) 743-4752 / fax: (806) 743-4746

    @ttuhsc.edu

    EDUCATION Virginia Smith, BS, Educational Coordinator

    (806) 743-2991 / fax: (806) 743-4746

    Virginia.Smith@ttuhsc.edu

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What is subject to review?

    All research involving human subjects conducted at or in affiliation with TTUHSC must be reviewed and approved by a TTUHSC Institutional Review Board (IRB) prior to beginning the study.

    All research involving human subjects must be reviewed by the IRB if the research is sponsored by the institution, the research is conducted by or under the direction of any employee or agents of this institution (including students) in connection with his or her institutional responsibilities, the research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or the research involves the use of this institution’s non-public information to identify or contact

    human subjects.

What is considered human research?

    This is a two-part question: 1) is this research? and 2) does it involve human subjects?

DEFINITION OF RESEARCH

Research is defined as any systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge[45 CFR 46.102(d)]. Quality

    assurance and public health projects do not meet the definition of research and are not reviewed by the IRB. Classroom projects that have the sole purpose to teach research methods to students are not reviewed by the IRB.

DEFINITION OF HUMAN SUBJECTS

    Under the federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information.

    Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.

    Interaction includes communication or interpersonal contact between investigator and subject.

    Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and which can reasonably expect will not be made public (e.g., medical record information.)

Since the definition of a human subject is a living individual, research involving autopsy materials or

    cadavers is not considered human subjects research and is not reviewed by the IRB. Projects using commercially available, de-identified cell line do not meet the definition of interaction or private information. Therefore, the IRB does not review this type of research.

Consulting on Projects

    TTUHSC IRB review is required unless the investigator has a strict consulting relationship in which:

     The investigator is hired on his/her own time (refer to TTUHSC OP 50.27);

     The investigator holds no rights in the work; and

     Neither the investigator nor TTUHSC obtains, receives, or possesses identifiable private

    information or receive coded data while at TTUHSC.

    All three of these criteria must be met or the IRB must review the project.

Research Conducted at Another Site

    For a TTUHSC investigator to participate in a research project at another site, the project must be reviewed by the TTUHSC IRB as well as by the other entity’s IRB. For example, a TTUHSC investigator

    engaged in research at another academic medical center must secure approval from both entities’ IRBs.

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    TTUHSC will try to accommodate investigators who work at multiple sites by streamlining the IRB approval process. Investigators who must submit a project to another IRB should include copies of the application and the review conducted by the TTUHSC IRB.

Chart Reviews

    A human subject is defined, in part, as a living individual about whom an investigator conducting research obtains identifiable private information. The IRB approves who may have access to this information for research purposes and how access to this information for research purposes is obtained. All medical or other chart/record review for research requires IRB review and approval. The Principal Investigator should provide the IRB a list of specific variables that will be collected from the medical record chart. The data collection form that will be used to compile information from the chart can be used to fulfill this requirement. Medical record data that are already in existence at the time the application is submitted to the IRB and is recorded in such a way that subjects can not be identified directly or through identifiers linked to the subjects may be classified as having exempt status. However, the TTUHSC IRB, not the investigator, will make the determination of exemption from formal IRB review.

Research Conducted in Foreign Countries

    Research conducted by TTUHSC investigators in foreign countries must have prior approval by the

    TTUHSC IRB.

Resident and Student Research Projects

    In accordance with federal regulations, TTUHSC requires that all human research be prospectively reviewed by the IRB. Accordingly, resident research projects, theses, research practica, and Master’s or Doctoral theses involving human subjects must be submitted for IRB review.

Additional TTUHSC Approval

    Approvals by the following committees may be required prior to submission to the IRB. Information about these committees is available on the IRB website (www.ttuhsc.edu/research/hrpo/irb).

     Office of Sponsored Programs (grants)

     Division of Clinical Research (DCR) for commercially sponsored research and

    contract research operations.

     TTUHSC Institutional Biohazards Committee (IBC)

     TTUHSC Radiation Safety Committee (RSC)

     TTUHSC Recombinant DNA Biosafety Committee

     TTUHSC Conflict of Interest Committee (COIC)

     Texas Tech University IRB

WHEN IN DOUBT - ASK YOUR IRB ADMINISTRATOR

    Always contact the IRB administrator when clarification is needed PRIOR to beginning

    any phase of research.

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TTUHSC IRBs

    TTUHSC has three (3) registered Institutional Review Boards (IRBs) which review research conducted by investigators in the following geographic areas:

    TTUHSC IRB 1 00000096 Lubbock, Midland, Odessa

    TTUHSC IRB 2 00000097 Amarillo, Dallas

    TTUHSC IRB 3 00000098 El Paso

    The purpose of the IRB is to ensure the protection of the rights, safety, and well-being of human subjects involved in research. The IRBs review all human research conducted at TTUHSC or affiliated entities. For a list of affiliated entities contact your local IRB office.

GUIDING PRINCIPLES

    The IRBs are guided by ethical principles applicable to all research involving human subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research known as the Belmont Report (http://www.fda.gov/oc/ohrt/IRBS/belmont.html). The

    ethical principles are:

    Respect for Persons Recognition of the personal dignity and autonomy of individuals and

    special protection of those persons with diminished autonomy

    Beneficence Obligation to protect persons from harm by maximizing anticipated

    benefits and minimizing possible risks of harm

    Justice Fairness in the distribution of research benefits and burdens

FEDERAL-WIDE ASSURANCE

    TTUHSC has filed an assurance of compliance called a Federal-Wide Assurance (FWA) with the Office of Human Research Protections (OHRP) in the Department of Health and Human Services (DHHS). An FWA is an agreement between TTUHSC and DHHS which states that TTUHSC is guided by the ethical principles of the Belmont Report and will comply with federal regulations for all research involving human subjects.

    This Assurance applies to research conducted at TTUHSC or by its employees or agents regardless of the research site.

AFFILIATED ENTITIES

    The TTUHSC IRB also reviews research for ―affiliated entities‖. These ―affiliated entities‖ are separate facilities or institutions that have designated the TTUHSC IRB on their Federalwide Assurance with DHHS and have a contractual relationship with the TTUHSC IRB.

    TTUHSC provides IRB review for human subjects research conducted at these entities under a DHHS IRB authorization agreement. Research reviewed for these entities receive the same level of IRB review as those conducted at TTUHSC. A list of Affiliated Entities can be found on the IRB Website. If the entity where you wish to conduct research is not listed, contact the IRB office

    (www.ttuhsc.edu/research/hrpo/irb/) for assistance.

FEDERAL REGULATIONS AND TTUHSC POLICY

    All research involving human subjects, regardless of funding source, conducted at or in affiliation with TTUHSC shall be conducted in accordance with federal regulations, TTUHSC Operating Policy (including HSC OP 73.06, 10.16), TTUHSC IRB Policies and Procedures and VA policies and regulations where applicable.

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Applicable federal regulations include, but are not limited to :

     45 CFR 46, generally known as the Common Rule

     21 CFR 50, Human Subject Protection (Informed Consent)

     21 CFR 56, Institutional Review Boards,

     21 CFR 312, Investigational New Drug Application,

     21 CFR 812, Investigational Device Exemptions,

    References to federal regulations are current through revision date October 1, 2003 (for 45 CFR 46) and April 1, 2003 (for 21 CFR 50, 56, 312, 812). All of these can be found on the IRB website

    . (www.ttuhsc.edu/research/hrpo/irb/)

SCOPE OF THE IRB

    IRB approval is required for any research involving human subjects that meet any of the following criteria.

    If you answer yes to any of the following questions, your research project will need to be reviewed by the TTUHSC IRB.

     Are you an employee or student of TTUHSC?

     Is the research being conducted at TTUHSC or at an affiliated entity?

     Does the research use any property, equipment, and/or facilities of TTUHSC or an affiliated entity?

     Are you using TTUHSC patient, student, or employee data?

    For additional requirements regarding industry-sponsored research refer to TTUHSC OP 73.08 (www.ttuhsc.edu/research/hrpo/files/IRB_P&P.pdf).

AUTHORITY OF THE IRB

     The IRB has the authority to approve, require modifications of, or disapprove all human research

    that falls within its jurisdiction. Research that has been reviewed and approved by the IRB may

    be subject to further review and disapproval by TTUHSC officials. However, as stated in 45 CFR

    46.112, TTUHSC officials may not approve research if it has been disapproved by a TTUHSC

    IRB.

     The IRB monitors and conducts continuing review of approved research at intervals of at least

    once per year.

     The IRB has authority to inspect research facilities and obtain records and other relevant

    information relating to the use of human subjects in research.

     The IRB has authority to observe or have a third party observe the consent process.

     The IRB takes actions to comply with federal regulations or other applicable laws, including action

    to suspend or terminate approval of research.

     The IRB must report to appropriate TTUHSC and federal government officials and any funding

    agency:

    o any suspension or termination of research

    o any unanticipated problems involving risks to subjects

    o any serious or continuing noncompliance with IRB requirements.

IRB CALENDAR

Refer to the IRB website at www.ttuhsc.edu/research/hrpo/irb/ for information on submission deadlines

    and meeting dates.

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Who can be a Principal Investigator?

    The Principal Investigator has ultimate responsibility for conducting and overseeing the research (refer to the Appendix for a description of Principal Investigator responsibilities). Only employees with faculty status may be Principal Investigators in research involving human subjects for TTUHSC-sponsored research projects.

TTUHSC FACULTY

    TTUHSC employees with a faculty appointment (full or part time) may be designated as the Principal Investigator in a human research study. TTUHSC employees who do not have faculty status (including

    staff, residents, students, assistants, fellows or other individuals receiving training at TTUHSC) cannot be designated as Principal Investigator for a research study involving human subjects. These individuals may participate in research as sub-investigators or study personnel.

“AFFILIATED FACULTY”

    Affiliated faculty are faculty members who are not employees of TTUHSC but hold clinical or adjunct appointments. Affiliated faculty may be designated as the Principal Investigator in a human research study reviewed by TTUHSC IRB.

INVESTIGATORS FROM AFFILIATED ENTITIES

    Employees of entities affiliated with TTUHSC (see complete list on IRB website) may be designated as Principal Investigator in a research study if all of the following conditions are met:

     Affiliated entity has a Federalwide Assurance (FWA) approved by DHHS;

     Affiliated entity has designated the TTUHSC IRB on its FWA;

     Affiliated entity has a current IRB Agreement with TTUHSC;

     Investigator submits professional qualifications appropriate for the conduct of the proposed

    research for review and approval by the affiliated entity and by TTUHSC prior to IRB submission

    (See IRB Policies and Procedures).

     Investigator has completed required human research protection training required of TTUHSC

    investigators.

    Collaborators from institutions that are not affiliated with TTUHSC may not be Principal Investigators on TTUHSC IRB applications.

INVESTIGATORS WITH APPOINTMENTS AT MULTIPLE INSTITUTIONS

    Contact your IRB Administrator to determine if your research is eligible for a streamlined review.

NOTICE OF ABSENCE/SEPARATION

    If they are engaging in on-going human research, Principal Investigators are required to notify the IRB in writing at least two (2) months prior to any extended absences, faculty development leaves, or

    separations. (See TTUHSC OP 60.02) Principal Investigators shall submit information and/or an amendment to the IRB designating an alternate investigator responsible for any active research study during their absence. Notice and/or amendments shall be made in accordance with local IRB submission requirements. Principal Investigators who are terminating employment with TTUHSC shall submit information and/or an amendment to the IRB designating an alternate investigator responsible for any active research study or their research will be terminated.

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Training Requirements

HUMAN RESEARCH PROTECTION TRAINING

    Principal Investigators, Co-Investigators, and research personnel are required to receive training regarding the protection of human research subjects prior to beginning any human research-related

    activities. The course currently approved by TTUHSC is the web-based Course in the Protection of

    Human Research Subjects through the Collaborative IRB Training Initiative (CITI).

To begin the on-line course, go the following website: www.citiprogram.org and select ―Register for the

    Course.‖ After selecting Texas Tech University Health Sciences Center as your institution, you will be directed to select a Username and Password. Upon successful completion of the course, you will be able to download a course transcript. TTUHSC is also notified of your successful completion of the course.

    Abbreviated Course

    Personnel who work only with previously existing data or biological specimens for which subjects

    cannot be identified may be eligible to complete an abbreviated version of the course. To request

    approval for the abbreviated course, send a request by email to: Virginia.Smith@ttuhsc.edu with a

    brief explanation of the person’s involvement in human research.

    Exceptions

    In cases where co-investigators or other research personnel are not associated with TTUHSC, other

    forms of human research protection training may be approved. A description of the training and a

    copy of a completion certificate should be submitted to the IRB Office for consideration.

    ADDITIONAL TRAINING REQUIREMENT “HIPAA FOR INVESTIGATORS

    TTUHSC Principal Investigators, Co-Investigators and research personnel must also complete institutional training related to HIPAA compliance in research. Please contact the Privacy Officer on your campus for information regarding completion of this training.

     Lubbock Regional Privacy Officer 806-743-4365

     Amarillo Regional Privacy Officer 806-354-5474

     El Paso Regional Privacy Officer 915-545-6540

     Odessa Regional Privacy Officer 432-335-1845

    Non-TTUHSC personnel should contact your local IRB Administrator.

    RENEWAL OF TRAINING FOR THE PROTECTION OF HUMAN RESEARCH SUBJECTS

    Every 3 years all investigators and research staff are required to renew their training for the protection of human research subjects. The currently approved course is the Basic Course in the Protection of

    Human Research Subjects administered by the University of Miami through the Collaborative IRB

    Training Initiative (CITI) as described above (www.citiprogram.org). Initial and Continuing Reviews cannot be approved if training requirements are not up-to-date.

CONTACT INFORMATION

    For training-related questions, contact Virginia Smith, Educational Coordinator, at (806) 743-2991 or by email at Virginia.Smith@ttuhsc.edu.

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