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Presentation on theme: "LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER NEW ORLEANS."— Presentation transcript:


2 Office of Research Services Ph. 504-568-4970 Suite 206, Resource Bldg.  Kenneth Kratz, PhD –Director  Staff: u Nicole Hammill – Pre-award (Grants and Contracts) u Rose Castay – IACUC/IBC u Charlene Walvoord – IRB u Sylvia Young – IRB u Dyan Melson - IRB  Office Responsibilities: u Pre-award Sponsored Research - Proposal and Contract Review, Negotiation, and Routing u Institutional Animal Care and Use Committee (IACUC) u Institutional Review Board (IRB) u Institutional Biosafety Committee (IBC)

3 Office of Research Services Staff Nicole Hammill Ro s e Castay Dyan Melson Lynn ArnoldCharlene Walvoord

4 LSUHSC-NO IRB STAFF Chair - Dr. Kenneth Kratz Coordinators - Ms. Charlene Walvoord Ms. Lynn Arnold Ms. Dyan Melson


6 Human Subjects Protection Program (HSPP)

7 Institutional Review Board (IRB) Purpose To protect the welfare of humans participating in research studies

8 National Research Act (1974) National Commission for the Protections of Human Subjects of Biomedical and Behavioral Research “ Ethical Principles and Guidelines for the Protection of Human Subjects of Biomedical and Behavioral Research ” (The Belmont Report - Federal Register 1979) Code of Federal Regulations - 1981 Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) - Title 45, Part 46 Food and Drug Administration (FDA) - Title 21, Chapter 1, Parts 50, 56, 312, 600, 812

9 The Belmont Report Office of the Secretary Dept. of Health and Human Services Ethical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research April 18, 1979

10 Basic Ethical Principles 1. Respect for Persons - Respect for persons incorporates at least two ethical convictions: First, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. 2. Beneficence - Persons are treated in an ethical manner not only respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being: (1) do not harm and (2) maximize possible benefits and minimize possible harms. 3. Justice - Who ought to receive the benefits of research and bear its burdens? This is a question of justice in the sense of “ fairness in distribution ” and “ fairness in who will contribute ”.

11 Applications 1. Respect for persons captured in “ Informed Consent ” Information Comprehension Voluntariness 2. Beneficence captured in “ Assessment of Risks and Benefits ” The Nature and Scope of Risks and Benefits The Systematic Assessment of Risks and Benefits 3. Justice captured in “ Selection of Subjects ”

12 Human Subjects Research LSUHSC-NO Training Requirements (CITI)



15 Institutional Biosafety Committee (IBC)



18 HIPAA Health Information Portability and Accountability Act (Privacy and Security Rules)





23 Institutional Review Board (IRB)

24 Human Subjects Research “ Human subjects ” means a living individual about whom an investigator (whether professional or student) conducting research obtains: 1.) Data through intervention or interaction with the individual or 2.) Identifiable private information The term “ research ” designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships

25 Committee of 11 members: ♦ Medical personnel of various disciplines ♦ Scientists of various disciplines ♦ Non-scientist ♦ Unaffiliated member from community LSUHSC-NO IRB

26 Initial Board Actions on New Studies Exempt Expedited Full Board Review Potential recommendations from the Board are: Approval: No further changes needed. Modifications Required to Secure Approval: Moderate revisions are necessary. Withheld: Extensive revisions needed. Modifications must be re-submitted for Full Board Review. Disapproval: The scientific or ethical problems posed by the study are of grave concern to the Board. A new proposal must be submitted to the Board.

27 Responsibilities of the IRB:  Review new applications and consent forms for approval  Conduct continuing reviews (projects approved no more than one year)  Review adverse event reports  Review amendments to protocols and consent forms Responsibilities of Investigator to IRB:  Respond to IRB requests in a timely fashion  Submit adverse event reports  Submit continuing re-approval documents  Submit all amendments to protocols  Submit all proposed advertising  Copy all communications to FDA or OHRP




31 1) Exempt Status

32 2) Expedited Review

33 3) Full Board Review

34 4) Demographics

35 5) Conflict of Interest

36 6) Waivers

37 7) Consent Form

38 Common mistakes made by P.I.s on IRB applications: Difference between QA and Research. Who can be a PI (Faculty/individuals in training)? Minimal Risk Studies  1. Confusion between “retrospective” and “prospective” studies.  2. Issue of “practicability” in waiver applications.  3. Difference between “de-identified” and “anonymous”. Greater than Minimal Risk Studies  1. Underestimating the risk in drug studies.  2. “n” - Must have a statistical section with justification of “n”.  3. Protocol writing.  4. Data Monitoring Board.  5. Informed consent document problems.

39 Association for the Accreditation of Human Research Protection Programs (AAHRPP)

40 AAHRPP Accreditation Domains I. Organization (2 Standards with 24 Elements) II. IRB (5 Standards with 25 Elements) III. Researcher and Research Staff (8 Standards with 11 Elements)

41 I I I I > December 2009April 2010 June 2010 March 2012 Pre-paid FeeAAHRPP Commence Submit Step 1 App. Annual Meeting Self-Study > I II July 2012September 2012 December 2012 Submit Step 2 App Site Visit Full Accreditation Proposed Time-line for LSUHSC-NO Human Research Protection Program AAHRPP Accreditation Process


43 HRPP Institutional Review Board Policy and Procedure Guidebook Updates

44 Safety Reporting and Compliance Section 4.6 (Continuing Review) Post Approval Monitoring Section 4.7 Unanticipated Problems Involving Risk to Subjects and Others (previously referred to as adverse event reporting)

45 Post Approval Monitoring Purpose  Extension of the LSUHSC-NO HRPP formal procedures to monitor compliance and UPs in research studies  Exercise to assist the IRB in the review of internal QA practices of Investigators  Exercise to assist investigators in reviewing and improving practices regarding their studies

46 Post Approval Monitoring

47 Implementation  Effective March 2012  Studies are randomly selected each yearly quarter for participation  Comprehensive study self-assessment  7 working days

48 Post Approval Monitoring Evaluation Results  Final evaluation results are disseminated to the Principal Investigator by the Chair  Possible Review Outcomes No deficiencies Deficiencies – Corrective Action Plan Deficiencies – Directed or Non-Directed Audit

49 Post Approval Monitoring On-Site Audits  Collaborative effort with the Office of Compliance Program Privacy Officer  Directed and non-directed audits  All study material must be made available for review

50 Unanticipated Problems Rationale for the Change  Alignment with current regulatory guidance  Reduce the burden of reviewing external reports that do not aid in the protection of human subjects

51 Unanticipated Problems

52 Implementation  Effective April 12, 2011  Significant changes to the reporting of individual external events  Minimal changes to the reporting of individual internal events (local SAEs)

53 Unanticipated Problems Unanticipated problems in general, include any incident, experience, or outcome that meets all of the following criteria: Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied; Related or possibly related to participation in the research; and Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

54 Unanticipated Problems UPs = adverse events or other incidents Small subset of adverse events  Serious, Unexpected, and Possibly/Definitely Related  Serious, Expected, and Possibly/Definitely Related Other Local Incidents  Problems that place subjects or others at increased risk of harm

55 Unanticipated Problems What must be Reported to the IRB? Non Local Occurrences (External)  Summary safety information or analyses of adverse events provided by the sponsor that describe significant changes in a product's safety profile.  Reports of aggregate data (e.g., analyses and line listings of adverse events) identifying serious unexpected adverse events.  Reports from a data monitoring committee (DMC), whether these describe concerns or identify no problem.

56 Unanticipated Problems What must be Reported to the IRB? Non Local Occurrences (External)  Individual Reports – Sponsor Determination  Individual Reports – The opinion of the Local PI  All other individual reports related to subjects enrolled by non- LSUHSC-NO investigators in a multi-center trial where a non- LSUHSC-NO investigator is the PI of the overall trial that do not meet these criteria will not be accepted by the LSUHSC-NO IRB

57 Unanticipated Problems How to Report UPs to the IRB? Unanticipated Problems/Local SAE Reporting Form 5 working days; Fatal or life threatening submit report within 48 hrs Reviewed by the Chair (or designee) to determine if immediate action is necessary Full Board Review Consideration

58 Unanticipated Problems Studies Involving Devices Unanticipated Adverse Device Effects (UADE) Same IRB reporting criteria as UPs Sponsors must immediately conduct an evaluation of the UADE, report the evaluation to the FDA, all reviewing IRBs, and participating investigators within 10 working days after first notice

59 Questions?

60 National Library of Medicine Clinical Trials Gov

61 National Library of Medicine

62 The NLM is part of the National Institutes of Health It is the world’s largest medical library. NLM has many databases including TOXNET, Medline, and PubMed. It also provides disaster assistance to 1 st responders through the WISER system

63 One of the most important offerings provided by the NLM is a clinical trials database. This database is updated daily and contains 1000s of studies of diseases and disorders. The FDA requires registration to clinical trials gov for all studies involving FDA regulated products.

64 The FDA also requires that informed consent documents include a specific statement that refers to the trial’s description on 21CFR§50.25(c )


66 Clinical Trials Gov is a virtual library of information right on your keyboard.

67 Clinical Trials Gov offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions. A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

68 Clinical Trial Records Each record provided in lists the following: Disease or condition and experimental treatments studied Title, description, and design of study Requirements for participation Locations where the study is available Contact information Links to relevant information at other health Web sites, such MedlinePlus and PubMed MeSH headings used for this record

69 Clinical Trials Gov Registration Mandated by the FDA Registration for applicable clinical trials must be in compliance with 21 CFR 50.25(c ) and a specific statement that refers to the trials description on www.

70 Protocol Registration System Trial data may be submitted by the following entities: Sponsors legally responsible for conducting clinical trials, e.g., holders of investigational new drug applications from the U.S. Food and Drug Administration. Governmental or international agencies conducting or supporting clinical trials, e.g., the U.S. National Institutes of Health. Lead principal investigators who are responsible for conducting and coordinating the overall clinical investigation across multiple study sites. Trial data should not be submitted from each individual study location. If you meet the above criteria we invite you to submit data with the Protocol Registration System (PRS). The PRS account registration form and additional information, including a Guided Tour, is available at the PRS Information site at Information site A Protocol Registration System (PRS) account is required for submitting study information to Data submitters must coordinate with all of their partners so that trial information is submitted only once, by one of the entities listed below, to

71 Informed Consent Language The FDA requires word for word reproduction of the following statement. This is to avoid the need for individual analysis and determination of what is appropriate to include. IRBs may require an additional sentence that provides the National Clinical Trials number.

72 Informed Consent Language “A description of this clinical trial will be available on as required by U.S. law. This web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

73 Applicable The trial is ‘an applicable clinical drug trial’ if the trial is a controlled clinical investigation, other than a Phase I clinical investigation of a drug subject to FDA regulations. 42 USC §282(j)(1)(A)(iii)(I). For the purpose of this definition, a clinical investigation is any experiment in which a drug is administered or dispensed to or used involving one or more human subjects. 21 CFR §312.3

74 For drugs, Phase I clinical investigations are not categorized as applicable clinical trials. Uncontrolled clinical investigations of drugs are not considered applicable. 42 USC §282(j)(1)(A)(iii).

75 Controlled Before a new drug or biologic can be marketed, is sponsor must show through adequate and well controlled clinical studies that it is effective. A well-controlled study permits a comparison of subjects treated with a new agent with a suitable control population, so that the effect of the new agent can be determined and distinguished from other influences, such as spontaneous change, “placebo” effects, concomitant therapy or observer expectations. FDA Regulations cite ??? kinds of controls

76 5 Types of Controls Placebo Concurrent Control Dose-Comparison Concurrent Control No-Treatment Concurrent Control Active Treatment Concurrent Control Historical Control 21 CFR §314.126

77 The definitions are similar for devices.

78 Clinical Trials Gov records

79 Oncology Study Long-Term Bone Quality in Women With Breast Cancer Enrolled on Clinical Trial SWOG-S0307 The recruitment status of this study is unknown because the information has not been verified recently. Verified January 2010 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting First Received on April 1, 2009. Last Updated on January 29, 2010 History of ChangesHistory of Changes Sponsor: Southwest Oncology Group Collaborator: National Cancer Institute (NCI) Information provided by: National Cancer Institute (NCI) Identifier: NCT00873808 National Cancer Institute (NCI)

80 Clinical Alert The database has a special section on Clinical Alerts and suspended studies.

81 Searchability Anyone can search the database by: Disease process Sponsor Drug NCT number For example searching Juvenile Diabetes will yield over 1000 citations. The results can then be sorted by status to let interested people know what studies are still accepting new volunteers.

82 Information about clinical trials should be shared so that injured and ill patients can participate. Clinical Trials Gov provides potential subjects and families the opportunity to review what trials are open without having to travel to distant health care centers. As part of NIH, the library mission is to provide the up-to- date healthcare information to the citizens of the US and throughout the globe.

83 MeSH

84 MeSH Medical Subject Headings A thesaurus of controlled vocabulary terms It consists of sets of terms naming descriptors in a hierarchical structure that permits searching at various levels of specificity.

85 Because the Clinical Trials Gov database uses MeSH subject headings it presents the widest search strategy. The NLM databases use a consistent set of search terms. The MeSH headings used on each record can be used to search for other information on PubMed.

86 Medline Medical Literature Analysis and Retrieval System

87 Medline MEDLINE is the U.S. National Library of Medicine's® (NLM) premier bibliographic database that contains over 19 million references to journal articles in life sciences with a concentration on biomedicine. A distinctive feature of MEDLINE is that the records are indexed with NLM Medical Subject Headings (MeSH®).Medical Subject Headings

88 Medline More than 5,500 biomedical journals are indexed in MEDLINE. New journals are not included automatically or immediately. Selection is based on the recommendations of a panel, the Literature Selection Technical Review Committee, based on scientific scope and quality of a journal. [ The Journals Database (one of the Entrez databases) contains information, such as its name abbreviation and publisher, about all journals included in Entrez, including PubMed.

89 Information from journal articles is assigned 5 to 15 MeSH headings

90 Medline Data Base Search Engine The Medline database is freely accessible on the Internet via the PubMed interface and new citations are added Tuesday through Saturday.

91 PUBMED PubMed comprises more than 21 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full- text content from PubMed Central and publisher web sites.

92 OMG. You can search all of the NLM and without ever leaving your desk.


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