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UC DAVIS OFFICE OF RESEARCH. IRB Submission . Miles McFann IRB Administration Outreach, Training, and Education . Smallpox Vaccination . Objectives. Explain the history of Institutional Review Boards (IRBs) Define Research and Minimal Risk - PowerPoint PPT Presentation

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UC DAVIS OFFICE OF RESEARCH

IRB Submission Miles McFannIRB AdministrationOutreach, Training, and Education 1 Smallpox Vaccination

How many here received a small pox vaccination?

In 1796, Edward Jenner, tested a theory about people who caught cowpox (weaker variation of smallpox) were immune to smallpox. So he injected his gardeners 8 year old son with cowpox. After the child recovered from cowpox, he then inject the same child with smallpox. The child did not contract small pox.

I know this is 200 years ago, but what is wrong with this picture?

ObjectivesExplain the history of Institutional Review Boards (IRBs)Define Research and Minimal RiskDescribe the IRB review categories and regulatory criteria for approvalDiscuss the IRB application processDiscuss tips for success

3History of Human Research ProtectionCreated the first principles of: Informed ConsentProper formulated scientific experimentationBeneficence towards participants

Nuremberg Code (1947)

Several of the accused had argued that their experiments differed little from pre-war ones and that there was no law that differentiated between legal and illegal experimentsHistory of Human Research Protection (cont.)Created by the World Medical AssociationFurther focus on clinical researchConsidered the cornerstone document of human research ethics

Declaration of Helsinki (1964)

It is not a legally binding instrument in international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations (Human and Fluss 2001)History of Human Research Protection (cont.)Established three fundamental ethical principles:Respect for PersonsBeneficenceJustice

Belmont Report (1978)

Respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent. Researchers must be truthful and conduct no deception;Beneficence: The philosophy of "Do no harm" while maximizing benefits for the research project and minimizing risks to the research subjects; andJustice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly the fair distribution of costs and benefits topotentialresearch participants and equally.

Institutional Review Board (IRB)UC Davis IRB AdministrationFederalwide Assurance #00004557Approve/modify/disapprove research protocols involving human subjectsProtect rights and welfare of human subjects Multi-campus collaborative review and agreementsEducation and trainingAdministration and record-keeping

UC COLLABORATIVE RESEARCHA Streamlined Approach

Multi-UC Campus Research at University of California Campuses and UC-Managed LaboratoriesResearch to be reviewed by a single UC IRB instead of multiple UC IRBsFor UCLA, UCSF, UCSD, UCB, UCI, UCSB, UCSC, UCD, LLNL, LBNL--research eligible for expedited or exempt review onlyFor UCB, UC Davis, UCSF and LBNL- research eligible for full committee review as well as expedited and exempt reviewFor UC Davis and LLNLresearch for full committee, expedited or exempt review.

Committee A Clinical (12 interdisciplinary members)Committee B Clinical (20 interdisciplinary members)Committee C Social/Behavioral (6 interdisciplinary members)Committee D Fast Track/Emergency (5 interdisciplinary members)

The Common Rule45 CFR 46 (Public Welfare)

Basic Policy for Protection of Human Research Subjects

Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

Protections for Children Involved as Subjects Research

FDA, 21 CFR Parts 50 and 56, and California Health and Safety Code section 24170

Additional requirements for specific research:DHHSDODEDFDADOEEPAICH-GCPDOJVA

FDA Definition:Clinical Investigation: An experiment involving a test article and control when the results must meet requirements for prior submission to the FDA or are intended to be later submitted to or held for inspection by the FDA

9OHRP Definition:Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. ResearchDid you know there are two different definitions for research the IRB utilizes to make a human subject research determination

The first one is the FDA definition:As most of you noticed this one mainly pertains to drugs and devices

The second one is the one we apply mostly, the OHRP definition

9What is a Human Subject?A living individual about whom an investigator (professional or student) conducting research obtains:data through intervention or interaction with the individual, oridentifiable private information.45 CFR 46.102(f)

1.If UC Davis is the grant recipient;

2. If for purposes of human subject research:(a) Data about subjects through intervention or interaction;(b) Identifiable private information (c) Informed consent from a research subject

11UCD is engaged in human subject research when:

even if all research activities are done at other organizations;

UC Davis employees/agents obtain11Definition of Minimal Risk (45 CFR 46.102(i))Risk encountered in your daily life

Minimal riskmeans that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Types of IRB ReviewDeterminations not requiring IRB review

Exempt

Expedited Review

Full Board Review

Exempt ReviewMust be minimal risk research

Fits one of six categories

Review is typically conducted by a designated IRB member

Exempt Review CategoriesResearch conducted in established or commonly accepted educational settings, involving normal educational practices.

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior.

Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section. (Public Official)

Research involving the collection or study of existing data that subjects cannot be identified, directly or through identifiers linked to the subjects.

Research and demonstration projects which are conducted by or subject to the approval of Dept. or Agency heads.

Taste and food quality evaluation and consumer acceptance studies.

Examples1.) School setting testing new curriculum that are defined as research (minors ok)

2.) information obtained is recorded in such a manner that Human Subjects can be identified, directly or through identifiers linked to the subjects; and any disclosure of the Human Subjects responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, or reputation.

3.) surveys and the subject is identifiable, public officials, and you keep the information confidential

4. (For research conducted, funded, or otherwise subject to regulation by any federal agency existing means existing at the time the research is proposed. Otherwise, it means existing at the time the research is proposed or will exist in the future for non-research purposes.) Also, because of California HIPAA laws chart reviews cannot fall under this.

5.0 and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs

Example: ED wants to implement new service program within high schools for under privilege teens, they want to conduct surveys and group meetings.

6.) (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the Dept. of Agriculture.

Expedited ReviewMust be minimal risk

Rigor same as full committee review, but only one IRB member reviews the project

Fits one or more of the nine categories

Expedited Review CategoriesClinical studies where an IND or IDE is not requiredBlood CollectionProspective collection of biological specimens for research purposes by noninvasive meansCollection of data through noninvasive procedures routinely employed in clinical practiceResearch involving materials that have been collected for any purposeCollection of data via audio/visual recordings made for research purposesResearch employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies Continuing review of a study previously reviewed by a convened IRB and meets three categories.Continuing review of research, where categories (2) through (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than Minimal Risk.

1. or the medical device is cleared/approved for

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