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Presentation on theme: "UC DAVIS OFFICE OF RESEARCH"— Presentation transcript:

IRB Submission Miles McFann IRB Administration Outreach, Training, and Education

2 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 gardener’s 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?

3 Objectives Explain the history of Institutional Review Boards (IRBs) Define “Research” and “Minimal Risk” Describe the IRB review categories and regulatory criteria for approval Discuss the IRB application process Discuss tips for success

4 History of Human Research Protection
Nuremberg Code (1947) Created the first principles of: Informed Consent Proper formulated scientific experimentation Beneficence towards participants 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 experiments

5 History of Human Research Protection (cont.)
Declaration of Helsinki (1964) Created by the World Medical Association Further focus on clinical research Considered the cornerstone document of human research ethics 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)

6 History of Human Research Protection (cont.)
Belmont Report (1978) Established three fundamental ethical principles: Respect for Persons Beneficence Justice 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; and Justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly — the fair distribution of costs and benefits to potential research participants — and equally.

7 Institutional Review Board (IRB)
UC Davis IRB Administration Federalwide Assurance # Approve/modify/disapprove research protocols involving human subjects Protect rights and welfare of human subjects Multi-campus collaborative review and agreements Education and training Administration and record-keeping UC COLLABORATIVE RESEARCH—A Streamlined Approach Multi-UC Campus Research at University of California Campuses and UC-Managed Laboratories Research to be reviewed by a single UC IRB instead of multiple UC IRBs For UCLA, UCSF, UCSD, UCB, UCI, UCSB, UCSC, UCD, LLNL, LBNL--research eligible for expedited or exempt review only For UCB, UC Davis, UCSF and LBNL- research eligible for full committee review as well as expedited and exempt review For UC Davis and LLNL—research 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)

8 The Common Rule 45 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: DHHS DOD ED FDA DOE EPA ICH-GCP DOJ VA

9 Research 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 OHRP Definition: Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Did 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

10 data through intervention or interaction with the individual, or
What 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, or identifiable private information. 45 CFR (f)

11 UCD is “engaged” in human subject research when:
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 – even if all research activities are done at other organizations; UC Davis employees/agents obtain

12 Definition of Minimal Risk (45 CFR 46.102(i))
Risk encountered in your daily life…… Minimal risk means 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.

13 Types of IRB Review Determinations not requiring IRB review Exempt Expedited Review Full Board Review

14 Exempt Review Must be minimal risk research Fits one of six categories
Review is typically conducted by a designated IRB member

15 Exempt Review Categories
Research 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. Examples 1.) 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.

16 Expedited Review Must 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

17 Expedited Review Categories
Clinical studies where an IND or IDE is not required Blood Collection Prospective collection of biological specimens for research purposes by noninvasive means Collection of data through noninvasive procedures routinely employed in clinical practice Research involving materials that have been collected for any purpose Collection of data via audio/visual recordings made for research purposes Research 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 marketing and the medical device is being used in accordance with its cleared/approved labeling. 2.a. Withdrawal of blood from an indwelling venous line is a “venipuncture.” Multiple withdrawals of blood from an indwelling venous line are more than one collection. Therefore, a research study involving withdrawal of more than two blood samples from an indwelling venous line in a week is not eligible for review using the expedited procedure. 2.b. Withdrawal of blood from an indwelling venous line is a “venipuncture.” 3. Non-invasive procedures include, but are not limited to: (1) vaginal swabs that do not go beyond the cervical os; (2) rectal swabs that do not go beyond the rectum; and (3) nasal swabs that do not go beyond the nares. Examples: (a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum-base or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization. 4. Non-invasive procedures include, but are not limited to: (1) vaginal swabs that do not go beyond the cervical os; (2) rectal swabs that do not go beyond the rectum; and (3) nasal swabs that do not go beyond the nares. Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. 7. Examples: Research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (a) Continuing review of research previously approved by the convened IRB where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects. (For a multi-center protocol, an expedited review procedure may be used by the IRB at a particular site whenever these conditions are satisfied for that site.) (b) Continuing review of research previously approved by the convened IRB where no subjects have ever been enrolled at a particular site and neither the investigator nor the IRB at a particular site has identified any additional risks from any site or other relevant source (c) Continuing review of research previously approved by the convened IRB where the remaining research activities are limited to data analysis. (For a multi-center protocol, an expedited review procedure may be used by the IRB at a particular site whenever these conditions are satisfied for that site.) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption 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 and no additional risks have been identified.

18 Full Committee Review Any study which does not meet the Exemption or Expedited Criteria A full quorum is assembled Decision is rendered by a majority of the assembled quorum No member with a conflict of interest can participate in the decision All members participate in the discussion and comments The most rigorous level of review Reviewed by two to three members and presented

19 How does the IRB figure this all out?
Answer: Worksheets HRP-310 Human Research Determination HRP-311 Engagement Determination HRP-312 Exemption Determination HRP-313 Eligibility for Review Using the Expedited Procedure Found on the OOR website at Copies in the back of their handouts

20 Criteria for Approval of Research
Risks to subjects are minimized by using procedures, which are consistent with sound research design and which do not unnecessarily expose subjects to risk. Risks to subjects are minimized by using procedures already being performed on the subjects for other purposes. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. Selection of subjects is equitable. The research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. HRP-314, provided copy at the back of

21 Criteria for Approval of Research (cont.)
There are adequate provisions to protect the privacy of subjects. There are adequate provisions to maintain the confidentiality of data. Additional safeguards have been included in the study to protect the rights and welfare of subjects vulnerable to coercion or undue influence. (“N/A” if no vulnerable subjects) The informed consent process is adequate. The documentation of informed consent is adequate.

22 How Do Researchers Meet These Regulations?

23 IRB Documents (Available on the IRB Website)
Human Research Protection Program Plan (HRP-101) Investigator Manual(HRP-103) Application Forms Initial (HRP-211) Continuing Review Progress Report (HRP-212) Modification (HRP-213) Reportable New Information Form (HRP-214) Template Protocol (HRP-503) Template Consent Document (HRP-502) SOPs on consent process and documentation (HRP-90, HRP-91) Designed w/input from investigators Clearly indicates what is needed Focuses on what the IRB must review to make a determination Consent and Protocol are templates Guides to utilize Skip it not applicable, or write NA Consent form remove the section

24 Basic Elements of Informed Consent (45 CFR 46.116(a))
The 8 Necessities Research Description Risks Benefits Alternatives Confidentiality Compensation Contacts Voluntary participation and withdrawal Provide copy of HRP-502 1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;  (2) A description of any reasonably foreseeable risks or discomforts to the subject;  (3) A description of any benefits to the subject or to others which may reasonably be expected from the research;  (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;  (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;  (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;  (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and  (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:  (1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;  (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;  (3) Any additional costs to the subject that may result from participation in the research;  (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;  (5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and  (6) The approximate number of subjects involved in the study.

25 California Health and Safety Code Section 24170
Impact on Informed Consent States that subjects in a “medical experiment” must sign a consent form California’s definition of “medical experiment”; The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, as defined in Section or , electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject. The investigational use of a drug or device as provided in Sections and Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject You cannot request a waiver of documented consent with this

26 Alteration or Waiver of Informed Consent (45 CFR 46.116 (d))
What criteria need to be met? The research involves no more than minimal risk to the subjects; The waiver or alteration will not adversely affect the rights and welfare of the subjects; The research could not practicably be carried out without the waiver or alteration; and Whenever appropriate, the subjects will be provided with additional pertinent information after participation. (e) The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective. FDA regulated studies cannot allowed to be altered or waiver Research studies involving non-viable neonates Most Common Examples of waiver or alteration: Waiver of documented consent Waiver of Informed consent for retrospective chart review If deceit is being used (mostly social/behavorial studies when providing informed consent)

27 Consent Form Common Mistakes
Information in the Consent Form is not consistent with the Protocol Utilization of medical jargon Not fully identifying risks Consent Form is not a HIPAA Authorization form No release of medical information unless the HIPAA Authorization form is signed separately.

28 My protocol is ready, what do I do now?

29 Application for Initial Review (HRP-211)
Submit the Protocol IRB Submission Forms Application for Initial Review (HRP-211) Administrative Approvals (HRP-226) The following forms, if applicable: Sponsor Fee Form Qualifying Clinical Trials Form Go over the forms with the class


31 Yeah, it’s approved! Anything else?

32 Investigator Responsibilities after Approval
Protect human subjects. Ensure all personnel comply with protocol requirements and determinations of IRB. Avoid undue influence in enrolling subjects. Ensure that informed consent is adequate and understandable to subjects. Report new information as stated within HRP-214, Reportable New Information Form. Submit changes in research to IRB for approval prior to implementation.


34 Submitting to the IRB Forms eDocs Guidance IRB Certification (CITI) Guidance IRB Certification (CITI) es/roe Standard Operating Procedures

35 Subscribe to our Listserv
Additional Resources Contact the IRB Staff Subscribe to our Listserv Advisories

36 Regulatory Agencies UC Davis IRB Belmont Report References
UC Davis IRB Belmont Report www.


38 Download applications and forms from our website to ensure you have the latest version.
Gather all signatures prior to submission. Place version dates on your documents at initial submission and only change them when updating the document. Utilize and follow the Protocol and Consent Form Template instructions when creating your application and forms.

39 Attach all relevant documentation
Attach all relevant documentation. If it is listed on HRP-211 and applicable to your research, submit it. Have your research staff complete their human subject research certification (CITI and GCP training) prior to submission. Respond to the IRB in a timely manner. Follow all UCDHS regulations. When in doubt, contact us!

40 Input? Suggestions? Feedback? Miles McFann


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