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SUBMITTING HUMAN SUBJECTS RESEARCH

SUBMITTING HUMAN SUBJECTS RESEARCH. AT UC SANTA CRUZ. 1. DETERMINE WHETHER YOU ARE ENGAGED IN HUMAN SUBJECTS RESEARCH. Are you conducting RESEARCH?. • Research means a systematic investigation, including research development, testing, and

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SUBMITTING HUMAN SUBJECTS RESEARCH

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  1. SUBMITTING HUMAN SUBJECTS RESEARCH AT UC SANTA CRUZ

  2. 1. DETERMINE WHETHER YOU ARE ENGAGED IN HUMAN SUBJECTS RESEARCH Are you conducting RESEARCH? • Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. • Can be quantitative or qualitative • Designed to enhance academic or scientific understanding

  3. 1. DETERMINE WHETHER YOU ARE ENGAGED IN HUMAN SUBJECTS RESEARCH Does your research involve HUMAN SUBJECTS? • a living individual about whom an investigator (whether professional or student) conducting research • (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or • (2) Identifiable private information. • (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or • identifiable biospecimens.

  4. COMMON TYPES OF HUMAN SUBJECTS RESEARCH AT UCSC • Interviews and focus groups • Questionnaires • Classroom activity evaluations and study of educational activities • Ethnographic observations and interviews • Behavioral tasks (e.g., computer games, drawings, psychology lab experiments, etc.) • Secondary data analysis (previously collected genomic, survey data, etc.) • Participatory action research

  5. ACTIVITIES THAT MAY NOT BE HUMAN SUBJECTS RESEARCH • Class project (interviews done for class grade-not intending to also use data in a thesis/dissertation) • Oral histories and journalism interviews that focus directly on the specific individuals about whom the information is collected • Secondary data received with no identifiers • If unsure contact Office of Research Compliance Administration 459-1473

  6. 2. COMPLETE REQUIRED TRAINING AS APPLICABLE • CITI Human Research course training required for: All students (undergrad, graduate) and postdocs, all staff, and non-tenure track faculty; • All personnel with with funding that requires adherence to 45 CFR 46 training requirements (e.g., NIH, NSF, FDA, sponsors listed here http://nrc59.nas.edu/pub/fcoi_agencies_phs_regs.html, etc.); and • All personnel on studies collaborating with other institutions where UCSC is either reviewing for or relying on another institution

  7. 3. DETERMINE WHO THE PRINCIPAL INVESTIGATOR/FACULTY SPONSOR IS • This is the person with oversight of the research who is eligible to be a PI/Faculty sponsor, or who may be eligible for exceptional PI status based on this chart: ETP Determination Chart by Appointment Type Direct link: https://officeofresearch.ucsc.edu/osp/files-osp/etp- chart-20160811.xlsx

  8. 4. DETERMINE WHICH APPLICATION TO COMPLETE • For exempt research, all activities must fall under one or more UCSC exempt categories. If exempt, complete the Exemption Request Form. • For exempt categories 2iii and/or 3iii, in addition to Exemption Request Form, complete the Limited IRB Review addendum. • For non exempt research complete the Full Protocol Form. • Full board is potentially greater than minimal risk (e.g., very sensitive data, deception on sensitive topic, FDA product, etc.)

  9. EXEMPT CATEGORY 1 Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (Attest you will comply with FERPA)

  10. EXEMPT CATEGORY 2 • Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: • (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; • (ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or • (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7)

  11. EXEMPT CATEGORY 3 (i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met: • (A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; • (B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or • (C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7). • (ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. • (iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. •

  12. EXEMPT CATEGORY 4 Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: • (i) The identifiable private information or identifiable biospecimens are publicly available; • (ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects

  13. EXEMPT CATEGORY 5 Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.

  14. EXEMPT CATEGORY 6 Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level, and for the use 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 U.S. Department of Agriculture.

  15. EXEMPT CATEGORY 3X UC Category 3x: Minimal risk exempt research activities that will not induce distress beyond that of daily life may include (but are not limited to) non-physically invasive interventions or performance of tasks such as: Reading/writing/drawing tasks; Physical activities such as walking, sitting, or manipulating an object; Computer tasks and/or Internet searches; Talking and/or listening to words, then making selections, or “think-aloud” exercises; Viewing media; Role-playing; Completing a specific physical or mental action (“imagining”); Passive monitoring of space (environment) with sensors; Playing a game; Height/weight measurements.

  16. EXEMPT CATEGORY 3X EXCLUSIONS 1. Federally funded research, or funding from non-Public Health Service (PHS) agencies that adhere to federal regulations in their award contracts (for a current list of these agencies see http://sites.nationalacademies.org/PGA/fdp/PGA_070596); 2. Prisoners as subjects. 3. Children/minors as subjects. 4. Federal personnel or the Department of Veterans Affairs. 5. Procedures, devices, or drugs subject to FDA oversight. 6. Biomedical procedures. 7. Clinical interventions. 8. Sponsor or other contractual restrictions. 9. An NIH-issued Certificate of Confidentiality to protect identifiable research data. 10. Deception or incomplete disclosure to subjects. 11. Identifiable, private existing data. 12. any disclosure of the subject’s responses outside of the research could reasonably place the subject at risk of criminal or civil liability, be damaging to the subject’s financial standing, employability, insurability, or reputation, or be stigmatizing in any other way. The information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects, and

  17. 5. KEEP THE BELMONT REPORT ETHICAL PRINCIPLES IN MIND WHEN CRAFTING YOUR RESEARCH 1. Respect for persons • Autonomy • Informed Consent 2. Beneficence • Minimizing risks • Favorable risk to (societal) benefit ratio 3. Justice • Equitable selection of subjects

  18. 6. COMPLETE THE APPLICATION THOROUGHLY • List anyone engaged in human subjects research (recruiting, consenting, conducting procedures, analyzing identifiable data, etc.) and have training completed as required. • List any funding source (note any federal grant will be checked so be sure to have procedures in grant congruent with the application procedures). • Provide signatures for principal investigator,/faculty sponsor and student investigator if applicable. • If exempt, describe your procedures and how they fit into the exempt category. • For non exempt, all instruments, recruitment materials, and consent documents must be submitted.

  19. 6. COMPLETE THE APPLICATION THOROUGHLY • Describe plan to identify and contact potential subjects. • Describe the purpose of study and procedures (consent should match). • Explain how protecting subject privacy and confidentiality of data collected.

  20. 6. COMPLETE THE APPLICATION THOROUGHLY • For non exempt, the informed consent/parent permission/assent must be submitted with signature line, unless applying for waiver of documentation of consent. Waiver of documentation approved when criteria met: 1. consent document is the ONLY record linking the subject and the research and the principal risk is a breach of confidentiality, OR 2. research presents no more than minimal risk and involves no procedures for which written consent is normally required outside of the research context

  21. 6. COMPLETE THE APPLICATION THOROUGHLY • For non exempt, the informed consent/parent permission/assent must be submitted with all required elements of consent, unless applying for waiver or alteration of consent. Waiver is approved when criteria are met: 1. No more than minimal risk to the participants; 2. Waiver or alteration will not adversely affect the rights and welfare of the participants; 3. Could not practicably be carried out without the waiver or alteration; AND 4. When appropriate, participants will be debriefed. • The FDA does not waive/alter the consent requirement except in special circumstances (e.g., emergency research).

  22. 7. SUBMIT IN ENOUGH TIME TO GET APPROVAL/EXEMPTION BEFORE STARTING • Human research activities cannot begin until exemption/approval is received; IRBs do not give retroactive approval. Please contact ORCA if you collected non research data that you now want to use for research • Email the application to orca@ucsc.edu • Please have PI and faculty sponsor sign application (then scan & email) • Once your application is submitted you will receive an acknowledgment email with the protocol number

  23. 7. SUBMIT IN ENOUGH TIME TO GET APPROVAL/EXEMPTION BEFORE STARTING Time from submission to approval can vary but expect 8-12 weeks, or 10- 14 for full review. Factors include: • Whether all items in application are addressed • Complexity and risk of research • Time of submission (mid quarter is high volume, as is Spring quarter).

  24. 8. KNOW WHAT THE IRB IS LOOKING FOR Criteria for IRB Approval 45 CFR 46.111and 21 CFR 56.111 (1) Risks to subjects are minimized: • (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and • (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. • (2) 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. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. • (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. • (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, §46.116. •

  25. CRITERIA CONTINUED • (5) Informed consent will be appropriately documented or appropriately waived in accordance with §46.117. • (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. • (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. • (i) The Secretary of HHS will, after consultation with the Office of Management and Budget's privacy office and other Federal departments and agencies that have adopted this policy, issue guidance to assist IRBs in assessing what provisions are adequate to protect the privacy of subjects and to maintain the confidentiality of data. • (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

  26. 9. AFTER APPROVAL/EXEMPTION • Once you receive your exemption/approval letter, human research activities may begin. • You must conduct activities as written in the protocol; if any changes are needed you need to submit and get approval for your amendment with the Modification application. • Exempt applications don’t expire, but you will receive an expiration date for non exempt and need to submit a Renewal application approximately 6 weeks before expiration if planning to continue. • If unanticipated problems involving risks to subjects or others occur (loss of identifiable data, video of incident that could cause harm), please complete and submit a Report Problem application.

  27. 10. WHERE TO GO FOR MORE GUIDANCE • UCSC IRB website: https://irb.ucsc.edu/ • UCSC IRB email: orca@ucsc.edu • UCSC IRB phone number: 831-459-1473

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