Submitting human subjects research At UC Santa Cruz

1. Determine whether you are engaged in human subjects research Are you conducting RESEARCH? A systematic investigation designed to contribute to generalizable knowledge Can be quantitative or qualitative Designed to enhance academic or scientific understanding

1. Determine whether you are engaged in human subjects research Does your research involve HUMAN SUBJECTS? A living individual about whom an investigator obtains: -data through intervention or interaction with the individual, or -identifiable private information

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

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

2. Complete required training as applicable CITI Human Research course training required for: All students (undergrad, graduate) and postdocs 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.) All personnel on studies collaborating with other institutions where UCSC is either reviewing for or relying on another institution

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

4. Determine which application to complete For exempt research, all activities must fall under one or more of the 6 exempt categories. If exempt, complete the Exemption Request Form. For non exempt research, complete the Full Protocol Form.

4. Determine which application to complete-exempt Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: 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.

4. Determine which application to complete-exempt Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: the human subjects are elected or appointed public officials or candidates for public office; or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

4. Determine which application to complete-exempt Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: Public benefit or service programs; 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 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 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 U.S. Department of Agriculture

4. Determine which application to complete-Full protocol form The full protocol form is used for research going through either expedited or full board review. Expedited is minimal risk research fitting into one or more of 7 categories-ORCA and the IRB will determine this. Full board is potentially greater than minimal risk (e.g., very sensitive data, deception on sensitive topic, FDA product, etc.)

5. Keep the Belmont report ethical principles in mind when crafting your research Respect for persons Autonomy Informed Consent Beneficence Minimizing risks Favorable risk to (societal) benefit ratio Justice Equitable selection of subjects

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, and faculty sponsor 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.

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.

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: consent document is the ONLY record linking the subject and the research and the principal risk is a breach of confidentiality, OR research presents no more than minimal risk and involves no procedures for which written consent is normally required outside of the research context

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: No more than minimal risk to the participants; Waiver or alteration will not adversely affect the rights and welfare of the participants; Could not practicably be carried out without the waiver or alteration; AND When appropriate, participants will be debriefed. The FDA does not waive/alter the consent requirement except in special circumstances (e.g., emergency research).

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

7. Submit in enough time to get approval/exemption before starting Time from submission to approval can vary but expect 6-8 weeks, or 8-12 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).

8. Know what the irb is looking for Criteria for IRB Approval 45 CFR 46.111and 21 CFR 56.111 Risks to subjects are minimized by using: i) procedures consistent with sound scientific design and which do not unnecessarily expose subjects to risk ii) whenever appropriate by using procedures already being performed on subjects for diagnostic or treatment purposes Risks to subjects are reasonable in relation to the anticipated benefits Selections of subjects is equitable Informed consent will be sought from each prospective subject or the subject's legally authorized representative ... as required by #46.116 Informed consent will be appropriately documented to the extent required by §46.117 When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects When appropriate, there are adequate protections to protect privacy of subjects and to maintain the confidentiality of data.

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.

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