SAN DIEGO CITY COLLEGE RESEARCH COMMITTEE INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS

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1 BACKGROUND SAN DIEGO CITY COLLEGE RESEARCH COMMITTEE INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS The first priority of the San Diego City College Research Committee Institutional Review Board (IRB) is to protect student and employee participants from harm. Should the IRB members judge that there is more than minimal risk of harm to participants, or that risks could be further minimized, they will either negotiate some change in the research methods or disapprove the research proposal entirely. The research proposal may already have approval from an Institutional Review Board (IRB) of another institution, but the San Diego City College Research Committee IRB must still approve all research proposals coming from outside the campus. The primary objective of the IRB is to act as advocates for the safety of San Diego City College students and employees. While the IRB tries to accommodate investigatory endeavors, conduct of those studies will always have a lower priority than the safety of our students. Wherever possible, investigators should strive to make the research an educational experience for City students. TYPES OF RESEARCH All research conducted under the auspices of San Diego City College and involving human subjects may be subject to review and approval. However, it should be noted that any research posted on the freespeech bulletin boards around the San Diego City College campus may not have received IRB approval since the IRB does not have the authority to restrict what is posted on these bulletin boards. The following describes the degree of review necessary, depending on the type of research proposal presented. This should help guide researchers in their research proposal submissions. Research that does NOT require IRB review or approval from the Research Committee: 1. District Research and Planning Projects: Research intended for campus-wide planning (i.e., institutional research on the San Diego City College College-wide Research Agenda) is not subject to IRB review and approval. However, it should be noted that District research projects that use San Diego City College students as subjects must comply with the same ethical standard applied to outside/external research proposals. The Director of the District Office of Research and Planning will be responsible for compliance with such ethical standards as stated above. 2. San Diego City College Student Research Projects: San Diego City College faculty may use research projects as part of the educational activities of their classes with the understanding that the faculty member is entirely responsible for these projects, including those designed and/or administered by students. Students may not do research using other individuals as subjects unless it is under the supervision of a San Diego City College faculty member. As an aid to faculty, the IRB is available to faculty for discussion of such projects. San Diego City College Research Committee Page 1

2 Faculty members are strongly encouraged to discuss with their students the importance of protecting their subjects and adhering to the same ethical standard applied to outside/external research proposals. Since students may be inexperienced in the ethics of doing research, they must be reminded to respect the privacy and dignity of their potential subjects. Students must keep any personal data collected in strict confidence. If students are proposing to carry out their research activities in off-campus facilities, they must ask for and be granted permission by facilities management or the security office, especially if the research activity is intrusive. 3. Student Learning Outcomes Assessment: San Diego City College faculty involved in student learning outcomes assessment are not subject to IRB review. However, faculty members must adhere to the Guidelines for Implementing the Research Planning Agenda (GIRPA) applied to outside/external research proposals. As an aid to faculty, the campus based researcher is available to assist faculty in implementation of these standards. Research that may require information and/or approval from the Research Committee but does not require IRB review: The following types of research may need to obtain information from the Research Committee. Complete IRB review and approval is not necessary for these types of research. Approval for this research may be obtained directly from the Research Committee, without a full review by the IRB. 1. Faculty Research for Institutional Purposes: San Diego City College faculty involved in assessment to support aspects of program review and other internal processes are not subject to full IRB review. However, faculty members must adhere to the same ethical standards applied to outside/external research proposals. As an aid to faculty, the IRB is available to assist faculty in implementation of these standards. Research that requires IRB review: 1. External Research: Research conducted by individuals or groups outside San Diego City College that seeks to include San Diego City College students as subjects must undergo review and approval by the IRB before any research activity may commence. 2. Faculty Research: Research conducted by San Diego City College faculty members that seeks to include San Diego City College students as subjects and obtain data for external usage, such as external publications and/or presentations must undergo review and approval by the IRB before any research activity may commence. San Diego City College Research Committee Page 2

3 THE PROCESS FOR RESEARCH THAT REQUIRES IRB REVIEW After reviewing the proposed research in its entirety, the IRB will consider approval on the San Diego City College campus. Any researcher found to be conducting a study on the San Diego City College campus without written IRB approval will not be allowed to complete their investigation and will be reported to their institution of employment/study. Once the Research Committee IRB receives the appropriate materials, these materials will be forwarded to the IRB members for review. Appropriate Dean(s) and Department Chair(s) may be notified of the proposal by the administrator in charge of granting approval or disapproval for research proposals. Dean(s) and Chair(s) will have one week to evaluate the research proposal for any anticipated disruptive impact. If a Dean or Chair has any insurmountable objections to the research, they will notify the administrator in charge and the Chair of the IRB that approval shall not be granted to the proposal. If no objections are raised, after a complete review of the materials, the IRB members will reach one of the following decisions: The research is approved and can commence. The research requires modifications and further review. The research is denied. After the IRB has reached a decision on approval or disapproval, that decision will be sent to the administrator. The administrator in charge will then notify the researcher(s) of the decision and provide IRB approval documentation. If approval is granted, the researcher(s) will be advised of the appropriate way to contact faculty/students in order to commence their research. Unless otherwise indicated, the IRB approval is valid for one year from the date the approval was granted, as long as no changes are made to the protocol. Any change in protocol requires a resubmission of the required forms and documents to the IRB for review and re-approval. San Diego City College Research Committee Page 3

4 San Diego City College IRB Review Request Form SECTION A INVESTIGATOR/INSTITUTIONAL INFORMATION Principal Investigator Department/Institution Telephone Project Title Name of External Reviewing IRB (if applicable): If applicable, attach approval from other external IRB reviewing board. San Diego City College Research Committee Page 4

5 SECTION B COVER MEMO ACCOMPANYING PROPOSAL IF STUDY IS TO BE CONSIDERED EXEMPT OR OTHER THAN HUMAN SUBJECTS RESEARCH 1. If an investigator has no IRB approval, the study should be categorized by the San Diego City College IRB Chair as other than human subjects research in order for the study to proceed. The San Diego City College IRB will review and categorize all proposals. 2. Activities other than human subjects research a. Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. If your proposal is not to be considered research then a cover memo submitted with your proposal should explain why it should not be considered research under this definition. b. Human subject means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. If your proposal does not utilize human subjects then a cover memo submitted with your proposal should explain why it should not be considered to use human subjects under this definition. 3. Exempt human subject research categories: a. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. b. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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 subject s financial standing, employability, or reputation. San Diego City College Research Committee Page 5

6 c. 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: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. d. 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. The Investigator shall explain in a cover memo accompanying their research proposal which exemption category, if any, the investigator believes applies, as well as their rationale for that categorization. San Diego City College Research Committee Page 6

7 SECTION C PROPOSAL CONTENTS AND SUPPLEMENTAL DOCUMENTATION The proposal itself must address all of the below scientific, legal, and ethical considerations. If a proposal receiving prior IRB approval clearly addresses all of the issues below, then submission of a separate document in addition to the IRB-approved research proposal is not needed. If supplemental information to the approved IRB proposal is needed to address any of the considerations below, that is permissible only where there are no conflicts between the supplemental information and the already-approved research proposal. All proposals submitted must indicate that informed, voluntary consent will be obtained from student participants and that student participants will be accorded the dignity and respect that all humans deserve. 1. The Investigator shall provide evidence of independent scientific review of their proposal; 2. Unless non human subjects research, exempt research, or expedited research, the Investigator shall provide IRB approval documentation of their research proposal, consent form, recruitment materials, and all instruments including the exact proposal, survey, and consent form that were reviewed by the IRB. An approved Consent Form shall have the stamp of the reviewing IRB affixed; 3. The Investigator s proposal should contain all of the below elements: a) A background section referencing any related research conducted in the past and the significance of the current effort to that past research, as well as a delineation of the objectives of the present research effort; b) A methods section that clearly indicates the facilities or setting of the proposed research, the number of proposed subjects, any inclusion or exclusion criteria for subject participation, the names of all investigators who will be active on the San Diego City College campus and what their specific duties will be, the length of time commitment for each subject, the expected duration of the research project, and a thorough explanation of the informed consent procedures including dealing with minors. c) A sample size section that indicates the minimum number of subjects needed to obtain statistically significant findings and the maximum number of subjects to be enrolled, unless the proposal explains why sample size should not apply to the proposed effort; d) A risks section that details any physical, psychological, or data confidentiality risks that participants are subject to as well as the safeguards in place to mitigate those risks; e) An adverse events section that indicates the procedure and time frame for notifying the Chair of the CC-IRB and the Chair of the approving IRB of any adverse events that occur on the City Campus involving either the investigators or the subjects of the study; San Diego City College Research Committee Page 7

8 f) The informed consent document which meets the requirements of the SDCCD Administrative Policy AP Student Records, Release, Correction and Challenge and the SDCCD Board Policy BP 3001 Student Records; g) Any subject recruitment materials, scripts to be read to subjects, surveys, or test instruments to be employed; and h) The Investigator Compliance Attestation signed by investigator and their immediate supervisor. San Diego City College Research Committee Page 8

9 SECTION D THE INVESTIGATOR COMPLIANCE ATTESTATION I, the Principal Investigator cited as responsible for performing and monitoring the research under the protocol titled [insert Protocol Title], have read and understand the provisions of Title 45 Code of Federal Regulations Part 46 (Protection of Human Subjects) and the San Diego City College Research Committee Institutional Review Board (IRB) Investigator Guidelines for Research Using Human Subjects. In the event that I have a question regarding my obligations during the conduct of this project, I have ready access to these regulations. I understand that as the Principal Investigator I am wholly responsible for the understanding that my immediate resource for clarification of any issues related to the protection of research volunteers is the Chairperson of the San Diego City College Research Ethics Review Board. I also attest that I will immediately inform the Chairperson of the San Diego City College Research Ethics Review Board of any actions taken by a reviewing IRB concerning my study and will inform the Chairperson of the Research Ethics Review Board when all study activities at the San Diego City College campus have concluded. Signatures and dates: (DD/MM/YY) [Type in Principal Investigator Name] / / [Type in Name of Principal Investigator s supervisor or research sponsor] / / San Diego City College Research Committee Page 9