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

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1 BACKGROUND SAN DIEGO COMMUNITY COLLEGE DISTRICT INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS The first priority of the SDCCD 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 changes 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 Community College District (SDCCD) designated IRB must still approve all research proposals coming from outside the District. The primary objective of the IRB is to act as advocates for the safety of its 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 and employees. Wherever possible, investigators should strive to make the research an educational experience for students and employees. TYPES OF RESEARCH All research conducted under the auspices of any of the SDCCD institutions (including San Diego City College, Mesa College, Miramar College, Continuing Education and the District) and involving human subjects may be subject to review and approval. However, it should be noted that any recruitment for research posted on the free speech bulletin boards around the 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: 1. District Research and Planning Projects: Research intended for campus wide planning (i.e., institutional research on the College wide Research Agenda) is not subject to IRB review and approval. However, it should be noted that campus or District research projects that use students or employees as subjects must comply with the same ethical standard applied to outside/external research proposals. The Director of the SDCCD Office of Institutional Research and Planning will be responsible for compliance with such ethical standards as stated above. 2. Student Research Projects: SDCCD 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 an SDCCD faculty member. As an aid to faculty, the IRB is available to faculty for discussion of such projects.

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: SDCCD faculty members who are 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 internal 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 campus Research Committee but does not require full or complete IRB review: The following types of research may need to obtain information and/or approval from the campus 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: SDCCD employees involved in assessment to support aspects of program review and other internal processes are not subject to full IRB review. However, faculty and staff members must adhere to the same ethical standards applied to outside/external research proposals. All employees must adhere to the internal Guidelines for Implementing Research Planning Agenda (GIRPA). As an aid to employees, the IRB is available to assist employees in implementation of these standards. Research that requires IRB review: 1. External Investigator Research: Research conducted by individuals or groups outside of the SDCCD (including employees who are enrolled in educational programs outside of SDCCD) that seek to include SDCCD students or employees as subjects must undergo review and approval by the SDCCD IRB before any research activity may commence. 2. Faculty Research: Research conducted by SDCCD faculty members that seek to include SDCCD students or employees 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. 2

3 THE PROCESS FOR RESEARCH THAT REQUIRES IRB REVIEW Studies may only be conducted on the SDCCD campus by investigators that have received IRB approval from institutions that have been granted a Federal Wide Assurance (FWA) or Assurance from another federal agency, unless that research has been found to be classified as other than human subjects research. It should be noted that approval by an external IRB does not guarantee that the research proposal will be approved by the SDCCD IRB. Determinations that an investigation is exempt, expedited or is not human subjects research may only be made by individuals with the appropriate research ethics backgrounds (e.g., IRB) and never by the investigator proposing the research. Only after reviewing the proposed research in its entirety will the SDCCD IRB determine the classification of research and consider the approval of the research. Any researcher found to be conducting a study on the SDCCD campus without written SDCCD IRB approval will not be allowed to complete their investigation or use the information they may have already collected, and will be reported to their institution of employment and/or program of study. Once the Chair of the IRB receives the appropriate materials, these materials will be forwarded to the IRB members for review. Appropriate Dean(s) or Department Chair(s) may be notified of the proposal by the IRB to discuss granting approval or denial of the research 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 denial, the Chair of the IRB will then notify the researcher(s) of the decision and provide the IRB decision documentation. Note that if the research is approved, the researcher is required to retain a copy of the approval notification to present to faculty, staff and/or administrators on the campus prior to commencing the research. The review process may take up to six weeks, depending on how complex the proposal is and whether all documentation has been accurately submitted. The submission and IRB review dates will be posted on the IRB website at the beginning of each academic year. The IRB does not review proposals during the summer months. If approval is granted, the researcher(s) will be advised of the appropriate way to contact students or employees 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. 3

4 San Diego Community College District IRB Review Request Form SECTION A INVESTIGATOR/INSTITUTIONAL INFORMATION Principal Investigator Department/Institution Telephone Project Title Federal wide Assurance (FWA) number of Investigator s Institution (if applicable): (see if unknown) Name of External Reviewing IRB (if applicable): If applicable, attach approval from other external IRB reviewing board. 4

5 SECTION B COVER MEMO ACCOMPANYING PROPOSAL IF STUDY IS TO BE CONSIDERED EXEMPT, OTHER THAN HUMAN SUBJECTS or EXPEDITED RESEARCH To determine the type or classification of research and level of IRB review required, the first step is to determine whether or not the study is research. The next step is to determine whether or not the study involves human subjects. 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. Human subjects 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. Research Classifications 1. Other Than Human Subjects Research a. If the research proposed does not involve human subjects or fails to meet the definition of research, it may be classified as Other Than Human Subjects research and does not need IRB approval. However, the SDCCD IRB will review and categorize the research proposal accordingly. 2. Exempt Human Subjects Research 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. 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. 3. Expedited Research a. Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the categories listed below, will be reviewed by the IRB through the expedited review procedure. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects= financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. This list includes the following types of studies and methodologies: b. Clinical studies of drugs or devices in which an IND or IDE application is not required. c. Collection of blood samples by venipuncture in amounts not exceeding 450 mls d. Noninvasive collection of biological specimens e. Collection of data through noninvasive, routinely employed clinical procedures (not x rays) f. Research involving materials that have been/will be collected for nonresearch purposes g. Voice recordings for research purposes,.(i.e. to investigate speech defects) h. Research on individual or group behavior via surveys, interviews, observations that is not exempt based on the classification of HHS regulations for the protection of Human Subjects. The Investigator shall explain in a cover memo accompanying their research proposal which classification of research, the investigator believes applies, as well as their rationale for that categorization. 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 this proposal may be submitted along with the IRB approval notice. 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 or employee participants and that student or employee 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, as well as Human Subjects review and approval from the IRB at their institution or agency; 2. Unless non human subjects research, the Investigator shall provide IRB approved documentation of their research proposal, consent form, recruitment materials, and all instruments including the exact proposal, survey or other data collection instruments, and consent form that were reviewed/approved by the external 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 SDCCD 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 sampling section that indicates the sample design, the minimum and maximum number of subjects needed to obtain statistically significant findings, 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; a. An adverse events section that indicates the procedure and time frame for notifying the Chair of the campus IRB and the Chair of the approving IRB of any adverse events that occur on the campus involving either the investigators or the subjects of the study; e) The informed consent document which meets 45 CFR as well as the requirements of the SDCCD Administrative Policy AP Student Records, Release, Correction and Challenge and the SDCCD Board Policy BP 3001 Student Records; f) Any subject recruitment materials, scripts to be read to subjects, surveys, or test instruments to be employed; and g) The Investigator Compliance Attestation signed by investigator and their immediate supervisor. 7

8 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 Community College District 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 Community College District campus IRB. I also attest that I will immediately inform the Chairperson of the IRB of any actions taken by a reviewing IRB concerning my study and will inform the Chairperson of the IRB when all study activities at the 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] / / 8

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