INSTITUTIONAL REVIEW BOARD (IRB) PROCESS AND GUIDELINES FOR CONDUCTING RESEARCH AT ORANGE COAST COLLEGE

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1 1 INSTITUTIONAL REVIEW BOARD (IRB) PROCESS AND GUIDELINES FOR CONDUCTING RESEARCH AT ORANGE COAST COLLEGE Developed by: Dr. Eduardo Jesús Arismendi-Pardi Department of Mathematics Sheri Sterner Office of Institutional Effectiveness Kristin Clark Office of Student Services February 2012

2 2 Table of Contents Overview of Institutional Review Board (IRB)... 3 Purpose and Scope of IRB... 3 Guiding Principles of the IRB... 4 IRB Guidelines... 6 IRB Review Required: Exempt Research... 6 IRB Review Required: External Requests, Expedited Review and Full Review... 7 Requests from External Researchers or Entities and Graduate Study Requests for Data (Quantitative or Qualitative)... 8 Expedited Review... 8 Full Review... 9 Researcher Responsibilities IRB Decision Charts Chart 1: Is the research involving human subjects? Chart 2: Is the research involving human subjects EXEMPT from IRB review? Chart 3: Does Exemption for Educational Settings Apply? Chart 4: Does Exemption for Tests, Surveys, Interviews, Public Behavior Observation Apply? Chart 5: Does Exemption for Existing Data Documents and Specimens Apply? IRB Forms Institutional Review Board Request Form Institutional Review Board Report IRB Resources... 20

3 3 Overview of Institutional Review Board (IRB) The function of the IRB at Orange Coast College is to ensure the well-being of participants who may volunteer for or participate in research studies or investigative inquiries. The IRB assists researchers and members of the institution: Comply with state and federal regulations that may apply to their studies or investigative inquiries Protect them from potential liability from which they may be exposed Protect Orange Coast College from any liability it may be exposed. The IRB is composed of an institutional researcher, a faculty member and one additional member from college community. All members of the IRB shall have training in applied and theoretical research, understanding the state and federal guidelines protecting human subjects in an educational setting. Purpose and Scope of IRB Under Food and Drug Administration (FDA) regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. In accordance with the Office of Human Research Protection (OHRP) guidelines and FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role of the rights and welfare of human subjects. The purpose of an IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research

4 4 protocols and related materials (e.g., informed consent documents and investigator brochures) to insure protection of the rights and welfare of human subjects of research. At Orange Coast College, the main purpose of the IRB is to ensure compliance with state and federal laws and the protection of faculty, staff, students and management when research related to the institution is being conducted. This may be related to internal research directly related to the college or the district, research conducted on the institution by external entities, or research related to graduate students (district or non-district employees) seeking degree requirements. These guidelines do not regulate student research under faculty supervision. Most internal research related to an employee s professional duties at Orange Coast College is exempt and does not require IRB approval. For instance, SLO assessment, in most cases, does not require IRB approval. Orange Coast College s IRB guidelines delineates between exempt and non-exempt research and details proper protocol for research requiring IRB approval. Guiding Principles of the IRB The Belmont Report is the seminal work in establishing protocol for protection of human subjects. This report identifies three guiding principles that drive IRB protocol process. The Belmont Report in its entirety can be accessed from: 1. Respect for Persons: Researchers should obtain the informed consent of all human subjects invited to participate in research. The consent process should include giving subjects full and understandable information about the research and provide a clear guarantee of the subjects voluntary participation. 2. Concern for the Well-Being of Subjects: The risk of harm to subjects should be minimized. The overall benefits to the subjects and the importance of the knowledge

5 5 to be gained should outweigh the remaining risk of harm to the subject as to justify a decision to allow this risk. 3. Justice: The selection of human subjects should be fair and equal. The risks and benefits of research should be distributed among subjects in a fair and equitable manner, with particular concern for subjects whose personal status or condition (such as children, prisoners, and/or patients) places them in a vulnerable or dependent status.

6 6 IRB Guidelines Research projects that gather data from human subjects should undergo, at least, some review by a faculty member, administration or department to determine if the activity requires IRB review. Thus, all members of the campus community who are involved in collecting data from must review their research according to the IRB guidelines and submit their research proposal(s) for review if deemed necessary by the guidelines, even if the research is being conducted off campus. Additionally, members outside the campus community who wish to use or collect data from the campus or its students must undergo IRB review. There are three main types of research projects outlined in these guidelines: exempt, expedited review and full review. The Office of Institutional Effectiveness is excluded from IRB review for routine Institutional Research activities, provided all data collected is reported without reference to individuals. The Office of Institutional Effectiveness will coordinate with the campus Custodian of Records if there are any questions with regard to FERPA (Family Education Right to Privacy Act). A series of IRB decision charts were developed to assist researchers in determining whether their request requires approval through OCC s IRB. These are outlined in the next section of this document. IRB Review Required: Exempt Research Exempt Research is not subject to formal review. This encompasses the majority of research in which: (a) Orange Coast College faculty, staff and management are collecting data related to their professional role and (b) is in accordance with FERPA requirements. Exempt research is applicable to archival research involving the collection or study of standard institutional data (such as, grades, success rates or demographics), documents, or records, if these

7 7 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. Examples of exempts review include classroom or job related activities and/or observations that do not compromise anonymity, FERPA regulations, or have the potential for either physical or psychological harm. Exempt Research also includes observation of behaviors or processes within the parameters of professional practice such as (a) classroom observations of everyday conduct, (b) use of educational tests or assessment tools, (c) survey procedures, or (d) observations of public behavior. Most types of student learning outcomes assessment, program review studies and program evaluations conducted by campus personnel fall under exempt research. However, IRB review is required if any information has the potential of compromising subject anonymity or the information to be recorded could potentially put the subjects at risk or hold the institution at risk of liability. Although Orange Coast College prompted surveys are generally exempt, there are three categories of surveys that must be reviewed by the IRB through expedited review (see expedited review below). IRB Review Required: External Requests, Expedited Review and Full Review Collection of non-exempt data is not permitted before IRB approval. n-exempt data fall under either expedited or full review. Both types of review need to complete the Orange Coast College Institutional Review Request Form for Research Study Involving Human Subjects Review-Board-(IRB).aspx and send to ssterner@occ.cccd.edu. The requestor is to indicate which type of review per these guidelines. Upon initial review, if the IRB Committee feels the request

8 8 is different than the researcher suggested, the researcher will be contacted since this may impact the review timeline. Requests from External Researchers or Entities and Graduate Study Requests for Data (Quantitative or Qualitative) Requests for data required to conduct graduate studies or external researchers and entities must be a minimum of 60 days prior to the anticipated start of the study. The Office of Institutional Effectiveness will consult with the Chair of the Institutional Review Board to determine if the request falls under exempt, expedited or full IRB review. The researcher will be notified within 14 days of the type of review and asked to submit further information if required. Graduate study reviews will be evaluated by at least two members of the IRB committee. Expedited Review Any research that requires any direct interaction (such as, face-to-face interviews or experiments) with participants which involves no more than minimal risk falls under expedited review. This excludes focus groups or interviews in the context of program evaluation, program review or SLO assessment as long as the data will be collected and reported without reference to the individual participants. Thirty (30) days may be required for processing an Expedited Review (there is no guaranteed 3-4 day turn-around time for Expedited reviews). The Expedited Review is used for those studies with low-to-moderate risk to the participants, which can be reduced through the protection-of-participants procedures planned by the researcher/principal investigator. Three types of OCC prompted surveys that must be reviewed: College-wide surveys to all employees or students Surveys that target a specific constituent or special population

9 9 Surveys that inquire about sensitive information or would place the individual at risk of criminal or civil liability or be damaging to the subject s financial standing or employability with the district. Expedited reviews will be evaluated by at least one member of the IRB committee. Full Review A Full Review entails sensitive or risky research topics or methodologies, vulnerable populations (e.g., children, elderly, and patients in clinical settings). This type of review requires a consent form and/or assent forms. Sixty (60) days may be required for processing a Full Review. Full IRB Review is also used in those instances where the researcher/principal investigator is working with a protected class of participants or in working with subjects with a high risk-to-benefit ratio. Examples that require IRB review include any information pertaining to a person s financial standing, employability, or reputation in terms of potentially putting individual subject at risk of civil or criminal liability. Further details pertaining to exempt review can be found at

10 10 Researcher Responsibilities The researcher is responsible for IRB requests for revisions and/or additional documents. These revisions and additional supporting documents must be forwarded by the researcher to the Chair of the IRB Committee. IRB submissions with incomplete documents or required revisions will be denied, sent back to the researcher, and the researcher may resubmit when supporting documents or revisions are received. Researchers are responsible for 1. Completing and assuring that IRB submission is complete and accurate. 2. Revisions and inclusion of pertinent documents to the IRB. 3. Provide all the necessary detail about the study in the request form. The methodology must be clearly explained with all the necessary details on how the data will be collected or what existing institutional data is being requested. 4. Researchers should refer their questions after submission to the IRB at 5. Researchers will get direct written official communication from the IRB to confirm the receipt of the IRB submission and then once a decision has been made on their IRB submission. The researcher may contact OCCIRB@occ.cccd.edu if they have not received an IRB decision within 30 days to check that status of their request.

11 11 IRB Decision Charts Charts adapted from US Department of Health and Human Services Office for Human Research Protections (OHRP) Human Subject Relations Decision Charts ( Chart 1: Is the research involving human subjects? Start Here Does the research involve obtaining information about living individuals? The research is not about human subjects and IRB approval may not apply Does the research involve intervention or interaction with individuals? Is the information individually identifiable (i.e., the identity of the subject is or may be readily ascertained by the investigator or associated with the information?) Activity is research involving human subjects. Is it conducted or supported by a member of the OCC community? IRB approval needed Unless exempt, IRB approval needed Is the information private or covered by FERPA? (Behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or provided for specific purposes by an individual and which the individual can reasonably expect will not be made public) Continue Go to Chart 2 Other Federal, State and local laws (such as FERPA) may apply to the activity. Research conducted by members outside of the OCC community need institutional approval.

12 12 Chart 2: Is the research involving human subjects EXEMPT from IRB review? From Chart 1, Research Involves Human Subjects Which of the categories will the involvement of human subjects be in? Research conducted in established or commonly accepted educational setting, involving normal d i i? Go to Chart 3*** Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior? Go to Chart 4*** Research involving collection or study of existing data, documents, records, or pathological or diagnostic specimens? Go to Chart 5*** ***Does the research meet any of the following conditions? *Request from external researcher or entity *Research involving extraneous exercise by the subjects. *Research that will involve manipulating the subject s behavior in a way that is stressful to them. *Research involving minors (under 18). *Research involving subjects institutionalized as mentally disabled. *Research involving prisoners. *Research involving noninvasive procedure routinely used in clinical practice. *Research involving voice and video recordings. t Exempt; IRB Review Needed

13 13 Chart 3: Does Exemption for Educational Settings Apply? From Chart 2 Does the research involve the assessment of SLOs? Research is not exempt; IRB Approval Needed Does the research study involve only normal education practices? (Such as research on regular and special education instructional strategies, or research on effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.) IRB Approval Needed

14 14 Chart 4: Does Exemption for Tests, Surveys, Interviews, Public Behavior Observation Apply? From Chart 2 Does the research involve only the use of educational test, survey procedures, interview procedures, or observation of public behavior? Does the research involve children Does the research study involve survey procedures, interview procedures, or observation of public behavior where the researcher/investigator participates in the activities being observed? Research is not exempt. IRB approval needed Is the information obtained recorded in such a manner that human subjects can be identified, directly or through identifiers linked to subject; and could any disclosures of the human subjects responses outside the research reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, or reputation? AND/OR Campus wide or constituent based survey or sensitive information? AND/OR Research involving extraneous exercise by the subjects. AND/OR Research involving noninvasive procedure routinely used in clinical practice. AND/OR Research involving voice and video recordings. AND/OR Research that will involve manipulating the subject s behavior in a way that is stressful to them. AND/OR Research involving minors (under 18). AND/OR Research involving subjects institutionalized as mentally disabled. AND/OR Research involving prisoners. IRB Approval Needed

15 15 Chart 5: Does Exemption for Existing Data Documents and Specimens Apply? From Chart 2 Does the research involve only the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens? ( Existing means existing before the research is proposed to an institutional official or the IRB to determine whether the research is exempt.) Are these sources publicly available? Research is exempt. IRB approval needed Will information be recorded by the researcher/investigator in such a manner that the subjects cannot be identified, directly or through identifiers li k d t th bj t? Member of OCC Community Research is exempt. IRB approval needed. Research is not exempt. IRB approval needed Research is not exempt. IRB approval needed

16 16 IRB Forms Institutional Review Board Request Form The request form can be accessed online at: XXXXXXXXXXXXXXXXXX Institutional Review Board Request Form Research Study Involving Human Subjects Researcher / Investigator: Check one: Faculty Staff Management External/Graduate Program / Department: Telephone: Project Title: Timeline: Type of Review: Full: Expedited: I. Check each of the following that are included in your research (may require review): Survey or observational research in which the subject s responses or behaviors, if they become known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject s financial standing or employability. Survey or observational research that deals with sensitive aspects of the subject s own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.* Research involving the collection or study of existing data, documents, records, pathological specimen, or diagnostic specimens which are not publicly available OR from which information is recorded by the investigator in such a manner that subjects can be identified.* Research involving interviews, questionnaires, or observations that include college-wide, specific constituent/special population targets or sensitive information.* Research involving tests not normally used in educational or clinical settings.* Specify: Other

17 17 Special areas that require review: Research involving extraneous exercise by the subjects.* Research involving noninvasive procedure routinely used in clinical practice. Research involving voice and video recordings.* Research that will involve manipulating the subject s behavior in a way that is stressful to them.* Research involving minors (under 18).* Research involving subjects institutionalized as mentally disabled.* Research involving prisoners.* *These procedures generally require gathering Informed Consent from all participants. *These items are likely to be reviewed if circumstances apply. II. Researcher/Investigator and other key personnel involved with human subjects on this project: III. Description/Abstract. Provide words stating the objectives and specific aims of the research. Describe concisely the research design and methods for achieving these goals. Also address issues such as: What OCC resources and/or data are requested? What type of participants are requested and in what setting will the participants be engaged? The amount of time and contact required for each participant; How, if at all, participants will be rewarded for participating; Methods of ensuing anonymity and confidentiality; Debriefing measures, if necessary; If and how will feedback be provided to the participants. Description / Abstract:

18 18 IV. Protocol. Include the research question or hypothesis, population selection (inclusion and exclusion criteria), recruitment, study procedures and timetable, sample size determination, outcome evaluation (i.e., measures, statistical analysis plan), safety review, criteria for stopping, and anticipated accrual. Attach copies of any grant research plan/specific aims, survey instruments, telephone scripts, etc. Attach this information to this form. For graduate studies or dissertations attach the IRB approval from the granting institution. V. Accrual Information. Estimated number of participants: Beginning Date: Ending Date: VI. Risks. Describe potential risks to the study participants. Include physical, psychological, emotional, and privacy issues. Outline what support will be available to participants experiencing undesirable consequences of participations. Describe: VII. Procedures to Minimize Risks. Describe: VIII. Benefits. Describe the potential benefits to the research participant, the institution or the field of study. Describe: XI. Assurance. The undersigned assure that the protocols involving human participants described in this application are complete and accurate, and are consistent with applicable protocols submitted to external funding sources. All protocol activities will be performed in accordance with the College, State, and Federal regulations. activities involving the use of human participants will be initiated without prior review and approval by the Institutional Review Board of Orange Coast College. Researcher/Investigator Date Please submit completed application and pertinent materials to te that IRB guidelines indicate that approval can take up to 30 days.

19 19 Institutional Review Board Report The IRB report will be sent directly to the requestor once the request has been review by the IRB and a decision granted. The review time frames are outlined under the expedited and full review sections of this document. Project Title: Institutional Review Board Report Principal Researcher/Investigator Date COMMITTEE RESPONSE: Signature Date Approve / Review Further / Deny Signature Date Approve / Review Further / Deny Signature Date Approve / Review Further / Deny IRB Committee Comments:

20 20 IRB Resources The Belmont Report: Ethical Principles and Guidelines for the protection of human subjects of research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 1979) Department of Health and Human Services (DHHS) DHHS Code of Federal Regulations 45 CFR 46 Exempt Categories Expedited Categories Family Educational Rights and Privacy Act (FERPA) FERPA Homepage Orange Coast College FERPA Policy (home page on OCC portal) Title34 CFR 99 Food and Drug Administration (FDA) Title 21 CFR 50 Title 21 CFR 56 Office of Human Protections (OHRP) OHRP Home Page OHRP Glossary of Terms