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Standard Operating Procedures for the IRB

Standard Operating Procedures for the IRB

11.1 Procedure for Incomplete Applications
11.2 Procedure for Post-Hoc Review of Research
11.3 Procedure for Research Involving Multiple and/or Visiting Researchers
11.4 Procedure for Reviewing Oral History Projects
11.5 Procedure for Reviewing Research Involving the Internet or Electronic Mail
11.6 Procedure for Reviewing Research Conducted in a Public or Private Educational Setting
11.7 Procedure for Reviewing Student and Course-Related Research Projects
11.8 Procedure for Reviewing Research Involving University-Collected Student Information
11.9 Procedure for Reviewing Program Evaluations and Quality Improvement Programs
11.10 Procedure for Using University-Provided Survey Tools

11.1 Procedure for Incomplete Applications

All protocol submissions are received and reviewed by the IRB Support Staff for processing. For purposes of this SOP, an Incomplete Application is defined as an application that contains one or more of the following: (a) incomplete or missing cover page, (b) incomplete or missing a signed cover page by the PI and/or his or her faculty advisor, (c) missing supplemental materials such as consent forms and/or debriefing statements, (d) non-completion of ethics training; and/or (e) incomplete or missing subsections.

Once an incomplete application is received, the IRB Support Staff and/or IRB Chair will conduct the following procedures:

(a) A written request will be made to the PI and/or faculty advisor for the necessary application materials.

(b) The PI will be notified at that time that his or her protocol application will remain on hold in the OARS office until all remaining documentation is received.

(c) Once all application materials are received, an application is considered complete and it will be submitted to reviewers.

(d) Incomplete applications will be held in the OARS office for a period of 30 days. If the required components are not submitted after 30 days, the incomplete application will be returned to the PI(s).

11.2 Procedure for Post-Hoc Review of Research

Although the federal and institutional policy is very clear that research projects involving human subjects are to be submitted and approved prior to engaging in research activity, in rare cases The Institutional Review Board for Human Subjects (IRB) will conduct a post-hoc review on a case-by-case basis where research is in progress without prior IRB review and approval.

In such cases, formal verification with the PI will be conducted (i.e., project initiation dates will be checked) to ensure that the research is in fact either in progress or has been completed without prior IRB review and approval. Once this confirmation is secured the following process will be followed:

(a) The PI is to immediately stop all research activities that involve direct contact with human subjects until further notice from the IRB.

(b) The PI is to submit a New Protocol Application along with a short letter requesting Post-Hoc Review. The letter should also provide a rationale for submitting the protocol post initiation of the research.

(c) Since conducting research without IRB approval is a research non-compliance issue, the application will be reviewed by the IRB Chairperson and the Research Compliance Officer. If warranted, a full committee review by the IRB may also be conducted.

(d) As part of the reviews mentioned above, the following issues that will be considered may include, but are not limited to:

a. a review the methods that are being used or were used to provide for basic human subjects protections;
b. an identification of any problems with the research procedures which were conducted and those areas which are still open to revision;
c. the risks and benefits of the study;
d. the procedures used to ensure informed consent, confidentiality and safeguarding of data;
e. if the PI is a student, the level of faculty involvement

(e) Approval will not be granted retroactively for the stages of the project that have already been completed. However, for researchers whose projects have been initiated and/or are currently in progress, the IRB may provide approval only for those segments of the project which have not been initiated at the time of review.

(f) Written comments will be provided to the PI regarding the research activities that involved human subjects and the degree of risk associated with the study. In the case of student research, the written comments will also be given to his/her faculty advisor and if warranted, the department chair will also receive written notification.

(g) If the IRB finds that there were serious problems in the human subjects protections during data collection and/or it finds that the researcher(s) knowingly (i.e., he or she completed human subjects ethics training which details the importance of submitting an application) engaged in the research without prior IRB approval, the Research Compliance Officer will also conduct an investigation of non-compliance and the findings of the investigation will be sent to the researcher in writing.

11.3 Procedure for Research Involving Multiple and/or Visiting Researchers

For the purposes of this SOP, these procedures apply in cases where a Miami University (MU) faculty, staff or student is engaged in a collaborative project with a researcher(s) from another institution or in cases where a researcher from another institution wishes to conduct research at MU that involves human subjects. This procedure includes MU (or visiting) researchers who serve as PI, co-PI, or in any research capacity where direct contact with human subjects is in involved (i.e., data collection and analysis). The following procedures will be followed regarding IRB review and approval:

(a) The MU researcher is required to submit an IRB application for his or her component of the research project. In this protocol application, he or she should also clearly explain that the research is a multi-investigator/multi-site project.

(b) The MU researcher should include written verification of approval from the collaborating institution(s) in his or her MU protocol application materials.

(c) Approval will only be granted for the MU researchers component of the project.

(d) If the researcher is from another institution (visiting researcher) and wishes to conduct research at MU, he or she must identify a member of the MU faculty or staff who will serve as an advisor to the project and who is willing to sign the IRB application. The visiting researcher should also secure IRB approval from his or her home institution and include a copy of that verification with his or her MU IRB application.

11.4 Procedure for Oral History Projects

Oral history interviewing projects in general do not involve the type of research as defined by Department of Health and Human Services (DHHS) regulations and therefore are excluded from IRB oversight *. If the project does not fall within the guidelines below it does require IRB review and routine application submission procedures apply.

For purposes of this SOP, if your project fulfills the following criteria it is considered to be an oral history project and does not require IRB review:

(a) Oral history projects involve interviews that are explicitly intended for preservation as a historical document.

(b) Projects involving oral history interviews that are not designed to contribute to generalizable knowledge as the 45 CFR part 46 regulations describe. The project does not seek underlying principles or laws of nature that have predictive value nor can it be applied to other circumstances for the purposes of controlling outcomes.

(c) Projects involving oral history narrators that are not anonymous individuals selected as part of a random sample for the purposes of a survey. Individuals are selected due their unique relationship to the topic and the questions are gradually developed and open-ended.

(d) Projects involving oral history interviews where the historian (PI) follows the Oral History Associations Principles and Standards and Evaluation Guidelines as part of his or her work.

(e) Oral history projects involve interviews in which those being interviewed fully understand the purposes, potential uses and their freedom not to answer questions. In most cases, the narrators are required to sign a release that addresses copyright and terms of access and reproduction (for interviews deposited in a library or archives), identification of narrators, and disposition of tapes and transcripts.

*Office of Human Research Protections & Oral History Association 2003 joint policy-IRB http://www.dickinson.edu/organizations/oha /)

11.5 Procedure for Reviewing Research Involving the Internet or Electronic Mail

In such cases where MU researchers use email, listservs, and/or Internet-based mediums to conduct their research, the following procedures will be used in reviewing such protocols to ensure that ethical procedures are followed:

(a) The PI should submit to the IRB as part of his or her application all materials that will be submitted to subjects via email, listservs, and/or Internet-based mediums. These materials may include, but are not limited to: (1) the studys face page or information page explaining the study, (2) URL website address, (3) the website address for web-based surveys, (4) related materials that are part of the study and require direct subject involvement.

(b) If the PI is studying an online group (e.g., listserv, blog, etc.) the PI should provide evidence that the group owner/host has given permission to recruit participants. If this is not a feasible procedure, the PI should provide an explanation as to why.

(c) All recruitment materials should clearly specify the age limit for participation. If a PI is conducting research with underage participants, then information should be provided as to how consent will be obtained or a justification for a waiver of parental permission must be provided.

(d) The PI should clearly state in his or her information letter and/or consent form that Although every effort will be done to ensure confidentiality of your subjects responses, that all Internet-based communication is subject to the remote likelihood of tampering from an outside source.

(e) PIs should clearly state to his or her subjects what types of confidentiality measures will be utilized (i.e., IP addresses will not be investigated, responses will not remain on the Internet server, all Internet correspondence will only go to the PI, etc.).

(f) If the research, particularly the initial recruiting, is being conducted via an electronic mail listserv, the PI should ask interested individuals to contact him or her by a separate email and not directly to the listserv address to protect confidentiality.

(g) For online survey forms, the PI should provide a home or face page containing an introductory message that describes the project, how the data will be used and other relevant information of informed consent. The bottom of the message could contain a button that indicates that they volunteer to participate and another one that indicates that they decline participation.

11.6 Procedure for Reviewing Research Conducted in a Public or Private Educational Setting

For purposes of this SOP, an educational setting is defined as: (1) designated public school settings (including after-school programs that are affiliated with a public or private school), (2) designated private school settings, and (3) educational training facilities (i.e., training centers, day care settings). The following procedures will be followed by the IRB in reviewing such research:

(1) Prior to submitting a protocol, the PI should consult with the educational setting to determine if the setting has a designated IRB or ethics review board. In such cases where there is such a board, approval of the project should be secured prior to engaging in the research and written confirmation should be submitted with the MU application materials.

(2) All research procedures and materials that will be submitted to the subjects should be reviewed by the teacher and/or principal where appropriate to ensure compliance with educational setting guidelines.

(3) In cases where the research will pose an interference with routine school activities, then it is effective research practice to secure approval from a school official stating that he or she is aware of the project and approves of it being conducted in his or her school.

(4) MU applications should address issues of informed consent (and assent where appropriate). In addition, the No Child Left Behind Act of 2001 identified eight classifications of protected information for surveys, questionnaires, interview materials or testing measures used with students in the school system. Research involving any of the following eight areas requires written parental informed consent prior to the participation of a student in research: (a) mental or psychological problems of the student or the students family; (b) political affiliations of the student or the student or the students parents; (c) religious practices, affiliations or beliefs of the student or the students parents; (d) income; (e) illegal, anti-social, self-incriminating or demeaning behavior; (f) political affiliations of the student or the students parents; (g) sexual behavior or attitudes; and (h) critical appraisals of others with whom students have close family relationships.

(5) In cases where the PI is using his or her own students as part of his or her research project (i.e., his or her students are the primary subjects), the PI should clearly describe how issues of coercion and voluntariness will be addressed with research subjects.

(6) In cases where the PI wishes to use education records (printed, computer file, e-mail) and use those records as part of his or her research, all guidelines under the Family Educational Rights and Privacy Act (FERPA) must be adhered to and compliance with these guidelines must be addressed in the MU application materials.
*Refer to ed.gov for details on the FERPA.

11.7 Procedure for Student and Course-Related Research

For the purpose of this SOP, Student Research is defined as any observation or intervention by a student as part of a Miami University (MU) course which is designed to develop or contribute to student learning or to general knowledge. Course-related research is any research that is being conducted as part of a MU course. This SOP does not apply to masters theses or doctoral dissertations - such protocols must follow standard IRB procedures.

There are two types of student and course-related research projects: (a) student projects that are strictly for in-classroom exercises and (b) student projects that will be used beyond the classroom environment. For clarity, the IRB has established the following guidelines:

(A) Student Projects That are In-Classroom Exercises

For student projects that are solely classroom directed exercises (purpose of the student investigation is solely for the fulfillment of a course requirement) these projects do not require IRB review if they meet all of the following criteria:

(a) involve the learning of research techniques; AND

(b) involve no more than minimal risk; AND

(c) the data is recorded anonymously by the students (i.e., with no names, Social Security numbers, Banner Identification numbers, or any other codes that can be linked to a list of names, or the recorded data will not identify the subject through their behavior); AND

(d) the data will not be used beyond the classroom environment (i.e. will not be published, orally presented, presented at a conference, seminar/workshop, departmental colloquium, poster presentation or used in further research by the student, other class members or the instructor).

*If protocols/projects meet ALL of the above criteria, these projects shall be deemed to be "classroom exercises" and are not subject to review by the IRB. Instructors should consult with IRB if there is any question if your course content fulfills this requirement.

(B) Student Projects That will be Used Beyond the Classroom

For student projects that are part of a course requirement, but the student and/or instructor, plans to either publish, and/or present at a conference, seminar/workshop, departmental colloquium, or poster presentation, the following guidelines should be followed:

(a) If the research protocol is generic (i.e., all student researchers will use the same instruments, methods and consent procedures), the course instructor will submit an IRB Application form. He or she will be listed as the Principal Investigator (PI) and a listing of the students in the course will be provided as part of the application. Once approved by the IRB, the generic protocol may continue to be used by
student researchers for that course by the IRB unless:

a) the protocol is changed;
b) there is a complaint and/or adverse reaction from a subject;
c) the PI, instruments, methods and/or consent procedures have changed; or
d) there is a change in the research environment or new information that would indicate greater risk to human subjects than that assumed when the protocol was initially reviewed and approved.

(b) If the research protocol is not generic (i.e., each student will utilize different instruments, methods and consent procedures), then each student researcher, with the support of a faculty advisor (i.e., the course instructor or other faculty member if appropriate) will submit an IRB Application.
As with all IRB protocols, such protocols still must be reviewed annually through continuing review and submitted for revision if warranted in case of a change in PI, instruments, methods and/or consent procedures. If you are unsure if your course content is in compliance with this procedure, please contact the IRB at (513) 529-3600 or via email at (humansubjects@muohio.edu).

*Adapted from The University of Tulsa with grateful acknowledgement.

11.8 Procedure for Reviewing Research Involving
University-Collected Student Information*

In cases where a researcher wishes to utilize University-collected information (i.e., Data that is given to and maintained by the University such as SAT/ACT scores, student GPA, and/or related academic data) for purposes of human subjects research, the following guidelines have been established:

(a) Use of the Miami University Banner system to obtain such information is not allowed. Faculty/staff access to student information via Banner is for academic advisement and guidance purposes only and is not to be used to facilitate research in any manner. IRB applications that indicate the use of Banner for this purpose will be returned. For guidance on the purpose of and access information, refer to (www.muohio.edu/mcs).

(b) Since some students have requested that such records be kept confidential, University-collected student information may be obtained from the Office of Institutional Research (OIR) at (513) 529-3636. OIR will provide you with requested information in a confidential format and will only release information from those students who have not placed a restriction on their data. In this case, the researcher should develop a consent form that specifically allows the researcher to obtain the requested information from OIR for the project.

*This procedure only applies in cases where the researcher wishes to obtain University-collected information. If the researcher wishes to obtain such information directly from the subject, then normal consent procedures apply.

11.9 IRB Procedure Regarding Program Evaluations and Quality Improvement Programs

If the program evaluation or quality improvement program is being developed for purposes of creating generalizable knowledge and there are plans to publish the data gathered, then it is considered “research.” In this case the project does require IRB review and routine application submission procedures apply.*

However, since methods used in program evaluation and quality improvement employ some of the methods used in research, it may be challenging to determine whether or not the evaluation is considered research under the purview of the IRB. If your project fulfills the following criteria it is considered Program Evaluation or Quality Improvement and does not require IRB review:**

1) The data collection and analysis activities are not intended to generate scientific knowledge, but rather are used as a management tool to improve the provision of services to a specific population, organization or program; AND

2) The activities that are examined are not intended to have any application beyond the organization or program that is the target or source of the evaluation; AND

3) The purpose of the activity is to assess the success of an established program in achieving its objectives and the information gained from the evaluation will be used to provide feedback, monitor and/or improve the program.

*Some federal government agencies and private research organizations may require IRB review and approval of program evaluation or quality assurance projects. In such cases, the IRB should be notified of this requirement and the project should meet the criteria for IRB review as noted above.

**In some instances, evaluations may gather data from human subjects through direct or indirect interaction for purposes of evaluation. Even in cases where the project does not fall under the purview of the IRB, projects must be conducted with the highest level of regard for ethical standards and policies.

11.10 Procedure for Using University-Provided Survey Tools

The following SOP is designed to provide guidance to inform researchers of IRB –related issues when using the university-provided survey tools.

The Prezza Checkbox Web and Snap Surveys tools are available to faculty and staff for conducting surveys at Miami University. The Prezza Checkbox Web survey tool provides the ability to create and deploy online surveys using either a Windows or Macintosh computer. The Snap Surveys tool provides the ability to create and deploy both online and paper surveys and requires a Windows computer.

Attending the Survey Tools and Data Protection workshop is required in order to obtain an account for either of the University-provided survey tools. This workshop introduces the University-provided survey tools, ensure that faculty, staff and students are familiar with the University data confidentiality requirements and how to meet these requirements when using the survey tools. For more information about this workshop, please visit: http://survey.muohio.edu

Sponsored Accounts
Faculty and staff can request an account for a graduate student, a student employee or faculty may elect to request student accounts for a class project. These accounts are referred to as 'sponsored' accounts and remain active on a per semester basis.

Student accounts are created with a reduced feature set and will require collaboration with the faculty or staff sponsor.
Graduate student accounts are granted full access and require less interaction with the faculty or staff sponsor.

Reminder: Before an account can be created for you or a student you are sponsoring, both you and the sponsored account holder must attend the 'Survey Tools & Data Protection' workshop.

Survey Data Protection and Storage:
The Institutional Review Board (IRB) and the IT Services Information Security Office highly recommends that all survey results, public and confidential, be stored in a secure location. A dedicated survey data storage location is available to faculty and staff who use either the Prezza Checkbox Web or Snap Surveys tools. If you store data that should be protected in an unsecured storage space, you may assume risk associated with it being breached. To learn more about saving your survey results to a secure location, please see the MU Knowledge Base .

Important Information to Include in Your IRB Application:
Informed Consent-When using either Prezza or Snap, participants will be able to provide consent in one of two ways: (a) Through an electronic informed consent form (e.g., an information page with all of the informed consent guidelines) that participants will read and then notify the researcher that they authorize consent to participate in the study; or (b) Through reading the informed consent form and then completing the survey (receipt of the survey will serve as informed consent). These are only two examples of how informed consent may be secured. It is important that whatever method that is chosen, the process should be clearly outlined in your IRB application.

Procedure for Safeguarding Confidentiality-Since both Prezza and Snap utilize a firewall protected server, your IRB application should state this and also provide information regarding who in your research team will also have permission/access to the data.
If you have any questions regarding the survey tools, please visit the Survey Tools Web site at http://survey.muohio.edu or contact IT Services, Learning & Information Services at LIS@muohio.edu.