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Human Subjects Research >> References >>  

Standard Operating Procedures


11.1 Incomplete Applications
11.2 Post-Hoc Review of Research
11.3
Procedure for Research Involving Collaboration with Researchers External to Miami
11.4 Outside Researchers on Miami's Campus
11.5 Oral History Projects
11.6 Research Involving the Internet or Electronic Mail
11.7 Research Conducted in a Public or Private Educational Setting
11.8 Student and Course-Related Research Projects

New 11.8.a FERPA, Research and Consent
New Faculty using Students Enrolled in their Class as Research Subjects
11.9 Research Involving University-Collected Student Information
11.10 Program Evaluations, Quality Improvement Programs, and Accreditation Assessment
11.11 Using University-Provided Survey Tools

11.12 Permission to Conduct Research at a Location
11.13
Protocol Application Submission and Signature Policy
11.14 Use of Entity Accounts with Qualtrics


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 Human Subjects Research Application. The application should provide information on all activities that have occurred and decribe them as they did occur. Alon with the application, a short letter requesting Post-Hoc Review providing a rationale for submitting the application after the research was begun.

(c) Since conducting research without IRB approval is a research non-compliance issue, the application will be reviewed by the IRB Chairperson and the Director of Research Compliance. 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 were used or could be used for future activities 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 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 Director of Research Compliance will also conduct an investigation of non-compliance and the findings of the investigation will be sent to the researcher in writing.

The focus and goal of the post-hoc review process is to protect human subjects. The resolution of such cases can take many forms, each resolution will depend on the research project.



11.3 Procedure for Research Involving Collaboration with Researchers External to Miami

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 and research activities will occur on a Miami Campus or involve Miami students as subjects:

(a) The MU researcher is required to submit an IRB application if he or she is the lead researcher. In this protocol application, the activities of the Miami researchers should be distinguished from those of the external collaborators.

(b) If it is a multi-institution study with multiple collection sites. Miami may accept the IRB review and approval of another institution. Contact the compliance office for study specific information.



11.4 Procedure for Research Conducted by Researchers from Outside Miami

In cases where a researcher from another institution is the principal investigator on a project and wishes to conduct research at MU that involves human subjects:

(a) It is Miami Policy that all human subjects research being conducted on a Miami campus be reviewed by an Institutional Review Board. That IRB review or exemption could be provided by the home institution of the researcher.

(b) If the outside researcher is collaborating with a Miami employee and the Miami employee is functioning as a researcher, the Miami researcher must be listed as personnel on the external collaborator's IRB approved protocol or the Miami IRB must conduct a review of the protocol using the Miami procedures.

(c) If no Miami personnel will be obtaining consent of subjects, collecting data or having access to data with identifiers, then Miami is not engaged in research therefore Miami IRB approval or Compliance Office exemption are not required. However, we ask that external researchers send us a copy of the protocol and approval letter because we may be contacted about the project by potential subjects or the university administration granting access. Copies of the research description and the approval letter should be sent to the Miami's Research Compliance Office for our records.

(d) Researchers must still obtain permission to use Miami facilities from the appropriate official (e.g. Dean of Student Affairs, Dean of a College, Department Chairs, Provosts Office etc.). The IRB and compliance office do not have the authority to grant or deny access to Miami facilities, staff, or students. Rather, the IRB or Compliance office review and approve procedures.

Note: Unless the Miami IRB has conducted a review and issued an approval letter, Miami University or the Miami IRB cannot be referenced as approving of the research. Compliance office acceptance of external review does not constitute Miami IRB approval.

You can refer subjects to the Miami Compliance Office for questions or concerns about the procedures (per our policy, we will have a copy of the protocol on file)

11.5 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 to 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.

See the MU FAQ's Entry on oral history for more information.

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


11.6 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.


11.7 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.


11.8 Procedure for Student and Course-Related Research

This 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 an MU course.

This policy does not apply to masters theses or doctoral dissertations - such protocols must follow standard IRB/Exemption 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, email addresses, or any other codes that can be linked to a list of names, or the recorded data will not identify the subject through deduction); 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).

* Projects must meet all of the conditions stated above and instructors should consult with the compliance office before assuming that their class assignment does not fall under the purview of the IRB.

Note:
For activities utilizing the "In-Classroom Research" status (11.8 (A), the onus of responsibility for the ethical and safe conduct of students in the class and the welfare of their subjects is placed on the instructor.

In all cases, it is expected the activities will meet the code of ethics associated with the professional society(ies) of that field.

 

(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, poster presentation, or any other public dissemination, the following guidelines should be followed:

Management, Training for and Review of Class Projects

(a) If the research protocol is generic (i.e., all student researchers will use the same instruments, methods and consent procedures), the course instructor may submit an IRB Application form or Exemption Application form. Information should be provided regarding the training students will receive. The faculty advisor would be listed as the Principal Investigator (PI) and a listing of the students in the course will be provided as part of the application. The instructors should emphasize the importance of human subjects protection with their students and the students should complete the online CITI training.

Once approved by the IRB, the generic protocol may continue to be used by student researchers for that course in any future semester by the IRB unless:

a) there is a complaint and/or adverse reaction from a subject, or;
b) 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, or;
e) the instructor fails to renew the protocol through the annual status report.

If utilizing the approved protocol for multiple semesters, the list of students for subsequent terms can be updated via a protocol modification form as can minor changes in procedures and consent forms.

Instructors using this method should use the "General Research" form or Exemption Screening form but include information about the course, e.g. title, number, syllabus.

(b) If the research protocol is not generic (i.e., each student/group will utilize different instruments, methods and consent procedures), then each student/group, with the support of a faculty advisor (i.e., the course instructor or other faculty member if appropriate) will submit an IRB Application or Exemption Screening Application.

Suggested method of managing class projects:

Description of procedures:

  1. All of the students complete Part I of the training program: the CITI online training for research using human subjects.
  2. The faculty member must complete all training and be familiar with the class projects policy (Parts I and II, and discuss the class project with the IRB Administrator).
  3. The students may or may not (faculty member choice) be required to complete Part II of the training application writing training (we may be able to send someone to the class to conduct the training).
  4. The students must submit their applications to the faculty member for pre-review. The advisor pre-review should address risk assessment, the consent process, methods etc. as well as address whether the activitiy meets the definition of regulated research.
  5. The faculty member is responsible for submitting all of the applications (sender MU email address serves as the advisor signature).
  6. ALL of the applications should be submitted at once. (The faculty might consider including the IRB application as an assignment for which there is a late penalty).
  7. The IRB chair distributes all of these protocols to a sub-committee that will act as the reviewers for all of these projects.


    Note:
    Faculty advisors are expected to pre-review and approve all applications before submitting them for institutional review to ensure that the applications are complete and the project is understandable and can be accomplished safely and ethically by the students.

    With multiple projects per class, this can be time-consuming and challenging. However, the pre-review responsibilites cannot be transferred to the IRB/Compliance Office. Applications may be rejected or review/approval will be delayed. It is wise for instructors to set bounds on the types of research that can be proposed by students for these assignments or set aside sufficient time to pre-review all applications.

Instructors: please contact the IRB administrator before distributing the class assignment for details regarding this procedure and for scheduling in-class training. One of the primary advantages of heeding the advice offered here and adopting these methods is timely review of protocols.

Preferred Organization:

If you are a PC user, here is a way that works well:

1. For each student/project, the application documents (there could be several documents) are traiaged and stored in a Zip file by the faculty advisor (FA) and given a unique name (e.g. including a students uniqueid). Word documents and other files (including zips) can simply be dragged into the zip file.

2. The FA emails many of the resulting zips in one or a few submissions (gmail can handle attachments totaling up to 25 MB). It may or may not be easy to attach multiple files to an email message. That is, it depends on your browser and email software. For Outlook and Gmail, you can drag zip files into the message. In fact, you could create a zip file for each student as well as one zip file for the class and drag the individual project zips into the class zip and then just send the class zip to us.

We like to work with zip collections because they behave like a single file and can be moved around very easily.

If you are a mac user,we do not know enough about macs to advise you how to accomplish the same thing, but 7it can be done (from : google search "mac and zip files"). http://macs.about.com/od/faq1/f/How-To-Zip-And-Unzip-Files-And-Folders-On-A-Mac.htm

As with all IRB approved 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. Projects approved as Exempt, do not have to be renewed annually.

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@miamioh.edu).


11.9 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 institutionalresearch@muohio.edu.
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.


11.10 IRB Procedures Regarding:
Program Evaluations,
Quality Improvement Programs,
and Accreditation Assessments

There are two major issues to address with these activities:

1. Distinguishing between activities that would occur regardless of the research activities and those activities that comprise the research. The IRB does not have purview over any activities that are adopted by some entity including Miami. The IRB only has purview over activities that meet the federal definition of regulated research.

2. If data is to be collected to evaluate the activity, then the way that data is to be used determines if the evaluation is regulated human subjects research. If the data is to be used by the entity for improving the program without public reporting, then it is not regulated human subjects research. If the data is going to be used by Miami personnel for public presentation/publication, then the activity requires IRB oversight or IRB Exemption.

However, since methods used in program evaluation, quality improvement, or assessment employ methods typically 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 the project 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. This may include external reviewers and program evaluators; 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 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.


11.11 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 to 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 consent form (e.g., an information page with all of the 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 consent form and then completing the survey (receipt of the survey will serve as informed consent). These are only two examples of how 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://www.units.muohio.edu/uit/research/survey-tools or contact IT Services, Learning & Information Services at LIS@muohio.edu.


11.12 Permission to Conduct Research On or Off Campus

The IRB reviews applications based on anticipated risks and benefits and the protections afforded to the subjects, however, the IRB cannot grant permission to researchers to use any location to conduct research. Researchers must seek and obtain permission to conduct research from the owner or appropriate official at that location.

a) Miami Researchers conducting research at off-campus locations:

It is the policy of Miami University that personnel conducting research as Miami employees or students obtain permission from the appropriate official to conduct research at any off-campus location. With the exception of research involving a vulnerable population (pregnant women and fetuses, prisoners, children, and economically or educationally disadvantaged persons), it is the responsibility of Miami PI’s to obtain permission and maintain documentation of that permission.

When vulnerable populations are the subjects of research, documents granting permission must be submitted to the IRB before research can be initiated. Accepted documentation includes: original signed paper copies on letterhead from the appropriate official OR email messages sent directly from the authorized official to the IRB email address (humansubjects@muohio.edu). Electronic messages not originating from the official or forwarded by researchers through their email account are not acceptable. If the application is being reviewed by the Psychology Department Review Board (DRB), researchers should arrange to have the permission documents sent to the chair of that board.

b) Non-Miami Researchers conducting research on a Miami Campus:

It is Miami Policy that all human subjects research being conducted on a Miami campus be reviewed by an Institutional Review Board. If the home institution of the researcher has an IRB, that review process may be accepted by MU. A copy of the approved protocol and a copy of the approval letter must be sent to the Miami's Research Compliance Office prior to initiating research. If the home institution of the researcher does not have an IRB, the Miami IRB may be used for the review process. If the outside researcher is collaborating with a Miami employee and the Miami employee is functioning as a researcher, the Miami IRB must conduct a review of the protocol using the Miami procedure. Researchers must still obtain permission from the appropriate official (e.g. Dean of Student Affairs, Dean of a College, Department Chairs, Provosts Office etc.)


11.13 Protocol Application Submission and Signature Policy

An original signed paper copy of your application is not required. However, applications will not be accepted directly from undergraduate or graduate students.

1. All protocols must be submitted electronically to humansubjects@muohio.edu by a faculty researcher or the faculty advisor of a student researcher (or submitted by an authorized non-faculty staff member).
2. Submissions must be emailed from faculty using their MU email account.

See the FAQ / Guidance for further information regarding this policy


11.14 Use of Entity Accounts for the Collection of Data using Qualtrics:

Since anyone, past or present, who has the password for an entity account using Qualtrics will have access to the data collected, this raises issues of confidentiality and personal accountability with regards to complying with federal regulations and Miami policies regarding human subjects research. To address these issues and respect the rights of subjects:


1. If the entity account is going to be used for any activities that meet the regulatory definition of human subjects research, all personnel with knowledge of the entity account password must be listed as personnel on the Institutional Review Board (IRB) approved protocol (or listed on the exemption certification application). All personnel must complete the relevant training requirements.

2. In addition, since it is likely not all personnel need to have access to the data from all activities for which the entity account is used, as soon as is possible after the end of data collection, the data must be downloaded by the researchers and deleted from the entity account Qualtrics storage space.

3. In IRB protocol applications and Exemption Screening Applications, the use of the entity account must be specified and details related to personnel access and subject protection must be included (Note: for existing approved research, this information can be provided through the use of a modification application).

 

Please contact The Office for the Advancement of Research and Scholarship if you have questions about this web site:
513-529-3600 or email: sullivnh@miamioh.edu

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