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  Research using Humans as Subjects:
    Standard Operating Procedures


1. Course-Related Research Projects

a. For class assignments
b. For class assignments and external use of data
c. Use of Miami Course Evaluation data

2. FERPA and Research with Humans as Subjects

2.a . Faculty using Students Enrolled in their Class for Research

3. Permission to Conduct Research at a Location

4. Procedure for Research Involving Collaboration with Researchers External to Miami

5. Outside Researchers on Miami's Campus

6. Oral History Projects

7. Program Evaluations, Quality Improvement Programs, and Accreditation

8. Regulated Activities

9. Collaboration with Researchers outside Miami

SOP 1: Procedures for Student-Course Centered Research

Student research is defined as any observation or intervention that meets the regulatory definition for "Human Subjects Research" by a student as part of a Miami University (MU) course. There are two types of student-course centered research projects:

(A) student projects that are strictly for meeting curriculum requirements and not to be used outside of the course, and
(B) student projects where results will be used outside the normal curriculum.



(a) Student projects that are In-Classroom Exercises

For student projects that are solely classroom directed exercises (the 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 to the subjects and students; 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(d) the data will not be used beyond the classroom environment (i.e. will not be published, orally presented, presented at a conference, seminar/workshop, departmental colloquium, poster presentation or used in further research by the student, other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. If there is a any question about meeting the criteria, instructors should consult with the compliance office. Given the time constraints of a class and the objectives of most courses, it would be wise if all student projects entailed minimal risk.

For classes using this method, it would be wise for the instructor to inform the students regarding the limitations on use of the data. They may also advise the students that if they want to use the data outside of a class assignment, they can seek IRB approval independently (although they would need to find a faculty advisor). Review should be conducted and approval obtained prior to beginning the recruitment of subjects and collection of data.

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 as well as 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. A faculty member who is negligent regarding research oversight may be found at fault under the Miami policy for Research Misconduct (RM) as being behavior not "commonly accepted within the research community."

(RM Policy Link)


(B) Student projects that will extend 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

One Project per Class:

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.

Multiple Projects per class:

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:

All of the students complete Part I of the training program: the CITI online training for research using human subjects.
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).

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).

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.

The faculty member is responsible for submitting all of the applications (sender MU email address serves as the advisor signature). 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).

The IRB chair distributes all of these protocols to a sub-committee that will act as the reviewers for all of these projects.

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 this method is timely review of protocols.

Preferred Organization of Applications:

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 checked and stored in a Zip file by the faculty advisor (FA) and given a unique name (e.g. include a students uniqueid or name). Word documents and other files (including zips) can simply be dragged into the zip file.We like to work with zip collections because they behave like a single file and can be moved around very easily.

2. The FA emails 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 file to us.

If you are a mac user,we do not know enough about macs to advise you how to accomplish the same thing, but it 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).

 


(c) Use of Miami Course Evaluation Data in Research

Summary: It is Miami policy that use of course evaluations for research purposes requires approval from the Provosts office. Instructors do not have the authority to provide course evaluation information to researchers. It is implicit in the course evaluation system that the evaluation data is to be used for course improvement only. Most assessments of teaching methods employ data collection separate from course evaluations that can include examination of submitted materials/test scores etc. An approved passive consent/notification process is used for past students and their de-identified data (instructors remove identifiers from narrative responses) and an active consent process is used for current and future students which allows for adding specific questions addressing the research question.

Rationale and Examples:

Course evaluations are conducted for evaluating instructors and courses for purposes internal to Miami. They are not conducted to collect information about students or for publishing research. The data that is collected belongs to Miami.

Instructors do not have the authority to use or grant the use of the data for purposes other than that intended, e.g. public use of data without subject consent. The Miami Research Ethics and Integrity Office (MREI or IRB) has limited authority to approve use of course evaluation data for research purposes if the methods employed are acceptable.

An instructor may have taught a course for several years using a particular teaching method (e.g. lecture style) and the course evaluations were conducted using the standard university and departmental procedures. If the instructor noticed that after changing to a new teaching method (e.g. active learning) that there seemed to be a change in student perception of the course or learning of concepts and that this information may be useful for other instructors, they may wish to use the course evaluations as part of the data used in the analysis (along with grades and other course materials). When this type of research is proposed to the IRB, it is recognized that it would be nearly impossible to obtain student consent. It is also recognized that the research has potential value. The IRB requirements under such circumstances usually include provisions such as these:

1. Retrospective Analysis of Unplanned Research Data-

a. use of a passive consent process (e.g. an attempt is made to notify students regarding the course evaluations usually via an email message explaining the project).

b. researchers ensure that identifiers are removed from data before analysis (e.g. narrative responses in course evaluations may include identifiers and those are removed, identifiers are replaced with random identifiers in gradebooks).

c. active consent is obtained whenever there use of quoted material (essay excerpts) or intellectual property of the students (essays) is proposed to be conveyed to anyone who would not have access to the information as part of their normal role (an instructor of the class in which the student is enrolled would have access to the work but a colleague in another institution or department should not have access without student/subject consent (FERPA related)).

Depending on the nature of the data, permission from an institutional authority may be required (e.g. Provost’ office). The requirement would be determined during the review by the MREI/IRB.

2. Prospective Research -

If this researcher (or any researcher) decides that it would serve the research by either collecting additional data using the course evaluation system or any other data collection (surveys, interviews, grades), then the normal review, approval, and subject consent processes must be used. Often, projects involve elements of retrospective analysis and prospective research and on applications to the IRB the differences (e.g. consent and degree of confidentiality) should be readily distinguishable

Considerations:

• Many students take part in human subjects training and research. They are aware of the consent process and would expect the faculty to adhere to the ethical principles of research.

• Miami staff have access to data as part of their role in education (course evaluations, grades etc.). Some have assumed that they can use this data without consent rationalizing this by saying that the subjects would not know of the use, , therefore it is not an ethical problem. Given the way that personal data has been used in recent years without consent/permission and the response of the public (e.g. Facebook, Google ,etc) it might not be wise for Miami to knowingly promote similar behavior. Being able to provide documentation that the methods and use of the data has been institutionally reviewed and approved is wise.

• Routine use of course evaluation data for research can lead to misuse. In the past, instructors have added their own questions to the evaluation process specifically for research purposes (for both prospective project and post-hoc applications). For example, collecting individual demographic and other data to describe responses to the change in curriculum, e.g. GPA, major, age, ethnicity, gender. This is potentially valuable information but not the purpose of the course evaluation system and could compromise the evaluation. This sort of data should be collected outside the course evaluation system.

 

 



SOP 2: FERPA, Regulated Research, and the Consent Process

The Family Educational Rights & Privacy Act (FERPA) is a 1974 federal law designed to protect the privacy of students. FERPA protects the privacy of students' education records by setting forth strict limitations governing the release of information about students. The university-wide general policy regarding FERPA is found at: http://miamioh.edu/about-miami/leadership/general-counsel/

A FERPA release from students is required if data is being requested for use in research from the registrars office, an instructor, or any other Miami office. If, as a question on a survey, a subject is asked to provide their current GPA, this would not entail FERPA requirements but would require appropriate provisions for consent and confidentiality.

For research reviewed and approved through the Miami Research Ethics and Integrity Office (e.g. IRB), the FERPA release can be incorporated into the consent process.

Information conveyed to the potential research subjects must include specific information about:

1. Who will have access to records that would include implicit or explicit identifiers.
2. When identifiers would be removed from the stored records (or if identifiers would not be removed).
3. What records are being released to the researchers (e.g. full transcript, final grades for a course, course assignments etc.)
4. When research data will be destroyed.
5. How protected records will be incorporated into the research (e.g. results will be presented as aggregate summaries).

If the title of the project implies information of a sensitive nature, the FERPA permission form should not be combined with the research consent form. A separate document should be used.

Acceptable methods for obtaining a release:

Direct Interactions with research subjects:

For activities where the researcher will have face-to-face contact with the subjects, a FERPA release form with a physical signature is required. An oral release is not adequate when there is an opportunity for collecting a physical signature. The form provided on the General Counsels web page includes a place for certification by a notary, this is not required for research, however, there should be some means of assuring the signatory has the authority to release the records (i.e. it is the individual or their legal guardian). For observing FERPA restrictions outside of Miami, researchers must comply with the policies of that institution. For example, a graduate student who is also a teacher in a public k-12 school must follow the policies of their school district when obtaining a release/use of student records.

Online interactions with research subjects:

For online research activities involving Miami students, an electronic process may be used that includes the use of Miami Unique-ID login and password to document that the student is releasing the data. A passive release is not adequate. Such a form could be developed using Google Forms. An example of such a web based form can be found at: https://goo.gl/forms/0xUrCAhvTGtnlSrI3 . Basic information about creating a google form can be found at: Responses to the form are automatically collected on a spreadsheet stored on Google drive space.
For online research involving non-Miami students where FERPA protected records are going to be used, an alternative means of assuring that an appropriate person is granting the release may be proposed in the IRB application (for example, a teacher who has interactions with parents through email exchanges, may use an email exchange to document a FERPA release).

The following should be included as part of the consent form or as part of an independent FERPA release (edited as appropriate):

The Family Education Rights and Privacy Act (FERPA) is a Federal law that protects the privacy of student education records, both financial and academic. For the student’s protection, FERPA limits release of student record information without the student’s explicit written consent. By signing this form you are consenting to the release of information as described in the research description above. Note: once identifiers have been removed from the data and the data is added to the data set to be analyzed, it will be impossible to extract your individual data if you withdraw from the research project.




SOP 2.a: Faculty using Students Enrolled in their Class as Research Subjects


Overview -

When you are seeking to do research with your students as your subjects, you are functioning in two capacities:

- As the instructor who would have access to student generated materials to provide information, evaluate work, and assign grades (the work the students submit is their intellectual property and along with grades, is FERPA protected (see below)).

- As the researcher who would like to analyze this information (and possibly modify the teaching methods) for use outside the institution.

Basically, you are asking for permission to release the information for a different use and the nature of the use is specified in the consent form/FERPA release.

Part of the challenge of this type of research is distinguishing between the teacher function and the researcher function for both yourself and your classes. If your research really has no reasonable relationship to the coursework, then asking to use class time for your research is problematic. You could ask the students to participate outside of class, but under these circumstances, incentives like offering extra-credit for participation is problematic as it might be perceived as coercive. When participation in the research is also an educational experience related to the course topic, review and approval is easier.

Note: Use of Institutional Course Evaluations for Research -
It is Miami policy that use of course evaluations for research purposes requires approval from the Provosts office. Instructors do not have the authority to provide course evaluation information to researchers. It is implicit in the course evaluation system that the evaluation data is to be used for course improvement only. Most assessments of teaching methods employ data collection separate from course evaluations that can include examination of submitted materials/test scores etc. An approved passive consent/notification process is used for past students and their de-identified data (instructors remove identifiers from narrative responses) and an active consent process is used for current and future students which allows for adding specific questions addressing the research question.

Preparing your application -

As with all projects, the approved procedures would be those that are appropriate for your subject population and the risk inherent to your research. That is, there isn’t a one-size-fits-all set of procedures. That said, there are some common concerns and common situations that are described below.

1. The consent process needs to be enhanced to ensure that the subjects (and the parents of minors) are comfortable with participating or declining to participate. In addition to the use of direct communication regarding the voluntariness, a researcher may indicate an element of accountability by providing contact information for an administrator/supervisor. Examples include, a school principal, a department chair, an employer.

2. If you are conducting research that tests new methods of teaching (a novel approach or new to you) for a course, it would be wise to discuss the issue with your department chair so that they understand what you are doing. While instructors often have great latitude in choosing their teaching methods, when your curriculum is associated with research through the consent process, the perception of the subjects/parents might be negative.

You may have access to the material as an instructor, but use of the materials requires institutional review and consent of the subjects.
If the research information includes materials that might be considered the intellectual property of the students (e.g. essays), analysis of the materials might be conducted with consent, but there must be explicit consent for the use of quotations, especially if the materials are on the internet where the quote might be used to link to subject identity.

If FERPA protected data is part of the research, the extent of release should be described to the reviewers in the application and the subjects in the consent information. If you as the researcher/instructor are the only person who will have access to the data with identifiers, then essentially you are asking for a release of the information for research use. If collaborators who would not normally have access to the private information are going to have access, that needs to be specified. Likewise, if collaborators are only going to have access to de-identified data,, that should be specified. If an instructor is going to request FERPA information from outside the course (e.g. from the Registrar’s Office, Banner, Demographic information from Student Affairs), then this too must be explicit. Since identity would need to be maintained to make the link between the FERPA data and the research data, it should be specified in the application and consent information when and if identifiers will be replaced with a random code.

Scenarios -


If you are seeking to recruit the students in your current or future class for your research:

Get consent prospectively unless there is a valid justification for with-holding knowledge about the research (i.e. foreknowledge would negatively impact the research).

If you are conducting an experiment where more than one section is involved and the sections will receive different instruction/experiences, seek to mitigate the potential perception that some students are being denied an opportunity. If the research involves only a part of the coursework or an assignment, offer the alternative experience in some way to each section. If the research requires all the materials for the full semester, either the potential impact on the students opportunities need to be low (justified) or there

Get permission from an appropriate administrator (again, department chair, principal) and include their contact information in the consent form.

To enhance the perception of voluntariness in the consent process, have a colleague present the consent/assent information to the subjects/parents indicating that the consent forms will be held by the colleague until after grades have been submitted and the subjects can decline to participate or withdraw without the instructor’s knowledge.

Incorporate a FERPA Release into the consent information following the policies outlined here (SOP 2; above).

If you are seeking to recruit the students from courses from the past:

Justify the fact that review and approval was not sought before the data was collected. This does understandably occur, for example, an instructor has learned a new method of presenting materials and as a metric of its efficacy, would like to compare the quiz scores from past semesters to that of the current semester.

Describe a system where the data is de-identified before the researchers will have access to the data.

Ideally, data would be limited to quantitative materials (e.g. exam and quiz scores). If qualitative data is to be used in the research, (e.g. essays, to include essays on exams), quotations may not be included in presentations/publications without explicit permission of the owners of that property.

If it is in the recent past, attempt to contact the students/parents about consent. This might take the form of an attempt at notifying the subjects/parents about the anonymity of the analyzed data and that essays would be analyzed and the notes on the analysis would be the data rather than the essays.

If the data was collected from the student/subjects in the distant past and re-contacting the subjects/parents is unlikely. The researcher must very explicitly describe how data would be limited. For example, only quantitative data, only a defined section of a lab report, data would not include information beyond grades about the subjects (demographics). The closer the researcher gets to using personal or confidential information where identification is implicit or explicit without consent, the more difficult the approval process will be.

If data with identifiers includes FERPA protected information, the FERPA policy of the General Counsel must be observed although a FERPA release via google form MU login / password for current students can be used in place of the collection of a physical signature (see SOP 2 above).

 



SOP 5: Outside Researchers on Miami's Campus

When 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 forms and 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 (humansubjects@miamioh.edu).

(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.

On invitations to participate in research, you may refer subjects to the Miami Compliance Office for questions or concerns about your procedures (per our policy, we will have a copy of the protocol on file)

 

 

SOP 7: 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.

If you are a Miami staff or faculty member and are going to be using data about Miami students,
programs, or personnel for research purposes, you must obtain permission to use that data from an
appropriate higher authority. This may be your Program Director, Supervisor, your Dean,
or the Provost's office.
 


 

SOP 8: Regulated Activities

Human Subject:
a living individual about whom an investigator conducting research obtains (a) data through intervention or interaction with the individual, or (b) private information that may be linked to subject identity.

Research:
is defined as a systematic investigation, inquiry or analysis-including critical analysis or inquiry-that is designed to develop or contribute to generalizable knowledge.

    Regulated Research:
    an activity that involves human subjects as defined above and research as defined above;

        • There is a plan or design to collect data,
        • that can effect live humans, and
        • the intent is to develop or contribute to generalizable knowledge for public consumption by sub-sampling from the population you are trying to describe.

          Note: course assignment related research may meet this definition, however, limited public exposure reduces risk and SOP 1 (above) may be employed (the faculty advisor is responsible for ethics and research may not be used outside of the class).

SOP 9: Collaboration with researchers external to Miami
 
- What type of Agreement is required? Decision Tree (draft)

SOP 10: Research in Europe, GDPR, and Consent
 
 

 



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

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