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Darden College of Education
Human Subjects Review Committee 

              The Darden College of Education Human Subjects Review Committee is charged with reviewing all applications for exempt research that involve human subjects.  Exempt research is defined by Federal law 45 CFR 46.101(b) which is intended to expedite research with human subjects that presents a minimal risk or presents no risk to participants.  The material on this site is intended to provide college researchers, including students at all levels, with information that assists with preparing an application for exempt research. 

              For information regarding ODU's policies for compliance when human subjects are involved in research studies, see the ODU web page at https://www.odu.edu/research/compliance/humans.

              Prior to submitting an Application for Exempt Research to the Darden College of Education Human Subjects Review Committee, researchers must determine that the research project is eligible for exempt status.  See the Human Subjects Decision Tree to determine whether a Human Subject Research Review Application Form should be submitted to the ODU Institutional Research Board (IRB) or whether an Application Form for Exempt Research should be submitted to the Darden College of Education Human Subjects Review Committee.  Also, see the possible exempt categories (categories 6.1, 6.2, 6.3, 6.4, or 6.6) listed on the Application for Exempt Research to determine whether the research project fits into one of the exempt categories. The Human Subjects Decision Tree and the Application for Exempt Research may be accessed at the following web page:  https://www.odu.edu/research/compliance/humans.

Review Committee Members

Dr. Theodore P. Remley, Jr., Chair (Counseling and Human Services) tremley@odu.edu
Dr. Angela Eckhoff (Teaching and Learning) adckhoff@odu.edu
Dr. Eddie Hill (Human Movement Sciences) ehill@odu.edu
Dr. Sabra Gear (Communication Disorders and Special Education) sgear@odu.edu
Dr. Ginger Watson-Papelis (STEM and Professional Studies) gswatson@odu.edu
Dr. Cherng-Jyh Yen (Educational Foundations and Leadership) cyen@odu.edu

 


DCOE Human Subjects Committee Review Process

            Applications for Exempt Research are considered as they are submitted throughout the calendar year (including summer term).  (Instructions for Submitting Exempt Applications)

            Throughout the process of review, correspondence from the committee chair is sent to the RPI with copies to the additional investigators associated with the research project who are listed on the application. 

            Applications for dissertation or thesis projects may be submitted once the dissertation or thesis committee chair has determined the research project plan is complete.  It is not necessary that the dissertation or thesis project have been previously formally approved by the student's committee.  Dissertation or thesis committee chairs are cautioned, however, to avoid submitting applications prematurely that would result in changes to the project having to be resubmitted to the Darden College of Education Human Subjects Review Committee at a later time for approval.

Step One:

            Responsible Project Investigator (RPI) submits to the committee chair (currently Dr. Ted Remley, tremley@odu.edu) by email attachment an Application for Exempt Research in one PDF document with the name of the RPI first followed by the names of the other researchers listed in the application (for example:  Smith-Jones-Brown-Davis).  The application must be signed and dated by the RPI prior to creating the PDF document.  Hard copies of applications are not accepted.  For guidance in completing an Application for Exempt Research, see below the "Instructions, Information, and Suggestions for Completing the Application for Exempt Research to be Submitted to the Darden College of Education Human Subjects Review Committee."

Step Two:

            Committee members conduct an initial review after an application has been submitted to the committee chair and one of the following three determinations is made:  the Application for Exempt Research (1) does not meet the criteria for exempt research; (2) is approved as exempt; or (2) is eligible for exemption if required modifications are made to the application.

Step Three:

            If the committee determines that an Application for Exempt Research does not meet the criteria for exemption, researchers are notified by the committee chair by email message that a different ODU Human Subjects Research Review Application must be submitted to the university Institutional Research Board (IRB).

            If an Application for Exempt Research is determined to be exempt by the committee, the committee chair notifies the researchers by email message, attaches a copy of the letter of exemption, and sends a signed hard copy of the exemption letter to the RPI through the ODU campus mail.

            If an Application for Exempt Research will be exempt if required modifications are made to the application, the committee chair notifies the researchers by email message of modifications to the application that are required to be exempt and may also make suggestions regarding the application.  The RPI modifies the application and resubmits it (in one PDF document) to the committee chair.  Once the chair determines the required modifications have been met, the committee chair notifies the researchers by email message that the exempt application has been approved, attaches a copy of the letter of exemption, and sends a signed hard copy of the exemption letter to the RPI through the ODU campus mail.

Step Four:

            Once an application has been approved, a number is assigned to the application.  The first four digits represent the academic year (academic year 2012-2013 is noted as 2013).  The 5th and 6th digits represent the semester (01=fall; 02=spring; 03=summer).  The 7th, 8th, and 9th digits represent the order in which applications were approved for the semester (starting with 001). 


Instructions, Information, and Suggestions
f
or Completing the
Application for Exempt Research
to be Submitted to the
Darden College of Education Human Subjects Review Committee

Introduction

            These instructions, information, and suggestions were developed by the committee to assist faculty members, staff members, and students in submitting applications.  This document supplements the instructions and information provided on the Application for Exempt Research form.

            A current version of the Application for Exempt Research form may be obtained at http://ww2.odu.edu/ao/research/compliance/humans.shtml.

            Completed applications must be signed by the Responsible Project Investigator (RPI) and submitted in one PDF document as an email attached sent to the Darden College of Education Human Subjects Review Committee chair, Dr. Ted Remley at tremley@odu.edu.  The signature of the RPI is essential and applications cannot be reviewed without signatures.  Signatures must be affixed prior to scanning the application package into one PDF document.

            A Collaborative Institutional Training Initiative (CITI) certificate awarded after completing the on-line Program entitled Basic Course in the Protection of Human Research Participants - Social and Behavioral Focus is required for each faculty member or graduate student listed as an investigator on an exempt application. Follow these guidelines regarding CITI certificates:

  • Certifications must be updated annually.  Out of date certificates will not be accepted.  If your certificate is more than one year old, go to the website and complete the refresher course and after you pass the refresher course, submit your updated certificate.
  • The website for taking the required module is located at https://www.citiprogram.org.
  • If the study is part of a master's thesis or doctoral dissertation, the graduate student completing the thesis or dissertation must be listed as an investigator.
  • The CITI Human Subjects module is different from the CITI Responsible Conduct of Research module that must be completed by all graduate students at ODU by the end of their first year of graduate studies. 
  • Faculty members or students who are assisting with a research project in minimal ways (such as data entry) should not be listed on the application. Responsible Project Investigators (RPIs) are responsible for making sure that all individuals involved in a study conduct it in an ethical manner. 

Parts of the Form

Responsible Project Investigator (RPI)

            Under "Code Name (One word):" please select one word from the title of your research project and insert that word as the code name.

Investigators

            If this research project is the dissertation or thesis research of graduate students, then the student must be listed in this section.

            Faculty members or students who are assisting with a research project in minimal ways (such as doing data entry or serving as dissertation/theses committee members) should not be listed on the application. 

            Others who are significantly involved in the research project should be listed in this section.  A CITI certificate must be submitted for each investigator listed on the application.

Type of Research

            Self-explanatory.

Funding

            Self-explanatory.

Research Dates

            3.a.  Indicate as the wished for start date a date in the future that is no sooner than two weeks after the application is submitted.  Regardless of the date listed here, the research project may not begin and data may not be collected until after the exemption application has been approved and approval has been communicated to the researchers.

            3.b.  The anticipated end date of the study should be listed.  It is best to extend the end date anticipated to perhaps a year from the start date.  If an application is determined to be exempt, the exemption is for an indefinite period. It is not necessary to request an extension for an exempt application if the end date is exceeded if a project has been determined to be exempt.

Human Subjects Review

            4.  If ODU is the only entity reviewing this research application related to Human Subjects, then mark Item 4 "No" and leave Items 4a and 4b blank.

            5.  Do not submit an entire dissertation or thesis proposal document.  Instead, describe the proposed study in sufficient detail to allow the Human Subjects Review Committee to determine if the study can be classified as exempt.  The Description of the Proposed Study should be no longer than 3-5 single space pages.  Descriptions that exceed 5 pages will be returned to be condensed to 3-5 pages.  In addition, include all documents checked. 

            The Description of the Proposed Study should include the following sections:

  1. Purpose of the study and research questions.
  2. Study procedures.
    a.      Research design.
    b.      Instruments to be used.
    c.      Participants.  Describe the proposed involvement of humans including their anticipated number, age range, and other demographic information.  Also, identify the criteria for inclusion of exclusion of any subpopulation.
    d.      Data collection procedures including how and when data will be gathered.
    e.      How anonymity for participants will be ensured (if it will).
    f.       How confidentiality will be maintained (if it will). 
    g.      Explain steps to be taken to provide options to not participate without penalty.  If extra credit in a course is given for participating in the research project, provide an alternative option for students who wish to receive extra credit but who do not wish to participate in the research project.
    h.      How the data will be managed, stored, reported and kept secure.  Also include specific plans for destroying the data five years after the project is completed.  Give sufficient details in this section for readers to understand exactly how data will be managed and destroyed.
    i.        If the proposed research will be conducted in a school system or agency, explain how the research policies for the system will be followed and describe how the system's or agency's consent to the research project will be obtained.
  3. Risks and Benefits for Participants
    a.      Specify any potential risks and the levels of potential risks to participants in the study (if any).  In some studies there are none.
    b.      Specify any potential benefits to participants in the study (if any).  In some studies there are none.
    c.       If potential risks exist, describe the procedures planned to protect against or minimize potential risks.
  4. Informed Consent (if consent will be obtained)
    a.      Informed consent usually is not required in exempt studies.  Exempt studies are deemed to have little or no risk to participants.  Informing participants and securing signatures when such actions are not necessary can inhibit participation in a study.  On the other hand, if participants' privacy may be affected, securing consent may be important from an ethical perspective.  Depending on the circumstances of the study, informed consent in some form may be required by the committee to ensure privacy of participants is respected or to ensure parents or guardians are informed of the study if they could be concerned if they were not informed about it.  Researchers may choose to obtain informed consent even though it is not required.  If informed consent will be obtained from participants (or their parents or guardians), include a copy of the informed consent form.
    b.      When a study involving minors or legally dependent adults is conducted and, whether exempt or not, includes a consent form that is signed by parents or guardians, then, if children are in the second grade or higher or the legally dependent adult has the capacity, an assent form should be signed by them as well.  If assent is not appropriate for participants because of their age, disability, or some other reason, researchers should indicate they will take feedback from participants (verbal or non-verbal) into consideration in order to determine whether participation in the study should be discontinued.

Exemption Categories       

            6.  Only one exemption category is necessary.  Identify and justify all exemption categories that apply.  Only one category is necessary to achieve exemption.  Most exemptions granted in the Darden College of Education are granted under categories 6.1, 6.2, and 6.4.

            6.1.  Exemptions under 6.1 sometimes are difficult to determine.  If a standard educational process is being studied (as opposed to a process that is unique or experimental), the study could be exempt.  It is acceptable if an exempt study introduces something new to the classroom (such as a new instructional tool).  However, the addition to the classroom should be in keeping with normal educational practices.  That is, the class should seem like a normal class to the students.  There are circumstances in which research with minors may be exempt.  Research studies with minors may be exempt under 6.1 if it is research conducted in standard educational settings.  Questionnaires can be used with minors in the context of the Category 1 exemption. A questionnaire completed by minors would be allowed if the questionnaire is part of the course activity (such as a commonly collected course evaluation).

            6.2.  This exempt category is appropriate when anonymous surveys and educational tests are used.  Minors may not be surveyed under this exemption. 

            6.3, 6.4, 6.5, and 6.6.  Self-explanatory.

Human Subjects Training

  1. Human Subject Training Certification
    a.      List the date the RPI completed Human Subject Protection training or the refresher course (must have been in the last year). 
    b.      See information at the top of this page regarding who must submit certificates and guidelines regarding certificates.

Signature

            RPI must sign and date the application form prior to converting the application and attached documents into one PDF document.

            Via Email and attachment, the RPI should submit the application and associated documents in one PDF document to the committee chair, Dr. Ted Remley at tremley@odu.edu.


Class Projects Policy

  1. Class projects that involve data collected for a course or courses that will be presented and/or published or disseminated in any form off campus must go through the usual DCOE human subjects review before data are collected.
  2. When the intent to present, publish, or disseminate findings from classroom projects in any off-campus venue is not known in advance, the following is in effect.
  3. An application for exempt research must be filed with the DCOE Human Subjects Review Committee.
    a.      Participants ( students) from whom data were gathered must be notified of the intent to present, publish or disseminate the information, and their assent to have their data used secured.
    b.      When identifiers are used; such as gathering data about the students from other sources, or as follow up to the class; the application must be submitted to the university IRB.
    c.       Publication, presentation or any other dissemination of the data may not occur prior to receiving formal approval for the chair of the Human Subjects Review Committee.
  4. When the researcher proposes to use archival data, such as data from previous classes, other policies are in effect. See the policy on "Archival Data".


Informed Consent

               As stated above, informed consent usually is not required in exempt studies.  Exempt studies are deemed to have little or no risk to participants.  Informing participants and securing signatures when such actions are not necessary can inhibit participation in a study.  On the other hand, if participants' privacy may be affected, securing consent may be important from an ethical perspective.

               Often, even though it is not required, study participants are given some type of information about a study in a cover letter to a survey or in introductory materials.  Researchers may wish to disclose that data being collected will be used in a study and may wish to explain who the researchers are and who participants should contact if they have any concerns.  Also, sometimes parents and guardians are informed about studies, but their permission is not sought.  Communications of these types may be brief and informal.

               Researchers may choose to obtain informed consent even though it is not required.  Depending on the circumstances of the study, informed consent in some form may be required by the committee to ensure privacy of participants is respected or to ensure parents or guardians are informed of the study if they could be concerned if they were not informed about it. 

               When a study involving minors or legally dependent adults is conducted and, whether exempt or not, includes a consent form that is signed by parents or guardians, then, if children are in the second grade or higher or the legally dependent adult has the capacity, an assent form should be signed by them as well.  If assent is not appropriate for participants because of their age, disability, or some other reason, researchers should indicate they will take feedback from participants (verbal or non-verbal) into consideration in order to determine whether participation in the study should be discontinued.

               If informed consent or assent will be obtained from participants (or their parents or guardians), you must include a copy of the informed consent forms you will use in your study.  Below are some sample forms you may choose to utilize if you determine that informed consent (or assent) should be obtained in your study.  Click on the title below to see the sample form.

Informed Consent Form
(for study participants who are 18 or older)

Parent or Guardian Permission Form
(when minors or adults who lack capacity are participants)

Assent Form
(for minors or adults who lack capacity)