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FAQs on Human Subjects in Research

FAQs on Human Subjects in Research
  1. Why must human subjects protocols be submitted?
  2. When do I need to submit an application?
  3. How will ORIA triage my project once I submit an application?
  4. Who can answer questions about the protocol?
  5. When are the IRB meetings?
  6. How long will the review process take?
  7. How will researchers be notified of the status of their protocols?
  8. When is a decision made by ORIA and when is it made by the IRB?
  9. How do I know if my project needs to be reviewed by the full IRB board?
  10. If my project needs full IRB review, will it be reviewed immediately?
  11. When should I submit a “human subjects research determination” form?
  12. What types of attachments should I include in my application?
  13. Are there any requirements for an informed consent form?
  14. Does an informed consent form always need to be signed by research participants?
  15. I am doing a research project involving minors.  Are there any additional requirements to which I must adhere?
  16. My project has been approved.  Is there anything else that I need to do?
  17. I am an undergraduate or graduate student.  May I submit an application for a project?
  18. I am doing a project for a research methodology/pedagogy class.  Do I need to submit a human subjects application?
  19. Are there any academic disciplines, like history or journalism, that are not required to go through ORIA/ IRB review?
  20. One of my research participants has experienced a problem.  What should I do?  
  21. Does a pilot study need to be reviewed by the IRB?

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1. Why must human subjects protocols be submitted?

All institutions that receive federal funding for research are required to comply with certain regulations regarding the treatment of people in research activities.  These regulations can be found at 45 CFR 46.  In order to comply with these regulations, research activities at GMU involving humans must undergo some level of ethical review by ORIA or the IRB.

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2. When do I need to submit an application?

45 CFR 46 defines “research” as a “systematic investigation designed to contribute to generalizable knowledge.”  “Human subject” is defined as “an individual about whom an investigator conducting research obtains data through intervention or interaction, OR identifiable private information.”  Investigators must submit an application for all projects that involve “research” and “human subject” per the federal definition.

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3. How will ORIA triage my project once I submit an application?

ORIA will triage a project into one of the four categories:

  1. Not human subjects research—The project is not research on human subjects (per the federal definitions above) and thus does not need to be reviewed by ORIA/the IRB.
  2. Exempt human subjects research—The project involves research on human subjects per the federal definition, but falls into one of the exemption categories listed in the regulations.
  3. Human subjects research subject to expedited review—The project involves research on human subjects and requires review.  However, the project does not require review by the full IRB (likely because it poses no more than minimal risk to research participants).
  4. Human subjects research subject to full IRB review—The project involves research on human subjects and must be reviewed by the full IRB.

4. Who can answer questions about the protocol?

You may discuss your proposed project with one of the compliance specialists in the ORIA. Contact Us

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5. When are the IRB meetings?

Meetings for the IRB are held once a month. See the IRB meeting schedule for IRB meetings for protocols requiring full board review. For review at a full board meeting, you must submit your completed protocol by the listed deadline (approximately three weeks prior to the board meeting).

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6. How long will the review process take?

If the protocol involves educational testing or survey procedures, does not use identifying information that can link subjects to data, and the subjects are healthy adult volunteers, the protocol may not require full IRB review. This type of protocol is reviewed through the expedited or exempt review process. The time involved in this process is shorter than full board review but depends on the number of projects submitted and under review by the office and the IRB members.

If the protocol involves invasive procedures and/or vulnerable subjects such as minors, prisoners, or mentally disabled persons, full review by the IRB may be required. The IRB has monthly scheduled protocol review meetings. Protocols requiring full board review must be received in the ORIA by the due date listed on the IRB meeting schedule in order to meet the deadline for a given meeting.

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7. How will researchers be notified of the status of their protocols?

An email will be sent to the principal investigator and the student researchers if appropriate regarding the status of the protocol after it has been reviewed initially. The IRB can issue an approval, a request for minor revisions, a tabling of the protocol, or a disapproval of the protocol.

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8. When is a decision made by ORIA and when is it made by the IRB?

ORIA performs the initial triage of a project and issues “not human subjects research” and “exempt human subjects research” determinations.  If a project is subject to expedited review, the project does not have to be reviewed by the full IRB but an IRB member will review it and make a determination on the project.  If a project requires full IRB review, it will be reviewed at the meeting associated with the submission deadline by which you have submitted your project.

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9. How do I know if my project needs to be reviewed by the full IRB board?

After you have submitted your application to ORIA and the staff has had a chance to review it, someone will let you know if your project requires full board review.  You may contact ORIA staff at any time before you submit an application to discuss your project and understand beforehand how ORIA will triage your project.  If you know you need a project reviewed by a certain time, it is best to check the IRB meeting schedule and make sure that you submit a completed application prior to the submission deadline for the meeting date that best suits your needs.

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10. If my project needs full IRB review, will it be reviewed immediately?

No, your project will not be reviewed immediately.  Because IRB members need time to review materials before they meet to discuss specific projects, we have a strict policy that only projects submitted by a deadline listed on the IRB meeting schedule page will be reviewed at the corresponding meeting.

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11. When should I submit a “human subjects research determination” form?

If you have experience working with ORIA and understand when an activity does not involve “research” or “human subjects” per the federal definition, then you may fill out a “human subjects research determination form.” You need only submit this form if you would like a letter from ORIA indicating that your project is not human subjects research (typically either for a sponsor or for an eventual journal publication).  Any questions may be directed to an ORIA compliance specialist. Contact Us

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12. What types of attachments should I include in my application?

The following is a description of the types of attachments you should include.  Remember, the attachments will change depending on the type of project that you are doing:

  • Proposed Consent Form (See Template Consent and Consent Guidelines available in IRBNet)– All instructional language removed, written at the appropriate reading level for participants
  • Proposed Assent Form (If minors are involved) – Written at the appropriate reading level for the age group (Contact ORIA for a sample of a 6th grade Assent Form)
  • Instrumentation – All surveys, questionnaires, standardized assessment tools, interview questions, focus group questions/prompts or other instruments of data collection
  • Recruitment Materials – Letters to potential participants, advertisements, flyers, listserve postings, emails, brochures, SONA postings, telephone scripts, presentation scripts, etc.
  • Grant Applications – If the research is funded, include the grant application as submitted to the funding agency (Please note that the human subjects application title must match the grant application title.)
  • Debriefing Form – If the study proposes to use deception or incomplete information to participants
  • Cultural Contact Information – If the study is being conducted outside the United States, ORIA/the IRB must inquire about the conduct of research in that country.  Submit the name and contact information of an individual who can provide that information. A faculty member (including the PI for the project) or any other individual with cultural knowledge may serve as the cultural contact.

13. Are there any requirements for an informed consent form?

Yes.  All informed consent documents must include:

  • A statement that the study involves research
  • An explanation of the purpose of the research
  • A description of the study itself and the study population
  • The expected duration of the subject’s participation
  • A description of the procedures/tasks subjects will be asked to complete
  • A description of any foreseeable risks or discomforts to the subject
  • A description of any benefits to the subject or to others which may reasonably be expected from the research.
  • How the data be used, and the extent to which confidentiality of records identifying the subject will be maintained.
  • A statement that the activity is voluntary and that subjects may withdraw at any time
  • PI (and other research team members as appropriate) contact information
  • ORIA contact information
  • A statement confirming that the individual gives their consent to participate
  • A signature line (unless documentation of informed consent is being waived)

Additional information is required in specific circumstances.  Please review our informed consent guidelines and template for more information.

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14. Does an informed consent form always need to be signed by research participants?

No.  On the human subjects application, there is a section where one may apply for a “waiver of documentation of informed consent.”  In certain minimal risk circumstances where it would either be impractical to collect signatures or the only record linking an individual to his or her responses would be the signature on the consent form, ORIA/the IRB will waive the requirement for signature.  Typically, waivers are granted for electronic surveys.  If you do not specifically request a waiver of documentation of informed consent, you are required to obtain signature on the consent form of each participant of a project.

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15.  I am doing a research project involving minors.  Are there any additional requirements to which I must adhere?

For research involving minors, the consent form must be signed by the parent or guardian of the minor, and the minor should (when possible or appropriate) sign a separate assent form.  The assent form does not have to include all of the elements of an informed consent document, but it must give the participant enough information about the project that he or she can make an informed choice about whether to participate.  The assent form should also be written in a way appropriate to the age of the participant.

For children whose age and/or comprehension level limit their ability to fully comprehend the nature of the research activity but who are still capable of being consulted about participation in research, it is best to convey a general picture of what the actual experience of participation in research is likely to be (for example, what his/her experience will be like, how long it will take, whether it might involve any pain or discomfort). The assent procedure should be a reasonable effort to allow the child to understand, to the degree they are capable, what their participation in research would involve. It is important to note that simply failing to object should not be interpreted as assent.

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16. My project has been approved.  Is there anything else that I need to do?

Once a project has been approved, you must communicate to ORIA in the following circumstances:

  • If you make any changes to the protocol or the instrumentation or recruitment materials associated with the project (using the amendment form, available in IRBNet).  You must also use the amendment form to alert ORIA/the IRB to changes in funding source.
  • If a research participant experiences an unexpected problem related to the research activity (using the Reportable New Information form, available in IRBNet)
  • When you have completed the project and are no longer recruiting participants or doing analysis (using the continuing review form, available in IRBNet)
  • If your project was reviewed via the full IRB board or through the expedited review procedure: you must complete the continuing review form at least annually updating ORIA and the IRB of the progress you have made with your project.  ORIA will send reminders about this requirement via IRBNet.

17. I am an undergraduate or graduate student.  May I be the primary investigator (PI) on a project?

No.  Only faculty members may be PIs.   If you as a student are conducting a research project, your faculty sponsor or the professor of the class for which you are doing the project is considered the PI.  That person must be listed on the application.

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18. I am doing a project for a research methodology/pedagogy class.  Do I need to submit a human subjects application?

Please review our Classroom Projects SOP for more information on which classroom projects require IRB review and which do not.  We are currently BETA testing an online tool to streamline this decision process for students taking pedagogy courses and instructors teaching them.  With this new tool, students will answer a series of questions and receive an automatic answer of whether or not the student’s project needs ORIA/IRB review.  More information will be released about this tool in the coming months.

In general, if you are collecting new information and:

  • That information will be collected and stored without direct identifiers;
  • You will not be using individuals under the age of 18 in your sample;
  • You will not be asking any sensitive questions; and
  • You will not be including any “vulnerable populations” in your study,

then a project conducted for a pedagogy class will not require ORIA/IRB review.  In general, if you are analyzing pre-existing data and your analysis file has no direct identifiers and the possibility of passive identification has been minimized, a project conducted for a pedagogy class will not require ORIA/IRB review.

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19. Are there any academic disciplines, like history or journalism, that are not required to go through ORIA/ IRB review?

ORIA has not exempted specific disciplines from undergoing ethical review.  In any discipline, if a project does not meet the definition of research or the definition of human subjects, it is not required to be reviewed by this office.

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20. One of my research participants has experienced a problem.  What should I do?

There are specific circumstances in which ORIA must be informed of research related problems.  Specifically, if:

  • A problem occurs that is directly related to the research activity; AND
  • The problem was not anticipated by the research team and thus not listed in the protocol document reviewed by ORIA/the IRB or the consent form given to participants; OR
  • The problem experienced was listed in the protocol document and the consent form, but the magnitude/severity that a research participant experienced was not anticipated

then the reportable new information form (available in IRBNet) must be filled out and submitted to ORIA promptly.  Depending on the funding source of the project, a formal report of the incident may need to be submitted to a federal funding agency.

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21. Does a pilot study need to be reviewed by the IRB?

The number of participants does not determine whether review is needed. The determining factor is whether or not human subjects are involved in research per the federal definition.

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