Students as Researchers Guidance-January 1, 2024

Students as Researchers Guidance

Note that the following guidance will replace the current Student as Researchers Guidance on January 1, 2024. We encourage student researchers and faculty sponsors to review this content prior to the January 1, 2024 effective date. Beginning January 1, 2024 undergraduate students will no longer be allowed to serve as the PI on new IRB applications. 

In order to constitute student research a project must be initiated and conducted by the student, under the guidance of a faculty sponsor. This includes the development of the purpose and objectives of the research, description of research methodology, construction and distribution of surveys and related consent documents, and analysis of data.

  • Undergraduate students should be listed as the co-PI on the IRB application with the faculty advisor sponsor listed as the principal investigator (PI).
  • Graduate students may be listed as the PI, but these applications must include a faculty or staff member listed as the Faculty Sponsor.

Categories of Student Research Involving Human Participants

Questions regarding these categories and human research participant requirements should be directed to the Research Compliance Coordinator in ORGA. Course IRB approval may be appropriate in some circumstances.

1. Research Practica or Course-Based Research Assignments

A number of departments offer courses that require students to undertake projects in which other people are interviewed, observed, or otherwise serve as participants. The purpose of these course projects is to train students and provide them with a closer view of social, educational, or psychological processes, and an opportunity to practice various research methods. Such projects typically do not lead to generalizable knowledge and are not undertaken with that goal in mind. Therefore, the IRB does not consider them to be research and they do not need to be submitted for Human Subject Participant (IRB) review UNLESS study subjects include persons who are not enrolled in the course and/or departmental research participant pool AND involve:

  • minors,
  • other special or vulnerable populations whose ability to give informed consent may be compromised,
    pregnant women or fetuses who may be put at risk of physical harm,
  • a topic of a sensitive nature, the examination or reporting of such may place the participant at more than minimal risk, or
  • any type of activity that places the participant at more than minimal risk.

However, even when human participant involvement in course projects or pilot studies is not considered research, these projects should follow the same guidelines for the protection of people's privacy, dignity, and welfare. In these instances, we encourage the use of our informed consent template for non-human subjects research (forthcoming).

If the instructor and the students have completed the CITI training and this course work unexpectedly results in a project worthy of publication or presentation beyond the class, the IRB does not consider there to be barrier to dissemination (unless determined otherwise by the publication or presentation venue). A letter to this effect can be secured from the Research Compliance Coordinator if needed.

NOTE: If there appears to be a chance that the project will result in generalizable information, it is strongly recommended that IRB approval be secured before the research begins.

2. Individual Research Projects

Student-initiated and/or student-conducted research using human participants that does not fall under the exceptions outlined above requires human research participant review (IRB application submission) and approval. This includes, but is not limited to,

  • Undergraduate bachelor’s essays,
  • Capstone or senior research projects,
  • Graduate thesis research, and
  • Independent studies.

Training in Human Participant Research

The IRB recommends inclusion of basic CITI Program training as a course requirement for research methods courses and other courses in which students may be involved in research with human participants.

Class guest presentations may also be arranged by contacting the Research Compliance Coordinator at compliance@cofc.edu. 

Responsibilities of the Student Researcher

In addition to the responsibilities incumbent in the conduct of research, the student researcher is responsible for the following:

  • Reading all information for researchers posted on the IRB section of the ORGA website;
  • Initiating any necessary communications with ORGA;
  • Completing IRB-approved training;
  • Completing the Human Participant Research Review application with assistance from the faculty sponsor;
  • Completing all paperwork associated with requests for continuation or modifications, if needed; and
  • Submitting a final report as soon as the project is complete, when applicable under the Flexibility Policy, student research will be administratively closed one year after the approval date, unless additional time is requested.

Responsibilities of the Faculty Sponsor

Faculty Sponsors are responsible for the conduct of research conducted by student Co-PIs, including providing guidance and oversight of the project. This includes:

  • Ensuring the timely submission and accurate completion of protocols,
  • Submission of protocol modifications and/or requests for continuing reviews,
  • Compliance with the ethical conduct of human participant research, and
  • Submission of final reports, if applicable or if a student fails to do so. When applicable under the Flexibility Policy, student research will be administratively closed one year after the approval date, unless additional time is requested. 

It is imperative that students be afforded ample opportunity to design and conduct their research projects. Therefore, it is important that early in the course they are provided with full information and ample guidance.

Timeline for Successful Student Research involving Human Participants

The IRB recommends not rushing human participant research whenever possible. Students can often underestimate the amount of time it takes to secure IRB approval. It is very important to follow these recommended timelines since failure to do so can leave the student without adequate time to collect and analyze data. Note that these timelines can vary depending on the nature of the research. Contact compliance@cofc.edu for more specific guidance.The faculty sponsor should be aware of these timelines and help provide alternative methodologies that do not require IRB approval if a student falls behind this schedule. This is especially imperative if the student must complete the research to graduate on time. 

Be aware of these items that can add extra time:

  • Completing the CITI training.
  • Obtaining permission from another organization or school to recruit participants from their population.
    • This can take days to months, depending on procedures of the site providing permission.
  • Creating the attachments. Be sure to use the correct consent template to reduce the amount of time.
  • Multiple rounds of revisions. It is important that revised applications only be resubmitted for review after after all requested revisions have been made.
    • IRB approval is not guaranteed. Time to approval is influenced by a number of factors, including the type of review (exempt, expedited, full board) and the comprehensiveness of the application. Some reviews may take two months or more.
  • Getting enough participants for analysis.

Example 1- Recommended Timeline for Student Independent Research with a May Graduation Deadline

  • April- August:
    • Student identifies faculty sponsor and tentative research topic. We strongly advise you approach a faculty advisor at least one semester before the project is scheduled to begin.
    • Student and faculty sponsor begin developing the research question and defining the participant population.
    • Student and faculty sponsor complete the appropriate CITI training (Basic is fine for most, but additional courses are recommended for certain types of research).
    • Student conducts background research on the topic. Student begins developing rationale of why their proposed research is needed, stating what it would add to the existing research. This literature review should be under the guidance and consultation of the faculty sponsor.
  • September:
    • Student and faculty sponsor develop the research methodologies and survey instrument(s) to best answer the research question. Be as detailed as possible, such as: include details of how the survey will be distributed, where interviews will be conducted, how the data will be recorded and transcribed.
    • Student and faculty sponsor should refine the participant population and determine how they will be recruited. Be mindful of outside approvals required to reach the targeted population.
    • Create the informed consent and recruitment documents.
    • Create a final copy of the survey instrument.
    • Obtain outside approvals (if needed)
  • September-October:
    • Complete and submit the IRB application prior to October meeting deadline in case full board review is required.
      • Faculty sponsor will start the protocol, student can contribute as co-PI with edit access (if provided by faculty.
      • Faculty sponsor will review the completed application and faculty sponsor or student can submit.
    • Wait for review. Can take up to 5 business days.
    • Student makes all requested revisions, faculty sponsor reviews and resubmits to the IRB.
    • Obtain approval.
  • November-February
    • Data collection by student, under supervision of the faculty sponsor.
  • March
    • Data analysis by student, under supervision of the faculty sponsor.
  • April:
    • Final product reviewed by faculty sponsor, published/disseminated by student.
  • May:
    • Student or faculty sponsor submits final report to close the protocol.

Example 2- Recommended Timeline for Classroom Research that Requires IRB Approval- Spring Semester

Whenever possible, IRB approval should be secured in the semester prior to data collection. Otherwise, we recommend submitting the IRB protocol in advance of the January meeting deadline. Meeting schedule available here. 

  • Prior to semester start:
    • Faculty sponsor identifies tentative research topic(s) relevant to the course materials.
    • Faculty sponsor begins developing the research question and defining the participant population. Once population is determined, IRB determination can be made.
    • Faculty completes the appropriate CITI training (Basic is fine for most, but additional courses are recommended for certain types of research).
    • Faculty conducts background research on the topic and begins developing rationale of why their proposed research is needed, how students can be involved with the research, stating what it would add to the existing research.
  • January:
    • Students complete the CITI training
    • Students conduct background research on potential research topic.
    • Student(s) and faculty sponsor develop the research methodologies and survey instrument(s) to best answer the research question. Be as detailed as possible, such as: include details of how the survey will be distributed, where interviews will be conducted, how the data will be recorded and transcribed.
    • Student(s) and faculty sponsor should refine the participant population and determine how they will be recruited. Be mindful of outside approvals required to reach the targeted population.
    • Students create the informed consent and recruitment documents.
    • Create a final copy of the survey instrument.
    • Obtain outside approvals (if needed)
  • Early February:
    • Faculty completes and submits the IRB application.
      • Faculty sponsor will start the protocol, student can contribute as co-PI with edit access (if provided by faculty.
      • Faculty sponsor will review the completed application and faculty sponsor or student can submit.
    • Wait for review. Can take up to 5 business days.
    • Student makes all requested revisions, faculty sponsor reviews and resubmits to the IRB.
    • Obtain approval.
  • Late February-late March:
    • Data collection by student, under supervision of the faculty sponsor.
  • April:
    • Data analysis by student(s), under supervision of the faculty sponsor.
    • Final product reviewed by faculty sponsor, published/disseminated by student.
  • May:
    • Student or faculty sponsor submits final report to close the protocol.

Example 3-Recommended Timeline for Student Independent Research, Spring Semester Only

  • Prior to semester start:
    • Student identifies tentative research topic(s) relevant to the course/independent study
    • Student identifies faculty sponsor and begins developing the research question and defining the participant population. Once population is determined, human subjects research determination can be made.
    • Student and faculty sponsor completes the appropriate CITI training (Basic is fine for most, but additional courses are recommended for certain types of research).
    • Student conducts background research on the topic and begins developing rationale of why their proposed research is needed, how students can be involved with the research, stating what it would add to the existing research.
  • January:
    • Students conduct background research on potential research topic.
    • Student and faculty sponsor develop the research methodologies and survey instrument(s) to best answer the research question. Be as detailed as possible, such as: include details of how the survey will be distributed, where interviews will be conducted, how the data will be recorded and transcribed.
    • Student and faculty sponsor should refine the participant population and determine how they will be recruited. Be mindful of outside approvals required to reach the targeted population.
    • Student creates the informed consent and recruitment documents.
    • Create a final copy of the survey instrument.
    • Obtain outside approvals (if needed)
  • Early February:
    • Faculty sponsor completes and submits the IRB application.
      • Faculty sponsor will start the protocol, student can contribute as co-PI with edit access (if provided by faculty.
      • Faculty sponsor will review the completed application with the student and faculty sponsor or student can submit.
    • Wait for review. Can take up to 5 business days for each round of review.
    • Student makes all requested revisions, faculty sponsor reviews and resubmits to the IRB.
    • Obtain approval.
  • Late February-late March:
    • Data collection by student, under supervision of the faculty sponsor.
  • April:
    • Data analysis by student(s), under supervision of the faculty sponsor.
    • Final product reviewed by faculty sponsor, published/disseminated by student.
  • May:
    • Student or faculty sponsor submits final report to close the protocol.

 

Created: October 16, 2009

Revisions approved by IRB: September 1, 2023

Version effective date: January 1, 2024