Student Investigators' Guide
This guidance introduces students to the process of submitting an application to the Lehigh University Institutional Review Board (IRB), including key information and associated content links to other areas of the IRB website. The Research Integrity office is the administrative office that supports the IRB. The Research Integrity office is staffed with friendly, knowledgeable IRB professionals, ready to answer your human subjects research-related questions.
The guidance is organized into four parts:
• Part 1 focuses on when IRB review is needed (not all projects constitute human subjects research as defined by the federal regulations).
• Part 2 addresses pre-submission steps and planning.
• Part 3 covers submitting an application to IRB and the IRB review cycle.
• Part 4 provides post-approval tips for maintaining an IRB-compliant protocol.
Start the process early! If your project needs IRB review, you should submit your application at least six to eight weeks in advance of when you plan to begin the research. The IRB receives a high volume of applications, and most need adjustments before they may be considered review-ready. Please plan accordingly. You may not begin recruiting, collecting data, or working with participants in any way until you have IRB approval.
Part 1: Determine if you need to submit an application to IRB
Go to What Needs Review for general guidance and helpful examples of activities that may or may not trigger the requirement to submit an application for IRB approval. In particular, note that while some student research activities involving human subjects may require approval by IRB, many others do not. This is discussed in detail in the IRB guidance Ethical Issues in Research.
If you are an undergraduate student planning to conduct a research project, be sure to read the Ethical Issues document referred to in #1 above as well as Research Design Guidance. These guidance documents were written specifically to assist students and their faculty mentors.
If it appears that you need to submit an IRB application, go to Levels of IRB Review and read the descriptions for new Exempt, Expedited, and Full Committee (greater than minimal risk) applications. This information will help you determine which type of application is appropriate for your research.
After reviewing the descriptions, if you are still unsure whether to submit or which type of application to submit, email firstname.lastname@example.org, or call us at (610) 758-2871. Staff are also available for in-person consultation, by appointment only. To schedule an appointment, email email@example.com.
Part 2: Pre-submission steps and planning
1. Students submitting an application to the IRB, are required to work with a faculty advisor who will serve as Principal Investigator (PI). Student Investigators who wish to conduct human subjects research at Lehigh must obtain the sponsorship of an eligible Lehigh faculty member eligible, per IRB Policy: Human Subjects Research Principal Investigator. If you do not have a faculty advisor who is eligible to serve as PI, please contact the Research Integrity office for further guidance.
2. Human subjects training requirement. Lehigh faculty, staff, and students engaged in human subjects research must complete the online CITI Protecting Human Research Participants Training course.
• Save a pdf of your completion report; you will need to upload it as part of your IRBNet protocol application.
Note: If the research protocol is federally sponsored, the sponsor may have additional training requirements. Please contact the Office of Research and Sponsored Programs for questions about sponsor requirement.
3. IRB Guidance on specific topics. Before you start the IRB application, review the guidance topics listed, many of which will be helpful to first-time researchers (e.g., recruitment, informed consent, parental permission and child assent, data security, secondary analysis of existing data Authorization Agreements; Assessing Risk Level, HSR Engagement, Best Practices for Gender & Sexuality Demographic Questions, International Research / Research With Non-English Speaking Populations, Required Elements of Informed Consent, Informed Consent templates). The guidance documents will provide you with a framework for what to include in the application.
• If your research is non-exempt and involves direct contact with human subjects, review the Informed Consent Guidelines, then the consent document templates (under Forms on the IRB's main page), and locate the one(s) most suitable for your research. You can tailor the template as needed before attaching as part of your IRBNet protocol application.
• If you plan to submit an Exempt application, consent documents are not needed for review. However, you should follow the consent requirements outlined in the section entitled "Criteria for approval of exempt research" in the LU IRB Exempt Determination Worksheet on the IRB's main page.
4. Off-site recruitment permissions. In order to recruit subjects at an off-site location (e.g., a clinic, a k-12 school, etc.), you will need to obtain advance letters of permission/cooperation from each site and upload them as part of the IRBNet application.
5. Research collaborations involving an external institution. Research involving external collaborating investigators from outside of Lehigh University will require additional planning and coordination. If your external colleagues are engaged in the research, this may also involve IRB review at the other institution, or a process whereby one IRB relies upon the review of another IRB. If this applies to you, please seek consultation from your faculty PI and/or the Research Integrity office immediately.
Part 3: Submitting a protocol to the IRB / the IRB review cycle
1. IRBNet is the IRB online application system. Before you begin the application, review the instructions. Be sure to select the most appropriate form for your research. If in doubt, contact the Research Integrity office for assistance.
2. The Review Cycle. Submitted IRBNet applications are triaged to an appropriate review panel (i.e., exempt, expedited, or full IRB Committee). Exempt and expedited protocols are reviewed on a rolling basis, and in the order received. Protocols that require full Committee review are assigned for review at the next available meeting.
• Your protocol will be held in the review queue and pre-reviewed by staff as soon as possible. Protocols are reviewed in the order in which they are received.
• Exempt review applications. The staff reviewer will send comments via IRBNet. Respond to these comments as soon as possible. Sometimes response clarifications generate more questions, and therefore more rounds of IRBNet comments/responses; it is all part of the process. Once the review is complete, you will be informed of the outcome (i.e., exempt determination; not human subjects research as defined by the federal regulations; does not fit exempt criteria/submit non-exempt application). Exempt research is not assigned an expiration date.
• Expedited review applications. The staff reviewer will send comments in IRBNet (see information for Exempt, above). Once the pre-review process is complete, the protocol will be submitted to the committee reviewer(s). The reviewers may request additional information or specific modifications to be completed. You will address each of these items as a response to the committee via IRBNet. Once all issues have been addressed, unless an reviewer has additional concerns, the last step in the approval process is typically completed within one week.
• Full Board review applications. The staff reviewer will pre-review the application (see information for Exempt, above). If there are any missing documents (e.g., consent forms) necessary for the review, the staff will either submit IRBNet comments or contact you outside of the system, as appropriate to the situation/timeline. Following the meeting, you will be notified of the vote outcome (e.g., full approval, modifications required to secure approval, deferral to another convened meeting). Post-meeting comments are sent in IRBNet to you and the Principal Investigator as soon as possible, usually within several days of the meeting date.
Part 4: Post-approval tips for maintaining a IRB-compliant protocol
Once you have your IRB approval (congratulations!), be sure to review the following information so that you remain alert to your ongoing responsibilities as a Lehigh Student Investigator. Communicate regularly with your PI/research team throughout the implementation of the study. Contact the Research Integrity office at any time if you have any questions or concerns.
Approval Period. The IRB approval letter will include an effective date and an expiration date, if applicable. Exempt research is not assigned an expiration date.
• Study Renewal/Continuation. Federal regulations require that IRBs review continuing research until the time of study closure. At Lehigh, protocols are assigned a one-year approval period. *In some circumstances, the IRB may designate a shorter approval period.
* Effective January 21, 2019, IRB policy will be updated to correspond to revised federal regulations and most minimal risk research will be approved without an expiration date. Please visit the Revised Common Rule webpage for updates on this process.
• If the study was assigned an expiration date, several months before it expires, IRBNet will generate courtesy reminders. Continuing review applications should be submitted six weeks prior to the expiration date to allow sufficient time for the renewal process. It is a Principal Investigator / Student Investigator responsibility to submit for renewed approval in a timely manner. In keeping with federal regulations, if approval is not reviewed prior to an applicable expiration date, all human subjects research activities—including data analysis—must cease until re-approval from the IRB is received.
• Amendments/Modifications. IRBNet amendment applications must be submitted to and approved by the IRB prior to implementation. This requirement pertains to all proposed modifications/changes to exempt and non-exempt currently approved protocols. Amendments include (but are not limited to): Requests to increase the approved total subject sample size; changes or additions to subject contact materials/consent documents; consent document translations; study personnel changes; changes in funding sources; study design modifications.
• Unanticipated Problems and Adverse Events. Discuss any issue promptly with the faculty PI. Together, you will need to determine if it triggers the need for a prompt report to the IRB. See the IRB Policy: Reporting Unanticipated Problems/Adverse Events to the IRB for more information.
- Any unanticipated problem involving risks to subjects or others, and/or a serious adverse event, must be reported promptly to the IRB within five business days by phone or email.
- A written report (via an Unanticipated Problem Report submission in IRBNet) must be sent within two weeks (14 calendar days), of the Principal Investigator becoming aware of the event.
- Unanticipated Problems and Adverse Events must be reported for all exempt and non-exempt research.
• Protocol Deviations (includes noncompliances). Any deviation from an IRB-approved/exempt must be reported to the IRB promptly. The IRB will review the report to determine whether the incident was a serious or a minor noncompliance and assess whether any corrective actions or substantive changes are needed in order to protect the safety, welfare, and rights of subjects or others.
This guidance was adapted, with permission, from U.C. Berkley Human Research Protections Program’s “Student Investigators Guide” website.