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Colby College IRB: Frequently Asked Questions (FAQ)
Colby College IRB: Frequently Asked Questions (FAQ)
Q: How long does IRB review take? A: The IRB reviews submissions within 5 business days during the academic year, though many applications are processed sooner when possible. Researchers are encouraged to submit early, especially near academic breaks or holidays.
Q:How long is IRB approval valid? A:
Faculty and staff research: IRB approval is typically valid for three years from the date of approval.
Student research: IRB approval is valid for one academic year, after which projects must be renewed or closed.
Q: Will I receive documentation of IRB approval? A: Yes. After approval, the IRB will issue a formal approval letter, which includes:
Institutional ID number for your IRB study
Approval period
Review classification (e.g., exempt, expedited, full board)
Any special conditions or reporting requirements
Q: What if my project involves people, but I’m not sure if it needs IRB approval? A: If your project involves interacting with people, collecting data from individuals, or using information about them, but you’re unsure whether it qualifies as human subjects research requiring IRB review, you should contact the IRB for clarification before starting your project. The IRB can help determine whether your project meets the federal definition of human subjects research or falls outside IRB oversight. Researchers are also encouraged to review the IRB’s policy on activities outside IRB oversight and best practices for ethical research. Even if your project does not require formal IRB approval, it is considered best practice to obtain informed consent from participants whenever possible. When in doubt, always check with the IRB.
Q: What if I’m collaborating with someone at another institution and want Colby’s IRB to serve as the IRB of record? A: If a Colby faculty or staff member is working with an external collaborator and wishes for Colby’s IRB to serve as the IRB of record, a legal reliance agreement must be established between Colby College and the collaborating institution. The IRB will coordinate with Colby’s legal counsel to arrange this agreement.
Q: Does all student human subject research need IRB approval? A: No, all student human subject research does not need IRB approval. In some courses, the faculty are allowed to forego IRB approval. However, student conducted human subject research that meets the federal definition of human subjects research requires IRB review and approval prior to data collection. This includes human subject international research, honors theses, capstone projects, independent studies, and other projects intended for dissemination outside of the classroom. Researchers should review the IRB’s policies on student research.
Q: What about students conducting research abroad or as part of an internship?
All students conducting human subjects research abroad or as part of an internship must consult the IRB to determine if IRB approval is required. International research often involves additional considerations related to local laws and ethics standards, so early consultation is essential.
Q: Are there requirements after receiving IRB approval?
Yes. Approved researchers must submit any proposed changes to their project for IRB review and approval before implementation. Depending on the study’s classification, annual updates or final closure reports may also be required.
Q: Do I need to complete ethics training before submitting an IRB application? A: Yes. All researchers (faculty, staff, and students) and study team members must complete human subjects research ethics training (such as CITI or equivalent) prior to submitting an IRB application. Proof of completion must accompany your submission.
Q: Where can I find IRB policies and guidelines? A: All researchers are expected to review the IRB policies and guidelines available on this site. These documents explain the requirements for conducting human subjects research at Colby College and provide guidance for preparing IRB applications.
Q: What if I have questions or need assistance? A: The IRB is available to help clarify policies, answer questions, and support you in preparing your application. Please contact the IRB office directly for guidance.
Why Research Data Management (RDM) Matters for IRB and Human Subjects Research
Why Research Data Management (RDM) Matters for IRB and Human Subjects Research
Why Research Data Management (RDM) Matters for IRB and Human Subjects Research
Research Data Management (RDM) plays a critical role in ensuring ethical, compliant, and responsible handling of data in human subjects research. Proper RDM practices help safeguard participant privacy, ensure data integrity, support reproducibility, and meet institutional, federal, and international legal requirements. For any study involving human participants, especially those reviewed by the Institutional Review Board (IRB), thoughtful data management planning is essential from the earliest stages of research design.
Why RDM is Important for IRB Data:
Participant Privacy and Data Security:
Human subjects research often involves collecting sensitive or personally identifiable information (PII). Proper RDM helps ensure that data are stored securely, access is restricted to authorized personnel, and privacy is protected in compliance with regulations like HIPAA, FERPA, and GDPR, as well as ethical standards for confidentiality.Compliance with Regulations and Policies:
Federal regulations (such as the Common Rule) and institutional IRB policies require researchers to explain how they will collect, store, protect, and share research data. The IRB reviews these plans to confirm that researchers are following best practices in data security and ethical data use.Transparency and Accountability:
Clear data management plans help demonstrate to the IRB that researchers are prepared to handle data responsibly, reducing risks to participants and enhancing institutional accountability.Data Retention and Sharing Obligations:
Many funders and journals require that data supporting research findings be shared or archived in a de-identified, ethical manner. Planning for how data will be cleaned, de-identified, and stored facilitates compliance with these requirements while protecting participant privacy.Data Integrity and Reproducibility:
Well-managed data help ensure that research findings are accurate, credible, and reproducible. Poor data management can lead to data loss, errors, or ethical breaches that compromise research outcomes.
Key Data Considerations When Planning Human Subjects Research:
Data Collection:
What types of data will you collect?
Will you collect personally identifiable information (PII)?
Are you using online surveys, interviews, or biometric data?
Will participants know what data you’re collecting and how it will be used?
Informed Consent Language:
Does your consent form explain how data will be stored, used, and shared?
Are participants informed about future data sharing or archival plans?
Are there clear limits on data confidentiality explained in consent materials?
Data Storage and Security:
Where will data be stored (encrypted drives, institutional servers, cloud storage)?
Who will have access to raw data?
How will access be restricted and monitored?
Are backups in place to prevent data loss?
De-identification and Anonymization:
Will identifying information be separated from research data?
Are you using codes or pseudonyms?
At what stage will data be de-identified?
Data Sharing and Future Use:
Will data be shared with other researchers, deposited in a repository, or used in future projects?
Are there plans for sharing de-identified datasets?
Have participants consented to data sharing?
Data Retention and Disposal:
How long will you retain identifiable data?
What are your plans for securely destroying data after the retention period?
Are there sponsor or institutional policies regarding retention?
International Data Considerations:
If collecting data from participants outside the U.S., are you following relevant international data privacy laws (e.g., GDPR)?
Does your data storage comply with cross-border data transfer restrictions?
Third-Party Tools and Data
When using third-party tools like transcription services or AI platforms such as ChatGPT, privacy risks arise due to the handling of sensitive or personal data by external providers. These tools often process data on remote servers, which may expose information to unauthorized access, data breaches, or misuse if proper safeguards aren't in place. Users should carefully review privacy policies and terms of service to understand how their data is stored, shared, and protected. In institutional settings, additional considerations around data governance, confidentiality agreements, and compliance with regulations like FERPA or GDPR become essential. Ultimately, while third-party tools can enhance productivity and streamline tasks, relying on them without clear awareness of privacy implications can inadvertently compromise sensitive information.
Final Note
The IRB expects researchers to address these data management issues clearly in their protocol submissions. Proper planning and documentation of RDM practices not only help protect research participants but also strengthen the ethical and scholarly integrity of the research itself. Researchers are encouraged to consult Colby’s IRB policies, as well as institutional data privacy and security guidelines, when preparing their IRB applications.
Examples of Research That Might Require an IRB
Examples of Research That Might Require an IRB
Because human subject research can take many forms—ranging from interviews and archival work to digital projects and creative practices—it’s not always immediately clear when IRB review is required. Research methods are diverse, and the line between scholarly inquiry, artistic expression, and human subjects research can sometimes be blurred.
Inquiry about whether your project might need an IRB should happen when the research project involves living human subjects and the information collected about them will be analyzed and shared in a way that contributes to generalizable knowledge. When in doubt always ask for guidance from the IRB.
A few hypothetical examples of the many types of human subject research/projects that might need an IRB:
Digital humanities projects that involve collecting and analyzing community stories
Analyzing personal correspondence of living individuals housed in an archive
Surveys of students on mental health and academic stress
Interviews with formerly incarcerated individuals
Human subject interviews, surveys, etc. on drug use or sex
Cognitive experiments measuring stress
Collecting biometric data (e.g., EEG, heart rate)
Surveys on public attitudes toward GMOs
Interviews with developers about AI and ethics
Studying food insecurity through surveys and ethnography
Theater-based research with trauma survivors
Testing health-related apps with user experience interviews
Interviews with refugees about their migration experiences
Use of data sets with personally identifiable information
Regardless of whether a study formally requires IRB review, informed consent is often still necessary when engaging with human participants. This includes situations such as when a researcher might:
Interview or interact with individuals, even in informal or exploratory ways
Record audio, video, or photograph people
Collect or use personal stories, opinions, or reflections
Access sensitive or private information, such as health, identity, or family history
Finally, an IRB operates at the intersection of ethics, governance, and the law. In the area of privacy and data protection laws, these various laws necessitate compliance, regardless of whether IRB approval or oversight is explicitly required by Colby’s policies.
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