The purpose of IRB review is to ensure the privacy, safety, and, welfare of participants in research are protected, and that any risks to participants are minimized.

• Every activity involving human participants that meets the definition of Human Subjects Research must undergo review and receive approval from our Institutional Review Board (IRB) of record. To determine if your research meets the definition of human subjects research, please visit the OHRP decision chart.

• Wellesley College contracts with Brandeis University for Institutional Review Board (IRB) services.

• The Brandeis IRB conducts reviews at monthly meetings of the IRB Committee. See the Brandeis IRB website for schedules and deadlines. Expedited and exempt reviews are conducted on a rolling basis.

• You will need to use Brandeis forms, available on their IRB website. You will need Acrobat Adobe on your computer to complete the forms. You should download the Brandeis forms to your computer to complete them and then submit them following the instructions on the Brandeis IRB website. To submit a proposed project for IRB review, follow this link to the Brandeis University IRB page and follow all instructions regarding forms, deadlines, and review processes. If you have questions regarding the Brandeis IRB process, please reach out to their office directly.

• If you are collaborating with a colleague at another institution, you will need to follow Brandeis procedures for an IRB Authorization Agreement between the two institutions. Contact the Brandeis IRB office (HRPP) at hrpp-group@brandeis.edu for guidance. See also Wellesley’s OIR policies on research using Wellesley students, faculty or staff as subjects.

• Student investigators will need to submit their IRB applications with their research advisor as the Principal Investigator and the student listed as “Student Researcher”. Please see the Brandeis IRB page for details on when student researchers require IRB review.

It is essential that all individuals (faculty, staff, or students) engaged in human subjects research demonstrate understanding of the principles of human subjects protections. As part of the IRB review process outlined above, training in human subjects protections will be required.

• Wellesley College subscribes to the Collaborative Institutional Training Initiative (CITI) for this purpose. Through this service, personnel are able to complete their human subjects training in a convenient, online environment.

• Note: when registering for CITI training, be sure to affiliate yourself with Wellesley College (not Brandeis University), as we continue to maintain our own CITI training program. The Brandeis IRB will verify with CITI that you have completed the training required by Wellesley College.

• To learn more, please visit the Required Training page.

The Office for Institutional Research policies on research using Wellesley students, faculty or staff as subjects by investigators or co-investigators who do not have a Wellesley College Affiliation must be followed.

Research conducted at the Child Study Center (CSC). If you are an external researcher (i.e., you do not have a Wellesley College appointment) AND you are conducting research at the Child Study Center, please contact the Child Study Center Director first, info@childstudycenter, who will coordinate all Wellesley College approvals. Once you have approval from the CSC, then you may apply to the Brandeis IRB for IRB approval.

Secure Data Storage

Investigators are required to describe “the extent, if any, to which confidentiality of records identifying the subject will be maintained” as part of the informed consent procedure. Investigators therefore often seek to provide the maximum confidentiality for identified data about research participants. Wellesley College provides guidance on secure storage of data files. Per this policy, “Library and Technology Services will provide secure file storage space, maintain the servers and provide back-up for the data.  The Chief Information Officer has responsibility for this policy.” Investigators should be familiar with these options, and address any questions or concerns to the Chief Information Officer.

The Google Platform utilized by the College has been reviewed by Brandeis University's Human Research Protection Program office (our designated IRB) and deemed appropriate for IRB purposes.

Data Retention

Even once your research is complete, you are still required to keep certain records and data from your research. In general, any records required as part of your IRB review (e.g., informed consent documents) should be kept for at least three years after the completion of the research ("completion" means that all data analyses specified in the IRB application have been completed).

Other regulations or policies may apply to the retention of records, including study data. How long investigators need to store data depends on the funding source, the type of data and other factors. At a minimum, data should be stored for three years from the end of the funding, if the project was funded by NIH or NSF. The federal Office of Research Integrity offers some guidance on this.

Data Sharing

Before sharing your data with colleagues outside of your original research team, consider the following:

• NIH offers the following advice on informed consent and data sharing: "In preparing and submitting a data-sharing plan during the application process, investigators should avoid developing or relying on consent processes that promise research participants not to share data with other researchers. Such promises should not be made routinely or without adequate justification described in the data-sharing plan."

• Is your data fully de-identified? NIH provides a Data Sharing Workbook, which includes recommendations for de-identifying data. Note: "It is rarely sufficient to simply remove names, addresses, telephone numbers, Social Security Numbers, and the like."

See the NIH FAQ on data sharing.

See also the Brandeis IRB guidance on protecting the privacy and confidentiality of your data.

Consult our Frequently Asked Questions for more information.

Questions? Submissions?

Contact: The HRPP at Brandeis University welcomes your comments and questions — their staff are always happy to assist you. You can contact the Brandeis IRB office (part of HRPP) by email or phone.