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In the words of OHRP, “Publishing something does not make it research and not publishing something does not make it non-research activity”. Instead, researchers should ask themselves why they are conducting the activities. What is their motivation? Is it to obtain knowledge that can be used to understand people or contexts beyond those directly studied? If so, it is likely designed to contribute to generalizable knowledge.   

There are, however, projects that can resemble research in a lot of ways, but that are not designed to contribute to generalizable knowledge. Some examples follow: 

• A quality assurance/quality improvement/organizational effectiveness study where the intent is to assess, improve, or develop programs or services for a specific organization rather than draw conclusions about programs or services of a particular type would not be considered as contributing to generalizable knowledge.   

• An oral history or journalistic piece that is limited to documenting or reporting on specific people, events, situations, policies, institutions, or systems without the intent to form hypotheses, draw conclusions, or generalize their observations to new people or contexts would not be considered as contributing to generalizable knowledge.  In contrast, an oral history or journalistic piece that intends to draw broad conclusions about people, events, situations, policies, institutions, or systems would be subject to IRB review.  

• Classes, independent studies, and honors projects may involve activities that resemble research (e.g., hypothesis generation, data collection, analysis).  If these activities are being conducted for training purposes only, they would not be subject to IRB review and oversight.   However, even in these situations we strongly recommend that faculty provide their students with training in the ethical conduct of human subjects research (e.g., CITI), carefully review and oversee student activities, and ensure that any data collected is deleted at the completion of the project.  In some situations, activities carried out for a class, independent study, or honors project have a dual purpose: 1) to train students and 2) to obtain knowledge that can be used to understand people or contexts beyond those directly studied.  When this is true, these projects would be subject to IRB review and oversight.  

If you are unsure if your planned activity is designed to contribute to generalizable knowledge, please reach out to us at irb@bowdoin.edu. We would be happy to discuss it with you.   

Am I Qualified to Supervise Human Subjects Research?

Please complete the following questionnaire - IRB Faculty Questionnaire. 

Role and Responsibility of the Faculty Advisor

This information should be shared and discussed with your faculty advisor prior to protocol submission.

What is the faculty advisors role in student led research?

1. The faculty advisor shares with the student the responsibility for the ethical conduct of the research.
2. The advisor is responsible for ensuring that the research activities involving human subjects are reviewed and approved by the IRB before they are initiated.
3. The faculty advisor is expected to take an active role in student research activities and provide supervision for the duration of the project. 
4. The faculty advisor must review, approve and certify the all submissions to the IRB.

What are the responsibilities of the faculty advisor in student led research?

1. Be informed. Contact the Research Compliance Manager to discuss policies and procedures for obtaining IRB review before the initiation of research activities. Faculty advisors are expected to be familiar with institutional requirements for the conduct of human subjects research. 
2. Complete the required CITI training for human subjects research. Faculty advisors are expected to be familiar with ethical and regulatory requirements. 
3. Know what must be reviewed. Determine when a student lead research project contitutes human subjects research and requires IRB review. If the faculty advisor is unsure, it is their responsibility to reach out to the Research Compliance Manager for guidance.
4. Assist students with the IRB process and protocol submission. When proposed activities constitute research with human subjects, it is the responsibility of the faculty advisor to determine what the requirements are for submission to the IRB, help the student to understand the IRB process and assist students in preparing and reviewing materials to be submitted to the IRB via . 
5. Educate students on the role of the IRB and the importance of research review. Take an active role in the review process and assist students when presented with questions and comments from the IRB committee and/or Research Compliance Manager.
6. Oversee changes. Ensure that before a change is implemented to an approved protocol that it is approved by the IRB. All changes must be reviewed and certified in  by the faculty mentor.
7. Maintain ethical standards. Faculty advisors ensure that projects are conducted to the highest ethical standards and that students understand and implement these ethical standards in the conduct of their research.
8. Report any adverse events or other research-related problems to the IRB as soon as possible. Incident reports can be accessed and submitted to the IRB through . 
9. Ensure that continuing review requirements are satisfied, if applicable. 
10. Ensure that the study is closed at the conclusion of the study. 

At a minimum, your recruitment materials should include:

1. Name of the investigator and affiliation
2. A statement conveying that the project is research and that participation is voluntary
3. A brief description of:

• The purpose of the research project
• Any relevant inclusion criteria
• Time commitment
• Compensation or incentives, if offered

4. Contact information

As the researcher, it is your responsibility to safeguard the confidentiality of your research data.  A key component of this is consideration of how you collect your data, where that data is stored, and how it is accessed. 

General guidance:

The ºÚÁϳԹÏÍø±¬ÍøÕ¾ IRB recommends that, whenever possible, data be recorded and stored in a way that minimizes the likelihood that participants could be identified by a breach in security (e.g., hacking, loss or theft of a device that stores identifiable information). For example, you might collect the data in such a way that participants remain anonymous (e.g., by changing the settings in your data collection platform so it does not automatically record name or IP address).  When this is not possible, you might separate the identifiers from the data and code the data with a pseudonym or number and then have a separate, confidential file that connects the code to the identifiers.

Collecting and/or storing data electronically:

The College has contracts with for data collection (e.g., surveys), Zoom for videoconferencing (e.g., online interviews and focus groups), and Microsoft O365 for data storage. These agreements ensure adequate data security to store Federal Educational Rights and Privacy Act (FERPA)- and Health Insurance Portability and Accountability Act (HIPAA)-protected information. ºÚÁϳԹÏÍø±¬ÍøÕ¾ IT strongly recommends that researchers use these platforms to collect and store their data. When you use these platforms, please sign into them with your ºÚÁϳԹÏÍø±¬ÍøÕ¾ credentials and not with a personal account. Personal accounts likely do not have the same level of security as those connected with the College.   

At the same time, there may be legitimate reasons why you cannot use these platforms to collect or store your data. For example, you might use a handheld recorder to collect audio or video.  In this case, data should be immediately transferred from the recording device to a more secure platform (e.g., Microsoft Office (O365)/One Drive) and deleted from the device on which it was collected.  In the case of recordings, we also recommend that you record only what is necessary for the conduct of your study.  For example, if you want a transcript of an interview, you should only create an audio recording and not a video recording.  If you elect to use alternative online platforms to collect and/or store your research data (e.g., Google Forms, Survey Monkey, Google Drive), your protocol may need additional review. Should this be necessary, you should be prepared for a lengthier review process.

ºÚÁϳԹÏÍø±¬ÍøÕ¾’s IT policy recommends that passwords that are at least 12 characters in length and that researchers use multi-factor authentication whenever possible. 

Guidance on email communications:

Email is not a secure way to transmit information. Information sent by email can be easily intercepted by third parties. If your study requires that you communicate with participants via email, participants should be informed that the confidentiality of email communications is not assured.

If you need to share research data with a collaborator, ºÚÁϳԹÏÍø±¬ÍøÕ¾ IT recommends that you share it within Microsoft O365. If Microsoft O365 does not serve your needs, please contact ºÚÁϳԹÏÍø±¬ÍøÕ¾ IT (itsecurity@bowdoin.edu) to explore other options. 

Collecting and/or storing your data on paper:

Physical data should always be stored in a secure location (e.g., a locked filing cabinet).

Who has access to your study data:

It is also important to consider who will have access to your study data. Only individuals who need access to perform their duties on the study should be granted access. If you are unsure how to restrict access to your study data, please contact us at irb@bowdoin.edu.  If you intend to share de-identified data with others (e.g., collaborators, in a data repository), this should be clearly outlined in your consent form. 

What to do if you have experienced a breach in security:

If you believe your research data has been inappropriately accessed or stolen, you must notify the ºÚÁϳԹÏÍø±¬ÍøÕ¾ IRB within 72 hours (irb@bowdoin.edu). 

How long to keep your study files:

Your plan for retention of consent forms and other study data should be clearly stated in your protocol and consenting documents (e.g., consent form, assent form, information sheet). 

Consent forms

require that signed consent forms be retained and available for inspection for at least 3 years after completion of the research, regardless of the source of funding for your research.  It is your responsibility to ensure the safe and secure retention of these records. 

Other study data

If your research is externally funded, you should consult with requirements set forth by the sponsor of your research regarding retention of other study data (e.g., federally-funded data must be retained for at least 7 years). 

If your research is internally funded or not funded, it is up to you how long you store your other study data.

What to do with study documents if/when you leave the College:

Consent forms

If at the time of your departure, you have consent forms for a project that is active or concluded within the last three years, you are still responsible for maintaining these documents in a secure and confidential manner until at least 3 years following the conclusion of the research. 

If you are a student, please transfer these documents to your faculty advisor prior to your departure. 

Other study data

If your research is externally funded, you should comply with the requirements set forth by your sponsor and the plan outlined in your grant application (e.g., a copy of all federally-funded research data must be retained by the College).

If your research is internally funded or not funded, you may destroy the data or take it with you when you depart, consistent with the plan described in your IRB protocol and/or closure form.  Please note that if the data you take with you is identifiable, then any future analyses done with that data would require an active IRB approval.  You could pursue this approval at your new host institution and/or at an IRB that allows outside investigators to use their services.  If, however, the data you take with you is not identifiable, then future analyses would not be considered human subjects research and would not need IRB approval. 

If you are a student, please ask your faculty advisor how you should retain or dispose of your data. 

Questions?

For more information, please see guidance on ºÚÁϳԹÏÍø±¬ÍøÕ¾ IT policies and standards.  For general questions contact irb@bowdoin.edu.  For information technology questions, please contact ºÚÁϳԹÏÍø±¬ÍøÕ¾’s Chief Information Security Officer (itsecurity@bowdoin.edu). 

If you are collecting data online, you should ensure that your data collection platform is not automatically collecting identifiable information (e.g., IP address, geolocation data). 

For instructions on how to enable this setting in Qualtrics, please watch the following video:

If you are doing a Zoom interview, and only need a recording of the audio, it is recommended that you change your settings to only capture this information. 

For instructions on how to enable this setting in Zoom, please watch the following video:

 

Each investigator conducting research in a foreign country has the responsibility to clearly understand and abide by the laws and regulations governing review of human subjects research in a host country. These guidelines, which must inform the design and conduct of your study, can be found here:

Yes, a student can conduct human subjects research under the supervision of an experienced faculty advisor. The faculty advisor must be identified on the student PIs initial submission as the principal investigator and will be responsible for approving all components of the student PIs research application. Please visit our Student-Led Research page for more information.

If you desire to make a change to the research procedures or the research staff you must submit a Modification Form via . The IRB reviews and approves any proposed modifications to approved research activities before they are initiated. The letter from the IRB to the principal investigator at the time of approval states that any proposed changes must be submitted to the IRB prior to implementation. Principal investigators should use the Modification Form (above) to describe any modifications to either the described research procedures or staff.

In the unlikely event that a change to approved research must be initiated without IRB approval in order to eliminate apparent immediate hazards to a research participant, these changes must be submitted to the IRB within 3 business days after the event. The IRB reviews these changes to certify that they were consistent with ensuring the participants continued welfare.

If a subject has experienced an unexpected or serious event that is related to study procedures, researchers must submit an Incident Report via . 

For any research that was approved by full committee review, investigators must submit a Renewal Form via  every 12 months while data is still being collected. 

Expedited review requires annual administrative check ins and exempt review requires no further review by the IRB.

Federal regulations require that all IRB records be retained for at least three (3) years after completion of the research. These files will be managed by the IRB Administrator using Cayuse HE.

Files to be retained include:

• Copies of all proposals reviewed, approved consent documents, progress reports, and reports of injuries to subjects.
• Detailed minutes of all IRB meetings.
• Records of continuing review activities.