Assumption College

Assumption College

Institutional Review Board

FAQs for Applicants

The IRB or Institutional Review Board is charged with reviewing all research plans for research with human subjects. Specific details on this are available in the Guidelines for Review of Research Involving Human Subjects. The Assumption College IRB works with researchers to insure that research is ethical. The IRB is a group of faculty from various disciplines and volunteer community members who work hard to review IRB applications thoroughly and in a timely manner. Every application is different, which poses challenges for the IRB. Applicants can make the process smoother by 1) being familiar with and following the guidelines and 2) explaining their research project clearly, using widely accessible language. Informed consent forms and project materials that will be used with research subjects need to be particularly well organized and clearly written so they can be easily understood by potential research participants.

While every IRB application is different, the purpose of this document is to try and provide guidance on issues that the Assumption IRB has faced recently or regularly encountered. These are not hard and fast rules and whether or not they apply will vary by project. If you have questions as you prepare an IRB application, feel free to contact the IRB Chair via email at (please review and be familiar with the guidelines first).

Topics:

Allergies

Anonymous Data

Anonymous Participation

Audiovisual Recording

Confederates

Confidential Data

Confidential Participation

Data Storage

Deception

Department Chair Signature

Extra Credit

Group Administration

Incentives

Informed Consent (including waivers)

Journalism

Oral History

Recruitment

Research Approved Elsewhere

Support Resources

Do I have to screen participants for allergies?

If a research procedure involved direct exposure of participants to potential allergens, researchers need to make participants aware of the potential risk during the informed consent process, including on any informed consent forms. One example is use of latex gloves by the researcher to attach sensors to participants.

What is the difference between anonymous data and confidential data?

Data are anonymous if even the researcher does not know which research participant the data came from. Some examples include online surveys that do not match the survey with any identifying information (such as an email address) or when participants fill out questionnaires in person that cannot be linked to them afterwards. Data are confidential if the researchers can match the identity of a research subject to their data (which is often needed if data will be collected from the same subjects at different times or across different methods, such as filling out questionnaires and gathering physiological data, such as from an fMRI), but do not share that information with others. If data are confidential, it is recommended that research participants be assigned an id number and that id number is on their data, and a separate list contains id numbers matched to participant identity. The data and the list should both be securely stored, separately from one another.

What is the difference between anonymous participation and confidential participation?

Participation is anonymous if who participated is not even known to the researchers. Confidential participation is when the researchers know who participated, but do not share that information. If a study is going to award extra credit (so that professors will be provided with a list of some or all who participated) or collects data via a group administration (so that an individual’s participation is also known to the others who participated with them) while the researchers will keep who participated confidential, they need to make clear to participants that they request the same from professors and other research participants, but cannot guarantee that request will be honored.

My project includes audio and video recording of research participants. Is there anything special I need to do with that data?

Yes. Many research projects audio and/or video record participants or take still images. If a project will include audio or video recording or capturing of still images, this needs to be included in the description of procedures on the IRB application and in the informed consent form. This description needs to include whether or not participants can still be a part of the project if they do not want to be photographed or recorded (for example, sometimes a research may still want to interview them and only take notes), and how the recordings or images will be stored and used. If any of the recordings or images may be used in a future publication or presentation, that needs to be included and participants should sign a separate release allowing for that use (which should be included for review as a part of the IRB application as an appendix).

Many researchers use a mobile device, such as a phone or tablet, to record. At a minimum, these devices should be password protected and remain in sole possession and control of the researchers whenever project data are stored on them. Many of these devices automatically upload to a cloudbased system as a backup. Researchers need to understand the security of those systems and devices as storage and include those details in the IRB application and informed consent process. Depending on the nature of the research project and the level of risk disclosure of the recorded data would pose to participants, researchers may want to temporarily disable the cloud-based automatic back up system until the recordings can be downloaded to a more secure device.

Is the use of confederates in a research project considered deception?

Yes, the use of a confederate(s), typically defined as an individual acting as a research participant who is actually working as a part of the research, is considered a type of deception. One of the most well known research projects to use confederates was Stanley Milgram’s study of obedience ( which is familiar to many Assumption undergraduate and graduate students. Under Assumption College’s Guidelines for Review of Research Involving Human Subjects, any research with human subjects that involves deception will be subject to full review.

What do I need to do for the storage of my data to be considered secure?

One of the first things is to remember what all of the different things are that might be considered data or need to be kept secure. These might include participant sign-up sheets, records to track extra credit, and informed consent forms, in addition to the actual data.

Options for securely storing data vary by the research project and nature of the data. Data should be kept in secure locations, such as locked file cabinets, locked in offices or storage areas, on password protected computers, or something similar. Whenever possible, identifying information should be removed from data. Options for this include saving files with names that do not identify participations (for example, saving interview files with a label such as “participant 1 interview” instead of “Jane Smith’s Interview), removing identifying information from data, and storing informed consent forms, sing up sheets, extra credit tracking materials, and anything similar separately from the data. Once data collection is complete and identifying information is no longer needed (for example, to link data across different collection periods or collection types) researchers should delete or destroy identifying information.

What happens if deception is a part of my research project?

Under Assumption College’s Guidelines for Review of Research Involving Human Subjects, any research with human subjects that involves deception will be subject to full review. If deception is used as a part of a research project, it should be limited to only that deception or incomplete disclosure needed to answer the research question. When deception is used, participants should be debriefed at the end of their participation, typically with an oral debriefing and provision of a written debriefing statement, and told of the use and nature of the deception, as well as provided referral resources if it is likely that the deception might lead to distress or discomfort that a participant may need to deal with. Debriefing scripts and statements should be included for review as a part of the IRB application as appendices. Some researchers in studies utilizing deception have chosen to include a statement in the informed consent form such as “This informed consent process may not share with you the full purpose of the research at the outset.”

Why does my department chair or program/division directors have to sign a hard copy of my IRB application?

Department chairs or program/division directors are required to review all research from their departments, programs, or divisions for two reasons. First is that they are more likely than the IRB to be familiar with the research in the proposed area, so they are a first line of review that the research question is a valid question to ask and is based in the appropriate research, so that participating in the research is not a waste of research subjects’ time. As such, the IRB expects that department chairs will pay particular attention to parts 11a (purpose of the project) and b (background of the project) of the application. Second is that department chairs and program/division directors are responsible for knowing what is going on in their respective areas. IRB applications are not reviewed by the committee until the hard copy with all required signatures has been received.

Can I offer extra credit to research participants?

Yes. However, if a professor or department offers extra credit for participation in research, they also must offer an alternate extra credit opportunity that is comparable. This is so that participation remains voluntary (a hallmark of ethical research) and students do not feel coerced into participating. Comparable extra credit should involve approximately the same amount of time and effort as participation in the research study.

When offering extra credit, the application and informed consent form/process should specify what happens if a participant withdraws before completion or requests that their data be withdrawn after they complete their participation.

The application should also explain how participation will be tracked to award extra credit, including how those records will be securely stored. If students are being awarded extra credit for participation, then their participation is not anonymous (as their professor will know they participated, even if he or she does not know the nature of their participation). Instead, a researcher may inform participants that their participation will be confidential, with the exception that, with permission, their name as a participant will be shared with their faculty member so they may be awarded extra credit.

Do I have to do anything differently if I am performing an experiment with a group administration versus individual administration?

Yes. Whether or not the experiment is being performed on multiple people at the same time or one by one should be specified in the IRB application and the informed consent process and form. If it is a group administration, participants should also be informed that the researchers will ask that the other participants keep who was there confidential, but cannot guarantee that.

Am I allowed to give a monetary or other incentive to get people to participate in my research project?

Yes. Incentives to help recruit participants to research projects and recognized their time and effort are allowed, but within limits which would vary by research project. The incentive cannot be so large as to be considered coercive. Some examples of incentives are including a one dollar bill in a mail survey, with participants paid an additional $10 when they return a completed survey; being paid $15 an hour to participate in interviews; and being entered in a raffle for an ipad or a $100 gift card for participating in an online survey. IRB applications and informed consent processes and forms should clearly explain what incentives are and how they will be awarded, including what happens if a participant withdraws partway through the research or asks for their data to be withdrawn after they complete their participation.

Do I have to have participants sign an informed consent form?

Informed consent is one of the most important aspects of protection of human subjects in research. So, whenever possible, a research project should include an informed consent process and a signed informed consent form. When a hard copy informed consent form is used, there should be two copies of the informed consent form per participant, both of which should be signed by the participant and a member of the research team – one copy for the participant to keep for their records and one copy for the researcher’s records.

In some cases, a researcher may request a waiver of documentation of informed consent. In such a case, the research participant still goes through an informed consent process, but does not sign a form. This may be appropriate when signing an informed consent form would be the only recording linking the subject and the research, and that the primary risk of the research would be harm resulting from a break of confidentiality. It may also be appropriate for minimal risk projects where the research involves a procedure that does not normally require written consent when it is not a part of research. However, a waiver of documentation of informed consent is not appropriate just because getting written informed consent might be a pain or an inconvenience. Online surveys often waive documentation of informed consent. Instead, the first page of the survey would be an informed consent form, and at the bottom participants would indicate their consent by clicking a “continue” or “I agree” or similar button to acknowledge that they read the informed consent page, understand it, and are agreeing to participate in the survey.

In some cases, a researcher may request a waiver of informed consent. This is sometimes the case in ethnographies or participant observational studies, where an informed consent process with participants would change the nature of what is being studied. In such cases, the researcher needs to explain in detail in the IRB application what steps will be taken to protect the rights and interests of the research subjects, and why this cannot be accomplished via a traditional informed consent process. This may include, but is not limited to, using pseudonyms in field notes and publications, how data will be kept secure, and how identifying details of people and places might be altered for confidentiality.

My project is a piece of journalism. Do I have to submit the project for IRB review?

Typically journalism is not considered research under the IRB guidelines and is not subject to any level of IRB review (including exempt review)

My project is an oral history. Do I have to submit the project for IRB review?

It depends. In the past many IRBs exempted oral history from IRB oversight under the belief that oral history did not produce generalizable knowledge. However, it is clear that at least some oral history produces generalizable knowledge and that oral history can pose significant risk to participants, so many IRBs, including Assumption’s, do consider that many oral histories are subject to IRB review. If you are considering undertaking an oral history project, we recommend that you have a discussion with the IRB chair about if you should submit an IRB application for review.

I plan toemail all Assumption College undergraduate students to get participants for my research study. Is that allowed by the IRB?

It is not under the purview of the IRB to grant permission to recruit research participants by emailing the Assumption College student body. Requests to email the Assumption College student body for research should be made to the Vice President for Student Affairs.

What information about my recruitment process needs to be shared with the IRB?

The IRB application should include all details of the recruitment process and researchers should submit any materials included for recruiting participants as appendices to the IRB application. These may include, but are not limited to, emails, social media posts, posters, flyers, newspaper and magazine ads, and recruitment scripts (e.g., what will be said in a class when recruiting students).

My research project was already approved by an IRB at another institution. Do I still have to submit it to the Assumption IRB?

Yes. If the project has been approved by another institution’s IRB (and that IRB is registered with the federal government) in its entirely, including all the details of the research related to Assumption and/or Assumption researchers, then the researcher may submit a full copy of that approved IRB application along with the letter of approval from the other IRB, along with the Assumption IRB facesheet. The Assumption IRB will decide whether or not to accept the oversight of the other IRB. If accepted, the IRB application from the other institution will be kept on file at Assumption. If not accepted, the application would need to undergo the normal IRB review process at Assumption for the relevant level of review (exempt, expedited, or full).