Frequently Asked Questions
All research conducted by members of the Fordham community involving human subjects is subject to review and approval by the IRB. All external research which hopes to use the Fordham body for the recruitment of subjects is also subject to IRB review and approval. These statements remain true whether you are a member of Fordham's faculty, staff, or student body, and regardless of where the research is conducted, or if any funding that may be involved.
Research, as defined in Federal Regulations 45 CFR 46 and conducted by undergraduate and graduate students, is subject to federal regulations that require that all research protocols involving human subjects be reviewed by an Institutional Review Board. However, a number of schools and departments offer courses that require students to undertake projects in which other people are interviewed, observed, or otherwise serve as participants. The purposes of these course projects are to train students and to provide them with an opportunity to practice various research methods. These projects do not generally result in generalizable knowledge or publications and are not undertaken with these goals in mind. Therefore, the IRB does not consider them to be research and IRB review is not required. Such projects are considered "classroom exercises" and are typically quite limited in scope.
Please note the following restrictions:
- Any data collected under these circumstances cannot be used for future theses or publications. If the student might want to use these data for a future thesis or publication, the project requires IRB review and approval before the data are collected.
- Any student-initiated and/or student-conducted research that is not a research practicum or internship, that uses human subjects, and that is undertaken with the intent to contribute to generalizable knowledge, requires IRB review and approval. This includes, but is not limited to, undergraduate and graduate honors, thesis, and dissertation research.
- All class research projects that involve protected groups as defined in Title 45 Code of Federal Regulations Part 46 (such as, but not limited to pregnant women, children, prisoners, institutionalized mentally ill patients) require IRB review even if there is no intention to publish results.
Please contact the IRB at [email protected] if you are still not sure whether your research requires review.
The three different types of review are exempt, expedited, and full board. To determine which type of review you should submit your protocol for you can visit the Categories of Review page or take the pre-survey on the Mentor program.
Please note for expedited and exempt review, you must also specify the numerical category.
The following should be included in a site permission letter:
- Should be on letterhead of the site.
- Should indicate the title of the research study and the investigator's name.
- Should state the investigator has approval/permission to conduct the study at the site and include any other applicable information specific to the study. (If study involves use of existing data, the letter should indicate that the investigator has approval/permission to use the data for their research and state whether the data is de-identified or not)
- Should be signed by an authorized individual of the site and include their printed name, title and contact information.
- Make sure that each document is saved separately and clearly labeled. For example, Application form, consent form, recruitment flyer, assent form, etc.
- You, if applicable your faculty advisor, and any individual on the research team has completed the required online CITI training. The Instructions for registering and completing the CIIT course can be found on the Procedural Highlights page of the IRB website or on the Mentor IRB system.
Log-in to Mentor IRB to submit your protocol. You may access Mentor IRB from your my.fordham.edu account by clicking the Institutional Review Board button located on the bottom of the Employee tab or the lower-right hand side of the Student tab. Once logged-in, you arrive at the Info Page where further instructions can be found on how to submit your protocol.
As of 1/1/13, all new and continuing research submissions must include a copy of the completion report from CITI, the human subject protection online course. This applies to all key personnel involved in the study. Responsibilities of key personnel may include:
- Enrolling individuals
- Obtaining subjects informed consent by doing more than handing out or collecting forms or telling subjects how to get in touch with the investigators
- Intervening or interacting with subjects by performing invasive (e.g., drawing blood) or non-invasive (e.g., survey) procedures on them
- Collecting data directly from or follow-up directly with participants
- Collecting identifiable private information from participants or having access to information that links participants names or other identifiers with their data
- Acting as authoritative representatives for the investigator
Instructions for registering and completing CITI course
From the CITI website: "The average learner spends approximately 4.5 hours to complete the Basic Course site with approximately 5 logins to complete the course. The average learner requires approximately 2 hours to complete a CITI Program 'Refresher Course.'" Please note that these estimations are generous and it often takes investigators significantly less time to complete either course.
Based on feedback from Fordham researchers, the time it takes to complete the CITI training is:
1-2 hours for the Students Conducting No More Than Minimal Risk Research course
2 hours for the Refresher of Social and Behavioral Research Investigators course
2-3 hours for the Social and Behavioral Research Investigators course
4 hours or more for the Biomedical Research Investigators course
Once a study has been approved, if the investigator wishes to make a change to the approved protocol such as incorporating a different methodology of data collection, increasing the proposed number of subjects in the study, offering compensation, etc.? an amendment should be submitted to the IRB.
The IRB office is open all year round, including summer time from Monday through Friday, 9-5 (except on University Holidays and/or when the University is closed).
Full Board Submissions: There are no scheduled full board meetings for the months of June, July and August but submissions are still accepted for pre-review.
Exempt/Expedited Submissions: Are accepted and reviewed all year round as these submissions are not reviewed by the convened IRB.
It varies as this depends both on the IRB and on the investigator. At certain times of the year, a large volume of protocols appear in the reviewing queue. Sometimes, the investigator needs to make modifications to the research and to the protocol as a result of the review.
Please find general times below:
Full Board Submissions: An application that requires full board review must be submitted by the submission deadline for the meeting in which the investigator would like the application to be reviewed at. The submission deadlines can be found on our Schedule of Meetings page. If the submission is complete, it will placed on the agenda for the upcoming meeting. The investigator can expect to receive a letter indicating the outcome of the review within five working days after the meeting.
Exempt/Expedited Submissions: Generally, from when an investigator receives a confirmation of receipt and completeness from the IRB, the investigator can expect to hear a response about the outcome of their review in 15-20 business days.
Adverse events include any indices, events, effects, or outcomes that are undesirable or unintended for a participant that may occur during the course of research, regardless of whether or not it is related to the research procedures. Adverse events can be:
- The event was a known or foreseeable risk that was recognized and included in the approved protocol, recruitment materials, informed consent forms, or other relevant sources of information
- The event was an expected natural progression of any underlying disease or condition of the participant experiencing the adverse event.
- The event was a known or foreseeable risk that was not recognized or included in the approved protocol, recruitment materials, informed consent forms, or other relevant sources of information.
Related to the Research
- There is a reasonable possibility that the event was caused by participation in the research study.
Unrelated to the Research
- The event does not seem to result from participation in the research study.
Unanticipated problems include any incidences, events, effects, or outcomes that meet all of the following criteria:
- The problem was not anticipated to arise from the research procedures or within the anticipated characteristics of the subject population being studied
- Related (or possibly related) to participation in research
- There is, at the very least, a reasonable possibility that this event occurred due to the research procedures used in the study.
- Greater risk of harm
- The research places subjects or others at a greater risk of harm (including physical, psychological, economic, social, or legal harm) than was previously known or foreseeable
The following events or problems must be reported to the IRB within 5 business days from when the researcher receives knowledge of such events or problems:
- Adverse Events, which include:
- Adverse events that are (1) unexpected and (2) related or likely related to the research as determined by the principal investigator.
- Adverse events that require a change to the protocol or consent form.
- Protocol Deviations, which include:
- Any unintentional changes to or deviations from study procedure that occurred during the execution of the study.
- Deviations resulting from actions or inactions without prior IRB-approval taken to eliminate an immediate hazard to a participant.
- Information that indicators a change to the risks or potential benefits of the research, for example:
- A paper is published from another study that shows that the risks or potential benefits of the research may be different than initially presented to the IRB.
- Audit, inspection, inquiry, or written reports of federal agencies (e.g. notifications from OHRP or a granting agency)
- Allegation or finding of non-compliance
- A breach of confidentiality or otherwise unauthorized disclosure of confidential information
- Complaints from participants that are unresolved
- Suspension or premature termination by the investigator, sponsor, or institution
- Incarceration or other involuntary institutionalization of a participant enrolled in a research study not approved to involve prisoners or participants who are otherwise involuntarily institutionalized
- Any other information that the Principal Investigator deems related to the research that may indicate that participants or other individuals are at an increased risk of harm.
- Adverse Events, which include:
There is an important difference between anonymous data collection and confidential data collection.
Anonymous data has no identifiers recorded with no way for the investigator to link the data back to the individual participant. This means that no one not even the investigator is able to identify participants identities by their data. Anonymous just not mean no name other data can be used to identify the participant. Online surveys are generally the easiest way to design an anonymous study.
Confidential data can potentially be identified or linked to a specific participant. If any identifying information is collected, even if it is coded, it is confidential rather than anonymous. Special protections must be in place to prevent a data breech when conducting confidential research. Data must be kept in secure locations with codes or keys identifying specific participants kept separately from the data. Examples of secure locations are locked file cabinets in a private office, electronic data secured on a password protected computer, or data stored on an encrypted cloud. Any research assistants, investigators, or staff members that have access to the data must be properly educated on how to handle confidential data (which can be done through completing the CITI program, as required by the Fordham University IRB). High risk data can be protected by a certificate of confidentiality to ensure that the data cannot be subpoenaed. More information about obtaining a certificate of confidentiality can be found at grants.nih.gov/grants/policy/coc/index.htm.
A researcher can de-identify confidential data through aggregating data to report means and standard deviations rather than individual responses. If there are enough individuals in each demographic group, individual data can be reported without a risk of identification. Planning to de-identify your data at a later date does not mean that your initial data collection procedures are anonymous.
Examples of data collection procedures that are NOT anonymous:
- If you collect too much data from a small group of individuals (for example, ethnicity, age, gender, department, and number of years working at a company), your data collection procedures may not be anonymous.
- If you have a list of codes connecting the participant to their data, it is not anonymous.
- Face-to-face interviews are not anonymous.
- Online surveys that collect IP (Internet Protocol) addresses are not anonymous.
Please ensure that your consent forms make it clear whether your data collection procedures are anonymous or confidential.
The Qualtrics Research Suite is a web-based survey tool that Fordham IT provides for free to all Fordham students, faculty, and staff at fordham.qualtrics.com. This robust and professional survey system, designed for academic and business research, allows users to easily design and implement surveys and provides many tools to evaluate the results. As such, it is a standard for many universities.
If you are a student of any kind, a Faculty Adviser is needed to monitor your work. Student research cannot be submitted without a Faculty Adviser!
Because Mentor is connected with the Banner system, anyone who works for the Fordham Instution is considered faculty (even if you are technically a student). This does not mean you do not need a Faculty Adviser when sending your protocol to the IRB. In order to fix this, please just email the IRB at [email protected] and the staff will go in and fix it as soon as they can!