This application form should be used if the primary aim of the research is the education of researchers (as opposed
to the furthering the scientific knowledge base through the public dissemination of the information gathered in the
study). Data collected under a Tier II Application may not be disseminated in any form or forum that is accessible
by the general public. Data collected under a Tier II Application may not later be converted to or included with data
collected under a Tier I Application. Tier II applications and consent forms are evaluated by and retained in each
Response boxes have been provided for all requested information. The boxes will automatically expand to accommodate
your answers. To ensure rapid review of your application, please provide answers that are thorough and clear; cryptic,
confusing, and incomplete responses will simply delay approval. Keep in mind that the application is being judged
for its compliance with ethical guidelines, not its scientific merit.
The purpose of this guide is to anticipate questions or issues that may arise as you complete the application form.
The guide attempts to provide a point by point explanation. It is assumed that the applicant is familiar with the
ethical issues addressed by this application as a result of his/her completion of the appropriate training modules.
Please feel free to contact the IRB with any questions you may have about the application process or any comments
you wish to provide regarding the application form or this guide.
Screening questions This section serves as a guide for deciding whether a Tier II Application is
the proper venue for the project under consideration. If you answer YES to any of these questions, it indicates that
your research warrants a Tier I application.
- A. Public dissemination A Tier II application is intended for educational purposes and not to
advance the scientific knowledge base. Data collected under a Tier II application may be shared only with members
of the Iona community (current faculty, students, and staff). Publication or display of these data in a public area
constitutes a violation of ethics.
- B. Minimal risk Minimal risks are those a person may encounter or may expect to encounter in
everyday life, comparable to a non-invasive physical or psychological examination.
- C. Personal identifying information Ordinarily, data records do not contain information that
make it possible to ascertain whether a particular person has served as a research participant. While data such
as height, weight, and ethnic background are personal, individually and collectively they do not make possible the
identification of a particular person. Personal identifying information refers to data that individually or collectively
make personal identification possible. Examples of personal identifying information include, but are not limited
to, names, social security numbers, and home addresses (particularly when combined with other demographic information
such as age or sex).
- D. Special populations There is no prohibition against the use of special populations
in research; however, the added requirements for working with these populations must be assured by the IRB and are
considered beyond the scope of the Departmental Review Board (DRB).
Project Title The project title is meant as a descriptive handle to simplify discussion of the
Principal investigator The principal investigator is the person completing the application, who
has primary responsibility for oversight of the day-to-day workings of the project. This person is NOT the supervisor
(see below). Applicants must indicate their status in the appropriate box.
Supervisor List the name of the person with administrative responsibility
for the Principal Investigator. For students, it will ordinarily be the faculty
in whose class the Principal Investigator is enrolled. Adjunct faculty should obtain the signature of their chair
or designee. Ful- time faculty do not need to complete this section.
Co-investigator(s) Listed below are three common situations that will be encountered.
- A. Faculty designed project, data collected from class members. In this situation, the class
members may serve simply as participants or they may play the role of investigator with other students in the class.
The Co-Investigator section should be left blank.
- B. Faculty designed project, data collected outside classroom. It would be tedious to list the
names of all class members; instead the faculty member should simply write "All class members." In the section soliciting
the dates for completion of CITI or NIH training, indicate where the certificates are filed (e.g., with
the DRB or with the Department Chair). Indicate whether class members are graduate students, undergraduate students,
- C. Student designed project. It is assumed that student-designed projects will have five or fewer
Co-Investigators (more names can be added, if necessary). List the name of each Co-investigator along with the
CITI/NIH completion date and the status of the Co-Investigator.
The principal investigator and any co-investigators, listed by name, must sign the assurances page.
The signature of the supervisor, if the researcher is a student or adjunct faculty member, is intended
to ensure that he/she is aware of the research being conducted.
Please be aware that applications with missing responses will be returned as incomplete. If the answer for a particular
items is "none" or "not applicable" that should be indicated in the space provided.
I. Overview The overview should be clear and to the point, keeping in mind that board members are
most likely not familiar with your particular line of research. Avoid the use of jargon or overly technical terms
that will require further clarification (and, thereby, delay the approval process). In most cases, this section should
be completed in 150 words or fewer.
In the vast majority of cases the data collection process will be completed within the current semester and can be
stated that simply. If data collection will extend beyond one calendar year from the date of approval, the application
is subject to review and re-approval.
II. Benefits to Research Participants The issue here is whether it is anticipated that serving as
a research participant will have a direct benefit to the participant, beyond any compensation that may be provided.
Do not list benefits that may accrue in the future to similar individuals, but rather focus on current, discernible
benefits (e.g., improved mental health or increased skill at math).
III. Potential risks Do not list none for this item unless there will be no direct contact with
the participants. If appropriate, you may state that the risk is minimal and no more than that encountered in everyday
- A. Expected number This is not intended to limit or require a particular number of participants
but rather to provide a general indication for the board.
- B. Characteristics Include a general description of the types of individual you will be seeking.
If the study will limit participation based on personal or demographic characteristics (e.g., women only) provide
a rationale or justification.
- C. Recruitment How will participants be recruited and by whom?
- D. Time commitment Approximately how much time will participation require? Include the consent
and debriefing procedures in this estimate.
- E. Compensation If participants will be paid, include the amount; if they will receive extra
credit or other non-monetary compensation, please provide a description.
- A. Deception In many studies, information is withheld from the participant if
it is believed that the information would alter or invalidate the results. In some studies, participants are actively
misled about the nature of the study or about some aspect of the study (e.g., who the other participants might be
or how the participant performed on a particular task). This type of active deception is not considered unethical,
but it must be justified within the context of the study.
- B. Methods Provide a clear description of the anticipated experience for the participant. What
will each participant be asked to do and what will be the nature of his/her interaction with the research personnel?
This is a critical item for judging the ethical treatment of the participant.
- C. Record review These studies do not involve direct contact with the participant but the researcher
has access to personal and confidential information. Describe the type of record that will be reviewed and what
will be extracted from it.
- D. Standardized instruments Indicate the steps that have been taken to comply
with copyright law and/or provide compensation for use of copyrighted material.
VI. Informed consent If informed consent will be obtained through direct interaction
with the participant, include that statement in the supplied area. If that is not the case, explain why it is necessary
to use an alternative procedure (e.g., the participants are minors) or why obtaining consent will not be possible
(e.g., it would destroy the integrity of the study). It is expected that the consent form will be read or paraphrased
to the participant, unless the researcher explains why this cannot be done. Faculty-designed studies that collect
data from class members do not require a consent form; if this is the case, make that indication in the box provided.
- A. Debriefing process Describe the manner in which participant debriefing will
be undertaken or explain why debriefing will not take place. The purpose of debriefing is to explain fully the purpose
and method of the study. Many studies withhold information from the participant (e.g., the study hypotheses). In
addition, debriefing can serve an educational purpose, express thanks for participation, and provide important contact
information to the participant. It is understood that in rare cases debriefing may be problematic or impossible.
The lack of active deception is not, in and of itself, justification for omitting debriefing. The IRB encourages
investigators to provide a debriefing statement (paragraph) at minimum. Faculty-designed studies that collect data
from class members do not require debriefing; if this is the case, make that indication in the box provided.
- B. Deception If a participant has been actively deceived, it can affect his/her inclination
to serve as a participant in the future and may undermine the participant's faith and trust in the scientific community.
The debriefing process provides an opportunity to explain to the participant why the deception was necessary and
to regain his/her trust.