IONA

Tier II Application Instructions

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 academic department.

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.

Cover Page

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 research.

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, or both.
  • 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.

Assurances

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.

Narrative

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 life.

IV. Participants

  • 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.

V. Procedures

  • 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 whether or not standardized instruments (surveys, tests, questionnaires) will be used and, if so, the names or descriptions of the instruments and whether copyright permission has been granted or compensation provided to the copyright holder.  If copyright permission has not been obtained and the applicant wishes to make a claim of “fair use,” describe here the steps that have been taken to obtain copyright permission.  Please read carefully the section of the web-site pertaining to Copyright & Fair Use; complete the Fair Use Request Form and submit it along with this application.

VI. Informed consent

  • A. Consent statement 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.
  • B. Storage Describe the storage location for signed consent statements and the methods that will be used to assure their security.  Considering the three-year storage requirement, it is generally best if forms are stored in a centralized area within the applicant’s department.  Off-campus storage is acceptable only during the data collection phase of the project. 

VII. Debriefing

  • 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.