Tier I Application Instructions
This application form must be used by all researchers (faculty, staff, and students) whose intent is to further the scientific knowledge base through the public dissemination of the information gathered in the study. Research that is conducted with the primary aim of educating researchers should use the Tier II application form. See the U.S. Department of Health & Human Services' Code of Federal Regulations for the Public Welfare (Title 45) §46.201 for relevant definitions.
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 primarily for its compliance with ethical guidelines; in some cases scientific soundness may be considered as well.
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.
Principal investigator The principal investigator is the person at Iona College who is completing the application. This person is not necessarily the principal investigator as indicated in a grant application or in other documentation. Iona researchers involved in collaborative work at other institutions must complete this form even if none of the research activities will take place at Iona College. Adjunct faculty, part-time staff, and students (both undergraduate and graduate) must be supervised by a full-time faculty member or full-time staff member.
Project Title The project title is meant as a descriptive handle to simplify discussion of the research.
Co-investigator(s)/Faculty Supervisor Co-investigators must be full-time faculty or full-time staff members (they cannot be students, adjuncts, or part-time staff members).
If the Principal Investigator is a student, adjunct, or part-time staff member, a full-time faculty or staff member must serve as supervisor. Additional students, adjuncts, or part-time staff members should not be listed in this section, but rather included as Research Assistants.
Research assistants List the names of project assistants, research assistants, graduate assistants or any other person(s) you supervise who will be in direct contact with the research participants or have access to participants' personal identifying information. If the assistants are not yet known (e.g., will be hired during the course of the project), list the anticipated numbers and their role within the project. Names and completion dates for CITI or NIH training should be reported to the board as soon as possible and must be given to the board before those individuals interact with the participants or the participants' personal identifying information.
Outside collaboration Research undertaken with collaborators from another institution and research that will be conducted at a site other than Iona College must be approved by all institutions involved or the board must be provided with an explanation of why that is not possible. In most cases, an approved IRB application from the other institution(s) will fulfill this requirement. If that application is under review, a copy of the application can be submitted with the Iona application and an approval letter (or other approval documentation) can be submitted to the Iona IRB prior to the onset of data collection.
Review type Indicate whether you are seeking an exempt, expedited, or full review. The committee will use this as a starting point for consideration. Based on the content of the application, the committee may select a different review option.
The principal investigator and any co-investigators from Iona College must sign the assurances page. Research assistants are not required to sign this document.
The signature of a full-time faculty member or full-time staff member serving as Project Supervisor is required if the Principal Investigator is a adjunct faculty, part-time staff or student.
Please be aware that applications with missing responses will be returned as incomplete. If the answer for a particular item 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 discipline or 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. Do not copy and paste large sections of a grant application, for example, into the box provided.
If the data collection process will take more than 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.
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 Whether or not the study will involve special populations, 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 participant 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. A brief statement regarding data analysis is also useful here.
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. Materials Describe the materials that will be used in the proposed research (e.g. standardized surveys, questionnaires, interviews, photographs, audio or video recordings) and their source. If the materials were developed by the researcher, please state so. Otherwise, state whether or not copyright permission has been obtained for their use. If copyright permission has not been obtained and the applicant wishes to make a claim of “fair use,” complete the Fair Use Request Form and insert it into the application. Please read carefully the section of the web-site pertaining to Copyright & Fair Use before completing the form.
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.
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.
A. 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).
B. Need for personal identifying information It is not unethical to collect and maintain personal identifying information, but such data collection and record-keeping must be justified.
C. Information about others The concern for privacy extends beyond the participant and includes personal identifying information that he/she may provide about others.
D. Security Describe how personal identifying information will be protected and restricted. A locked cabinet in the investigator's department generally works well.
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.
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.