Every application must be accompanied by proof of completion of the Collaborative Institutional Training Initiative course on working with human subjects. The course is free. Follow the directions for how to take this mandatory instructional training.
It is also requested that all researchers inform the committee when their research has been completed, and submit a copy of any paper or article which results from the study.
Health science related IRB applications should be sent to the HSIRB Committee via email to the attention of the current chair, Dr. June Kume – HSIRB@touro.edu
If email is impractical, the forms should be mailed, in triplicate, to:
June Kume, Assistant Professor, Physical Therapy
Touro College Health Sciences IRB
1700 Union Blvd.
Bay Shore, NY 11707
Attn: Dr. June Kume
For further information, contact Dr. June Kume via email at the HSIRB@touro.edu or via phone: 631- 665-1600 ext. 6243.
Allow a minimum of THREE weeks for processing the forms (projects identified for expedited or exempt status may be faster). You may be asked to elaborate on or revise some portions of your submitted forms. When approval is granted, you, your advisor and your supervisor will get a letter to that effect.
You may NOT begin your project unless you have IRB approval.
If your project changes substantially after you receive IRB approval, you must resubmit it to the committee.
Items that are explained are in BOLD type.
Explanations are in italic type.
Put your name next to the space for Principal Investigator.
Put the name of your advisor next to the space for Research Advisor.
Write the title of your research project next to the space for Project Title.
P.2 – Part A:
The Federal government recognizes three levels of ethical reviews:
While the committee would like researchers to identify their project’s status, ONLY the committee can make the final determination. The committee will inform the researcher of the project status in a letter.
The description of the study should be short and concise, and should focus on the purpose and how human subjects will be used. More details will be provided later in the application.
Remember that most of the committee members are not members of your profession. Do not use professional jargon! Do not assume that others on the committee "should understand what you say." (For example, do not assume that an OT should understand PT terminology, since the professions are closely related). When in doubt, use simpler language or provide a list of terms with their definitions.
You are a professional – make sure to edit your application for spelling and grammar!
Pgs.3 to 7 - Part B: is self-explanatory.
P. 8 - Part C:
Please provide a typewritten response to these eight questions. Please answer the questions using full sentences.
Please address the following questions regarding your project. Answer as briefly as possible, but provide sufficient detail. Remember that some reviewers are not specialists in your field. Word your answer so that an educated layperson will be able to understand your study. Use a separate page(s) for each question.
Question 1. Who will the subjects be and how will they be selected?
You will need to address the following points:
Question 2. Where will the research be performed? Who will be your approved supervisor?
Question 3. What precisely will be done with the subjects? Describe in reasonable detail. If a questionnaire will be used, please enclose a copy.
Question 4. How will subject anonymity and confidentiality be guaranteed?
No personal data should be shared with anyone without their consent.
In addition to specifying procedures for ensuring the privacy of the participants, you also must specify how and where you will store material related to the study, who will have access to this material, and how do you plan to protect information saved on a computer.
Please note that all study materials (e.g., filled out surveys, signed consent forms, etc.) must be kept for at least 3 years after the completion of the study. Please specify were will you keep this material and who will have access to it. Also specify how you plan to discard this material (for example, use a shredder).
Question 5. Will the project require subjects to be uninformed, misled or misinformed in any way? (e.g. sham treatment, placebo effects)
If yes, discuss the rationale for this approach and what measures are being taken to remove the deception at the earliest possible moment.
Question 6. In your judgment, will the project involve discomfort, stress or risk to the subject?
If yes, describe all risks. Discuss the rationale for the approach selected and what measures are being taken to minimize or remove the discomfort, stress or other risk. Remember discomfort also includes both physical and emotional stress your study might cause.
Question 7. If a written consent form will be obtained from the subjects, please attach a copy. If your project is a survey, please attach the cover letter and questionnaire. Generally, surveys will not require a separate consent form.
The following information must be included in the consent form or cover letter:
Question 8. What benefits may there be to the subject(s) and/or society?
It is not sufficient to say that you will receive a degree.
Refer to the hypothesis, the theoretical issue, the social dilemma and what part of society will benefit.
This is your opportunity to convince the committee that your study is needed, that it has the potential to make meaningful contribution to your field, and that the benefits outweigh the risks. Support your argument with literature and previous research findings.
(I) Federal Criteria for Expedited Review and Exempt Status:
Expedite review and exempt status can be requested for non-experimental projects and for projects which meet the following criteria:
Expedited Review requiring review of only two members of the committee will be allowed under the following circumstances as voted by the committee on February 1, 2008 based upon 45 CFR 46.110 and 21 CFR 56.110. The decision as to whether the study meets these criteria will be made by the SHS IRB chairperson or the vice chairperson.
(A) Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
(B) The categories in this list apply regardless of the age of subjects, except as noted.
(C) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
(D) The expedited review procedure may not be used for classified research involving human subjects.
(E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review - expedited or full - utilized by the IRB.
(F) Categories one (1) through seven (7) below pertain to both initial and continuing IRB review.
1 An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.
2 Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a).
II. Sample Consent Form:
The Consent Form must be printed on your department’s stationary
Title of Study
Name of researcher and contact information
You have been invited to take part in a study to learn more about [enter the purpose of study here]. This study will be conducted by [researchers’ names and role, such as OT students], as part of [e.g., is this a part of degree requirements?]. The faculty sponsor is [enter the name of research advisor and department here, such as Dr. John X from the PT Dept.]
Participation in this study will include:
[Specify in detail what the participant will be required to do]
[If the study includes audiotaping and/or video taping add the following statement:] The study will involve audio recording and/or video recording. You may review the audiotapes and/or videotapes and request that information that includes your participation be modified or omitted.
Your participation will last [enter the exact time of the study. For example – one hour a week for 3 weeks].
Participation in this study may involve the following risks [list the risks. If there are no risks involved, include the following statement: There are no risks or hazards associated with participation in this study beyond those of everyday life.].
This research may result in [list the benefits of this study for the participant and in general].
Information obtained during this research is confidential, and will be used for the purpose of this study only. [If the study involves a group of participants that may be aware of each other’s participation, for example a study that involves a focus group, include the following statement: Your information will be kept confidential by the researcher, but the researcher cannot guarantee that others in the group will do the same.] Your name or other identifying information will not be disclosed to anyone but the researcher. All records will be kept locked and available only to the researcher, and will be destroyed 3 years after the study is completed.
Your participation in this study is voluntary and you can withdraw your consent to participate at any time without any negative consequences. Participation or non-participation in no way impacts your current employment or any services that you receive. [If the study includes interviews or surveys add the following statement: During interviews you can refuse to answer any question presented to you. You may also ask to stop the interview at any point.]
You can request a summary of the research findings from the researchers named above. If there is anything about the study or your participation that is unclear or that you do not understand, if you have any questions or concerns, or if you wish to report a research-related problem, you can call the researcher, [enter your name and contact information here]. You can also call the faculty sponsor, [enter your research advisor’s name and contact information here]. For questions about your rights as a research participant, you can contact Touro College Health Sciences Institutional Review Board for the Protection of Human Subjects (IRB) at 1700 Union Blvd, Bay Shore, NY 11706. Tel: 631- 665- 1600 ext 6243, or email: HSIRB@touro.edu.
You will receive a copy of this consent form to keep.
Name of Participant _________________________________
Signature of Participant ____________________________ Date _____________