About the Baruch IRB
Professional ethics require protection of research participants, but in addition federal law mandates that researchers working with human subjects acquire approval of an institutional review board.

The Institutional Review Board is a Baruch body consisting of faculty and one community member which must approve in advance all human subjects research involving Baruch personnel. The mission of the Baruch IRB is to facilitate quality research, with quality in this context emphasizing balancing risks and benefits for human subjects.

A researcher at Baruch must complete computer-based training and, prior to each new research study, submit an application to the Baruch Institutional Review Board. In brief, the application asks for concise descriptions of a study's purposes, design and procedures. Important criteria for IRB approval include voluntary participation, confidentiality, informed consent, and limited risk.

Information and resources are available at

www .baruch.cuny.edu
The computer based training is accessible at
www .citiprogram.org
Feel free to contact Donald Vredenburgh or Keisha Peterson with questions.

ALL Applicants must answer questions 1-8 (See Pages 12-20 of the PI Manual)

All researchers must submit a fully complete application and detailed research protocol to the IRB, addressing all questions, regardless of type of review the researcher is requesting. Please consult pages 6-9 of the PI Manual
for an explanation of expedited, full and exempt IRB review and the types of research that may be reviewed under each procedure. The IRB chair will determine the type of review for which your project qualifies under federal guidelines. Research cannot start until written IRB approval notification is obtained. Final judgement rests with the IRB.

Please answer the following questions on a separate sheet.

1. State the purpose of the research. Include major hypotheses and research design. If the study is part of a larger study, briefly describe that larger study and indicate whether it has received IRB approval from another institution (see page 13 of the PI Manual). Please keep in mind that the IRB is composed of individuals from many disciplines and thus the description of your research should be written in terms readily comprehensible by non-experts.

2. Describe the source(s) of subjects and the selection criteria. Selection of subjects must be equitable and, in the case of protected populations such as children, prisoners, pregnant women, the mentally disabled, etc. should address their special needs. Include the number of subjects. (See pages 13-15 of the PI Manual for a discussion of equity in subject selection and pages 9-10 for a discussion of protected populations). The text of any advertisement, letter, flier, oral script or brochure used to solicit potential subjects must be attached.

3. Provide a description of the procedures to be followed. If available, include copies of questionnaires and/or interview protocol, or a sufficiently detailed description of the measures to allow the IRB to understand the nature of subjects' involvement.

4. Describe any potential harms or benefits to be derived by subjects, with a discussion of the risk/benefit ratio.
For approval of any study with more than minimal risk, the benefits must clearly be shown to outweigh the risk. Describe how the study may expose participants to stress, physical, psychological or interpersonal hazard, including the possibility of pain, injury, disease, discomfort, embarrassment, worry or anxiety.

5. Describe the specific methods by which confidentiality and anonymity will be protected, including the use of
data coding systems, how and where data will be stored and who will have access to it, and what will happen to data after the study has been completed.

6. If applicable, provide the following: 1) a description of the debriefing procedures to be used in cases where deception has occurred; 2) a statement describing what actions you will take should the research reveal the possibility of a medical or other potentially troubling condition.

7. Before submitting this application, all investigators should familiarize themselves with the discussion of informed consent contained in pages 17-21 of the PI Manual. Describe the oral and written consent processes and attach all consent documents, including scripts for oral consent and assent form for research involving minors ages 12-17. When the consent form to be used will be in a language other than English, an English translation must be provided. Unless one or more of the required elements described below is explicitly waived by the IRB, informed consent documents should contain:

A. A fair explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

B. A description of any possible discomforts and risks reasonably expected. This includes any potential financial risks that could ensue;

C. A description of any benefits reasonably expected;

D. A disclosure of any appropriate alternative procedures;

E. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled;

F. An offer to answer any inquiries concerning the goals of the research or the research procedures and to provide a summary of results upon request and an explanation of whom to contact for answers to
pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;

G. An instruction that the subject is free to withdraw or discontinue participation at any time without prejudice.

H. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; and

I. Provisions for parent or guardian approval for participation of minors or for subjects from vulnerable populations when appropriate.

Upon approval of the study, the consent document will be stamped with an expiration date. Only this document may be used when enrolling subjects. Studies extending beyond the expiration date must be submitted for a continuation review. Any changes in the consent form must be approved by the IRB.

8. Please provide any other information that might be pertinent to the IRB's decision.

If you are requesting exempt status, please continue on page 6.

For expedited or full review, please continue on page 7.

Human Subject Research Application Worksheet