Institutional Review Board

General Principles

 

These general principles are presented to aid the researcher in the preparation of the research protocol. The researcher should provide information in his/her protocol addressing each of these topics, if applicable.

  1. There are two levels of anonymity to be considered in research with human participants;  (1) in no case should names or identifying data be used in reporting results,  (2) design considerations (such as a double-blind study) may require that research participants are anonymous to the investigator(s) also.  The type or types of anonymity for a study's participants must be explicitly stated in the Consent Form.

  2. All data should be recorded anonymously or identifying information deleted at the end of the study. The coding system to protect subjects’ identity should not use subjects’ initials, Social Security numbers, addresses, etc., in place of name. Such information could readily be used to identify specific individuals. Instead, assignment of unique or random numbers to subjects is recommended. In cases where follow-up is important, a master key could be maintained with the subject’s name and number in a separate place from the data. The master key, as well as the data, should be secured in a locked drawer or file cabinet. When the final analyses are completed and no follow-up is planned, this key is then destroyed.

  3. When required, subject/parental permission must always be written permission that is returned to the researcher. There should be a separate Assent Form for subjects under age 18, along with parental/legal guardian Consent Form. For children under age 12, there should be an Oral Assent Procedure or Script.

  4. Subjects should be given a copy of the signed Assent/Consent Forms for their records. It should be stated in the form that a copy will be provided.

  5. If a control group is used as part of the treatment-type study, the advantages derived from the research should be made available to the control group or the control group told of the advantages.

  6. Subjects should be given the office address and phone number of the researcher in order to request details of the research study. If the researcher is a student, subjects should be told to contact him/her through the department in which the student is studying. Home addresses and phone numbers should never be given out. In the Informed Consent and in the Solicitation/ Recruitment Letter, the researcher should specify his/her institutional affiliation with Seton Hall by identifying the department and college/school.

  7. If requested, results generally should be given to the subjects in aggregate or group form. As a rule, individual results, especially those which could require professional interpretation, should not be reported back to the subjects.

  8. Explain discipline specific terms when used in the application.

  9. Services, class standing, etc. are not to be terminated or negatively affected if the subject refuses to participate or withdraw from the study.

  10. Letters of authorization/permission from IRBs of cooperating institutions, school districts, hospitals, clinics, etc. must be on that institution's letterhead and included in the IRB proposal.

  11. The researcher must provide all cover letters, scripts, instructions to the subjects, introductory remarks, etc .to the IRB for review.

  12. Protocols not typed and properly collated as previously outlined, or with multiple grammatical and spelling errors, or missing a substantial amount of information will be returned to researcher without review.

  13. Total chapters from dissertations or class projects should not be attached as the description of methodology, etc. Rather, the researcher should provide concise answers to the questions on the application.

  14. Approval to conduct research: (1) Outside the University - permission on letterhead from appropriate administrative authority.  (2) with in Seton Hall University - letter of approval from faculty or staff member who oversees the subjects who are anticipated to participate in research.

  15. When there is minimal risk in mailed surveys, the Letter of Solicitation can replace the Informed Consent.  In that event, the Letter of Solicitation must contain all points of the Informed Consent except the signature.

  16. If the study is carried out outside Seton Hall University (e.g. hospitals, clinics, schools, etc.), approval of the site institution needs to be added to the material submitted to the IRB.   If the institutions have a local IRB (e.g. hospitals, colleges, universities), its approval of the study is also required.

  17. Federal regulations require that all state laws also be followed in conducting research.  Thus, researchers wishing to use lotteries, raffles, etc. need to abide by the regulations of the state in which they wish to conduct the research.  In New Jersey, this means a state license is required.

  18. Amendment Requests: If a researcher wishes to change any aspect of an approved study, please communicate this request in writing (with revised copies of the protocol and/or informed consent where applicable) to the IRB Director.  The new procedures cannot be initiated until IRB approval is received.    Student researchers must have the written permission of their mentor/faculty advisor;  adjunct faculty must have the written permission of their department chairperson.

Contact Us

Institutional Review Board
(973) 313-6314
Fax (973) 275-2361
irb@shu.edu
Presidents Hall Rm. 325

 
 

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