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.

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.
Surveys emailed to potential subjects need to have a clear statement in the letter of solicitation [under “Confidentiality”] that there is always a possibility of hacking of online material.
If an online recruitment tool such as Amazon Mechanical Turk is used, there must be a clear statement to the potential subjects that there is no confidentiality or anonymity for participation in the study because payment for participation is linked to the user’s Amazon account. There would be anonymity and confidentiality as to subjects’ actual responses/data in the study, if the researcher has incorporated that protection.
Socio-behavioral research using online surveys with vulnerable populations or with crisis-precipitating questions are not permitted. Researchers should not just assume they will know what will trigger a reaction [immediate or delayed] and a screening mechanism needs to be in place to protect potential subjects.
If there is payment which requires a W-9 form for participation in a research study, the letter of solicitation and the Informed Consent document need statements that (1) the subject’s payment information will be on a W-9 form for IRS [Internal Revenue Services] purposes, and (2) this form will be processed through all appropriate University offices and the IRS. Thus, there is not anonymity as to participation in the study. There would be anonymity and confidentiality as to subjects’ actual responses/data in the study, if the researcher has incorporated that protection.
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.
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.
Letters of Solicitation, Consent Forms and Assent Forms must be in lay language and at an appropriate reading level. Researchers must submit Flesch-Kincaid Grade Level document to verify reading level for their proposed subjects.
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.
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.
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.
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.
Explain discipline-specific terms when used in the application.
Services, class standing, etc. are not to be terminated or negatively affected if the subject refuses to participate or withdraw from the study.
Letters of authorization/permission from IRBs of cooperating institutions, school districts, hospitals, clinics, etc. must be on that institution's letterhead or official email account and included in the IRB proposal.
The researcher must provide all cover letters, scripts, instructions to the subjects, introductory remarks, etc .to the IRB for review. Do not submit screenshots.
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.
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.
Approval to conduct research: (1) Outside the University - permission on letterhead or official email account 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.
When there is minimal risk in mailed or emailed 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.
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.
FERPA or the Family Educational Rights and Privacy Act has requirements for researchers seeking to use educational records. Although there are restrictions for releasing this information, the holder of the information, i.e., the Superintendent of a district, may give approval for a researcher to use the educational data and must cite the exception to the regulation in writing.

The exceptions that may be used for educational research are:
1. if the researcher is a school official with legitimate educational interest [34 CFR 99.3(a)(1)]; or
2. if the researcher is conducting studies for or on behalf of the school [34 CFR 99.3(a)(6)].
The FERPA exception letter should be submitted to the IRB along with the IRB Application. In most cases involving educational records held by elementary and secondary schools, this letter should come from the Superintendent of the school district.
Proposed research must be in accord with Seton Hall University mission statement:
http://www.shu.edu/mission.cfm
http://www.shu.edu/mission-ministry/seton-hall-a-catholic-university.cfm
If a Seton Hall University researcher is a full time employee at another institution, then that institution is considered "engaged in research" through the researcher's activity and the researcher, therefore, must submit IRB approval from it.

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html
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 with the appropriate Amendment form. The amendment forms and associated materials should be submitted electronically through the SHU IRB website, and a hard-copy hand-delivered, sent via inter-office or the US Postal Service within 2 business days of electronic submission. 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. Amendment requests cannot be approved immediately after dissertation proposal defense and initial submission to the IRB unless the researcher submits valid documentation as to why the requested amendment was not incorporated into the original dissertation proposal.