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Printable Copy of the IRB Policy (PDF) Belmont Report - The Three Rules of Human Subject Research from the Office for Human Research Protections (OHRP), Department of Health and Human Services 1. No one should be involved in human subject research at any level without having first read The Belmont Report (1979). All regulations and IRB activities should be singularly focused on fulfilling the ethical responsibilities presented in the Belmont Report. The three basic principles are (1) respect for Persons, (2) Beneficence, and (3) Justice. 2. Not enough attention is given to the informed consent process. A signature on a form does not necessarily mean the subject fully understands what is expected of them. Consent can be a continual process during a long study, participants must be willing to remain involved. The signed form may be only one form of documenting consent: investigator notes, other written records, or audio- or videotape may be needed to confirm or prove consent. It is the degree of risk that determines the consent documentation requirement. 3. Everything must be documented, and this is equally true for the IRB as it is for the Investigators. For the full report, please click here: Belmont Report Introduction William Paterson University is deeply concerned with safeguarding the rights and welfare of all human subjects who participate in research projects conducted under its aegis. This concern extended to the intent of investigators to protect participants as well as to comply with the specific requirements established by the sponsors of its research. These guidelines provide the investigator with the information necessary to comply with University policy for review and approval of projects involving human subjects. In addition, it is hoped that they will confirm an awareness of the ethical and legal obligations assumed when such projects are undertaken. The investigator should also know the requirements of the Department of Health and Human Services as set forth in the Code of Federal Regulations 45 CFR 46 and certain other related laws and regulations on the protection of human subjects; and should be aware of and observe the standards established by the Declaration of Helsinki Recommendations Guiding Doctors in the Belmont Report. The Nuremberg Code, and Clinical Research. In compliance with NIH guidelines, the inclusion of women and minority groups and subpopulations must be addressed in developing a research design appropriate to the scientific objectives of the study. The research plan should describe the composition of the proposed study population in terms of gender and racial/ethnic group, and provide a rationale for selection and/or exclusion of such subjects. Such a plan should contain a description of the proposed outreach program for recruiting women and minorities as participants. For further information, refer to the NIH policy published in NIH Guide for Grants and Contracts, 23(11), 2-10. These documents are available for review in the Office of the Assistant Vice President for Graduate Studies and Research. These guidelines have been prepared by and for William Paterson University's Institutional Review Board (IRB). The IRB has developed a checklist which will be used by the Committee members for reviewing all research protocols submitted to the. Please review this list when preparing your protocol to make sure the appropriate documentation has been included in your submission. We hope that by providing this outline, the required information is present, the selection of subjects is equitable, the necessary signatures have been obtained and the number of tabled protocols can be reduced. PLEASE NOTE: It is essential that protocols for all research involving human beings be submitted to the IRB Chairperson. This includes research that may be eligible for exempted review and expedited review, as well as full review. If a research study is to be conducted at more than one institution, researchers must submit the protocol to the IRB at each institution and forward one copy of the IRB approval letter from the cooperating facility. Researchers should be aware that non-competing continuation applications to PHS no longer are afforded a 60-day grace period for submitting HHS 596 forms (certification of approval) to the sponsor. These proposals must have a current status (within a year of the funding start date) prior to processing through the Office of the Associate Vice President and Dean for Graduate Studies and Research. All correspondence and inquiries related to research involving human subjects may be directed to the IRB Chairperson. Chairperson, Institutional Review Board Office of Sponsored Programs Raubinger Hall 107 William Paterson University of New Jersey 300 Pompton Road Wayne, NJ 07470 Telephone: Voice 973.720.2852 Fax: 973.720.3573
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