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Guidance Documents
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NYU SoM IRB Guidelines for Writing a Research Protocol
Guidance of Required Elements of a Protocol
Guidance on Determining Human Subjects Research
Guidance on Submitting a New Application
Guidance on Using an FDA Regulated Product
Guidance for the Investigator as a Sponsor
Guidance for Data Monitoring Plans
Guidance for Emergency Use of an IND
Guidelines for Research in Pregnant Women, Human Fetuses and Neonates
Guidance on Research with Prisoners
Guidelines for Involving Children in Research
Guidance for Cognitively Impaired
Guidance for Students and Employees in Research
Guidelines for Recruitment of Research Subjects
Guidelines for Advertisements for Research Subjects
Guidance on Genetic Research
Guidelines on Protocol Development for Genetic Research
Guidance on the Consent Process and Documentation
Guidelines of Requests for Waiver of Consent
Guidance on Assent of A Minor
Guidance for Non-English Speaking Subjects
Guidance on Verbal Consent
Guidance on Waiver of Parental Permission
Guidelines for Amending a Protocol
Guidance on Continuing Review and Final Closures
Essential Documents
Guidelines to Investigator Responsibilities
Letter for Sponsors - Reportable Events Policy
Guidance for Reportable Events and Reporting Unanticipated Problems
Reviews Preparatory to Research

Research Data Compilations

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Guidance Document on the Inclusion of Students and Employees in Research

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When NYU SoM students and/or employees are being recruited as potential subjects, researchers must ensure that there are additional safeguards for these subjects. The voluntary nature of their participation must be principal and without undue influence. An institutional setting may pose the possibility of coercion for potential subjects, if they perceive that continued employment or other benefits are dependent upon their participation in the research.  For example, students may be concerned that refusal to participate may affect their grades. 

Researchers must emphasize to these subject populations that neither their academic status or grades, or their employment, will be affected by their decision to participate or not.  Researchers must also ensure that record of participation can not be linked to any type of academic or employee record. Certificates of Confidentiality should be sought when researching sensitive topics such as Mental Health, drug/alcohol abuse, sexual behavior, or others that fall in this category.

The Principal Investigator should ensure that the research design addresses such institutional pressures and preserves the right for subject to refuse participation.  For example, with regard to students, the IRB may require faculty-investigators to advertise for subjects generally rather than to recruit individual students or students enrolled in particular courses.

To minimize coercion, Investigators should avoid, whenever possible, the use of their students and employees in procedures which are neither therapeutic nor diagnostic. Ideal recruiting procedures include bulletin board placement of an IRB approved advertisement; IRB approved ad in a newspaper and announcements in other classes. If a survey is to be completed by a specific class, investigators must do so at the end of the class period to allow non-participating students the option of leaving the classroom.  This process alleviates the pressure of participating.

 

IRB Resources
HRPP Accreditation Tutorial
IRB Online Tutorials
IRB Online Tutorials Completion Search+Certificate Tool
IRB CITI Tutorials
Decision Charts -
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IRB Newsletter
IRB Course Calendar
Policies and Procedures
HELP Downloading Forms
Lay Glossary
Useful Web Links
Sponsored Programs Administration (SPA)
Office of Clinical Trials (OCT)
Email a Suggestion or Comment to the IRB
Contact the IRB
GCRC Web Page
Instructions for Research Conducted at Bellevue
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