Research Ethics and Human Subjects Consultation
This service is provided by the Regulatory Knowledge and Support and Ethics Resource (RKSER).
Overview
Consultations on ethics and regulatory issues are available to investigators as they plan and implement studies, including assistance with IRB submissions and consulting on ethical dilemmas that arise before, during, and after their studies. Among the issues addressed by this service are:
- Design of study procedures and informed consent forms
- Personalized support for addressing IRB requirements and correspondence
- Support for subject recruitment and fulfilling FDA requirements
- Assessment of competence to consent to research
- Effects of incentives on voluntariness of consent
- Appropriateness of return of research results to participants
- Protection of vulnerable subjects
Starting in March 2020, we are also providing support for COVID-19 research.
Eligibility
The service is open to all researchers at Columbia University.
When to Request This Service
Investigators are encouraged to request consultations with sufficient time prior to submission of a grant proposal or IRB protocol to allow consideration of options and modification of the procedures.
Cost
There is no cost for this service.
Cite it, Submit it, Share it!
If your research has benefited from one or more Irving Institute resources, please remember to:
- Cite our CTSA grant, UL1 TR001873, in any relevant publications, abstracts, chapters, and/or posters.
- Submit your publications to PubMed Central (PMC) for compliance with the NIH Public Access Policy.
- Share your research updates with us by sending an email to: irving_institute@cumc.columbia.edu
