The principal investigator (PI) is the individual responsible for all aspects of the design and conduct of the study.
- A PI must have relevant research and/or clinical experience to serve in this role,
- A PI must receive specific training in human subjects protections.
- Each study may have only one PI.
The following are minimal institutional criteria for the study PI at the NYS Psychiatric Institute (NYSPI)/Columbia University Department of Psychiatry (CUDP). The PI must have an appointment in the CUDP, RFMH, or NYSPI as follows:
- NYSPI research psychiatrists and those designated as psychiatrist II or III, or
- OMH or RFMH Research Scientist V or above, or
- Those who hold the rank of Assistant Professor or higher.
- Do I need approval from an IRB in addition to the NYSPI IRB?
- What are the requirements for human subjects research?
- Does my research require review by the NYSPI IRB?
- May I consent my own patients in a research study?
- Helpful Hints (learn the ropes; see one, do one, teach one; Consult with other investigators in your divisions; an IRB protocol should not look like your grant; do not submit a sponsor consent form without revisions)
Do I need approval from an IRB in addition to the NYSPI IRB?
If your research at another facility or institution requires local IRB review, but that site does not have an IRB, the NYSPI IRB can consider serving as the IRB of record for that institution. See directions for how to request such an arrangement.
If your research includes other Office of Mental Health facilities, you may not need separate IRB approvals for each site. Learn more about OMH multi-site approvals.
What are the requirements for human subjects research?
All those who play a significant role in the design, conduct, or oversight of research that is reviewed by the NYS Psychiatric Institute IRB are required to complete a web-based instruction course known as "CITI" (Collaborative IRB Training Initiative).
Does my research require review by the NYSPI IRB?
- The research is sponsored by (funded through) this institution (NYSPI or RFMH), or
- The research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities, or
- The research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
- The research involves the use of this institution's non-public information to identify or contact human subjects or prospective subjects.
Also, as per an amendment to a cooperative agreement with CUMC, all research originating in the Department of Psychiatry at Columbia is reviewed by the New York State Psychiatric Institute IRB for CUMC. Research submitted by a faculty member with a joint appointment in Psychiatry and another Columbia Department shall be reviewed by the NYSPI IRB when:
- The research is in a field of Psychiatry or related disciplines or NYSPI or Research Foundation for Mental Hygiene ("RFMH") patients, personnel, records, space, or funding is involved.
- In other circumstances, the Columbia Health Sciences IRBs conducts review of such research for Columbia and, when applicable, NYPH.
May I consent my own patients in a research study?
No. Clinicians/physicians may not consent their own patients. The Declaration of Helsinki, item #27 states, "When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship."
Learn the ropes:
You will save yourself and your colleagues time by becoming familiar with the IRB's policies and procedures and the federal regulations upon which our rules are based. Start with the CITI training, use the information on this website, ask questions of an IRB member who works in your division or field, and if your research group is interested in an in-service training about human subjects protection and PI-IRB procedures, we will gladly arrange one with you. Finally, consider sitting in on an IRB subcommittee meeting. Trust us, it will make things easier in the long run.
See one, do one, teach one:
Learn from the expertise of others. Preparing and submitting research for human subjects review should be an important part of the training for all research staff. Devote time to it. Ask your colleagues to share their approved protocols and consent forms with you, ask them to comment on yours. Share your knowledge of the IRB process and what works and doesn't with others on your team and in your division. Learn to discuss consent with subjects by observing more senior researchers and observe and supervise your junior team members. See one, do one, teach one.
Consult with other investigators in your divisions:
Why re-invent the wheel? Discuss your study with others who have approved studies using similar methodologies or populations. Review their approved studies. Many investigators have developed considerable expertise in navigating rocky shoals of IRB review. Use them, and if you don't know who they are, ask us.
An IRB protocol should not look like your grant:
Grants and sponsor protocols tend to focus on methodology and procedures from the investigator's perspective, not the human subject point of view. When investigators cut and paste extensively from the grant or sponsor protocol, they tend to provide information not needed by the IRB (how to ship blood specimens, the feasibility of recruitment strategies) and omit information that is required (how long will someone be in the scanner, who will be involved in carrying out the study procedures). Write your protocol after you have thought through the study with human subjects and PI-IRB requirements in mind.
Do not submit a sponsor consent form without revisions:
Consent forms written in-house at the major pharmaceutical companies are rarely written with the ideal of informed consent in mind. Most seem like liability documents, providing information to protect the sponsor, not facilitate a choice by a prospective research participant. In form and content, they require re-thinking and re-writing. For example:
- The alternatives section shouldn't be buried after nine pages of mind-numbing detail about each and every study visit. The presentation of ways to treat the condition outside of research participation should be presented clearly after the study purpose is introduced (in the form and in the process).
- There is no need to provide mind-numbing detail about each EKG and blood test and study visit. Summarize what the study visits will involve. Once.
- Revise the consent so it doesn't hide the fact that subjects will never learn what their treatment assignment or dose was in "pivotal" /FDA registration trials. Explain the impact that blinding will have on post-study treatment decisions.
- Carefully and simply explain what the treatment conditions are and what randomization involves.
- Revise the sponsor consent so the risks of delay to treatment and worsening as a result of treatment with ineffective treatments or placebo are described and discussed prominently.
- Describe the most serious risks and most frequent risks of the drug, and make sure subjects know how many people have been treated with the drug previously so you can help them put risks and adverse events in context (don't provide assurance that the drug is well tolerated when only 6 people have been treated with it!).
- Long lists of side effects don't provide information that is useful.
- Make sure it reads at the 8th grade level and is appropriate in length for the study population.
We can go on, but you get the point. See the Consent section for more information on everything from the principles of consent to sample language.