If you are considering being a research volunteer or are enrolled in one of the studies being conducted at the New York State Psychiatric Institute (NYSPI) / Columbia University Department of Psychiatry, then below are some questions to help guide you. If you are looking for a study to participate in, visit the Join a Study page.
What is NYSPI?
The New York State Psychiatric Institute (NYSPI) is the oldest and among the most highly regarded psychiatric research centers in the United States. The Institute's success and reputation derive not only from leadership in clinical science but also from the commitment of its researchers and research staff to excellence in research and patient care. Individuals who seek treatment through research at NYSPI or who volunteer in other research studies can be confident of this.
What is Research?
A research study is a careful, systematic investigation conducted to find and report new knowledge about something. There are different types of studies that scientists can conduct. For example, a research study may test whether a treatment is safe and effective. A research study may be done to find out what health care practices work best. A research study may be done to determine the best way to prevent an illness. A research study may use a survey or an interview to understand feelings people have about their health. One type of research study is a clinical trial. A clinical trial is a research study that will try to discover whether new treatments are safe and effective.
What is a Clinical Trial?
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. A clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) according to a protocol (or plan) and are then evaluated for their effects on biomedical or health outcomes. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators aim to determine the safety and efficacy of the intervention by measuring certain outcomes in participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.
Ways to engage in research at New York State Psychiatric Institute (NYSPI) / Columbia University Department of Psychiatry
RecruitMe is Columbia University’s recruitment tool that connects those interested in participating in clinical trials or research studies with researchers. Researchers post their studies after receiving IRB approval. To use RecruitMe, search for a medical condition or research field that interests you, then answer a few eligibility questions, and the researcher will get right back to you. If you have any questions about RecruitMe, please see the How It Works section of the RecruitMe page.
NYSPI encourages anyone interested in volunteering for research studies to register with ResearchMatch, a secure, easy-to-use volunteer registry funded by the National Institutes of Health. Researchers from academic institutions like NYSPI use ResearchMatch to find volunteers who are a “match” for their study.
People of all ages and health conditions, including healthy people, are welcome to join. Volunteers under the age of 18 must be registered by a parent or guardian. Registering with ResearchMatch takes less than 10 minutes. You are not registering to participate in any particular study. Registration lets you indicate your willingness to be contacted about studies that may be a good fit for you. Your name and personal information are not released to any research team until you indicate you would like to know more about their research study.
ResearchMatch is also available in Spanish and Chinese. Volunteers can now sign-up in Spanish or Chinese and receive messages in either language from ResearchMatch about research studies.
I'm thinking about taking part in a research study. What should I know?
If you are thinking about taking part in a research study, you should know that all research done here at the Department of Psychiatry at Columbia University and the New York State Psychiatric Institute (NYSPI) has been reviewed and approved by an Institutional Review Board (the "IRB"), which is responsible for assuring that research with patients or other individuals meets the highest ethical and safety standards and follows all Federal and State rules and requirements for research.
IRBs at academic research centers, hospitals, and universities across the U.S. are part of a federal oversight system established in the 1990s to safeguard the rights and well-being of people who volunteer to participate in research. Within this system of “research protections,” institution-based ethics review boards (i.e. IRB’s) provide prior review and approval of research with “human subjects.” The IRB promotes an institution’s application of the core ethical principles related to research and supports compliance with federal, state, and local research regulations.
The NYSPI Human Research Protection Program (HRPP): Through prior and continuing review of research, investigator training, consultation, and ongoing quality improvement activities, the HRPP supports and guides the Institute’s research activities. Our HRPP provides expertise in the ethical, regulatory and scientific dimensions of human subjects research. Diversity in background, gender, race and ethnicity enriches the HRPP's experience and cultural sensitivity. Our devoted research community brings the perspectives of patients and their families, to our work. The members of the NYSPI HRPP work closely with NYSPI leadership to foster a local culture consistent with our ethical ideals and our commitment to excellence.
Questions to Consider
For your convenience, here are some questions to consider when thinking about research participation:
Who will see my records?
Like your medical record, the information in your research study record will be confidential. Information will be given only to the people who need it. This includes researchers and staff who carry out the research study. This includes the HRPP, the company or group funding the research study, and various government oversight agencies. It is important for these groups to be able to look at your records, so they can ensure that the research study is conducted using acceptable research practices.
Why should I volunteer for a research study?
There are many reasons to participate in a research study. You may want to:
- Help find a cure for an illness
- Help other people who are sick
- Help find ways to provide better care
- Help scientists find out more about how the human body and mind work
- Take part in a research study that is trying to find a better treatment for a condition that you have.
- If you decide to take part in a research study, you do so as a VOLUNTEER. That means YOU decide whether or not you will take part. If you choose to do so, you have many important rights.
What is informed consent?
Informed consent is the process of learning the key facts about a research study before you decide whether or not to volunteer. Your agreement to volunteer should be based upon knowing what will take place in the research study and how it might affect you. Informed consent begins when the research staff explains the facts to you about the research study. The research staff will assist you with the "informed consent form" that goes over these facts so you can decide whether or not you want to take part in the research study. These facts include details about the research study, tests or procedures you may receive, the benefits and risks that could result, and your rights as a research volunteer.
Who will answer my questions?
The research team will explain the research study to you. The consent form includes this explanation. You should take your time when you read the consent form. If you have any questions, ask the research staff. If you don't understand something, ask them to explain it to you so you do understand. The information will be given to you in a language that you know. If English isn't your native tongue, ask for an interpreter to be present when you are discussing the research study with the research study with the research staff. You can take the information home. You can discuss it with your family, friends, a health care provider, or others before you decide whether or not to take part in the research study. If you decide to take part in the research study, you will be asked to sign the consent form. The informed consent process is more than just signing a piece of paper. It is a process that goes on throughout the research study. During the research study, you may be told of new findings, benefits or risks. At that time, you can decide whether or not to continue to take part in the research study. You may decide not to take part. You may change your mind and leave the research study before it starts. You may also leave at any time during the research study or the follow-up period.
Are there benefits to being in a research study?
There may or may not be a direct benefit to you if you take part in a research study. For example, your health or a health condition you have may get better as a result of your participation in the research study. It may stay the same. It may get worse. No one can predict what will happen with a research study or how it might affect you. The research study may not help you personally. The research study may result in information that will help others in the future.
Are there risks or side effects in a research study?
Sometimes research procedures and treatments may cause discomfort and bad side effects. The questions being asked could make you uncomfortable. The risks and side effects of the research study may not be known completely when you start the research study. The research staff will discuss with you known possible risks so you can decide if you want to volunteer. If you do volunteer, the research staff will tell you about any new risks that they learn about during the research study for as long as you take part in the research study.
What questions should I ask before I agree to take part in a research study?
Before you decide to volunteer to take part in a research study, you need to know as much as possible about the research study. If there are any issues that concern you, be sure to ask questions. You might want to write your questions down in advance or take this booklet with you. The following is a list of sample questions. Not every question will apply to every research study.
- Who is doing this research study and what question might it answer?
- Will this research study help in understanding my condition? If so, how?
- What tests or procedures will be done?
- Is it possible that I will receive a placebo (inactive substance)?
- Will I have to make extra trips?
- What could happen to me, good and bad, if I take part in the research study?
- How long will this research study last?
- What will happen to any specimens that I give?
I have a question, concern or complaint. What should I do?
Questions
Contact the NYSPI HRPP at:
Address: 1051 Riverside Drive, New York, NY 10032
Email: HRPP@nyspi.columbia.edu
Research Concerns or Complaints
For concerns or complaints regarding research at NYSPI, please visit and follow the steps outlined on the Concerned About Research Practices? webpage.
Who should I contact in the event of an emergency?
In the event of an emergency, please dial 911 or go to your nearest hospital Emergency Room.
If you are currently enrolled in a research study at NYSPI, please refer to your consent form for emergency contact information
What are some other resources of interest?
There are many valuable resources on the web for those interested in learning more about mental illness, its treatment, and mental health research. Try these:
ClinicalTrials.gov
A registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
Website: clinicaltrials.gov
The Office for Human Research Protections (OHRP)
Provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).
Website: www.hhs.gov/ohrp
The Food and Drug Administration (FDA)
Information about participation in a clinical trial.
Website: www.fda.gov
The National Institute of Mental Health (NIMH)
Provides information on the signs, symptoms, diagnosis, and treatment of mental illness.
Website: www.nimh.nih.gov
Brain & Behavior Research Foundation (BBRM; formerly NARSAD)
Awards grants for scientific research to better understand causes and improve treatments of mental illness.
Website: www.bbrfoundation.org
The National Alliance for the Mentally Ill (NAMI)
An organization for consumers, families, and friends of people with severe mental illness. Their site is a guide to getting informed and getting involved.
Website: www.nami.org/
Center for Global Mental Health Research
Develops and conducts postgraduate educational programs, training programs, and basic and applied research that has global relevance, advances community awareness and understanding of mental illness and advocating for human rights of people with mental health illness.
Website: www.nimh.nih.gov/about/organization/cgmhr