If you are a considering being a research volunteer or are enrolled in one of the studies being conducted at the New York State Psychiatric Institute (NYSPI), then below are some questions to help guide you.
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 its reputation derive not only from leadership in clinical science, but from the commitment of its researchers and research staff to excellence in the practice of 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 study that is done to find and report new knowledge about something. Scientists conduct many different kinds of studies. For example, a research study may test if 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 decide whether new treatments are safe and effective.
What is a Clinical Study?
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies.
What is a Clinical Trial?
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. 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 try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.
What is ClinicalTrials.gov?
ClinicalTrials.gov is a Web-based resource that contains information about on publicly and privately supported medical studies on a wide range of diseases and conditions in human volunteers. Most of the records in ClinicalTrials.gov describe clinical trials (also called interventional studies). A clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol (or plan) and are then evaluated for effects on biomedical or health outcomes. ClinicalTrials.gov also includes records describing observational studies and programs providing access to investigational drugs outside of clinical trials (expanded access). Studies listed in the database are conducted in all 50 States and in 190 countries. ClinicalTrials.gov does not contain information about all the clinical studies conducted in the United States because not all studies are required by law to be registered.
The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the website (that is, registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. This Web site and database of clinical studies is commonly referred to as a "registry" and "results database."
Please go to clinicaltrials.gov for more information.
What is an Institutional Review Board (IRB)?
Institutional review boards (IRBs) at academic research centers, hospitals, and universities across the U.S. are part of a federal oversight system created some thirty years ago to safeguard the rights and well-being of people who volunteer to take part 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 IRB: Through prior and continuing review of research, investigator training, consultation, and ongoing quality improvement activities, the IRB helps support and guide the Institute’s research activities. Our membership provides expertise in the ethical, regulatory and scientific dimensions of human subjects research. Diversity in background, gender, race and ethnicity enrich the Board's experience and cultural sensitivity. Our devoted lay membership brings the perspectives of patients, their families, and the community to our work. IRB leadership works closely with NYSPI leadership to foster a local culture consistent with our ethical ideals and our commitment to excellence.
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 has been reviewed and approved by an Institutional Review Board (the "IRB"). Our IRB is a committee of professionals and lay members with expertise in science, medicine, patient care, law, religion, and ethics. We are 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. We are of diverse background and include members of the community, members of patient advocacy organizations, and people who have personal experience with mental illness.
The New York State Psychiatric Institute ("PI") is the oldest and one of the most highly regarded psychiatry research centers in the United States. Members of the IRB volunteer their time to support PI's efforts to improve the understanding and treatment of mental illness and related problems by helping ensure that your participation in research respects your rights, needs and expectations.
Understanding the process of research participation.
Questions to consider when thinking about research participation.
Research done here at the Department of Psychiatry at Columbia University and the New York State Psychiatric Institute has been reviewed and approved by an Institutional Review Board (the "IRB"). Our IRB is a committee of professionals and lay members with expertise in science, medicine, patient care, law, religion, and ethics. We are 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.
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 Institutional Review Board (IRB), 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.
What is a research study?
Research study is an organized activity to learn more about a problem or answer questions. Scientists conduct many different kinds of studies. For example, a research study may test if 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 decide whether new treatments are safe and effective. In clinical trials, treatments are often compared with placebos to check the effectiveness of that treatment. A placebo is an inactive substance which may resemble an active substance. However, it typically has no value to treat or prevent an illness.
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.
Why should I volunteer for a research study?
There are many reasons to participate in 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. Please click here for more information about informed consent.
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?
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.
For minors, Parental Permission (rather than Consent) and Assent are required unless specifically waived by the IRB.
Required Sections of the Consent Form
Purpose and Overview: A statement that the study involves research, an explanation of the purposes and the expected duration of the subject's participation, and a description of the procedures, noting any procedures which are experimental.
Voluntary: A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject would otherwise be entitled.
Alternative Treatments/Alternatives to Participation: Disclosure of appropriate alternative procedures or courses of treatment.
Procedures: A brief description of study procedures.
Risks and Inconveniences: A description of reasonably foreseeable risks or discomforts.
Benefits: A description of benefits to the subject or others that may reasonably be expected.
Confidentiality: A statement of the degree to which confidentiality of records identifying the subject will be maintained.
Study Compensation: A description of compensation provided for time, effort, and reimbursement of transportation costs, if any.
In Case of Injury: A statement about our institution's policy with regard to compensation and payment for treatment of research-related injuries.
Questions: Who to contact for answers to questions about the research, about research about research subjects' rights, and about research-related injury.
Documentation of Consent: Attestation of voluntary participation (i.e., informed consent). Please note that the requirement to obtain informed consent can be altered or waived under certain conditions.
How do I find out more about research at NYSPI?
Research at NYSPI/Columbia University Department of Psychiatry covers a wealth of subjects ranging from basic neurobiology to clinical, epidemiological, child psychiatry and services-related studies. Our facility has been the site of many of the major discoveries in psychiatry. For a listing of all our current research studies, click here.
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. To learn more about clinical studies listed on this registry, please click on the following link: https://clinicaltrials.gov/ct2/search/index
I have a question, concern or complaint, what should I do?
Contact the NYSPI IRB at:
Address: 1051 Riverside Drive, Suite 5200, Box 10, New York, NY 10032
Research Concerns or Complaints
For concerns or complaints regarding research at NYSPI, please click *here* for our reporting form and follow the instructions for the quickest response. You may also call the IRB Executive Director at 646-774-7155.
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
How about 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:
A registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
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).
The Food and Drug Administration (FDA)
Information about participation in a clinical trial.
The National Institute of Mental Health (NIMH)
Provides information on the signs, symptoms, diagnosis, and treatment of mental illness.
Brain & Behavior Research Foundation (BBRM; formerly NARSAD)
Awards grants for scientific research to better understand causes and improve treatments of mental illness.
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.
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.