All submissions for Committee review must include:
- Original, fully completed and typed Application for Review by the UCAIHS. This includes:
- Investigator's signature;
- Faculty sponsor's signature (if required);
- All applicable attachments (recruitment materials, consent or permission forms, institutional approval letters, research instruments, and any other additional materials).
- 1 copy of the full research proposal if:
- Funding is being sought from an outside sponsor;
- The project is for dissertation research (Please include written confirmation of Dissertation Committee approval. Students in departments with no formal dissertation proposal requirements should submit a 5 page summary of their proposed project.);
- The project is for a master's theses, or faculty-directed non-funded research.
Incomplete submissions will be returned un-reviewed to the researcher for revision and resubmission.
Any material used to inform potential participants of the opportunity to participate as a subject (e.g. flyers, letters, etc.) should clearly identify the investigator, New York University, the school and department, the investigator's status (e.g., faculty, doctoral candidate, etc), the faculty sponsor (if applicable), and the institution.
Materials should give a brief idea of the purpose of the research, what participation entails (including any important subject inclusion/exclusion criteria), and a way for potential participants to contact the investigator if interested in participating.
Recruitment materials should also include sample letters to potential subjects and applications to organizations which are being asked to take part (or are taking part) in the project effort. This includes:
- Assisting in the recruitment of subjects;
- Providing space for meeting with potential/actual subjects;
- Access to records of individuals or the organization.
Investigators who are planning work with any organization that has an Institutional Review Board must apply to that IRB for review and approval. They then must provide written approval from that IRB to the UCAIHS before the UCAIHS may provide final approval. Investigators should take into account when planning their research that IRBs vary widely in the time required for review and approval.
Statement to Subjects
This statement is provided by the investigator to potential participants prior to obtaining informed consent and carrying out the proposed work. It explains in more detail (than the recruitment materials) the purpose(s) of the research and what the subject will be asked to do if s/he agrees to participate.
The statement is generally provided as a response by the investigator to interest generated through a recruitment effort. It may be written or verbal and may be delivered in person, by phone, by mail, or by email. In some cases, the recruitment material and statement to the subjects may be combined in one document.
Informed Consent and Permission Forms and Assent Scripts
Informed consent is designed to provide potential subjects, or those who must give permission for potential subjects, all the information they need to decide whether or not to participate in a research project.
Consent, permission, and assent materials must be written in language appropriate to the intended subjects, but in no case in higher than 10th grade language. If an investigator plans to recruit subjects from non-English speakers, or those who do not speak it well, certified translations should be provided once the English versions of the consent, permission, and assent materials have been approved by the UCAIHS.
The UCAIHS provides a Language for Consent & Other Forms and Child Assent (under age 12); investigators are expected to use that language unless there is a strong reason to make changes. These changes, if requested, must be justified in the application.
The materials should be on University departmental letterhead in a format which will allow them to be copied and distributed to subjects as is. Once approved by the UCAIHS, they will be stamped to signify Committee approval. Only stamped forms may be used to obtain a subject's consent.
The following information must be included in all consent forms and permission forms:
- New York University cannot provide either medical treatment or financial compensation for any physical injury resulting from the subject’s participation in the research; and
- that inquiries concerning this policy may be made to the principal investigator or the UCAIHS email: email@example.com or call (212) 998-4808
- a statement that the study involves research and an explanation of the purpose(s) of the research
- names and contact information of the investigator(s), of the faculty sponsor, including institutional affiliation and status
- Contact information for each investigator and faculty sponsor including school and department, phone number (including a local phone number if the work is to be done out of the United States), university and email addresses
- a description of the procedures to be followed, what the subject will be expected to do, and whether there are any procedures which are experimental
- how long participation will take, including how many sessions will be held if more than one will be needed
- a description of any benefits to the subject or to others which may reasonably be expected from the research, or, more commonly, since the benefits of research to the subjects are usually tenuous at best, a statement that there will be no direct benefit to the subjects
- a description of any reasonably foreseeable risks or discomforts to the subject, including any intervention which may be offered, OR the statement that there are no risks beyond those of everyday life
- for research involving more than minimal risk, a clear description of the risks and where further information may be obtained (note that no research with minors involving more than minimal risk may be carried out unless it holds the prospect of direct benefit to the subject)
- if the research involves more than minimal risk, a statement concerning the availability of medical treatment or compensation in the event of physical injury resulting from participation in the research. The statement should include the information that:
- if applicable, a disclosure of appropriate alternative procedures or courses of treatment, if any, that may benefit the subject
- a description of any incentives (monetary or otherwise) that may be available to the subject for participation, and information on what the subject will be entitled to, if anything, if they do not complete the study
- a statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits (if the subjects are in an educational setting, a statement that non-participation, participation, or withdrawal from the study will have no effect on the academic status or grades of the subject)
- a statement describing how and to what extent the confidentiality of subjects’ identity and any information about them will be protected and how records identifying the subjects will be maintained so as to preserve that confidentiality
- an explanation of any limits of confidentiality, for example, from participation in a focus group, for mandated reporting to the appropriate authorities of indications of harm to self, children, or others, or from any chance that identification of subjects might be possible because of the context of the research, a small sample size or the like
- an offer by the investigator to answer questions concerning the study at any time during or after the study
- whom to contact to report a research-related problem or injury to the subject (usually the investigator and, if applicable, the faculty sponsor)
- a statement, including contact details, that information on subject’s rights as a research participant may be obtained from the UCAIHS
- if audio or videotaping is involved, a statement that the subjects will be taped and that they have the right to review the tape and request that all or any portion of the tape be destroyed (parental permission forms, however, should not offer parents the right to review their child’s tapes)
- if subjects might be quoted by name or in any way that might make them identifiable, an attribution statement authorizing (or refusing) this use of their names and/or verbatim responses
- if the research is sponsored by or associated with a commercial enterprise, e.g. product evaluations or clinical trials, the name(s) of the research sponsors.
All surveys, questionnaires, and other data collection instruments must be submitted for review. If these are no longer than 10 pages, complete copies should be attached to all submitted copies of the Application. If longer than 10 pages, please attach one copy only to the original Application.
Surveys, questionnaires, demographic data sheets, interview questions, and observation guides are among the instruments commonly used by researchers at NYU. When experiments are conducted, investigators must submit complete descriptions of the differing conditions for each condition being studied.
If the investigator will be using proprietary instruments that are well established and known in the field, the instruments should be named and briefly described in the Application.
If you are applying for expedited review, please submit one completed copy of the Expedited Request Checklist. This should be placed on the top of your submission package.
What and Where to Submit
All applications must be submitted electronically to UCAIHS. For instructions on how to submit your documents electronically, review the submission instructions available here.