Protocol / Consent / Assent / Authorization Templates
The IRB is going to be revising our templates in the following weeks to better reflect the new workflows introduced with Research Navigator's rollout on November 19th, 2013. As we update these documents, look for updated version dates. You can also keep an eye on our home page which lists all updated materials in chronological order - the last 5 are always visible.
The Office of Science and Research has developed a new set of Protocol templates for human subjects research.
Biomedical Consent Form Template (Spanish)
Non Biomedical Consent Form Template (Spanish)
Standard Consent Language: Biomedical (Spanish)
Standard Consent Language: Non Biomedical (Spanish)
Biomedical Consent Form Template (Mandarin)
Non Biomedical Consent Form Template (Mandarin)
Standard Consent Language: Biomedical (Mandarin)
Standard Consent Language: Non Biomedical (Mandarin)
Biomedical Consent Form Template (Russian)
Non Biomedical Consent Form Template (Russian)
Standard Consent Language: Biomedical (Russian)
Standard Consent Language: Non Biomedical (Russian)
Data Use Agreement
Audio Video Consent (Release)
Consent/Release to HIV Antibody Test Information
NY State DoH Required HIV Related Consent and Authorization Forms
Emergency Use Consent Form
Full Telephone Consent
Humanitarian Use Device Consent Form
Specimen Banking Consent Template
Treatment IND/IDE Consent Form
Research Authorization Form
Research Authorization (Spanish)
Research Authorization (Mandarin)
Consent Templates - Short Forms
These forms are for use with non-English speaking persons who are going to be asked to participate in research. Use a short form written in the subject's native language in order to record consent. The English version of the short form is available here for your reference, although English speakers will be able to read and consent using a regular consent document.
Short Consent Form (English)
Short Consent Form (Mandarin)
Short Consent Form (French)
Short Consent Form (Korean)
Short Consent Form (Polish)
Short Consent Form (Spanish)
Short Consent Form (Russian)
Short Consent Form (Arabic)
Short Consent Form (Hungarian)
Foreign Language Medical Dictionaries
Standard Consent Language for Special Cases
If your study involves a CT scan, chest x-ray or other radioactive medical imaging study, the following language is required in the consent form document. Please contact the Scientific Manager reviewing your project for any specific questions.
Approval from the Radiation Safety Committee must be obtained for any study involving the use of radiation or radioactive agents in testing, imaging, etc.
Assent Templates for Children
In effort to build on our current assent process the NYU SoM Administrative Office of the IRB has been working closely with IRB members and researchers who have specific expertise in working with children. The result is more detailed Assent of Minor forms and clearly guidelines for the use of Assent of Minor.
Keep in mind, the change was made because when children or minors (<18 years of age) are involved in research, Federal Regulations require the assent of the child or minor. Out of respect for children as developing persons, a detailed written assent document provides the child with information that they can take home with them, the signature allows the child to feel that their decision matters and including the child in the process enhances the ethical principal of respect for person which should be present in all human subjects research.
Please consult our guidance on assent forms and use these templates with all new research proposals involving children. Should you have any questions, contact the IRB.
Assent for Children ages 7-11 years for Biomedical Studies
Assent for Children ages 7-11 years for Non-biomedical Studies
Assent for Children ages 12-14 years for Biomedical Studies
Assent for Children ages 12-14 years for Non-biomedical Studies
Assent for Children ages 15-17 years
Waivers of Consent
In certain cases, federal regulations allow the IRB to approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or to waive the requirement to obtain any informed consent. Most complete waivers of consent involve studies in which there are minimal risks to subjects, but complete waivers are also possible in emergency care and a few other circumstances. NOTE: Studies regulated under the FDA regulations differ from HHS regulations and are generally more restrictive in the area of waiver of informed consent. The differences are noted below.
Get the Request for Waiver of Authorization and/or Consent Form on the APPLICATIONS page
I. Waiver of Informed Consent
Federal regulations at 45 CFR 46.116(d) establish four criteria for waiving consent or altering the elements of consent in minimal risk studies. There are no corresponding provisions in FDA regulations, and these criteria may not be used to waive or alter the elements of consent in FDA-regulated studies:
- The research involves no more than minimal risk;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Minimal risk is defined in 45 CFR 46.102 as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
Example of requests for waiver of consent that may be approved by the IRB
Review of medical records of all patients who have undergone abdominal surgery in the past two years and correlate the data with blood chemistry values kept by pathology. Researchers are collecting limited data that will be assigned a random code # and the link is known only to the researchers. Results of the research will not affect clinical care of the individuals, since they will already have left the hospital.
- Minimal risk: evaluating patient records fits definition of minimal risk.
- Would not adversely affect rights and welfare of subject: Surgery and associated blood chemistry values are clinically indicated, therefore would be done regardless of the research. No study results would affect clinical decisions about the individual's care.
- Research could not be practicably carried out without the waiver: Identifying and contacting thousands of potential subjects, while not impossible, would not be feasible for a medical record review where results would not change care the individuals already would have received. (Note: In smaller studies, it is harder to argue that obtaining consent is not feasible, especially if subjects have not yet been treated or are still being seen.)
- Whenever appropriate, subject provided with additional pertinent information after participation: Not appropriate in this case, since results of research would have no effect on the subjects; there is no anticipated benefit to subject that would change what has already occurred*
II. Waiver of Documentation of Consent
Federal regulations [45 CFR 46.117(c)] allow the IRB to waive the requirement for obtaining signed consent if it finds that either:
- The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (These criteria cannot be used for FDA-regulated studies), or
- The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. This paragraph only also applies to FDA-regulated studies per 21 CFR 56.109(c)(1).
The IRB can also waive signed consent in studies that meet the requirements for waiving all consent. Often verbal consent used with use of an information sheet or implied consent will still be required for most studies where a waiver of documentation of consent is granted by the IRB. Investigators may wish to replace signed consent with implied consent (e.g., a prospective subject is informed about a study where participation consists only of filling out an anonymous questionnaire; the person completes the questionnaire and, by doing so, agrees to participate in the research). The IRB will consider approving such requests based on appropriate justification and information regarding the consent process.
Examples of approvable waiver of documentation of consent
- When the identities of subjects will be completely anonymous and there is minimal risk involved in the study. The signed informed consent would be the only record linking the subject to the study therefore it would be the only identifier in the study.
- When obtaining signed consent is not appropriate or feasible according to the cultural standards of the population being studied, and there is minimal risk involved in the study.
- When there is a possible legal, social or economic risk to the subject entailed in signing the consent form, e.g., for immigrants who might be identified as being illegal aliens, or for HIV antibody-positive individuals who might be identified as such by signing the consent form.
- When the study involved only a telephone interview.
Investigators may wish to replace signed consent with verbal consent. The IRB will consider approving such requests in limited circumstances, and will usually require use of an information sheet. If this is not feasible (for example, the only contact is by phone), the IRB may ask to see a script of what would be said to prospective subjects to evaluate the consent process.
Use of Information Sheets
As the regulations state, "in cases where the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research." In such cases, the IRB will usually call for use of an information sheet that includes most or all of the elements of a consent form but not the subject’s signature.
*Example used was provided by Institutional Review Board: Management and Function, R. Amdur and E. Bankert, Chap. 6-6, "Research without Consent or Documentation Thereof," M. M. Elliott.
III. Waiver of Parental Permission
The IRB may waive the requirement for obtaining consent from a parent or legal guardian for research that is not FDA-regulated if both of the following are true: the research meets the provisions for waiver in 45 CFR 46.116(d)(1-4); or the IRB determines that the research protocol is designed for conditions or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), and an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and that the waiver is not inconsistent with Federal State or local law.
A waiver of for obtaining parental consent (permission) may be approved by the IRB if the following evidence is provided:
- The research is minimal risk.
- The waiver will not adversely affect the rights and welfare of the subjects.
- The research could not be practicably carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
An appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and that the waiver is not inconsistent with Federal, State or local law. The choice of an appropriate mechanism depends on the type of research being conducted, the risk and anticipated benefit to the research subjects, and their age, maturity, status and condition.
In some cases, the IRB may determine that the requirement for parental consent is inappropriate. Examples may include research involving older adolescents and treatment for which they may, under applicable law, consent on their own behalf (e.g. treatment for sexually transmitted diseases or drug abuse). In other research (e.g. research on child abuse or neglect), there may be serious doubt as to whether the parents’ interests adequately reflect the child’s interests. In such types of research the children who are the research subjects should be given the full opportunity for informed consent as if they are adults, or the Principal Investigator should propose alternative procedures for protecting the rights and interests of children asked to participate.