Informed Consent Guidelines

All protocols submitted to the IRB must utilize an appropriate (and approved) recruitment and consent process(es) consonant with the risks involved. It is the responsibility of the PI and research staff to ensure that proper informed consent has been obtained from all research participants. Assent must be obtained from minors. Assent forms are typically much briefer than consent forms, and the language must be appropriate for the age of the participant.

Consent Guidelines:

Unless a waiver of documentation of informed consent is requested (see below), all research projects involving human subjects require a consent form signed by both the researcher and the subject.

The human subjects in your project must participate willingly, having been adequately informed about the research. If the human subjects in your project are part of a vulnerable population (i.e. prisoners, cognitively impaired individuals, or minors), special protections are required. Contact the IRB Office for more information.

Except where noted, written informed consent must contain all sections described in the templates.

The consent form should be able to be read easily (5th to 8th grade level) and should be formatted to separate required elements of the informed consent process (i.e. Risks & Benefits, Explanation of the Research Study, etc). For example, create section headings to guide the reader or use topic sentences to highlight pertinent information in each new section. Please do not include a copy of this consent form template with your application; only include the consent form you plan to use.

This website is useful for gauging the approximate reading level of a document.

Each section includes instructions for preparation and provides suggested text of the information to be included. Please customize the suggested text to adequately describe the research project.

If informed consent will be obtained in a language other than English, please include a copy of the consent document in that language, as well as a copy of the English version.

We have provided a number of informed consent templates that fit various kinds of research studies. The links to these forms are at the bottom of this page.

Waiver of Documentation of Consent

Under certain circumstances the IRB may waive the need for a signed consent from a research participant. This waiver of documentation of consent may be requested in the following circumstances:

When the research presents no more than minimal risk and involves procedures that do not require written consent when performed outside of a research setting.
The consent document is the only record linking the subject with the research.
The research can not be carried out without the waiver of consent When the principal research risks are those associated with breach of confidentiality.

PLEASE NOTE: The absence of a signed consent document DOES NOT release the researcher from obtaining research subjects’ consent to participate in the study. Participants should be aware that they are in a research study, who is conducting the study and for what reason, and that their participation is voluntary. One approach is to attach a consent -type document with the pertinent information (“elements of consent”), and indicate that completing the survey indicates consent to participate. Individuals may also be given information on the study to take with them. In circumstances when informed consent must be obtained verbally, oral instructions and the script detailing exactly what will be said to the participant are very important.

A waiver of documentation of consent may be requested by checking the appropriate box in the IRB initial application, and explaining why the request is being made, i.e. which of the above criteria applies, and how subjects will be provided the elements of consent.

Information Sheet:

Protocols granted a waiver of documentation of informed consent must employ an information sheet when enrolling subjects. All information sheets should include the following:

Name of the investigator, and organizational affiliation.
A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
A clear of any reasonably for-seeable discomforts or risks which the subject might encounter during participation in the project.
A clear description of any benefits to the subject or to which may reasonably be expected from the research.
A statement describing how confidentiality or records identifying the subject will be maintained.
A statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may withdraw or discontinue participation at any time without penalty or loss of benefits to which the subject is entitled. This should include informing the participant of what will be done with the data that has already been collected after discontinuing participation.
An explanation of whom to contact for answers pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject. The investigator must provide their name, phone number, and email address where they can be contacted for information about the study. Dr. Melany Puglisi, Chair of the IRB, irb@xiaoneizhi.com, must be listed as the person to contact if the participant has questions or concerns about their rights or treatment as a research subject.
An information sheet does NOT include space for a research subject to sign their name. Rather, a statement should be included that states (or along the lines of) "By completing and returning the attached survey you are giving your voluntary consent to participate in research." All information sheets used to enroll subjects must be photocopies of stamped and dated information sheet(s) issued by the IRB at the time of a study's approval.

Use of Protected Health Information and HIPAA Privacy Rule

Some healthcare data (Protected Health Information or PHI) is protected by the HIPAA Privacy Rule.

For more information, please see http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/research/index.html

Any investigator using Protected Health Information must complete the Responsible Conduct of Research (RCR) module on Information Privacy and Security - Health Privacy Modules.

Sample Informed Consent Templates

Note that these templates all meet the New Common Rule guidelines which went into place January 21, 2019.