Rider University Institutional Review Board- Submitter Guide

Before you begin your submission, please have the following materials ready.

All Proposals require:

1. Informed Consent (Document 1), which has 6 core area:
   1. An explanation of the purpose(s) of the research, the expected duration of the subject's participation, a description of the procedures to be followed, and the identification of any procedures which are experimental;
   2. A description of any reasonably foreseeable risks or discomforts to the subject and a description of any benefits to the subject or to others which may reasonably be expected from the research;
   3. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
   4. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
   5. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;
   6. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. Additional note on informed consent: If you are working with children or minors with cognitive disabilities you must also attach a copy of the informed consent statement that will be signed by parental and/or legal guardians.
2. Description of Procedures (Document 2), including how you will select research participants, who your participants will be, what participants will be exposed to and required to do, and potential risks for research participants.

For proposals that involve children, the following are required:

1. Permission from the school(s) if you are conducting research in a school setting;
2. Children assent forms, if children will be giving assent.

For proposals that involve prisoners, the following are required:

1. Permission from the prison facility and appropriate authorities if you are conducting research in a school setting

For proposals that involve cognitively impaired participants, the following are required:

1. Permission from the institutional setting where you are collecting data if you are conducting research in an institution,
2. Assent forms if the cognitively impaired participants will be participating