No. The IRB must review and approve any materials you plan to use before you begin recruiting individuals. This includes advertisements that appear in the newspaper, on radio or television or on the Internet, and flyers.
See IRB Policy 24: Recruiting Potential Research Subjects (PDF).
Because of the potential vulnerability to coercion or undue influence, federal regulations require that additional safeguards are incorporated in studies involving prisoners. Typically a researcher will anticipate beforehand that their study will involve prisoners and the IRB will review the study to ensure the additional safeguards are in place.
Sometimes, however, a research participant may become incarcerated after enrollment in a study that did not previously anticipate prisoner subjects. In this case, the investigator must notify the IRB immediately. All research interactions and interventions with, and obtaining identifiable private information about, the prisoner must be suspended until the IRB re-reviews the research proposal in accordance with the additional federal requirements for prisoner subjects.
In special circumstances in which the principal investigator asserts that it is in the best interests of the subject to remain in the research study while incarcerated, the IRB chairperson may determine that the subject may continue to participate in the research until the additional requirements are satisfied.
You are required to obtain IRB approval by submitting a Modification Request Form (DOC) before implementing any changes to an approved study.
The only exception to this requirement is when an immediate change is needed to eliminate a risk or hazard to a subject. In such a case the change must be submitted to the IRB as soon as possible for review.
See IRB Policy 23: IRB Review of Modifications (PDF) for additional information.
Under federal regulation the IRB is responsible for receiving and reviewing information about adverse events experienced by research participants.
See IRB Policy 26: Adverse Events Reporting (PDF).
In almost all cases, informed consent must be obtained from the research participants or their legally authorized representative(s) before participation in research begins.
It consists of providing adequate information to the subject about the study, giving the subject the opportunity to consider options, responding to questions the subject may have and ensuring that the subject or the legally authorized representative(s) understands the information.
In addition, the process includes obtaining the subject’s voluntary agreement to participate in the research, usually indicated by the participant’s or their legally authorized representative(s) on the written consent document.
The IRB may approve a waiver of consent or documentation of consent in limited circumstances.
See IRB Policy 13: Informed Consent (PDF) and IRB Policy 19: Documentation of Informed Consent (PDF).
Federal regulations require that there are adequate provisions made for soliciting the assent of children when they are capable of doing so. Age, maturity and psychological state need to be taken into account when determining whether to ask for assent. Usually children who are age seven and older are asked to sign an assent form, and adolescents age 14 and older sign the consent form. Both forms should be written at an appropriate reading level.
Because children have not yet attained legal age to provide consent, the parent or legal guardian is also asked to give permission for participation when a child is asked to take part in research.
See the Assent Form Template (DOC).
See Policy 20: Parental Permission and Child Assent (PDF).