Consent Process

Obtaining consent is not merely having a person read and sign a statement. The purpose is to ensure that the potential participant has complete understanding of the study and his/her role in it before agreeing to participate. It is the responsibility of the investigator to ensure that the information is presented in a manner that each person can comprehend, that the person understands the risks and benefits, and has the opportunity to ask questions. The investigator must also make it completely clear that the potential participant is free to either participate or not without any negative consequences, and may quit at any time. See 45 CFR 46.116 for the general requirements for informed consent.

• • No investigator can involve a person in a research study without the legally effective informed consent of the participant or the participant’s legally authorized representative, unless it has been determined otherwise by the Office of Human Subject Research Protection in accordance with federal regulations.

• • The investigator must obtain consent under circumstances that a) provide the potential participant or representative sufficient opportunity to consider participation and that b) minimize the possibility of coercion or undue influence.

• • The information must be written in language that the person, or representative, can easily understand.

• • The consent cannot include any language that waives or appears to waive any legal rights of the participant. It cannot include any language that releases the principal investigator, Northeastern University, a sponsoring agency or individuals from liability for negligence.

• • For children (under age 18 in MA) to participate in research, including surveys and interviews, signed permission is required from the parent or legal guardian, unless otherwise approved by the Office of Human Subject Research Protection. In some instances, depending upon the ages, maturity, and psychological stateof the children involved in the research, documentation of the assent of the child may also be required. See 45 CFR 46.408a.

Once the informed consent document has been approved in its final form by the NU IRB, the Office of Human Subject Research Protection will stamp it and include the IRB tracking number and the dates the consent is valid. Copies of this original stamped version MUST be used to consent participants. No changes to the authorization are permitted without prior approval and a new authorized version by the Office of Human Subject Research Protection. A copy of the consent document must be given to every participant.