Final answer:
The Institutional Review Board (IRB) is responsible for determining if re-consent or additional notifications are required when changes in anticipated risks or study procedures could influence participant's willingness to continue in research.
Step-by-step explanation:
When changes in anticipated risks or study procedures occur that may affect the willingness of subjects to continue participation in research, it is the responsibility of the Institutional Review Board (IRB) to determine whether re-consent or other notification is required. The IRB, which oversees the ethical aspects of the study, must ensure that all anticipated risks and benefits are clearly communicated to the participants, enabling them to make an informed decision about their continued involvement. If the IRB decides that the alterations in the study have the potential to affect subject consent, they will require researchers to obtain a renewed consent or provide additional information to the current participants.
Researchers are also ethically bound to prioritize the safety of their participants, comply with legal requirements, and ensure transparency during the entire research process. In the case of minors or those unable to consent, legal guardians or representatives must give consent on their behalf. Protecting the privacy of participants is paramount, and informed consent should always articulate the ability for participants to withdraw without penalty and the commitment to data confidentiality.