Indicate whether you will follow GUIDANCE: “INVESTIGATOR Documentation of Informed Consent (HRP-803).” If not, provide a description of how you will document consent in writing. Vulnerable Populations If the Human Research involves individuals who are vulnerable to coercion or undue influence, describe additional safeguards to protect their rights and welfare. Indicate whether you will include any of the following populations: Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners If the Human Research involves cognitively impaired adults, review the Adults Lacking Capacity (HRP-414)” to ensure “WORKSHEET: you have provided sufficient information for the IRB. If the Human Research involves persons who have not attained the legal age for consent to treatments or procedures involved in the research (“children”), review the Children (HRP-310)” “CHECKLIST: to ensure you have provided sufficient information for the IRB. If the Human Research involves pregnant women, review the Pregnant Women (HRP-305)” to ensure you have “CHECKLIST: provided sufficient information for the IRB. If the Human Research involves prisoners, review the Prisoners (HRP-308)” to ensure you have provided “CHECKLIST: sufficient information for the IRB. Drugs or Devices If the Human Research involves drugs or devices, describe your plans to store, handle, and administer those drugs or devices so that they will be used only on subjects and be used only by authorized investigators. Multi-Site Human Research If this is a multi-site study where you are the lead investigator, describe the management of information (e.g., results, new information, unanticipated problems involving risk to subjects or others, or protocol modifications) among sites to protect subjects. Sharing of Results or Incidental Findings with Subjects Describe whether results (study results or individual subject results, such as results of investigational diagnostic tests, genetic tests, or incidental findings) will be shared with subjects or others (e.g., the
Indicate whether you will follow “INVESTIGATOR GUIDANCE: Documentation of Informed Consent (HRP-803).” If not, provide a description of how you will document consent in writing. Vulnerable Populations If the Human Research involves individuals who are vulnerable to coercion or undue influence, describe additional safeguards to protect their rights and welfare. Indicate whether you will include any of the following populations: Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners If the Human Research involves cognitively impaired adults, review the “WORKSHEET: Adults Lacking Capacity (HRP-414)” to ensure you have provided sufficient information for the IRB. If the Human Research involves persons who have not attained the legal age for consent to treatments or procedures involved in the research (“children”), review the “CHECKLIST: Children (HRP-310)” to ensure you have provided sufficient information for the IRB. If the Human Research involves pregnant women, review the “CHECKLIST: Pregnant Women (HRP-305)” to ensure you have provided sufficient information for the IRB. If the Human Research involves prisoners, review the “CHECKLIST: Prisoners (HRP-308)” to ensure you have provided sufficient information for the IRB. Drugs or Devices If the Human Research involves drugs or devices, describe your plans to store, handle, and administer those drugs or devices so that they will be used only on subjects and be used only by authorized investigators. Multi-Site Human Research If this is a multi-site study where you are the lead investigator, describe the management of information (e.g., results, new information, unanticipated problems involving risk to subjects or others, or protocol modifications) among sites to protect subjects. Sharing of Results or Incidental Findings with Subjects Describe whether results (study results or individual subject results, such as results of investigational diagnostic tests, genetic tests, or incidental findings) will be shared with subjects or others (e.g., the
HRP-504%20-%20TEMPLATE%20Protocol.tu_.docx