Instructions for New IRB Application Appendix 1 – Vulnerable subjects

1. Instructions for New IRB ApplicationAppendix 1 – Vulnerable subjects

2. Appendix 1 of New Application Appendix 1 is only required if your research will include children, prisoners, pregnant women/fetuses, or individuals who are decisionally impaired. For Childrencomplete section A For Prisoners complete section B For Pregnant women, neonates orfetusescomplete section C. For Decisionally or cognitively Impaired subjectscomplete section D.

3. Appendix 1 of New Application Research with Children – Section A Section A. Research with children I. Risk Assessment Select the appropriate risk category. Minimal risk is defined in terms of the experiences of average healthy children • Category A includes minimal risk research such as surveys, observations, blood collection (within specified limits), chart review, and registries • Category B usually includes projects that present therapeutic treatments or interventions that hold out the prospect for direct benefit to each child • Category C research does not include direct benefit to individual children, but is a minor increase over minimal risk and will yield important information about the child’s disease or disorder under study • Category D research does not meet any of the above criteria. • Include sufficient information for the IRB to determine risks and potential benefits. For clinical trials, compare to standard treatment when possible.

4. Appendix 1 of New Application Research with Children – Section A II. Parental Permission • It is expected that parental permission will be obtained unless a waiver of consent is approved by the IRB. • If research is conducted in a group setting and it is possible that some parents will not have given permission for their child to participate, it is important to have a plan in place so that the other children do not know which children were not allowed to participate.

5. Appendix 1 of New ApplicationResearch with Children – Section A III. Assent from Children • The principal of respect for persons requires that children be asked whether or not they want to participate in the research if the children are capable of providing assent. • In general, children age 8 and older are expected to be capable of providing assent to participate in research. The IRB expects that investigators will explain the study to these young participants, answer any questions that the child may have, and document that the child agrees to participate by obtaining their signature on the minor consent form (in addition to parental signatures). • For studies that include a more in depth level of participation by children, such as completing surveys/diaries, participating in focus groups, undergoing lengthy procedures, etc., the IRB typically requires a separate Assent form for adolescent research subjects. The Adolescent Assent form should be written in child-friendly language and should describe what the child is being asked to do. Please note: a separate Assent form would not typically be used for younger children.

6. Appendix 1 of New ApplicationResearch with prisoners - Section B I. Prisoners as Subjects • Describe the circumstances why the research subjects are considered to be “prisoners” • Describe where the prisoners will be located (for example, intake center, Maximum security, training school, probation, etc) • You must have permission from the prison or Dept. of Corrections to conduct this research • Because of the special circumstances of prisoners, there are additional considerations for the IRB to review in order to further minimize risks. These additional considerations help ensure that the prisoner will be able to give informed consent and assure equitable selection of subjects • The IRB must carefully weigh risks and benefits to research subjects. Because of the nature of incarceration, many of the minor freedoms that we enjoy every day are not available to prisoners. As a result, routine procedures such as leaving the prison for a doctor visit, or meeting with study personnel may have significantly more value to a prisoner than to the general population. These opportunities to leave the prison environment, even for a brief while, may impart such value to prisoners that they may overlook serious risks in order to receive these “ benefits”

7. Appendix 1 of New ApplicationResearch with prisoners - Section B II. Allowable Categories • Check the category that best represents the nature of the research and the degree of risk and benefit to which the prisoners in this study will be exposed. • Reminder: The definition of minimal risk for prisoners is slightly different than the definition for other subjects. The definition of minimal risk for research involving prisoners is given in 46.303(d), is as follows: • Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

8. Appendix 1 of New ApplicationResearch with prisoners - Section B III. Additional Criteria • The questions in this section are intended to provide information to help the IRB to assess risk and benefits that are unique to the prison population, to ensure that subject selection is equitable, and to verify the adequacy of the informed consent process.

9. Appendix 1 of New ApplicationResearch with Pregnant Women and Fetuses- Section C • The Researcher must make a determination as to whether or not the research presents risk to pregnant women or their fetuses. The researcher must also state whether the research will have any effect upon the pregnancy and whether or not there will be direct benefit to subjects. • For research that does not present direct benefit, the researchers must justify why this work should be done • When appropriate, studies should be conducted in non-pregnant women first • Research with pregnant women and/or fetuses must present the least amount of risk possible to achieve the study aims NOTE: if the research holds out the prospect of direct benefit solely to the fetus, then the consent of the pregnant woman and the father must be obtained, except that the father's consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest. Otherwise, the consent of the mother is sufficient.

10. Appendix 1 of New ApplicationResearch with Pregnant Women and Fetuses- Section C Research involving neonates of undetermined viability: This section should only be completed for research that will include neonates of uncertain viability and nonviable neonates. • Neonate means newborn. • Viable neonatemeans being able, after delivery, to survive to the point of being independently maintaining heart and respiration (given the benefit of available medical therapy). For the purposes of IRB review, viable neonates are considered to be children. Section A of this appendix should be completed for viable newborns. • Non-viable neonatemeans the same as a non-viable fetus. • Research with this special population cannot add risk to the neonate without the prospect for direct benefit • Researchers are not allowed to play any role in determining viability of the neonate • Research with this population must be scientifically and ethically justified • Adequate informed consent must be obtained from the parents* *The legally effective informed consent of either parent may be waived because of unavailability, incompetence, or temporary incapacity, in which case the legally effective informed consent of either parent's legally authorized representative is obtained in accord with subpart A of CFR 45 part 46, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.

11. Appendix 1 of New ApplicationResearch with Subjects who are Decisionally/Cognitively Impaired -Section D • A decisionally impaired person is an individual having diminished mental capacity that interferes with the ability to make sound, informed judgments regarding medical treatment or, in the research context, regarding participation in research studies. A decisional impairment can be a temporary or permanent condition. If the impairment is temporary, the consenting investigator should, if possible, postpone the consent process until such time as the impairment has passed. • Describe why the subjects are considered to be decisionally impaired. For example, advanced stage Alzheimer patients, patients who are unconscious, patients who are in severe pain and/or distress.

12. Appendix 1 of New ApplicationResearch with Subjects who are Decisionally/Cognitively Impaired -Section D • Capacity to provide informed consent should be assessed for each subject as appropriate. Surrogate consent ( e.g. from a family member) should not be sought if the subject is capable of provide consent for themselves • If research subjects are not expected to have the capacity to provide informed consent to participate in this research, then complete Section A of Appendix 2 (Alterations in the Consent Process) to apply for permission to employ surrogate consent. • Lifespan policy states that research with individuals who are decisionally impaired must either present no greater than minimal risk, or present the potential for direct benefit to the subjects. • Research with subjects who cannot provide informed consent to participate must be scientifically and ethically justified