http//www.nemours.org/research/nohsp/policy/review.html
IRB Review & Approval Process
REVIEW & APPROVAL PROCESS
SPECIFIC RESEARCH CATEGORIES
| # | Policy | Date |
| HSP-019 | Research Involving Prisoners | 8/1/2007 |
| HSP-034 | Emergency Use of a Test Article Without Prior IRB Approval | 11/1/2006 |
| HSP-032 | Case Reports | 11/1/2006 |
| HSP-048 | Planned Emergency Research | 11/1/2006 |
| HSP-047 | Humanitarian Use Device | 11/1/2006 |
| HSP-053 | Research Involving the Use of Deception | 12/1/2006 |
| HSP-070 | Research Involving Pregnant Women and Fetuses | 5/1/2007 |
| HSP-061 | Exempt Research | 1/1/2007 |
| HSP-075 | Research Involving Investigational Devices | 5/1/2007 |
| HSP-076 | Research Involving Investigational Drugs or Biologics | 5/1/2007 |
| HSP-078 | Expanded Access of Investigational Drugs or Devices | 8/1/2007 |
RECRUITMENT & ENROLLMENT
| # | Policy | Date |
| HSP-004 | Enrollment of Research Participants | 8/1/2007 |
| HSP-045 | Recruitment | 11/1/2006 |
| HSP-028 | Compensation for Research Participants (Reimbursement) | 10/1/2006 |
| HSP-046 | Research Use of the Internet | 11/1/2006 |
| HSP-051 | Enrollment of Nemours Associates | 11/15/2006 |
| HSP-054 | Enrollment of Adults with Limited Capacity | 12/1/2006 |
| HSP-057 | Advertising for Recruitment of Research Participants | 8/1/2007 |
| HSP-064 | Screening Prior to Enrollment | 2/1/2007 |
| HSP-065 | Enrollment of Non-English Speaking - Reading Participants | 2/1/2007 |
| HSP-071 | Research Involving Wards or Foster Children | 5/1/2007 |
| HSP-074 | Enrollment of Investigators Children | 5/1/2007 |
PARENTAL PERMISSION, ASSENT & INFORMED CONSENT
| # | Policy Title | Date |
| HSP-014 | Telephone and Mail Informed Consent and/or Parental Permission | 8/1/2007 |
| HSP-033 | Assent of Children to Participate in Research | 11/1/2006 |
| HSP-043 | Parental Permission | 11/1/2006 |
| HSP-049 | Waiver or Alteration of Parental Permission or Informed Consent | 11/1/2006 |
| HSP-052 | Informed Consent of Adult Subjects | 8/1/2007 |
| HSP-072 | IRB Observation of the Parental Permission or Informed Consent Process | 5/1/2007 |
| HSP-079 | Parental Permission, Informed Consents, & Research Data Stored in the Medical Record | 8/1/2007 |
| HSP-081 | Waiver of Alteration of Research Authorization | 6/1/2008 |
| HSP-083 | Research Conducted in a State Other than DE, FL, NJ or PA | 5/1/2008 |
REPORTING REQUIREMENTS
| # | Policy | Date |
| HSP-035 | Closure of a Research Study | 11/1/2006 |
| HSP-058 | Reports Initiated by the IRB | 1/1/2007 |
| HSP-059 | Managing Human Subject Protection Noncompliance | 1/1/2007 |
| HSP-066 | Management of Complaints and Inquiries | 4/1/2007 |
| HSP-067 | Prompt Reporting of Adverse Events & Unanticipated Problems | 6/1/2008 |
| HSP-073 | Principal Investigator Accountability | 5/1/2007 |
| HSP-084 | Review of Problem Reports & New Information | 6/1/2008 |
| HSP-085 | Suspension or Termination of Approved Research | 6/1/2008 |
RECORD KEEPING
| # | Subject | Date |
| HSP-003 | Electronic IRB Records | 8/1/2007 |
| HSP-040 | IRB Requirements for Investigator Records | 11/1/2006 |
| HSP-041 | IRB Records | 11/1/2006 |
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