Beneficence - Protecting Human Subject Research Participants

More documents

Recommendations

Info

Protecting Human Research ParticipantsCodes and RegulationsMain Menu | Glossary | HelpVulnerable PopulationsPrevious Page 11 of 19NextSubparts B, C and D define the specific categories of research in which pregnant women, humanfetuses and neonates, prisoners, or children respectively may be involved. The subparts describeadditional requirements for informed consent, and may specify additional responsibilities for theInstitutional Review Board (IRB) when reviewing research involving these populations, and list therequirements for research that need additional levels of review and approval.Other vulnerable populations include, but are not limited to, mentally disabled persons and economicallyand/or educationally disadvantaged persons. While the regulations do not specify what additionalprotections are necessary for these groups, the HHS regulations (45 CFR 46.111) do require thatinvestigators include additional safeguards in the study to protect the rights and welfare of theseindividuals “when some or all of the subjects are likely to be vulnerable to coercion or undue influence.”Previous Page 11 of 19Nexthttp://phrp.nihtraining.com/codes/11_codes.php6/20/2008 9:30:58 AM
Protecting Human Research ParticipantsCodes and RegulationsMain Menu | Glossary | HelpCase Study: Fetal ImagingPrevious Page 12 of 19NextIndicate whether the HHS regulations require theinvestigator to provide additional protections for participantsin the study under Subparts B, C or D:A study proposes to test a novel fetal imaging technologydesigned to enhance image quality and allow physicians to assess moreaccurately prenatal health. This technology has been tested both onpregnant mammals and non-pregnant women with no adverse effects.Women will be recruited at their regularly scheduled prenatal check-upsand those who consent to participate will receive the experimental scan.Does this study require the investigator to provide additional protections for participants?Yes, the study involves a vulnerable populationCorrect!This study involves a vulnerable population. Because the research will be conducted with pregnantwomen and fetuses, the requirements of Subpart B apply.http://phrp.nihtraining.com/codes/12_codes.php (1 of 2)6/26/2008 2:41:20 PM
Page 1 and 2: Protecting Human Research Participa
Page 3 and 4: 2. Click on the word and a new wind
Page 13: Protecting Human Research Participa
Page 52 and 53: Consent Document 2Respect for Perso
Page 78 and 79:
Protecting Human Research Participa
Page 80 and 81:
Page 82 and 83:
Page 84 and 85:
Page 86 and 87:
Page 88 and 89:
Page 90 and 91:
Page 92 and 93:
Page 94 and 95:
Page 96 and 97:
Page 98 and 99:
Page 100 and 101:
Page 102 and 103:
Page 104 and 105:
Page 106 and 107:
Page 108 and 109:
Page 110 and 111:
Page 112 and 113:
Page 114 and 115:
Page 116 and 117:
Page 118 and 119:
Page 120 and 121:
Page 122 and 123:
Page 124 and 125:
Page 126 and 127:
Page 128 and 129:
Page 130 and 131:
Page 132 and 133:
Page 134 and 135:
Page 136 and 137:
Protecting Human Subject Research P
Page 138 and 139:
Page 140 and 141:
Page 142 and 143:
Page 144 and 145:
Page 146 and 147:
During the trial at Nuremberg, the
Page 148 and 149:
The National Commission for the Pro
Page 150 and 151:
financial conflicts of interest in
Page 152 and 153:
Respect for Persons - pg 21 of 25Ca
Page 154 and 155:
Justice- page 14 of 26Case Study: S
Page 156 and 157:
Frequently Asked Questions• I reg
Page 158 and 159:
Technical Support FormIf you experi
Page 160 and 161:
show all

Beneficence - Protecting Human Subject Research Participants

Create successful ePaper yourself

Delete template?

Save as template?