Procedures for monitoring adverse events for USA NIH Institutes
| Agency | Procedure | Web site |
|---|---|---|
| NIH=National Institutes of Health; NCI=National Cancer Institute; NEI=National Eye Institute; NHLBI=National Heart, Lung and Blood Institute; NHGRI=National Human Genome Research Institute; NIA=National Institute on Aging; NIAAA=National Institute on Alcohol Abuse and Alcoholism; NIAID=National Institute of Allergy and Infectious Diseases; NIAMS=National Institute of Arthritis and Musculoskeletal Diseases; NIBIB=National Institute of Biomedical Imaging and Bioengineering; NICHD=National Institute of Child Health and Human Development; NIDCD=National Institute on Deafness and Other Communication Disorders; NIDCR=National Institute of Dental and Craniofacial Research; NIDDK=National Institute of Diabetes and Digestive and Kidney Diseases; NIDA=National Institute on Drug Abuse; NIEHS=National Institute of Environmental Health Sciences; NIGMS=National Institute of General Medical Sciences; NIMH=National Institute of Mental Health; NINDS=National Institute of Neurological Diseases and Stroke; NINR=National Institute of Nursing Research. | ||
| NIH | General guidelines for all institutes and centers (IC). Requires establishment of Data Safety Monitoring Boards (DSMB) for multisite clinical trials. Gives each IC the ability to establish its own procedures. | http://grants1.nih.gov/grants/guide/index.hml/ |
| NCI | Follows general NIH guidelines. Additionally, defines “adverse events” and gives categories for severity and attribution of such events | http://ctep.info.nih.gov. |
| NEI | Follows general NIH guidelines. | http://wwwt.nei.nih.gov/funding/policy6.htm. |
| NHLBI | Follows general NIH guidelines. Specifies situations where the primary investigator submits safety monitoring plans. | http://rover2.nhlbi.nih.gov/policies |
| NHGRI | Issue does not appear to be specifically addressed | http://www.nhgri.nih.gov/ |
| NIA | Follows general NIH guidelines. | http://www.nia.nih.gov/funding/policies/gfunding.html#data |
| NIAAA | Issue does not appear to be specifically addressed | http://www.niaaa.nih.gov/ |
| NIAID | Gives guidelines for DSMBs | http://www.niaid.nih.gov/dmid/clinresearch/dsm.htm |
| NIAMS | Follows general NIH guidelines. | http://www.niams.nih.gov/rtac/clinical/safe_monitoring_plan.htm |
| NIBIB | Issue does not appear to be specifically addressed | http://www.nibib1.nih.gov/ |
| NICHD | Follows general NIH guidelines | http://www.nichd.nih.gov/funding/datasafety.htm |
| NIDCD | Follows general NIH guidelines. | http://www.nidcd.nih.gov/funding/clinical/clin_policy.htm |
| NIDCR | Follows general NIH guidelines. | http://www.nidr.nih.gov/research/ |
| NIDDK | Follows general NIH guidelines. Additionally, defines “adverse events” and gives categories for severity, attribution, action taken and outcome of such events. | http://www.niddk.nih.gov/patient/patient.htm#policy |
| NIDA | Gives detailed guidelines for DSMBs | http://www.nida.nih.gov/Funding/DSMBSOP.html |
| NIEHS | Follows general NIH guidelines. | http://www.niehs.nih.gov/dert/clinsafe.htm |
| NIGMS | Follows general NIH guidelines | http://www.nigms.nih.gov/ |
| NIMH | Gives detailed guidelines for DSMBs | http://www.nimh.nih.gov/research/safetymonitoring.cfm |
| NINDS | Institute appoints Performance and Safety Monitoring Boards | http://www.ninds.nih.gov/funding/ninds_patient_safety_guidelines.htm |
| NINR | Issue does not appear to be specifically addressed | http://www.nih.gov/ninr/ |