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CTSA Institution

University of Pittsburgh

Disclaimer Please cite the appropriate authors/contacts when using or adapting these materials.
Acknowledgment Christopher M. Ryan, Ph.D.
Professor of Psychiatry, Psychology, Health & Community Systems, and Clinical & Translational Science
Director, University of Pittsburgh Institutional Review Board
Contacts Christopher M. Ryan, Ph.D.
Format PDF
URL Download

Materials Provided PDF (88 Pages)
Title Human Subject Protection (Medical) Module 2a
Topics Description This comprehensive module covers the following topics: Basic IRB Regulations and Processes; History and Ethical Principals; Informed Consent; Principal Investigator Responsibilities and Documentation; Research Involving Records; Research Involving Minors.
Keywords 21 CFR 56.111; 45 CFR 46.111; Additional Costs to the Subject; Adoptive Parent; African-American Men; Alfred Hess and Mildred Fish; Amendments; American Academy of Pediatrics; Analysis of Data; Antibiotic Chloramphenicol; Anti-vivisection Movement; Asian-American Student; Assent; Autonomous Consent; Beecher Article; Behavior; Belmont Principals; Beneficence; Benjamin Waterhouse; Bioinformatics; Biological Specimens; Biologics 21 CFR 600.10; Birth Parent; Blood Samples; Bronchoscopy; Case Report Forms; Celsius; Certificate of Exemption; Characteristics; Children; Clinical Investigators; Coded Private Information; Coercion; Collection; Comatose Persons; Common Rule; Computational Genomics; Confidentiality ‘information’; Confidentiality of Data; Conflict of Interest; Consumer Acceptance Studies; Data Analysis; Data Elements Collected; Data Safety and Monitoring Summary Reports; Data Safety Monitoring Boards (DSMB); Data Safety Monitoring Plan (DSMP); Decisional Impairment; Declaration of Helsinki; De-identified Existing Data; Dental Dysplasia; Department of Defense (DOD); Department of Energy (DOE); Department of Health and Human Services (DHHS); Department of Veterans Affairs (VA); Diagnostic Specimens; Digital Recordings; Diphtheria Antitoxin; Documents; Educational Tests; Edward Jenner; Eight Basic Elements of Informed Consent; Electric Shock; Employment Discrimination; Enrollment; Equitable; Ethical Design; Ethical Principles; Ethnicity; Exclusion; Exculpatory Language; Exemption; Expedited Review; Expedited Review Categories; External Adverse Event; FDA Medwatch Form; Federally Regulated Authority of the IRB; Federally Regulated Composition of the IRB Membership; Federal-Wide Assurance (FWA); Fetuses; Financial Disclosure; Food and Drug Administration (FDA); Foreign Languages; Foster Children; Foundling Homes; Full Committee Review; Full IRB Review; Gender; Gene Therapy Trial; Generalizable Knowledge; Genetic Counseling; Genetic Research; Good Clinical Practices (GCP); Grey Baby Syndrome; Guardians; Guards; Health Insurance Portability and Accountability Act (HIPAA); Hebrew Infant Asylum in New York; Hepatitis; History; Homosexual Practices; Human Subjects Research; Humphrey ‘Tea Room Trade Study’; Image Recordings; Immanuel Kant; Inclusion/Exclusion Criteria; Informed Consent Document; Informed Consent Process; Institution Review Board (IRB) Process; Integrity; Internal Adverse Event; International Conference on Harmonization (ICH); Interview Procedures; Investigational Device Exemption (IDE); Investigational Devices 21 CFR 812.100; Investigational Drugs 21 CFR 312.60; Investigational New Drug (IND); Investigator’s CVs; Jesse Gelsinger; Justice; Karl von Ruck; Key Personnel; Konrad Bercovici; Lidocaine; Live Animals; Long-Term Follow-up of Subjects; Loss of Insurance; Louis Pasteur; Lutein; Mentally Retarded Children; Metabolic Disorder; Milgram ‘Obedience to Authority Study’; Minimal Risk; Minor; Modifications; Monitoring; Mumps; National Cancer Institute for Data and Safety Monitoring of Clinical Trials; National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; National Research Act of 1974; National Science Foundation (NSF); Native Language; Noncompliance; Non-English Speaking Subjects; Noninvasive Means; Nuremberg Code; Nutritional Deficiencies; Observation of Public Behavior; Office of Human Research and Protection (OHRP); Orphanages; Parents; Pathological Specimens; Penicillin; Pertussis; Phase II Randomized Clinical Trials; Phone Screening Interviews; Populations of Convenience; Pregnant Women; Primary Reviewer System; Principal Investigator (PI) Qualifications; Prisoners; Privacy ‘persons’; Progress Note; Proprietary Products; Prospective; Proxy Consent; Public Trust; Purpose of the Research; Quorum; Race; Record Keeping; Records-based Research; Recruitment Procedures; Regulations Designed to Preserve the Public Trust; Regulatory File; Regulatory Requirements; Reporting; Research Design; Research Involving Human Subjects; Research Involving Minors; Research Methods; Research Plan; Research Procedures; Research Subject; Respect for Persons; Restaurant Letter Study; Retrospective; Review Process; Rickets; Risk-Benefit Analysis; Safeguards; Safety Reports; Scurvy; Security; Select Subjects Equitably; Serious Adverse Event; Short Form Consent Document; Single Line; Six Additional Elements of Informed Consent; Smallpox Vaccine; Source Documents; Sponsor; Standard Care; Statement of Investigator, Form FDA 1572; Status Report; Stigmatization; Storage; Stored Biological Samples; Studies that Violated Ethical Standards; Subjects Accrued; Summary of Relevant New Information; Survey Procedures; Tape Recorded Jurors Deliberations; TB Vaccine; Terminally Ill Patients; Test and Food Quality Evaluation; Tetracycline; The Belmont Report; Traumatized Persons; Treatment Alternatives; Tuskegee Syphilis Study; Unanticipated Problems; Undue Influence; Varicella; Video Recordings; Voice Recordings; Vulnerable Populations; Waiver of Consent; Wards of the State; Wichita Jury Case; Willowbrook; Withdrawal of Subjects; World Medical Association; Zambardo ‘Simulated Prison’
See Also Instructions on how to access the link at University of Pittsburgh

The modules are available to anyone who creates an account in our system of record, HSConnect. Please follow these instructions:

1. Navigate to: http://cme.hs.pitt.edu (Internet Based Studies in Education and Research site).
2. Under the "Start Here" box, click the link to "Create Account." Follow the prompts, entering a valid email address and password of your choice.
2. The next section is First, Last Name field and simple demographic information.
3. To add an affiliation in the next section, you may do so using the "Other" categories and clicking Add Level. This helps us gather statistics for our site.
4. Click the "Return to Internet Based Studies bar in the top right. You will be presented with a SS# field which you may skip by pressing "Don't Store."
5. You will then see your account profile. Click the "Return to Internet Based Studies" bar once more and you logged into the site.
6. Choose any of the modules you would like to take.

Let us know if you have any difficulties. Our help desk line is 412-648-2222.

HSConnect Technical Support


Topic Data Acquisition Management Sharing and Ownership, Conflicts of Interest and Commitment, Human Subjects, Animal Welfare, Research Misconduct, Collaborative Science, Other
Topic revision: r2 - 23 Jul 2009 - 20:14:58 - NancyHills
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