Office of Clinical Investigation
Guidelines & Policies
Section 1: Ethical Principles and Regulations
1.1 Statement of Ethical Principles and Regulatory Requirements for Human Subject Protection
Section 2: Definitions
2.1. Definition of Human Subject and Research
2.2 Innovation versus Research: Guidelines and Concepts for Differentiation
2.3 What Quality Improvement and Educational/Competency Evaluation Activities are Considered Research
Section 3: Lines of Authority and Responsibilities
3.1 Jurisdiction of the Committee on Clinical Investigation
3.2 Committee on Clinical Investigation Autonomy and Functions
3.3 Institutional Official: Selection and Responsibilities
3.4 Chairperson: Selection, Appointment and Responsibilities
3.5 Committee on Clinical Investigation Members Selection and Evaluation
3.6 Consultants, Observers and Guests
3.7 Legal Counsel
3.8 Principal Investigator Responsibilities
3.9 Clinical Investigation Administrative Office Resources
3.10 Records and Files
3.11 Storage of Research Data and Informed Consent Documents
3.12 Detemining Whether a Protocol Requires Children's Hospital or Dana Farber Review
3.13 Multi-Center Research and Engagement in Research
Section 4: Credentials, Education and Training
4.1 Clinical Research Credentialing
4.2 Investigators and Research Staff
4.3 Administrative Staff, IRB Members and Others
Section 5: Review of Research Activities
5.1 Operational Review Procedures: Full Committee Review
5.2 Scientific Review
5.3 Exemptions
5.4 Expedited Reviews
5.5 Amendments and Revisions
5.6 Modifications: Exceptions and Deviations
5.7 Continuing Renewal
5.8 Protocol Activation/Release and Approval Dates
5.9 Verification that Material Changes Have Occurred
5.10 Additional Human Subject Protection Review
5.11 Emergency Exemptions
5.12 Disapprovals and Appeals
5.13 Guidance for Data and Safety Monitoring Plans
Section 6: Reporting, Unanticipated Problems, Noncompliance
6.1 Reporting
6.2 Unanticipated Problems Involving Risks to Research Subjects and Others Including Adverse Events
6.3 Noncompliance: Investigating and Reporting
6.4 Suspension, Termination, Temporary Administrative Holds
6.5 Research Related Injury
6.6 Managing Research Participant/Family Concerns and Complaints
6.7 Communication of Staff Concerns Raised During Research
6.8 Coordination Between Program for Patient Safety and Quality and Clinical Investigation Office
Section 7: Informed Consent/Assent
7.1 Process of Informed Consent, Assent, Parental Permission
What are the Principles of Informed Consent?
Who Should Obtain Consent/Assent ?
Who Should Provide Consent/Assent?
- General Requirements Consent
- Parents' Right to Consent to Participation of Their Children in Research
- Determining Whether Permission Should be Obtained From One or Both Parents/Guardians for Children and Adolescents who Participate in Research
- Age of Assent from Minor Subjects
- Minors Right to Consent in Certain Circumstances
- Consent by Judicially Approved Guardians and other
- Surrogate Consent for Adults Without Sufficient Decision-Making Capacity to Effectively Exercise Their Right to Informed Consent
- Obtaining Consent when Minor Subjects Become Adults or otherwise Acquire Capacity to Consent During the Course of research
- What it the Appropriate Timing For Informed Consent?
7.2 Documentation of Informed Consent/Parental Permission/Assent
General
Required Elements
Additional Elements that May be Required As Appropriate
Signatures
- Subject or Legally Authorized Representative
- Assent from the Child/Adolescent
- Signature of Individual Obtaining Informed consent/Assent/Parental Permission
- Witness Signature
- Obtaining consent/Parental Permission if Parent/Guardian is not present
- Informed Consent in other Languages
- Illiterate Subjects
7.3 Waivers and Alterations of Informed Consent/Parental Permission/Assent Children
- Waivers and Alterations of Documentation of Informed Consent/Parental Permission/Assent
- Waiver of Some or all Elements of Informed Consent/Parental Permission/Assent
- Exception from the Requirement of Informed Consent Under the Emergency Use of Test Article
- Exception from Informed Consent Requirements For Emergency Research
7.4 Use of Short Forms for Informed Consent
7.5 Decision Monitoring
7.6 Obtaining Informed Consent/Assent Via Phone & Mail
7.7 Emergency Research Under FDA 50.24
Section 8: Drugs and Biologics
8.1 Drugs, Biologics and Dietary Supplements Regulations
8.2 Patients Hospitalized with Investigational Drug from Another Institution/Investigator or with Supply of Drug Not Approved in United States
8.3 Requirements for Investigators Who are Also Considered Sponsors of New Drugs
Section 9: Devices
9.1 Investigational Devices
9.2 Requirements for Investigators Who are Also Considered Sponsors of Investigational Devices
9.3 Humanitarian Use Devices
Section 10: Vulnerable Populations
10.1 Children
10.2 Incarcerated Youth and Prisoners
10.3 Inclusion of Women
10.4 Pregnant Women, Human Fetuses and Neonates
10.5 Wards of the State
10.6 International Research and Cross Cultural Issues
10.7 Guidelines for Review of Research Involving Vulnerable Populations and Adults with Questionable Decision Making Capabilities
Section 11: Guidance for Special Topics/Procedures
11.1 Additional Anesthesia and Sedation Guidelines
11.2 Additional Guidance: Skin Biopsies
11.3 Research Blood Drawing Guidelines
11.4 Guidelines for Using the Internet to Conduct Research Activities
11.5 Guidelines for School Based Research
11.6 Certificates of Confidentiality Guidance
11.7 Discarded Human Biological Specimens
11.8 Medical Record/ Database Reviews
11.9 Special Confidentiality Issues When Performing Research Related Imaging
11.10 Multi Site Research When A Children's Investigator Oversees an Operations, Coordinating or Statistical Center
11.11 Research Involving Department of Defense Funding
11.12 Genome-Wide Association Studies Policy and Procedures
11.13 ClinicalTrials.gov
Section 12: Recruitment and Remuneration
12.1 Recruitment
12.2 Providing Remuneration to Research Subjects
Section 13: Process for Funding Agency Certifications/ Clinical Trial Agreements/ Budget Tracking
Section 14: Conflict Of Interest
14.1 Conflicts of Interest: Clinical Research
14.2 Conflicts of Interest: Procedures for Coordinating Investigations
14.3 Equity in Companies Sponsoring Clinical Research
14.4 Residual Funds in Corporate Sponsored Clinical Research Activities
14.5 Conflicts of Interest: Organizational Conflicts
