1. ICH (International Conference on Harmonization)
2. FDA (Food and Drug Administration)
3. THIS ANSWER NEEDS TO BE COMPLETED
4. THIS ANSWER NEEDS TO BE COMPLETED
5. THIS ANSWER NEEDS TO BE COMPLETED

• Study Logs
• Protocol
• Investigator Drug Brochure
• Informed Consent
• Commpetent Authority Regulatory Approval Documentation
• IRB/IEC Approvals
• IRB/IRC Communication
• FDA 1572/Regulatory Forms
• CV
• Drug Accountability
• Lab

SAE

Training

Trial Agreements

Regulatory Inspections/Audits

Correspondence

Title, Investigator Information

Purpose of Study

Background and Significance

Methods (Design and Procedures)

Selection ofSubjects

Subject Recruitment and Compensation

Consent Process

Subject's Capacity of Give Legally Effective Consent

Study Interventions

Risk/Benefit Assessment

Cost to Subject

Data Management and Statistical Analysis

Data and Safety Monitoring

Privacy, Data Storage and Confidentiality

Define

Significant Risk

Define

Insignificant Risk

Any board, committee or group

formally designated by an institution

to review, approve the initiation of and to conduct periodic review of biomedical research

involving human subjects.

The primary purpose of such review

is to assure the protection of the

rights and welfare of the human subjects

LOCAL: Affiliated with an institution

INDEPENDENT, CENTRAL OR NATIONAL: Not affiliated with an institution.  Sometimes used for multicenter studies in which subjects aren't hospitalized.

• Members must posess appropriate professional competence to review diverse types of protocols
• At least one member is not affiliated with institution and has no immediate family member affiliated with the institution other than IRB membership
• One member whose interests and background are non-scientific (layperson)
• If FDA regulated products are reviewed, one member must be a physician
• Members should be selected to assure diversity of profession, ethnicity, gender and education

1. Should the study be done at all?

2. If so, what constitutes informed consent?

• Children
• Pregnant women
• Prisoners
• Handicapped or mentally disabled people
• People with acute or severe mental illness
• People who are economically or educationally disadvantaged
• People who are institutionalized
• Employees

45 CFR 46

21 CFR 50 subpart D for children

• Current CV
• Protocol
• Investigator brochure or package insert if applicable
• Proposed Informed Consent document
• All advertisements and recruitment procedures
• Form FDA 1572 if applicable
• Grant application for federally funded research if applicable
• Any other specific forms or materials required by the IRB (application, etc.)

A process by which a subject

voluntarily confirms his or her willingness

to participate in a particular trial

after having been informed

of all aspects of the trial

that are relevant to the subject's decision to participate.

Informed consent is documented by means of

a written, signed and dated informed consent form.

It must completely and accurately describe all of the activities required by the protocol and what the subject's participation will involve.

It must be understandable by the study subjects.

It must contain all elements required by 21 CFR Part 50.

• All elements of consent have been presented orally to subject or subject's LAR
• Must be a witness to oral presentation
• IRB must approve written summary of what is said to subject or LAR
• Only short form itself is to be signed
• Witness to sign both short form and copy of written summary
• Person obtaining consent to sign written copy of summary
• Copy of short form and summary will be given to subject or LAR

Each individual who initiates, directs or engages in the experiment.

It is a personal duty and responsibility which may not be delegated to another with impunity.

RESPECT FOR PERSONS: autonomy, special protections (fetus, children, prisoners, mentally disabled, severe illness)

BENEFICENCE: Do not harm, maximize benefit and minimize harm

JUSTICE: Burdens and benefits of research should be justly distributed.