2. Roles And Responsibilities of IRB/ERC Flashcards
Outline membership of IRB for USA
- At least 5 members, with varying backgrounds
- No IRB consists entirely of men or women
- At least 1 scientist, 1 non-scientist, and 1 non-affiliated member
- No IRB may have a member who has a conflicting interest
- Use of consultant is permissible, but such person may not vote
What are the 8 listed IRB responsibilities?
- Conducting initial review
- Conducting continuing review at intervals appropriate to the degree of risk to human subjects, but at lease once per year
- Notifying the investigators about IRB decisions
- Determining which studies require review more often than annually
- Review and approval of changes in research activities
- Determining which device studies pose significant or non-significant risk
- Ensuring that changes in approved research are not initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards
- Ensuring prompt reporting to appropriate institutional officials, regulatory agencies, and funding sources of:
- unanticipated problems involving risks to subjects or others
- serious or continuing noncompliance with federal regulations
- suspension or termination of ORB approval
If subject receives payment for participating in research, does this count as a “benefit” to them?
NO, payment for participation in a study CANNOT count as a benefit to patient
What are the 8 criteria for IRB approval?
- Risks to subjects are minimized
- Risks are reasonable in relation to anticipated benefits
- Selection of subjects is equitable
- Informed consent is sought from each subject or the subject’s legally authorized representative (LAR)
- Informed consent is appropriately documented
- Data collection is monitored to ensure subject safety (Data Safety Monitoring Plan should be included in the protocol)
- Adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data (privacy=patient, confidentiality=data)
- Additional safeguards for vulnerable populations protecting from coercion or undue influence
What is coercion?
Occurs when an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance
What is undue influence?
Occurs through an offer of an excessive or inappropriate reward or other overture in order to obtain compliance.
Ex investigator might promise psych students extra credit if they participate in the research
What are the two types of IRB reviews?
- Full board review
- Expedited review
When is a full IRB board review conducted?
More than minimal risk studies
- initial and subsequent continuing review
- others (major amendments, unanticipated problem, serious or continuing non compliance)
When is an expedited IRB review conducted?
Conducted by IRB chairs and/or designees
- Initial subsequent continuing review (for minimal risk studies???)
- Exemption determination
- Amendment (minor changes to protocol)
- Other reports from investigators
T/F at least one non scientist member must be present at a full IRB review
True
What does IRB deferral mean?
IRB needs additional information or clarification from the investigator.
If the research was initially reviewed by full board the PIs response and revised materials must be reviewed at a subsequent convened meeting.
Different from “requires modification”.
What does require modification decision by IRB mean?
IRB provides investigator with SPECIFIC modifications to study related materials.
When can IRB use expedited review?
- Studies involving no more than minimal risk
- Minor changes in previously approved research during the period (of one year or less) for which approval is authorized
All of the requirements for IRB approval of research apply equally to expedited review. Should NOT be viewed as less rigorous review
T/F under expedited review the reviewers may exercise all the authorities of the IRB except that the reviewers may not disapprove the research
True
What interventions/data collection count under expedited review?
- Blood collection within limits
- Prospective collection of other biological specimens for research purposes by noninvasive means
- Collection of data through noninvasive procedures such as MRI/EKG
- Research on existing data, specimens, materials collected solely for non research purposes
- Collection of data from voice, video, digital, or image recordings made for research purposes
- Surveys, interview, questionnaires
