Regulatory criteria for approval

Bob Craig, July 2007

Initial Review

• The IRB can:– Approve– Give contingent approval– Table (or defer)– Disapprove

Approval – what needs to be answered?

• The IRB has the expertise to evaluate the research. If not, must defer until consultantship is obtained.

• Risks to participants are minimized– Consider other than physical risks– Would alternative procedures be safer?– Would fewer procedures be sufficient

What else needs to be answered.

– Would fewer participants answer the scientific question?

– Is research staff qualified and in adequate numbers?

– Are facilities adequate?– Are medical or psychological resources

available,if needed?

Risks to participants

• Are the risks minimized?– Are procedures already being performed for

diagnostic or treatment being considered?– Can data from these procedures be used to

minimize extra harm?– Must consider physical, psychological, social,

legal, and economic risks

Risks are reasonable in relation to benefits

• Will sufficient number of subjects be available?

• Will PI have sufficient time to complete the research?

• Is the research likely to achieve its proposed aims?

• Are the aims clear?• Consider direct benefits, if any.

Selection of participants is equitable

• Consider the purpose of the study.

• Consider the setting.

• Consider the involvement of vulnerable populations to coercion or undue influence

• Consider inclusion and exclusion criteria.

• Consider recruitment and payment methods.

Informed consent

• Informed consent will be sought from each prospective subject (or representative). If so, go to checklist 210aa.

• Or

• The informed consent process will be waived or altered. If so, go to checklist 210 l.

Advertisements

• If there are advertisements, are they acceptable? Go to checklist, 210i.

Payment to subjects

• If the research involves a payment to participants, are the payment arrangements acceptable (Go to Document 210j, checklist for payments).

Waiver of consent process or waiver of written documentation• If the informed process will be waived, go

to document 210 x

• If the requirement for written document document will be waived, go to document 210 l

Risks to participants

• The research involves no more than minimal risk.

Or,

The research plan makes adequate provisions for monitoring the data to ensure the safety of participants

When will data be monitored?

What data will be monitored?

Who will be doing the monitoring

Privacy

• Participants have no expectation of privacy– Will participants be comfortable in the

research setting?There are adequate provisions to protect the

privacy of participantsDo procedures for identifying subjects minimize any invasion of privacy?Are procedures designed to minimize any invasion of privacy?

Confidentiality

• All are true:

• Confidentiality is not pledged

• There are no legal or ethical requirements to maintain confidentiality

• Data release will not cause risk of harm

Possibility of coercion or undue influence

• None of the participants are likely to be vulnerable to coercion or undue influence

• Is there a power differential?

• Is there a communication issue?

• Is there a decisional issue?

• Is there an excessive motivation

Vulnerable populations

• If research involves pregnant women, fetuses, or neonates as participants,– Does the research provide additional

protections of subpart B? (See document 210 s)

Vulnerable populations

• If the research involves prisoners as participants,

• Does the research provide the additional protection of Subpart C? (See document 210 t)

Vulnerable populations

• If the research involves children as participants, – Does the research provide the additional

protections of Subpart D. See documents 210 m and n.

Vulnerable populations

• Have additional safeguards been included to the study to protect the rights and welfare of participants likely to be vulnerable to coercion or undue influence?

Period of approval

• Specify review interval:– Every ____months.– Every ____participants not to exceed every

___ months.– Other: ____________

Review will be obtained annually

• None of the following can be true:– The research uses procedures new to humans– The research has a prospect of serious harm

without potential benefits– The research promises more than minimal risk

to adults unable to consent.– The PI has a finding of serious or continuing

non-compliance in the past two years.– There are other reasons.

Continuing Review

• Additional Considerations:

• None of the following are true:– The information provided by the PI is

inconsistent with other information known to IRB.

– The IRB has questions about veracity of information

– The PI has a history of non-compliance

Continuing review

• There is verification from sources other than the investigator that no material changes have occurred since the last review

Continuing review

• The consent document is accurate and complete and

• No information has arisen that might affect participants to continue to take part.

Continuing review

• Information has arisen that might affect the willingness of participants to continue to take part in the research

• If this is so, this information has been or will be provided to participants

Modifications to previously approved research

(Amendments)• No information that might affect the

willingness of subjects to continue or

• If there is such information, the information has been or will be provided to participants.

Multi-site research

• The investigator is not the lead investigator

• WVU is not the lead site for a multi-site study. Or, if either of the above are true,

• The protocol includes adequate provisions to manage information, such as UPIRTSO, adverse events, protocol changes, etc among the various sites.

Additional considerations for VA research

• The medical record should be “flagged”• Or, the medical record does not need to be

flagged because one or more of the following are true:

• There is only one encounter

• There is only the use of a questionaire

• The study involves the use of previously collected specimens

• The identification of a patient could place the patient at greater than minimal risk.