Instructions: This is an overview of the criteria an IRB member must consider during the review of proposed research, proposed modifications to approved research, and continuing review of research. The main requirements are referenced in the IRB Reviewer Checklist applicable to each type of review. Supplemental checklists also address additional protection requirements that are needed for certain populations and categories of research, as noted below.

Summary Guide to IRB Review Criteria
Criteria That Must Be Met
Considerations to Evaluation Whether Criteria Are Met
 

1. Risks to subjects are minimized by using procedures which do not unnecessarily expose subjects to risk.  

• Consider physical, psychological, social, and legal risks.
• Does the investigator have a process to ensure that persons assisting with the research were adequately informed about the protocol and their research-related duties and functions?

2. Subject selection. 

• Who is to be enrolled? Men? Women? Children? Ethnic minorities? Healthy volunteers?
• Consider the purpose of the research
• Consider setting in which the research will be conducted
• Consider involvement of populations vulnerable to coercion or undue influence
• Consider inclusion and exclusion criteria
• Consider payment and recruitment methods

3. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with and to the extent required by the regulations.  

(a) The investigator will obtain the legally effective informed consent from the subject or the subject’s legally authorized representative.

• Is it clear who can serve as a legally authorized representative?
• Will the participants or representatives understand the facts?
• Will the participants or representatives appreciate the implications of decision?
• Will the participants or representatives be able to decide?
• Will the participants or representatives be able to communicate a decision?

(b) The circumstances of consent provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate.

• How much time will be devoted to the consent discussion?
• How much time will be allowed for a decision?
• What is the setting of the consent process?

(c) The circumstances to minimize the possibility of coercion or undue influence.

• Are there communication issues?
• Are there issues regarding the capacity to make a decision?
• Are there excessive motivating factors?
• Is the recruitment process acceptable?
• Are payment arrangements acceptable?

(d) The information that will be orally given to the subject is in language understandable to the subject.       

• What language do the participants speak?
• Can the research team communicate in understandable language to the participants?
• Will written information be in the language understandable to the participants?

4. Informed consent will be appropriately documented, in accordance with and to the extent required by the regulations.

(a) If formal or expedited form is used:

 • The consent document embodies the elements of informed consent required by the regulations (See checklist for Informed Consent Requirements)
• The investigator will give either the participant or the participant’s legally authorized representative adequate opportunity to read the consent document before it is signed.
• The participant or participant’s legally authorized representative will sign the informed consent document.
•  A copy of informed consent document will be given to the person signing the form.

(b) If exempt form is used:

 • The consent document states that the elements of informed consent required by the regulations have been presented orally to the participant or the participant’s representative.
• A written summary of what is to be said to the participant or the representative embodies the elements of informed consent required by the regulations (See checklist for Informed Consent Requirements)
• The informed consent document will be signed by both:

¨ The participant or participant’s legally authorized representative

¨ The person obtaining consent

5. If the research involves more than minimal risk to participant, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

• When will the data be monitored?
• What data will be monitored?
• Who will be doing the monitoring?

6. There are adequate provisions to protect the privacy of subjects.

• Will participants be comfortable in the research setting?
• Are the research procedures designed to minimize any invasion of privacy?

7. There are adequate provisions to maintain the confidentially of data.

• Is confidentially pledged?
• Are there legal or ethical requirements to maintain confidentially?
• Will data released not cause risk or harm?
• Is there restricted access to data?
• Are techniques used to protect the data from re-identification?

 

Informed Consent Requirements
Basic Elements of Consent Disclosure

The consent process will:

• Disclose that the study involves research
• Explain the purpose of the research
• Explain the expected duration of the participant’s participation
• Describe the procedures to be followed
• Describe any reasonably foreseeable risks or discomforts to the participant
• Describe any benefits to the participant or to others which may reasonably be expected from the research
• Disclose appropriate alternative procedures of treatment, if any, that might be advantageous to the participant
• Disclose the extent, if any, to which confidentially of records identifying the participant will be maintained
• For research involving more than minimal risk, explain whether any medical treatments are available if injury occurs and if so, what treatments are available and where further information may be obtained regarding those treatments
• Explain whom to contact for answers to pertinent questions about research participant’s rights
• Explain whom to contact for answers to pertinent questions about the research
• Explain whom to contact in the event of a research-related injury to the participant
• Disclose the participation is voluntary
• Disclose that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled
• Disclose that the participant may discontinue participation at any time without penalty or loss of benefits to which the participants is otherwise entitled