Human Research Protection Program: Guidance

Preparing a New Protocol for Full Review

All new research protocols that present more than minimal risk and do not qualify for an exemption from IRB review or for expedited review are reviewed by the full IRB. The IRB Office determines whether an application will be sent to the full IRB or through the expedited process or is exempt from IRB review after considering the materials submitted by the investigator.

Submission Requirements

When an investigator submits a new research protocol for review by the full IRB, the following information is generally required:

 

• A description of, and scientific rationale for, the proposed research activity

 

• A discussion of the human subjects protection issues which addresses, at a minimum:

 

• The risks to subjects
• All procedures that are experimental
• The anticipated benefits to subjects, if any

 

• Participant selection and recruitment procedures, and the anticipated number of participants

 

• The proposed consent document and process

 

• Appropriate additional safeguards, if potentially vulnerable subjects are to be enrolled. Potentially vulnerable participants include prisoners, children, those with impaired decision making capacity, institutionalized individuals, and people who are economically or educationally disadvantaged.

Review Criteria

UW-Madison IRBs review research activities to ensure the protection of the rights and welfare of human subjects. The federal Common Rule (45 CFR 46.111) and FDA regulations (21 CFR 56.111) require IRBs to evaluate proposed research activities to determine that all of the following requirements are satisfied:

 

In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

 

1. Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

 

2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

 

3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

 

4. 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 45 CFR 46.116 (or 21 CFR Part 50).

 

5. Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117 (or 21 CFR 50.27).

 

6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

 

7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

 

8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

Post Review Process

When the full IRB reviews a new research protocol, the IRB may:

 

• approve the protocol

 

• require modifications in the protocol

 

• defer the protocol until additional information is obtained, or

 

• disapprove the protocol.

 

In each case, the IRB Office notifies the investigator of the action taken and the reasons for that action. The IRB’s notice to the investigator will describe any concerns that the IRB has with a research protocol. It is unlikely that a protocol would be disapproved without discussion with the investigator regarding the IRB's concerns about the research.

 

If the IRB requests modifications or additional information before the protocol can be approved, the investigator is given the opportunity to respond by agreeing to the requested modifications or providing the requested additional information to the IRB.