Evaluation Plan Guidance (Page 32 of 68) in pdf

EVALUATION PLAN GUIDANCE

SOCIAL INNOVATION FUND

V. Human Subjects Protection

In general, SIF-funded evaluations (and other federally-funded evaluations) will require either Institutional

Review Board (IRB) approval, or an explanation of why IRB approval is not needed/appropriate for the

proposed study. Evaluation plans generally need to be designed to meet standards for human subjects

protection if they use individual level data collected from people (whether participants, controls or

comparison groups) that could be personally identifiable. If the evaluation collects new data from human

subjects, it is likely that the evaluation plan will need to include how the program or evaluator will obtain

approval for the data collection process from an IRB. If the data has already been collected, for example, from

a previously existing survey, IRB approval may not be needed. However, it is always a good idea to obtain a

waiver from an IRB stating that human subjects’ protection was not needed. This is particularly useful if, in

the future, the results will be submitted to certain peer-reviewed journals. IRB approval is not needed for data

that is not collected at the level of the individual person. For example, financial data, housing completions, or

jobs created at an organization would not need IRB approval to be collected or analyzed.

The specific information required by an IRB may vary, however. Generally, the application will include a

description of the study, sampling methods, data collection methods and instruments, and types of analysis to

be conducted. If needed, it may include the justification for collecting data from vulnerable populations. If

informed consent

is required, the IRB application will likely ask for the type of consent, as well as procedures

and documents to be used in obtaining informed consent. Finally, the IRB will be interested in how the

personally identifiable data will be handled and securely stored, as well as when and how the data will be

destroyed.

Specific Guidance: Human Subjects Protection

State how Human Subjects Protection will be ensured and whether or not IRB approval will be necessary. If

IRB approval will not be sought, explain why.

If the evaluation includes personally identifiable data, then the evaluation plan should include the following:



The name of the IRB that will be used;



The type of approval sought;



The process used by the named IRB for securing the approval;



What data will be subject to informed consent; and



An overview of how informed consent will be obtained.

In addition, IRB approval generally lasts for a specific period of time, and that time should be described and

conform to the evaluation timeline submitted.

The IRB approval process does take time and there may be associated costs as well. Check with the IRB you

plan to use during your evaluation plan development to find out its timeline and whether there are costs.

Include timing and cost information in the evaluation plan timeline and budget.

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Evaluation Plan Guidance Page 32