Evaluation Consent and the Institutional Review Board Process

Most evaluations, at some point in the process, involve collecting information from individuals. The evaluation team should take great care to protect the rights and privacy of these individuals and to ensure that they are treated with respect.

How do I protect participants' rights?

Imagine you were contacted about participating in an evaluation. Before you agreed to take part you would probably expect the evaluator to provide information about such things as the purpose of the evaluation and what would be expected of you. If the evaluator did not give you this information you would likely feel uneasy and decline to participate.

Being open and honest about the evaluation process is not only ethical, but also establishes trust between participants and the evaluation team. This trust, in turn, helps the process to run smoothly and generates more effective results. Consequently, getting off on the right foot by respecting participants’ time, privacy and confidentiality is of utmost importance. Protecting participants' rights includes such things as informing participants about the confidentiality of information and giving participants the ability to withdraw from the evaluation at any time.

It is the evaluator’s responsibility to clearly communicate to participants and to make sure they understand:

  • the purpose of the study
  • what participation entails in terms of time, effort, etc.
  • any possible risks of participation (to their health or well-being)
  • how any information associated with them will be reported
  • confidentiality regarding access to the results of the evaluation

Be aware: If any identifying information is collected or reported about individuals participating in the evaluation, the evaluator is required to obtain their informed consent.

 

What is informed consent?

Informed consent means telling individuals about your evaluation and asking whether they are willing to participate.

In most cases, you will need to prepare an “informed consent form” to be reviewed and signed by participants prior to their involvement in any part of the evaluation. This gives you written permission to use information from the participant in reports and presentations (Social Policy Research Associates, 2006).

Not all situations require consent forms

In some situations it may not be necessary to distribute consent forms. Evaluation in museums, zoos, and other nonformal settings often use observation or visitor tracking methods. In these cases posting a sign alerting visitors that research is being conducted (and possibly videotaped) may be sufficient for informed consent. Even in these situations, however, you must provide visitors with information about how to opt-out of the evaluation and who to contact should they have questions. You also should have copies of the evaluation’s purpose and methods available in case visitors would like more information. Before deciding to use this approach be sure to check with your organization about their policies regarding obtaining informed consent. Likewise, if you are distributing a survey where no identifying information is collected, informed consent is usually unnecessary. In this case, the participant’s decision to fill out and return the survey counts as their consent.

Children as Participants

When minors are participating in an evaluation, a notice of Active or Passive Consent must be sent to their parents or guardians. In addition, if the children are age 7 or older, you may be required to use an Assent Form. The table below describes the purpose of each form as well as considerations for using it.

Type of Consent
Description
Notes
 
Please place the cursor over the desired part of the diagram to see the associated definition.
Active Consent

Requires permission to be given by a parent/guardian before a child can participate.

Because active consent requires that permission is given, it is generally considered to offer better protection to both participants and evaluators.
 
Passive Consent

Parents/guardian must inform the evaluator only if they do not want their child to participate.

Some states and institutions have restrictions on the use of passive consent. It is best to check with your organization about their policies before proceeding.

Can require less time and resources.

Generally results in higher response rates.

May lead to more representative samples.
 
Assent Form

Asks minors if they are willing to participate in the study. Failure of a child to object to the study is not considered assent.

The purpose is to ensure an element of understanding and cooperation with the child and to demonstrate the researcher's respect for the child's rights and dignity.

Generally used with children between the ages of 7 to 17.

Used in conjunction with parental/guardian consent because minors lack legal authority.

Should cover the same elements of a parental consent form and be written in a manner easily understood by the participants.
 

When evaluating K-12 programs in a formal school setting, there are often other necessary actions to take. Permission to conduct the evaluation, work with the children, and collect data should also be obtained from the school district and/or the school. As with Institutional Review Board processes (described below), schools/districts will need to see your consent forms, instruments, etc.

Resources to help you prepare consent forms

Informed Consent Document (.doc)
Xavier University (2006).
This document includes criteria to include in all consent forms and two sample informed consent documents, one for adults and one for minors.

Sample Informed Consent Form (.pdf)
Morgan State University, Office of Sponsored Programs (2006).
This sample informed consent form (in Appendix 4 – Example 3) provides language and leaves spaces for you to insert your information.

Parental Consent Form for Treatment Group (.pdf)
Sample EE consent forms
These sample parental consent forms were used as part of an evaluation conducted by Anita Kraemer, eeEvaluations, for the NOAA Chesapeake Bay Offices in 2005-06. Note the slightly different language in the form for the parents of students in the treatment versus comparison group.

Parental Consent Form for Comparison Group (.pdf)
Sample EE consent forms
These sample parental consent forms were used as part of an evaluation conducted by Anita Kraemer, eeEvaluations, for the NOAA Chesapeake Bay Offices in 2005-06. Note the slightly different language in the form for the parents of students in the treatment versus comparison group.

Assent form guidelines (.doc)
Old Dominion University, Office of Research (2007).
This document provides guidelines for developing and using assent forms as well as a sample assent form.

 

What is an Institutional Review Board (IRB)?

Institutional review boards, or IRBs, (also known as independent ethics committees, or human ethics committees) are committees mandated by federal regulation that review and monitor plans for research and evaluations involving human subjects. It is important to keep in mind that these committees not only protect evaluation participants from unethical methods or inappropriate questions, but also protect you and your program in the event that someone does not like part of the evaluation (Washington State University, 2004).

Colleges, universities, and federal agencies, as well as some state and local agencies have IRBs with the authority to review, approve, require revisions in, or disapprove plans for all research and evaluations involving human subjects conducted by personnel or students. If the institution you are affiliated with has an IRB or similar committee and if your evaluation involves individuals or groups of people, you are required to have the IRB review your evaluation plan. This is regardless of the source of funding, location of evaluation participants, and even if your research presents minimal or no obvious risk to human subjects.

If you are not affiliated with an academic institution that has an IRB, but are interested in or required by funders to get such approval, you can use an independent or commercial IRB, which serves the same purpose. A listing of some commercial institutional review boards, with links to their websites, can be found on the CIRCARE webpage.

Schedule plenty of time for the IRB process!

 

What does an IRB application include?

A typical IRB application includes:

  • Basic information, such as who is involved in the study, dates, and the type and purpose of the research
  • Description of the study design
  • Description of costs and risks to subjects
  • A conflict of interest statement
  • Information on how data will be stored
  • Confidentiality agreement (which may instead be included in consent forms or on questionnaires)
  • Availability of research results
  • Informed consent documents, parental consent form, and assent form if minors are involved
  • Final drafts of data collection instruments such as questionnaires and interview guides

While applying for IRB approval may be an inconvenience, remember that it is often required by law and is critical in protecting the rights of both yourself and evaluation participants.

Unique Resource

Are you working for a federal agency? If so, you are likely to need approval for your evaluation from the Office of Management and Budget (OMB).

Check out these two approved applications to get a sense of what may be required:

Evaluation of NOAA's Bay Watershed Education and Training (B-WET) Programs (.pdf)

Evaluation of the NOAA Coastal Services Center’s Coastal Services Magazine and the Coastal Connections Newsletter (.pdf)

Courtesy of Anita Kraemer, eeEvaluations and the U.S. National Oceanic and Atmospheric Administration (NOAA)

 

Is IRB approval always required?

You may not need IRB approval if your evaluation poses minimal or no risk to participants. By federal law, you may seek exemption status if:

  1. Your evaluation is conducted in a commonly accepted educational setting and assesses regular educational practices, such as:
    • research on existing or potentially new instructional strategies, or
    • research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  2. Your evaluation uses educational tests, survey procedures, interview procedures or observation of public behavior, unless:
    • information obtained is recorded in such a manner that individuals can be identified, directly or through identifiers linked to the them; and
    • disclosing participants' responses outside the research context could reasonably put the individuals at risk of criminal or civil liability or be damaging to the their financial standing, employability, or reputation.
  3. Your participants are elected or appointed public officials or candidates for public office
  4. You collect or study existing data, documents, or records that cannot be linked to individuals either by name or through identifying codes (e.g. voting records by county, visitor counts at nature centers, etc.)

Only IRB can determine if your evaluation is exempt!

 
 

References

Washington State University Cooperative Extension. (2004). Participant Consent.

Social Policy Research Associates. (2006). Evaluation and Civic Activism Curriculum, Evaluation Consent Form (.pdf).

Upload file: NOAA B-WET Evaluation Supporting Statement Full Clearance Final 2005.pdf