Step 5. Determine what clearances you will need for gathering your data, then go about seeking them from the appropriate people.

As soon as possible in designing your evaluation, determine if you need to first obtain clearances. Below are descriptions of the three types of clearances: institutional review boards, U.S. Office of Management and Budget, and gatekeepers.

Clearances from institutional review boards or human subjects panels

A type of clearance that will likely be required is known as a human subjects clearance. "Human subjects" is a term used to describe the rights of research subjects to specific protections against risk that could come to them in the course of the research. To address how you need to handle the human subjects issue for a particular population from whom you would like to obtain information, first investigate if your informants are of a type for which there is a high probability that you will need human subjects clearance. An example would be young students. Many institutions that carry out research and evaluation projects have experts on staff who are authorized to make this decision. They are members of Institutional Review Boards or Human Subjects Panels.

When clearance is required, it usually means that the approached individuals need to read and sign an informed consent. If the individuals are minors, the letter of permission needs to be signed by a parent or guardian, and in addition, the minor will need to sign a document referred to as an Assent. The letter needs to clearly explain what the evaluation is about and describe the rights and protections to which the subjects are entitled. The U.S. Department of Health and Human Services posts on the Web (http://www.hhs.gov/ohrp/humansubjects/assurance/consentckls.htm) the following Informed Consent Checklist, which contains the basic and additional elements listed below.

Basic Elements

• A statement that the study involves research
• An explanation of the purposes of the research
• The expected duration of the subject's participation
• A description of the procedures to be followed
• Identification of any procedures that are experimental
• A description of any reasonably foreseeable risks or discomforts to the subject
• A description of any benefits to the subject or to others that may reasonably be expected from the research
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
• A statement describing the extent, if any, to which the confidentiality of records identifying the subject will be maintained
• For research involving more than minimal risk, an explanation of whether any compensation, and an explanation of whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained
• An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject
• A statement that participation is voluntary, and that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any given time without penalty or loss of benefits to which the subject is otherwise entitled.

Additional elements, as appropriate:

• A statement that the particular treatment or procedure may involve currently unforseeable risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant)
• Anticipated circumstances under which the subjects' participation may be terminated by the investigator without the subject's consent
• Any additional costs to the subject that may result from participation in the research
• The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
• A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject
• The approximate number of subjects involved in the study.

Explain your study's design to your organization's Institutional Review Board or Human Subjects Panel and ask for specifications of what you need to communicate to the potential subjects as you seek their permission and cooperation in the evaluation.

The complete set of federal regulations on research involving human subjects is available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

Clearances from the U.S. Office of Management and Budget

If you are conducting your evaluation for a federal agency either as a contractor for or as an employee of the agency, and you are seeking information from ten or more respondents, you will be required to get a clearance for your data collection from the Office of Management and Budget (OMB). This requirement does not apply if you are an NSF grantee. Getting clearance from OMB puts you in compliance with the Paperwork Reduction Act of 1995. The purpose of the act is to reduce the paperwork burden on respondents. An example of excessive burden is too many items on a questionnaire. Federal agencies post information on their Web sites about how to seek OMB clearance. For example, the U.S. Department of Education (USDE) posts the information at http://www.ed.gov/policy/gen/leg/pra.html. It is a good idea to seek OMB clearance as soon as possible because you cannot carry out the particular data collection in question until you have obtained the clearance. The process of obtaining a clearance has been known to take up to a year.

Clearances from gatekeepers

Gatekeepers are people who, due to their protective authority over others, are in the position to determine if the people from whom or about whom you want to collect data should be made available to you. The people who serve as gatekeepers for particular types of informants may vary from institution to institution. Examples of common types of gatekeepers include parents, teachers, principals, district-level administrators such as the superintendent, department chair-people, and deans of faculty at colleges and universities.

An additional thought on gatekeepers: Sometimes their formal approval is not required, but their onsite support for the project may promote for successful outcomes. Periodic communication with these individuals is advised. Such communication signals respect for their authority, keeps them abreast of the progress of the project, and may help to obtain their cooperation and help, should a problem arise that needs their attention.