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Practice: Get quality data into your evaluator’s hands

Key Action: Manage logistics and communications for data collection

SAMPLE MATERIAL: Obtaining Appropriate Consents for Collecting Data

Purpose: These pages explain the requirements of an Institutional
Review Board (IRB) related to obtaining consent from
research participants and maintaining their confidentiality
and anonymity. Obtaining consents for participation may
be time consuming, so it’s wise to start this process
early. Data collection for your evaluation can begin only
after you have received IRB approval and completed the
participant consent procedures.

Note: An Institutional Review Board is established under
federal regulations to approve, request modification of, or
disapprove research activities, based on compliance with
federal human subject regulations. While an evaluator
typically handles the IRB submission process, it is helpful
for project directors to understand how it is coordinated,
so that the implementation of consent procedures and
data collection runs smoothly.

Source: U.S. Department of Education, Office of Safe and
Drug-Free Schools (2007). Mobilizing for evidence-
based character education (pp. 31-32). Washington,
DC: Author. The entire guide can be downloaded at:
www.ed.gov/programs/charactered/mobilizing.pdf (last
accessed December 10, 2008).

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The notification is two types of consent from students. which NIH Web site http://grants. It is important to make clear to both parents and students that all participation is 2 . 2004). if the student is a minor Students and the research is supported by the U. math in the study or older and reading tests). consent simply by not sometimes heard in discussing evaluations. Department of younger than Education.S. A waiver of informed consent provides The terms active consent and passive consent are permission by default—that is. A signed form or another written affirmation definitively establishes informed consent.htm. In that case. the students themselves are en- couraged to assent to participate. use the term informed consent for active ing students.g.nih. to participate Students 18 lar-based tests given in the course of teaching (e. is preferred. Baseline data on human participants cannot be For frequently asked questions about this issue. see the collected until after informed consent is obtained. Practice: Get quality data into your evaluator’s hands Key Action: Manage logistics and communications for data collection 31 STEP 5 EXHIBIT 11 OBTAIN APPROPRIATE TYPES OF CONSENT THAT MUST BE CONSENTS TO CONDUCT OBTAINED FROM STUDY PARTICIPANTS THE EVALUATION TYPE OF REQUIREMENTS PARTICIPANTS CONSENT Step 5 involves meeting the requirements for obtain. the waiver sent procedures have both budget and timeline implica- can allow what is popularly referred to as passive consent. 18 (parental nity to allow or not allow the child’s participation. tions. request that or older They must also appropriately maintain anonymity and they return the accompanying Students confidentiality for participants. The Informed participants project director and the evaluator must obtain permission Consent by letter about Parents for subjects’ participation as well as informed (sometimes the study and Students 18 called “active”) consent and waivers of informed consent. needed) Federal regulations require that all participants in Informed Participants Teachers a research study consent to take part. form only younger than if they do 18 (parental not wish to notification is OBTAINING PERMISSION FOR PARTICIPATION participate. and allow IRBs to waive informed consent under some conditions for minimal risk studies (34 CFR 97. They must be Consent must give provided the opportunity to decide freely whether to written consent Parents participate—unless the research study uses only curricu.. Informed consent from parents will be required Policy for the Protection of Human Subjects. Project directors should be aware that informed-con- also see USED/GPOS 2005b). parents and teachers needed) are illustrated in Exhibit 11. then the parents also must have the opportu. as distinguished from a waiver of informed consent. The Federal saying no. Waiver of Inform Teachers ing consent as required by an IRB for research.gov/grants/policy/hs often can take six to eight weeks to acquire (Sherblom /faqs_applicants. While parents must consent to have their children participate in research. individual follow-up con- tacts before they will return the consent forms. or Common by an IRB in most cases of school-based research involv- Rule provisions. consent. Moreover. The costs associated with acquiring informed consent can range from the cost of postage for mailing consent forms to parents to the cost of staff time to reach parents who require multiple. Obtaining informed consent.

ally. In some that they understand the purpose of the study instances. This district stationery and should include the elements outlined strategy allows the evaluators to track the coded numbers in Exhibit 12. time to indicate personal or identifying information. Letters of consent are also subject to IRB approval evaluators can trace the coded number back to the and must be included in the IRB application. participant. however. sTimelines Character education evaluation protocols often sNotification that participants can withdraw from involve the collection of information that participants the study at any time for any reason consider sensitive (e. The In other words. they follow protocols that maintain the person’s confidentiality (Posey. sPotential benefits to the individual and to education bigotry and problem behavior). Davidson. Although the consent. indicating that they agree to participate and ation should be included in the IRB application. sInformation about how to get a copy of the results Procedures for secure storage or destruction and disposal sA place for prospective participants or their parents of all data at the specified time after the end of the evalu- to sign. CONTENTS OF LETTERS REQUESTING INFORMED CONSENT With anonymity. the evaluators know the identity of the letter explaining the project can be sent on official school or participants. and Korpi EXHIBIT 12 2003). RESOURCES FOR ADDITIONAL INFORMATION Anonymity and confidentiality are two strategies for ABOUT OBTAINING INFORMED CONSENT protecting the right of individuals to privacy and for FROM STUDY PARTICIPANTS easing any hesitation they may have about participating. participants and numbers. names or code numbers are not used during the study so even the evaluators sPurpose of the research cannot identify a participant’s data. obtaining both informed consent and a waiver of informed participation and long-term outcomes. the project director. Each subject is participate in research. Confidentiality is the promise of the evaluators not to reveal any personal or identifying information. not be used at any the parents of minor students must receive enough informa. Both confidentiality and anonymity assure partici. See Internet Resources on use and protection of human subjects at pants that any data they provide through surveys. Practice: Get quality data into your evaluator’s hands Key Action: Manage logistics and communications for data collection 32 MOBILIZING for EVIDENCE-BASED CHARACTER EDUCATION voluntary and that no penalty can result from declining to although this information is collected.. The disadvantage of anonymity is that the evaluators cannot follow individuals over time to sStudy procedures assess long-term outcomes or participant attrition. victimization. Protection of confidentiality requires that these code To decide whether or not to consent. emotionally or personally. Procedures should be clearly articulated for keeping pants and results all evaluation data secure at all points in the collection.g. assess. the end of Step 4 on page 29. but do not reveal it in their reporting. ment interviews or focus groups cannot be traced back to them. Even if the information is not sensitive. the evaluator. dishonest behavior. or other indirect identifiers. or both may want to maintain and preserve data that have been col- lected and stored in a manner consistent with informed MAINTAINING ANONYMITY consent and IRB-approved methods so they can use it AND CONFIDENTIALITY for further analysis or to inform future work on character education. Plans such as these should also be included in In addition to obtaining consent. assigned a code number to protect his or her identity. 3 . management. tion about the evaluation to make an informed choice. staff members and the evaluator must ensure that all participants are protected so their responses will not jeopardize them legally. Appendix C contains sample letters related to (rather than individually named people) for attrition. both the school the IRB application. Anonymity is used sWho will conduct the evaluation and their contact to encourage participants to provide more honest and information complete answers. it is the responsibility of the project director sPotential harm or risk of discomfort to the participant and evaluator to ensure that data are never treated casu- sProcedures to maintain confidentiality of partici. analysis. reporting and storage process.