Dear Faculty, Staff and Students:
The University of Washington requires that all research undertaken by faculty, students or staff involving human participants must be reviewed and approved by the UW Human Subjects' Division (HSD) PRIOR to contacting potential study participants or beginning a secondary data analysis.
The purpose of Human Subjects review is to ensure that the rights of individuals participating in research projects are protected. The University of Washington and the College of Education take seriously our responsibility to protect the rights of those who participate in our studies. Under HSD guidelines, there are three levels of review, all determined by the level of risk that the research could pose to the participants. For details on the three levels of review - exemption from institutional review, minimal risk review, and full review - consult the linked pages on this site or the main HSD website. The concept of "risks to participants" should be considered not only in terms of physical risks; research might pose emotional, economic, or professional risks that must be considered. It may require 6 to 8 weeks to go through the approval process, so please plan ahead!
HSD approval of an application filed for minimal risk or full review is granted for one year. Near the end of the approval period, you will be notified and asked to submit a status report. In the status report you summarize the study to date and inform HSD whether the study, as originally described, has been completed (including data analysis). If, during the study, you plan to make any change in your recruitment (e.g., adding more participants), your procedures (e.g., modifying your survey questions) or your consent forms, you must file a modification form prior to implementing any changes in your approved procedures.
HSD approval may not be required for class projects in many cases, but HSD approval is routinely needed for the Research and Inquiry projects that are part of the College of Education Ph.D. program. When research is conducted outside the UW campus (for example, in elementary or high schools), you should obtain a letter of cooperation from someone in authority at the off-campus site to submit with your HSD application.
For information about the process, type of review suitable for your project, application forms, and assistance with the process, please contact Louise Clauss via email at: email@example.com, or call (206) 616-8291.
Research that poses no risk to participants and falls within certain categories is considered exempt from institutional review by the HSD. Research with children may qualify as exempt in only two cases: 1) if previously collected anonymous data are used, or 2) if the data consist totally of work students would be doing as part of the standard educational practice within the school. You will find a full explanation of the exempt criteria at the Human Subject Division web site at http://www.washington.edu/research/hsd/hsdman3.html.
If you believe your study matches one of the exempt criteria, complete a Certification of Exemption, which can be downloaded from http://www.washington.edu/research/hsd/forms.php. Sign your Certification of Exemption form and submit to Louise Clauss, who will obtain the area chair’s signature and forward the form to the UW Human Subjects Division for administrative review. Keep in mind that you may not recruit participants until you receive word of approval.
The following is an example of a study that might be approved as exempt from institutional review:
A College of Education researcher will survey UW students (age 18 and older) within a given degree program about their satisfaction with course content on research methods. For one week, blank surveys will be available for pick-up from the student lounge. College students will be informed that this is an anonymous survey and told not to put any identifying information on the survey. Completed surveys will be returned to a locked box on top of the student mail files. In this case, Exemption #2 might apply.
The following is another example of a study that might be exempt from institutional review:
A doctoral student will conduct a secondary data analysis on a data set that has been given to her with all identifiers stripped. The data set contains no personally identifying information or codes that would reveal participant identities. Neither the doctoral student nor the investigators from the original study can link findings from the secondary data analysis back to individual participants. In this case, Exemption #4 might apply.
Keep in mind that if the content of the data collected is sensitive in nature, the research would not qualify for Certification of Exemption, even if the study were structurally similar to the above examples.
Minimal Risk Review is appropriate for projects that involve only a minimal amount of risk to participants (i.e., no more than would be encountered in daily life). To read more about studies eligible for minimal risk review, go to Section II.D. of the UW Human Subjects Manual at http://www.washington.edu/research/hsd/hsdman3.html
If your study meets minimal risk criteria, complete form UW 13-11, which can be downloaded at http://www.washington.edu/research/hsd/forms.php. Tips for completing the application form can be found at the same site.
Associate Dean Deborah McCutchen and Grants Manager Louise Clauss are available to review a draft of your application before it is sent to the HSD. When your application is final, including your faculty advisor's signature if you are a student, submit the appropriate number of copies of the application to Louise Clauss, who will obtain Dean Stritikus's signature and forward your application and materials to the UW Human Subjects Division.
The following is an example of a study that might be eligible for a minimal risk review:
For the purposes of dissertation research, a doctoral student will reanalyze previously collected data that includes codes that can be linked back to identify adult participants. The data are not of a sensitive nature. The student has developed and explained in detail on the human subjects application a system to carefully guard the confidentiality of the participants.
The following might also be eligible for a minimal risk review, with appropriate procedures in place:
A researcher will interview key personnel at various schools about implementations of educational reform efforts. With the participants' informed consent, the interviews will be audio-taped and transcribed. Voice (and video) recordings of participants are de facto identifiable, and thus the potential for possible risk to participants increases. In such cases where confidentiality could be compromised, it is crucial for the researcher to outline appropriate procedures to minimize the risks of invasion of privacy and breach of confidentiality. Consent forms should be clear about the uses planned for any video or audio-tapes.
Full review by a full committee of the Institutional Review Board (IRB) is required for research with more than minimal risk to participants. Submissions from the College of Education typically go to one of the two Social Sciences committees, each of which convenes twice a month at the UW Human Subjects Division (HSD). If your study requires full review, complete form UW13-11, which can be downloaded from http://www.washington.edu/research/hsd/forms.php
Useful information can be found on the same site, which discusses common problems encountered in the review process.
Associate Dean Deborah McCutchen and Grants Coordinator Louise Clauss are available to review a draft of your application before it is reviewed by the IRB. When your application is final, including your faculty advisor's signature if you are a student, submit the appropriate number of copies of the application to Louise Clauss, who will obtain Dean Wasley's signature and forward your application and materials to the UW Human Subjects Division.
The principle underlying informed consent is that human participants who are asked to contribute their time and effort to research should consent to do so freely. Federal regulations require that, in most cases, consent is to be documented by a signed and dated consent form that has been approved by a Human Subjects Review Committee, either within the HSD or the College of Education. The consent process is designed to provide the potential participant with all the information necessary to make an informed decision. Language used during the consent process (and in the consent form) should be comprehensible to the participant. Consent can be given only after the potential participant understands what he or she is consenting to, as well as any risks that may be involved. Participants should be assured that there will be no penalties for declining to participate and that they are free to withdraw from the research at any time after they have given their initial consent.
As you are writing a consent form or preparing an oral script for consent, see the federal and University of Washington elements of consent, which are available by accessing the Consent Form Checklist available at ttp://www.washington.edu/research/hsd/consent.php
Elements of consent are not optional - please include all information. Note instructions around the importance of language and readability http://www.washington.edu/research/hsd/consent_lang.html
The Human Subjects Division offers some helpful hints on consent form writing at http://www.washington.edu/research/hsd/consent_tips.html.
Sample consent forms written for fictitious research projects purportedly conducted by College of Education researchers can be viewed at Sample Consent Forms.
If you are working with teachers or students in schools, or if you are using existing school data, obtain a letter of cooperation from the school outlining the purpose of the research and the parameters of confidentiality of the data. Consider drafting a letter for the school to save school personnel some work. The letter should be signed by a school official. Letters of cooperation are required for institutional review.
The letter of cooperation should acknowledge the school's familiarity with the Principal Investigator, the Principal Investigator's affiliation with the University of Washington, the purpose of the study, and the school's agreement as to recruitment of participants, access to school records, and confidentiality of data. For example, if an investigator were recruiting teachers at a school in order to interview them about their role in implementing a new reform-based curriculum, the letter might say:
XYZ Elementary would like to cooperate with Professor Smith at the University of Washington in recruiting participants for her research. We understand that the purpose of this study is to better understand how teachers view their role in implementing new curriculum. [Some letters elaborate on the importance or significance of the results that may be obtained.]
In order to provide support to Professor Smith, we will send a letter to teachers asking for volunteers and stating that teachers’ jobs will not be affected by whether or not they volunteer. We understand that the interviews conducted by Professor Smith are confidential and that only she will have access to identifiable data. We will look forward to receiving the results of the study, when it is published.
Notice that the above letter states the parameters of confidentiality: (1) the investigator will have sole access to identifiable data, and (2) the report that the school receives will contain aggregated data. The letter should include the signature of the principal, vice principal, or a representative of the school governing team with appropriate authority.
College of Education class assignments may require approval from the Human Subjects Division (HSD) if the intent of the activity is research; however many class assignments do not require HSD approval. The following cases are intended as general guidelines only. If you have questions about whether your class assignments fall into these categories, please contact the HSD at 543-0098. Also be advised that the specific content of an activity may affect its status (e.g., activities that survey sensitive issues should be reviewed).
Case 1. When our students are learning a non-research skill that they will use in their professional roles (e.g., as teachers, principals), no Human Subjects application is required. For example, if preservice teachers are learning how interview students to evaluate student learning, this activity is part of learning to become a teacher; it is not research and therefore does not need to be processed through the HSD. The HSD asks, however, that we always show respect for the children and parents with whom our students work and acquire informed consent. A few students may become sufficiently involved in their projects that their intention changes midstream from completing a class assignment to conducting research. In such cases, the students should submit HSD applications as soon as possible, and HSD approval is required BEFORE the data are used as research (i.e., presented at a conference or submitted for publication).
Case 2. Even when the goal of the assignment is to teach a research skill, as in a course on research methods, the nature of the activities and the intent of the student should be considered in determining whether to seek HSD approval. If the course goals include possible publication, HSD approval should be sought from the outset. The students' projects can be submitted either as individual applications or, when the projects will be sufficiently similar, they might be described under an umbrella application for the course. The nature of the activities will determine whether the research is appropriate for a Certification of Exemption, Minimal Risk Review, or Full Review. If publication is not an explicit course goal, most student projects are undertaken as class assignments only, and these need not be submitted to for HSD review. Again, a few students may become sufficiently involved in their projects that their intention changes from completing a class assignment to conducting research. In such cases, the students should submit HSD applications as soon as possible, and HSD approval is required BEFORE the data are used as research (i.e., presented at a conference or submitted for publication).
Case 3. College of Education students sometimes fulfill a research-related component of their program by applying techniques in their own professional settings that they have learned on campus (e.g., a teacher implements a curricular change as part of standard classroom practice and documents the results as a masters project). If the activity is standard classroom practice (sometimes a principal's letter of cooperation can help document this), such an activity can qualify for a Certification of Exemption. The UW student should inform participants (e.g., children and parents) in advance via a letter of notification. The letter of notification should allow participants to decline the use of their "data" for research purposes, and the letter should clarify that declining would not affect children's grades. In both Case 3 and 4, "data" is defined as the standard classroom activities and student work generated as part of those activities.
Case 4. College of Education faculty sometimes do research on our own teaching in UW classes, and such an activity should be submitted to the HSD, typically as Minimal Risk. When UW faculty (or graduate students) assume the simultaneous role of investigator and instructor (with the power to assign grades), there may be concerns about students' potential feelings of coercion. Please see the suggestions from HS (received 11/26/01) for guidelines in this case.
There are at least two distinct types of research activities that we might undertake in our own classes: research on our own teaching and the resulting student learning, and results of an event that emerged unexpectedly as a part of classroom activities. When we want to do research on our own teaching (with the intent to publish, not just improve our pedagogy) it is advisable to secure HSD approval before the course, informing students of our intent at the outset in the course syllabus, and then ask for specific consent to use their course work as data AFTER grades have been recorded. (For studies that require collection of supplementary data during the course, other safeguards will have to be put in place to avoid potential coercion, for example, having a third party obtain consent and collect data.) When events occur unexpectedly in a class and are worthy of sharing in the research literature, we should submit an application requesting to use data collected originally for non-research purposes. If, however, we expect that such events may repeatedly present themselves in future offerings of our courses, we should be more proactive and develop an application that informs students at the outset in the course syllabus and request consent after grades are recorded.
Received from HSD 11/26/01The Category of Exemption #1 (see the UW Human Subjects Manual at http://www.washington.edu/research/hsd/hsdman3.html) is usually appropriate for research involving standard educational practices that take place in primary or secondary schools. Research that is clearly "experimental" is not exempt. Other exceptions for this exemption category are using a subset of a student population (for example, targeting a specific sub-population of a classroom) or accessing the students' school academic records. For research projects appropriate for this category of exemption, parents are informed about the research and given an opportunity to decline, and students are informed about the research and given the opportunity to assent (or decline).
Research conducted at the university level is more difficult to construct under the exemption category #1. These research projects should probably be reviewed at the institutional level under the "minimal risk" category. The participant population is often involved in their chosen profession or actively involved in a training process for their chosen profession, which they will undertake in the near future. The balance between the risk and benefit is different for this participant population than, for example, a 5th grade geography class. If the study data linked to the participants' identities is found by an unintended audience, it could potentially cause harm to the participant (risk the participants' reputation or chance of employment, embarrass or stigmatize).
We are also concerned about several elements of recruitment. Often the investigator would like to recruit her or his students as participants, which is potentially coercive. Since the investigator/teacher will grade the students on coursework, the power relationship is unequal, and students may feel compelled to enroll in the study. Students (rightfully) complain about this situation.
It is best for investigators to not recruit their own students, but recruit students from a class that the investigator does not teach or a class where the investigator is not a TA. An alternative is to carefully set up the research so that the investigator is unaware of who has agreed to participate and who has declined until after grades have been filed. The latter scenario has to be carefully constructed and presented to students so that the students are assured that the instructor will have no knowledge of who is participating until after he or she has submitted the students' course grades to the department. The recruitment procedure should occur early in the course so students have time to withdraw their permission after having second thoughts. The potential for students to feel some coercion is stronger in the latter case than where the investigator only enrolls students she or he is not teaching.
In addition, a system of coding data needs to be carefully reviewed. Although teachers have access to the students' coursework and grades that directly identify his or her students, investigators code data for research. (A parallel situation is that although physicians have access to patient medical records, a physician/investigator develops a coded system for research data.)
Because of the concerns outlined above, research procedures for the university-level participant populations should probably be reviewed using the full Human Subjects Application (Form 13-11) under the "minimal risk" category.
Name of School
Dear Parent or Guardian,
We are working on a unit this quarter that integrates math, science and art. Instead of studying each of those subjects separately, each assignment will cover two or more of those subjects. During this unit, students will learn to put concepts together for projects.
As many of you know, this year I am working on my Masters Degree in Education at the University of Washington. I would like to use some of your child's assignments, tests, and projects for my research project about integrated studies. Your child will not need to do any extra work, and the research will not affect your child's grades. I only want to use regular assignments and tests for my research. I will take care to protect your child's privacy by replacing her or his name with a code for each assignment, test, or project. Only my advisor and I will have access to the link between the names and codes. I will destroy the link between the code and your child's name by [some specific date].
If you would like more information about my research, please call me at [phone number]. If you would prefer that I did not use your child's regular work for my research, please contact me, and I will not include your child's work as part of my research.
[Name of graduate student]
5th Grade Teacher
When does a secondary data analysis qualify for exemption from full review?
If the complete data exists at the time of the Certification of Exemption request, and if the data are anonymous, the project qualifies for exemption status. For data to be anonymous, no one -- including the researcher and research staff of the original study as well as the researcher of the secondary data analysis study -- can link the data back to the participants' identities.
Under what circumstances would a minimal risk review be the appropriate level of clearance for a secondary data analysis?
If the data includes codes that someone could link back to identify participants, and if the data is not sensitive, then the Minimal Risk Subcommittee reviews the study. Sensitive data include self-reports of behaviors that people generally keep private, including such things as substance use, child abuse, and sexual behaviors. The Subcommittee will want evidence that the original study has human subjects clearance. The secondary study researcher will provide the Subcommittee with the human subjects approval reference number, the approval date and the name of the institution that reviewed and approved the original data collection activities. Additionally, the Subcommittee reviews the original consent form to ensure that it meets community standards here and to see what the original researchers promised their participants. Usually, to qualify for minimal risk review, the data must exist at the time of review and data collection activities must have ended.
When would a secondary data analysis require full committee review?
When the original data is sensitive and the links to the identifying codes still exist, secondary study researchers should plan to submit an application for full committee review. In addition to the full review application form, information about the original study, as described above for minimal risk review, will be needed. In some cases where data collection is continuing, such as in longitudinal studies, or where participants are videotaped, a full committee review may be necessary.
Should participants be told that a secondary data analysis is underway?
If participants are still in contact with the researchers (for example, when waves of information are being collected longitudinally), participants should be informed of the secondary analysis.
College of Education, University of Washington
Box 353600 Seattle, WA 98195-3600