1 IRB FAQ for Researchers June 2017 FAQs for Researchers Submitting Proposals to the NYC Department of Education’s Institutional Review Board The New York City Department of Education (DOE) is the largest school system in the nation. Its student population varies considerably in its demographic, cultural, linguistic, and academic characteristics. There is also a great variety of programs established to meet the needs of this diverse population. As a result, many researchers are interested in conducting studies in the system. While the DOE allows researchers to conduct studies in our school system, it must ensure that all research does not compromise the privacy of our students and their families or disrupt the work of our students and educators. Consequently, the DOE only approves research proposals that meet professional standards for the treatment of human subjects, research design and ethical practices, and additionally have significance and relevance for the NYC public school system. For this reason, the DOE has developed guidelines for investigators who wish to conduct research or evaluations in our schools and it has convened an Institutional Review Board (IRB), to review their proposals. This publication presents guidelines and summarizes the proposal review process, providing answers to questions that are frequently asked by researchers. Please read it carefully. Overview What is the Institutional Review Board? Who should submit a proposal to the IRB? Where do researchers submit a research proposal? What proposal materials should be submitted? What happens to a research proposal after it is submitted? DOE IRB’s Criteria and Jurisdictional Concerns Are any research or evaluation projects exempted from IRB approval? What criteria are applied by the IRB in considering a research proposal? What are the specific DOE jurisdictional concerns about conducting research in NYC Public Schools? How does the IRB define minimal risk? Recruitment What procedures for recruiting schools should researchers follow? What procedures for recruiting research subjects should researchers follow? Can researchers use snowball sampling to recruit study participants? Can researchers include a statement in recruitment letters that the DOE has approved the study? What are the rules around compensating participants? Consent & Assent What is required for informed consent? What should be included in an adult participant consent form? What should be included in a parent/guardian consent form? What should be included in a student assent form? What should be included in a principal approval to enter school form? Is parent/guardian permission needed for students who are not minors? What procedures should researchers follow for obtaining informed consent from parents/guardians? What is the difference between active and passive parental/guardian consent (permission)? Is parental consent ever waived?
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IRB FAQ for Researchers June 2017
FAQs for Researchers Submitting Proposals to the NYC Department of Education’s Institutional Review Board The New York City Department of Education (DOE) is the largest school system in the nation. Its student population varies considerably in its demographic, cultural, linguistic, and academic characteristics. There is also a great variety of programs established to meet the needs of this diverse population. As a result, many researchers are interested in conducting studies in the system. While the DOE allows researchers to conduct studies in our school system, it must ensure that all research does not compromise the privacy of our students and their families or disrupt the work of our students and educators. Consequently, the DOE only approves research proposals that meet professional standards for the treatment of human subjects, research design and ethical practices, and additionally have significance and relevance for the NYC public school system. For this reason, the DOE has developed guidelines for investigators who wish to conduct research or evaluations in our schools and it has convened an Institutional Review Board (IRB), to review their proposals. This publication presents guidelines and summarizes the proposal review process, providing answers to questions that are frequently asked by researchers. Please read it carefully. Overview
What is the Institutional Review Board?
Who should submit a proposal to the IRB?
Where do researchers submit a research proposal?
What proposal materials should be submitted?
What happens to a research proposal after it is submitted?
DOE IRB’s Criteria and Jurisdictional Concerns
Are any research or evaluation projects exempted from IRB approval?
What criteria are applied by the IRB in considering a research proposal?
What are the specific DOE jurisdictional concerns about conducting research in NYC Public Schools?
How does the IRB define minimal risk?
Recruitment
What procedures for recruiting schools should researchers follow?
What procedures for recruiting research subjects should researchers follow?
Can researchers use snowball sampling to recruit study participants?
Can researchers include a statement in recruitment letters that the DOE has approved the study?
What are the rules around compensating participants?
Consent & Assent
What is required for informed consent?
What should be included in an adult participant consent form?
What should be included in a parent/guardian consent form?
What should be included in a student assent form?
What should be included in a principal approval to enter school form?
Is parent/guardian permission needed for students who are not minors?
What procedures should researchers follow for obtaining informed consent from parents/guardians?
What is the difference between active and passive parental/guardian consent (permission)?
Is parental consent ever waived?
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IRB FAQ for Researchers June 2017
When do you need active consent from teachers?
Can a research participant be consented over the phone or electronically?
Research Procedures
Can researchers ask a teacher to administer a survey in the classroom?
Can researchers conduct research during instructional time?
What are the procedures for conducting focus groups in the school?
Can interviews and focus groups with teachers/students be audiotaped?
What are the procedures for researchers conducting classroom observations?
How can researchers provide anonymity for research subjects when the study design calls for pre- and
post-tests?
Proposal Submission Procedures
What procedure must researchers follow for multi-year studies?
What procedures must researchers follow if they wish to change some aspect of the research design?
What procedure must researchers follow if there is a deviation from the research protocol?
What procedure must researchers follow if there is a violation from the protocol or an adverse event?
What happens if I conducted my research without getting IRB approval?
Fingerprinting
Who needs to be fingerprinted and how do they go about doing so?
What do researchers who do not have a Social Security Number need to do to get fingerprinted?
When does fingerprinting /background information expire?
Data Procedures
What qualifies as an adequate data security plan?
What qualifies as an adequate data disposal plan?
What is the process for accessing school- or student-level administrative records maintained by the DOE
(e.g., test scores, grades, attendance) for use in a research study?
When a PI obtains IRB approval, who else is allowed to access the data that has been collected? Should
these people be explicitly named in the research proposal?
Other Policies and Procedures
When is it acceptable to use deception in a study?
Are researchers allowed to collect biological samples from participants?
Can researchers administer previously validated psychology/clinical tools (e.g., the Child Behavior
Checklist, Beck Depression Inventory and Beck Anxiety Inventory)?
Does research conducted in School-Based Health Centers (SBHCs) have to be approved by the IRB?
What is the IRBs policy on videotaping?
What is the IRB’s policy on randomized control trials?
What is considered product testing and what is the IRB’s policy?
What is the process for high school students to conduct studies in schools?
What is the process to interview Central staff for research purposes?
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Overview What is the Institutional Review Board? In 1980, the DOE established the Proposal Review Committee, now known as the IRB, to screen external requests to conduct research in NYC public schools. It is composed of staff from the NYC DOE, and at least one member who is not affiliated with the DOE. Other DOE staff and other city agencies provide expertise as warranted by specific proposals. The IRB reviews over 500 proposals every school year. Like all IRBs, the DOE IRB has the authority to: (1) approve, require modifications, or disapprove all research activities that fall within its jurisdiction; (2) suspend, place restrictions, or terminate approval of research activities that fall within its jurisdiction that are not being conducted in accordance with IRB requirements or have been associated with unanticipated problems; (3) observe or have a third party observe the consent process and/or the conduct of the research. Top of the Document
Who should submit a proposal to the IRB? Any person who wishes to conduct research or program evaluation at a school site or gather information from students or school staff must obtain written approval from the IRB. Graduate and undergraduate degree candidates, university faculty, independent researchers, and private and public agencies must all submit proposals before conducting research. This procedure applies even if the researcher is employed by the school system in another capacity (e.g., school administrators and teachers conducting research for graduate studies, studies undertaken for publication). Please note that approval to conduct research is in effect for one year only. If the study is not completed within a year, the researcher must apply for a continuation detailing any changes made to the previously approved research proposal, including changes to the original timeline, research participants yet to be recruited, copies of revised forms, letters and protocols and a summary of findings to date. Top of the Document
Where do I submit a research proposal? The IRB uses a fully electronic proposal submission/review platform. A link to the submission form can be found on the website (http://schools.nyc.gov/Accountability/data/DataRequests.htm) along with a schedule of proposal submission deadlines and corresponding IRB meetings. Top of the Document
What proposal materials should be submitted? When you open the electronic submission form in IRBManager, you will be asked to provide the following types of information about your research study:
A statement of the research questions and objectives and a description of the implications of the research for New York City schools, including the educational challenge(s) addressed by the research.
A research methodology that fully describes the subjects, study sites and details the instruments and procedures in collecting the study’s data. It should be as specific as possible in regard to the number of subjects and how they are recruited and the estimated time required of the participants for the study’s research activities.
Consent/assent letters for the study’s participants including school administrators, teachers, other school staff, students and families.
A plan to guarantee confidentiality for research subjects and to ensure that study findings are reported anonymously.
A statement of the risks and benefits of the study. All surveys, questionnaires, and protocols for interviews, focus groups and observations.
What happens to a research proposal after it is submitted? The length of time required to review and approve a proposal depends primarily on the completeness of the proposal and the researcher’s prompt response to requests from the IRB for clarification and/or modifications. Receipt of proposals is acknowledged electronically. Proposals that are received by 5pm EST on the submission deadline are typically pre-screened by IRB staff within five to seven business days and researchers are informed through an electronic notification of initial revisions that are needed and the disposition of the proposal (whether it will be sent for full committee review, expedited or rejected). Requested modifications should be made on the original submission form by clicking on the pencil on the upper left-hand side of the section needing revisions. Do not submit a new proposal with the requested changes. Proposals which are rejected outright during prescreening can be resubmitted, providing the issues that were identified have been addressed. Researchers whose proposals go to full committee review are encouraged to address issues that were identified during prescreening prior to the IRB meeting; however, this is not required. Proposals sent to full committee review are assigned to two IRB reviewers, who present the proposal to the full board. After the meeting, researchers are informed electronically of the Board’s decision to: (1) approve the proposal as is, (2) require the researcher to clarify or modify the proposal, or (3) not approve the proposal. Researchers whose proposals do not require modifications will receive an IRB approval letter within five to seven business days after the IRB meeting. If the IRB’s determination is to not approve a proposal, an issues letter is sent outlining the IRB’s issues with the proposal. Researchers whose proposals are not approved may submit a new proposal in which they have addressed issues identified at the IRB meeting. Top of the Document
DOE IRB’s Criteria and Jurisdictional Concerns Are any research or evaluation projects exempted from IRB approval? The DOE IRB does not exempt any proposal involving research or program evaluation from review. When a researcher’s institutional IRB makes a determination that the proposal is exempted from review, the DOE IRB requires a letter from that IRB documenting the exemption Top of the Document
What criteria are applied by the IRB in considering a research proposal? The IRB considers a number of factors in its review of a research proposal:
The proposed research should be of an educational nature and relevant to NYC schools. The benefits of the research must outweigh the costs, which include staff and student time and
other resources The study should embody procedures that respect the confidentiality and privacy rights of staff,
students, and parents in accordance with Family Educational Rights and Privacy Act (FERPA) guidelines.
Provision must be made for truly informed consent and assent of participants and families of student participants.
The proposal must include sound research methodology that uses reliable and valid instruments. Researchers should also be aware of the following:
Researchers must obtain prior approval from their own institution’s IRB, if the institution has an IRB.
Principals and other school administrators who wish to conduct research must do so with students and staff from a school other than their own.
Teachers, school administrators and other DOE staff cannot receive compensation (monetary or non-monetary) to participate in research studies. Researchers may provide donations directly to the schools or through an online service such as DonorsChoose.org.
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IRB FAQ for Researchers June 2017
Participation in research studies should be completely voluntary. School administrators should
not be asked to select teachers or other staff to participate. In addition, school administrators are not allowed to supply contact information for school/staff, parents, or students, or to provide student data. Data collection is the responsibility of the researcher and should not impose unnecessary burden on teachers and other school staff.
Research activities should not take place during instructional time. Researchers should work with school staff to find an appropriate time and location to conduct research activities.
Top of the Document
What are the specific DOE jurisdictional concerns about conducting research in NYC Public Schools? Children under the age of 18 (minors) are by definition a vulnerable subject group requiring special attention to protection of rights. Subpart D of the HHS regulations at 45 CFR part 46 outlines additional protections for children participating in human subject research. New York’s Compulsory Education Laws require that children between the ages of 6 and 16 attend school. Since school attendance is not voluntary, the DOE IRB has adopted broader protections for students in our schools than those offered by the federal regulations. This is allowed by OHRP. Although students aged 18 and older are not legally minors, the same protections are offered to them as to students 17 or younger, e.g., requiring parental consent for their participation in research. In addition to the federal regulations governing IRBs, the DOE IRB honors the following policies with regard to: 1) coercion; 2) informed consent and exemptions; 3) videotaping; 4) randomized controlled trials; and, 5) product testing:
Coercion: We are especially concerned with the potential for exploitation and coercion of students. Not only are children in NYC schools legally minors, they oftentimes are also socially and economically disadvantaged. Special attention is given to potential sources of manipulation and coercion, such as teachers or other school staff exerting undue influence on students to participate in research studies. For this reason, school staff are not allowed to assist researchers in identifying/recruiting students for research studies. Additionally, school administrators may not conduct research with other school staff and teachers may not conduct research with students in their classes. Teachers may conduct research with students who are not in their classes or with students in other schools.
Informed consent and exemptions: The NYCDOE never waives informed consent. With few exceptions, active consent is required. Passive consent, in which failure to “opt out” is interpreted as an affirmative answer, is rarely allowed except in cases where a very large number of students will be participating in the research and the data collection is very “low touch”, such as a short satisfaction survey. More information on this is available in this document.
Videotaping: The DOE IRB rarely allows digital recordings of students and staff because of possible misuse.
Randomized control trials: The DOE IRB rarely allows randomized control trials within schools. The key concern here is that students/schools in the control group get an equivalent benefit.
Product testing: The IRB does not approve research where the inclusion criteria are convenience and/or cost considerations for the researcher, or subject characteristics similar to a market/audience where the researcher plans to market a product resulting from the research.
Top of the Document
How does the IRB define minimal risk? Studies conducted in NYC public schools must involve minimal risk to participants. While researchers often state that their study involves minimal risk, it is up to the IRB to determine if this is the case. Minimal risk means that the probability and magnitude of harm or discomfort that might be caused by participation in the research are no greater in and of themselves than those ordinarily encountered in
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IRB FAQ for Researchers June 2017
daily life. Also, risks to subjects must be reasonable in relation to anticipated direct benefits, if any, to subjects, along with the importance of the generalizable knowledge that may reasonably be expected to result. Certain types of risk are of particular concern to the IRB, including the collection of certain types of private information such as information about a subject’s religious affiliation, sexual history, drinking/drug habits, etc., which might expose the study participants to:
Psychological risk such as discomfort, embarrassment, worry or anxiety; Financial risk including risk to employability, insurability, etc.; Social risk such as damage to reputation; Risk of breach of confidentiality or anonymity; and
Surveys should not include questions the answers to which might result in respondents providing incriminating information about themselves, even if the survey is anonymous. Top of the Document
Recruitment What procedures for recruiting schools should researchers follow? Approval by the DOE IRB to conduct research in the NYC school system does not guarantee access to any particular school, group, individual, or data source. A principal may choose for the school not to participate in the research and may withdraw the school from participation at any time. Researchers can contact principals of schools to elicit the principals’ interest in the research prior to receiving DOE IRB approval. Written approval can only be requested after IRB approval is received. It is the researcher’s responsibility to reach out to principals to get their approval prior to initiating the study. Specifically, the researcher must provide the principal with:
the DOE IRB approval letter; a principal letter approved by the IRB containing the information outlined in the section on
principal letters in this document Principal investigators should also be prepared to provide principals with proof that all key
research personnel who will be entering schools have been fingerprinted and undergone a security check by the NYC DOE. Other research support personnel need not be fingerprinted but must have completed a course in human research subject protections within the past three years.
Top of the Document
What procedures for recruiting research subjects should researchers follow? Researchers may not ask principals to assist them in identifying and recruiting school staff to participate in their study. Researchers can post a flyer in the staff lounge, distribute flyers in staff mailboxes, or request a meeting with school staff, with the principal’s permission. School staff may choose not to participate in a research study, even though the study has been approved by the principal. Researchers may not ask administrators, teachers or other school staff to assist them in identifying/recruiting students to participate in their study. Methods that can be used to recruit students include posting flyers in appropriate locations in the school, scheduling meetings with students, as long as instructional activities are not interrupted, and/or meeting with parent groups. All of these approaches require the principal’s permission. Parent/guardian consent does not require a student to participate in a research study. Active assent from the student is also required; however, students who want to participate in a study may not do so without parent/guardian consent. Top of the Document
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IRB FAQ for Researchers June 2017
Can researchers use snowball sampling to recruit study participants? Snowball sampling, (or chain sampling, chain-referral sampling, referral sampling) is a non-probability sampling technique where existing research subjects recruit future subjects from among their acquaintances. The DOE IRB does not approve snowball sampling. From a logistics standpoint, it is always preferable for the researcher to make the first contact with any prospective research subject. It is also an ethical responsibility for researchers to protect the privacy and confidentiality of research subjects and to ensure that all potential research participants have accurate information about the purpose of the research, inclusion criteria, the commitment required to participate, and the benefits and risks to the participant of making that commitment. On rare occasions, researchers have made a compelling argument for why it is necessary to ask existing adult research subjects such as school professionals to assist in identifying/recruiting additional subjects in their network. In these cases, the researcher may not request contact information for potential subjects known to the existing subject. Instead, the researcher should provide a flyer describing the research and his/her contact information so that second-order subjects can choose whether to follow up with the researcher or not. Top of the Document
Can researchers include a statement in recruitment letters that the DOE has approved the study? Researchers can say that the IRB has approved the study, but should not imply that the DOE as an organization is directly supporting the study. Researchers should not ask principals to write letters of support for their research to parents or other potential subject groups. Top of the Document
What are the rules around compensating participants?
DOE teachers, administrators and staff: NYC Conflicts of Interest Rules prohibit teachers and other school staff for receiving compensation in exchange for participation in research studies. Compensation/gifts that benefit the entire school may be donated directly to the school. Researchers also may contribute to a specific classroom project through online sites such as DonorsChoose.org and Adopt a Classroom. Exceptions are extremely rare and securing a waiver can be a lengthy process requiring a thorough review by the DOE Ethics Officer, the NYC Conflicts of Interest Board and, ultimately, the Office of the Schools Chancellor. Some DOE programs, especially Universal Pre-K programs, are located in Community-Based Organizations (CBOs). CBO staff are not members of the United Federation of Teachers and are not salaried DOE employees. Researchers conducting studies in CBOs should check with the CBO’s leadership to determine whether staff in their facility can be compensated for participating in research.
Students: Gifts may be given to students for their participation. For elementary school students, stickers, pens, or gift cards not to exceed $15 is allowed. For middle and high school students, the value of the incentive should not exceed $25. Amounts beyond this could be coercive.
Parents/Guardians: Compensation for parents/guardians can be based on the number of hours required for their participation in the research (for interviews, and focus groups) or per completed research activity (e.g., survey, interview) where the amount of time involved might vary depending on the type and number of research activities requested of parents. Compensation should not involve a sum of money that would be perceived as coercive (as determined during IRB review).
Quid Pro Quo: Additionally, compensation cannot be offered to schools on a quid pro quo basis since this has the potential to compromise the voluntariness of the schools or individual research subjects participation in the study; for example, basing the donation to a school on the number of teachers who agree to participate in the research and/or on the number of data collection instruments teachers complete.
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IRB FAQ for Researchers June 2017
Consent and Assent What is required for informed consent? Informed consent requires a clear appreciation and understanding of the facts, implications, and future consequences of participating in a research study. In order to give informed consent, the individual concerned must have access to all relevant facts at the time consent is requested/given. Reasons that might cause a participant to give consent that is not considered informed include:
perceived social pressure (e.g., coercion/undue influence exerted by persons in positions of authority);
difficulties with language; psychological difficulty in asserting true feelings; deception in explaining the study; and, participant’s inability to fully appreciate the possible consequences.
Institutional templates substituting for consent forms are not accepted. It is our experience that templates often lack the project-specific details required for truly informed consent or “cover all bases” with information about data collection activities that may not be employed in the research. Consent forms for data collection with identifiable research subjects must include a signature/date line. Surveys for adults should include an introductory page detailing the subjects’ rights (e.g., participation is voluntary) and include YES/NO check boxes for the respondent to indicate voluntary consent/assent. Another option would be for the researcher to explain that by that proceeding to answer the questions on the following page(s) subjects’ consent/assent is implied. Top of the Document
What should be included in an adult participant consent form? Selected items from the federal regulations which are relevant to research studies/activities allowed in NYC public schools:
A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which he/she is otherwise entitled.
A description of any reasonable foreseeable risks or discomforts to the subject; A description of any direct benefits to the subject or others which may reasonably be expected
from the research; A statement describing the extent to which confidentiality of records identifying the subject will be
maintained; An explanation of whom to contact for answers to pertinent questions about the research and
research subjects’ rights, and/or in the event of research-related distress or injury to the subject, including the researcher’s contact information and contact information for the researcher’s IRB.
A consent/assent form must explicitly alert research participants to any settings/situations where the confidentiality of the data being collected could/will be out of the researcher’s control. Additionally, where applicable, consent forms should also include some variant on the following standard language related to participants’ privacy: All of your survey and interview responses are strictly confidential, with the following exception: the researcher is required by law to report suspicion of harm to you, to children, or to others to the appropriate authorities.
Additional information required by NYC DOE IRB:
Inclusion/exclusion criteria for selecting research participants; Study title (at the beginning of the consent form and on the signature page); Procedures that will be used to guarantee anonymity, where feasible; Details on data security and disposal (data must be stored for a minimum of three years);
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IRB FAQ for Researchers June 2017
Who, beyond the research team, will have access to the data, both individual and aggregate data, and what uses it will be put to;
List of data items, when identifiable student data will be requested from the DOE; Signature/date line for consent to participate in the study; Check box/additional signature line(s) for (1) permission to audio- and/or videotape, (2) to request
identifiable student data from the DOE, (3) to examine and/or copy student work samples, and (4) for data use beyond the research team; and
Compensation, if any, for participation. Top of the Document
What should be included in a parent/guardian consent form? In addition to most items required for an adult participant consent form, the following information should be included in this form:
Reason(s) why a child’s school was selected for the study and why the child was selected; Assurance that the research will not interfere with instructional time; Where feasible, no one but the researcher will know the child’s answers to questions; Child’s decision to not participate and/or withdraw from the study will not impact his/her grades or
any benefits to which students are otherwise entitled; and, Compensation (financial or non-monetary), if any, for student participants. Consent forms for parents should be easily understandable and free of technical jargon (8th
grade reading level is recommended). If there is the possibility that parents do not speak/read English, forms in their native language must be provided.
Copies of parent consent forms that contain parent consent for the researcher to obtain identifiable student data (a check box or separate signature line should be included to indicate explicit, active consent, along with the list of data elements that will be requested) must be included as part of the data request process outlined here: http://schools.nyc.gov/Accountability/data/DataRequests.htm.
Parents should be provided with a copy of the form for their files. Top of the Document
What should be included in a student assent form? Assent is the mechanism for obtaining permission from minors under the age of 18, who are not legally able to give informed consent in NY State. Students between the ages of 18 and 21 should be consented. One form may be used for both assent and consent by providing two signature lines on the form – one for students 17 and under and one for students 18 and older. The amount and complexity of information provided on a student assent form depends on the age of the student. Assent forms should be written in age-appropriate language and contain content that the student can comprehend. Assent forms for middle and high school students could contain most of the information included on a parent/guardian permission form, whereas assent forms for elementary school and younger students should be much simpler. With a simple form/script, the most important elements to include are:
Explanation of what a research study is; What the student will be expected to do and how long it will take; Explanation that there will be no harm or danger involved; Statement that participation is voluntary – the student does not have to be in the study and can
withdraw at any time if he/she becomes uncomfortable; Explanation that no one will be upset if he/she chooses not to participate, the teacher and others
won’t know (if this is true), and the student can withdraw at any time without it having any effect on their grades or what the teacher or others think of him/her; and,
Signature-date line or, for young students, Yes/No check boxes to indicate assent. Students should be encouraged to ask questions during the assent process and at any time
during the study. Assent forms should contain a signature line for the researcher to attest to having witnessed the assent process.
An assent script that will be read to younger children giving oral assent should be included in the research proposal. Please note: even young students are able to place an X in a YES/NO check box. This method should be used with younger children whenever possible. Top of the Document
What should be included in a principal approval to enter school form? The purpose of the principal letter is to provide enough information about the research for the principal to make an informed decision about the school’s participation. This would include many of the items required for an adult participant form along with other information that is more pertinent to the impact of the research on the school.
how the research findings will be used the researcher’s credentials, rationale for selecting particular schools, how research participants will be identified/recruited, scheduling data collection activities so as to not interfere with instructional activity, managing time
commitment involved for staff and students, use of school equipment (e.g., computers), and procedures for obtaining parent/guardian permission.
If a study involves a randomized control trial (RCT), principals should be informed of whether their school will be in the control or treatment group before they are asked for their approval OR the principal approval should be requested after randomization has taken place.
Consent/assent forms should be printed on a university’s or research group’s stationery and not on that of any office or school of the NYC DOE (unless the study is being conducted by a DOE office).
Change of procedure: The DOE IRB has discontinued the use of the “Approval to Conduct Research in Schools” form to obtain principal consent for the researcher to enter the school to conduct researcher. Instead, the principal letter should include a signature/date line for the principal to consent to the research taking place in the school. Researchers may contact principals to elicit their interest in their schools’ participation in a research study. After IRB approval is obtained, the researcher must send a letter to the principal outlining the research design/methodology and a signature/date line for the principal to give official approval for the research to be conducted in the school. Top of the Document
Is parent/guardian permission needed for students who are not minors? Yes. In NYC, students may attend school up until the age of 21. For this reason, researchers must obtain parent/guardian permission for 18-21 year old students. Top of the Document
What procedures should researchers follow for obtaining informed consent from parents/guardians? Researchers may distribute consent forms to parents/guardians in a face-to-face meeting or by asking the school to send the forms home with students (“backpack them home”). The forms must be returned to the researcher, not the school, in a face-to-face meeting, or in a self-addressed, stamped envelope provided by the researcher, or deposited in a sealed box in a secure location in the school approved by the principal. The box should be picked up by the researcher. Schools should not be responsible for tracking down consents. Parents and all other adult research participants should be given a copy of the consent form for their records. Top of the Document
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IRB FAQ for Researchers June 2017
What is the difference between active and passive parental/guardian consent (permission)? Active consent requires that a signed form be returned to the researcher by parents/guardians stating that they DO, or DO NOT, give permission for their child to participate in the research. In the small number of instances when passive consent is approved, parents/guardians only respond in writing if they DO NOT want their child to participate. The IRB rarely approves passive consent. Passive parent/guardian permission is only allowed when the research is anonymous, of minimal burden (to be determined by the DOE IRB), and there is a very large sample of students involved, so that it is not feasible for the researcher to obtain active permission. When using passive consent, researchers must allow 10 business days between distributing consent forms and conducting their research with students. Top of the Document
Is parental consent ever waived? No. One exception to this rule is when data are collected as a component of instruction, such as pre- and post-tests for a curriculum intervention that the teacher would be administering anyway. However, collecting identifiable versions of this data would require active consent. Additionally, a parent/guardian information letter may substitute for a permission form for classroom observations that does not involve audio- or video-taping, when no data is being collected from students, when no student records are being accessed, and when all information collected is entirely confidential. Top of the Document
When do you need active consent from teachers? Active consent is required for classroom observations, surveys, interviews, focus groups, and any other type of data collection involving teachers. Top of the Document
Can a research participant be consented over the phone or electronically? Both electronic and phone consenting of adult research participants are allowed. Top of the Document
Research Procedures Can researchers ask a teacher to administer a survey in the classroom? No, researchers may not ask teachers to collect any type of data. Top of the Document
Can researchers conduct research during instructional time? The answer is “no” in most cases. The exception to this rule is when data are collected as a component of instruction, such as pre- and post-tests for a curriculum intervention that is being evaluated. Researchers should consult with the principal and/or teachers to determine the best time and location for collecting data from students. School staff who are participating in a research study should be given the choice of being interviewed at the school or at another location of their choosing. Top of the Document
What are the procedures for conducting focus groups in the school? All participants must consent to be involved in the focus group. Consent/assent forms must clearly state that the researcher cannot guarantee that focus group participants will respect the confidentiality of discussions that take place during the session. If the focus group will be audiotaped, all participants must consent to be taped or no taping may take place. A signature line or check box must be provided in the consent form for participants to give explicit, active consent to be audiotaped or, in the case of adult participants, videotaped. Focus groups should be held in a location that respects the privacy of the participants. Top of the Document
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IRB FAQ for Researchers June 2017
Can interviews and focus groups with teachers/students be audiotaped? Researchers may audiotape interviews and focus groups with adult research participants (e.g., principals, teachers) with their consent. The researcher must accommodate requests from adult participants to review transcripts of the audiotaping and comply with requests to delete material from the audiotape. Researchers may audiotape interviews and focus groups with students after obtaining parental consent and student assent. Focus groups with adult participants/students may only be audiotaped if every participant in the group consents/assents. Top of the Document
What are the procedures for researchers conducting classroom observations? Researchers who want to observe a classroom must obtain the consent of the teacher. Researchers who want to audiotape classroom interactions must get the permission of the teacher and active parental consent. The consent letter to parents must contain a check box or separate signature line for explicit consent to audiotape in the classroom. Researchers must work with teachers to make appropriate arrangements for students whose parents do not consent to audiotaping in their child’s classroom. Top of the Document
How can researchers provide anonymity for research subjects when the study design calls for pre- and post-tests? Researchers who conduct studies in which participants are tested before and after a treatment have a legal and ethical need to preserve the participants' anonymity, while matching the initial test responses to the follow-up test for research design purposes, so at some point they must know the identity of the respondents. Most researchers handle this data collection problem by numbering the tests with unique identifiers -- giving identical numbers to the pre-test and post-test documents of each participant -- and keeping a “master list" with names matched to questionnaire I.D. numbers. The master list is kept secure by the researcher in a separate location from the pre-tests. After the post-test is administered to the group, the matching tests are paired, the list is destroyed and the respondents remain anonymous. Another method for preserving anonymity when pre- and post-test surveys are administered involves handing out pairs of questionnaires with identical ID numbers. Each participant answers the pre-test and writes his/her name on an envelope containing the post-test. The pre-tests are collected by the researcher and stored in a secure place. The as-yet unanswered post-tests, in their envelopes, are kept at the school. At the time when the post-test is scheduled, the envelopes are distributed to students, who throw away the envelopes with their names on them and fill out and hand in the questionnaires inside. Top of the Document
Proposal Submission Procedures What procedure must researchers follow for multi-year studies? Researchers whose projects will extend beyond the year for which IRB approval has been granted must apply for a continuation four to six weeks before the approval will expire using the DOE’s IRB online form (researchers will receive several system-generated alerts that their approval is about to expire). They also must fill out an interim research report that documents activities that took place during the previous year and provides a rationale for any revisions to the research design that are proposed in the continuation request. The revised proposal and related documents, such as consent forms, must be submitted to the IRB for review before a continuation can be approved. Top of the Document
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IRB FAQ for Researchers June 2017
What procedures must researchers follow if they wish to change some aspect of the research design? Changes (referred to as amendments) in research design that will take place within the approval year must be reported to the IRB and reviewed for approval. Changes in research design that are planned for the future (in the case of multi-year projects) should be included in continuation requests. Forms for Amendments to proposals and Continuation of research beyond the original approval year are available online in IRB Manager. Top of the Document
What procedure must researchers follow if there is a deviation from the research protocol? Deviations must be reported within 48 hours of when they occur. The researcher must suspend the research until he/she can assure the IRB that the deviation will not re-occur or until they submit an amendment to the original research design incorporating the deviation into their original design. Such amendments must be reviewed and approved by the IRB. Top of the Document
What procedure must researchers follow if there is a violation from the protocol or an adverse event? Violations and adverse events must be reported immediately and research suspended until the IRB determines whether the research should be discontinued. IRBs are required to report adverse events to OHRP. Top of the Document
What happens if I conducted my research without getting IRB approval? Federal regulations are silent as to whether retrospective review is allowed. The DOE IRB’s policy is that requests for retroactive review/approval will be determined on a case-by-case basis and will not be taken lightly. The following conditions for retrospective review/approval of a completed research study must be met:
The researcher must present a compelling case for retrospective review/approval; The researcher or the researcher’s academic institution (in the case of graduate students) will
substantiate the researcher’s claims by documenting the circumstances that led to research being conducted without DOE IRB approval;
Said documentation will be available to legitimate third party organizations such as OHRP upon request;
Scholarly journals requesting confirmation of IRB approval for a submission from the researcher will be informed that approval was retrospective, leaving it to the journal to determine the disposition of the submission;
Any misrepresentation by the researcher of the nature of DOE IRB approval will be viewed as research misconduct with the attendant consequences.
Top of the Document
Fingerprinting Who needs to be fingerprinted and how do they go about doing so? Pursuant to New York State Education Law, and related Chancellor’s Regulations, the DOE has the duty to ensure employees and individuals doing business in DOE schools, or having access to confidential DOE data, have successfully passed a fingerprint-supported security clearance review. Fingerprints taken by other NYC and NY State agencies cannot be used by DOE for security clearance purposes. These individuals will need to be fingerprinted by the DOE. The NYCDOE’s Office of Personnel Investigation (OPI) has created a web-based application called PETS (Personnel Eligibility Tracking System) that enables the OPI and DOE offices and divisions to
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IRB FAQ for Researchers June 2017
electronically track and share basic information regarding the eligibility status of individuals who work under various combinations of vendors, contracts, programs and work sites. All researchers who have been approved by the DOE IRB to conduct research in NYC public and charter schools must be registered in the IRB PETS roster. This includes researchers who were previously fingerprinted by the DOE. These researchers will not be required to be fingerprinted again, but will need to be registered. In order to be registered in the DOE IRB PETS roster, research team leaders or individual researchers much provide the following information to the IRB: first and last name; full social security number; date of birth; full mailing address; primary telephone number; email address; title of the study and name of the Principal Investigator. Please email all information to [email protected]. IRB will enter this information into PETS and then delete your information. Subsequently, you will receive a nomination email within one to three business day providing you with a link to the NYCDOE’s Applicant Gateway website where you can submit required NYCDOE forms that must be submitted online prior to being fingerprinted. Please follow the instructions and then go to the HR Connect Walk-in Center at 65 Court Street, Room 102, Brooklyn, NY 11201 for fingerprinting. The cost of fingerprint processing is $135 (paid by check, money order or credit card, no cash). You will also need to bring a valid, government-issued photo ID. Once fingerprinted, notify the IRB via email so they can verify your security clearance status. You may not enter NYCDOE schools or access NYCDOE data until IRB indicates you may do so. Top of the Document
What do researchers who do not have a Social Security Number need to do to get fingerprinted?
International researchers must first reach out to the Institutional Review Board (IRB) at [email protected] for tracking purposes.
Researchers without SSNs must email the Office of Personnel Investigation (OPI) at [email protected] to schedule a fingerprint appointment and to provide the following information: name, postal address, telephone number, email address, indication that they are an International researcher, name of university/program.
A member of the OPI staff will contact the researcher to schedule an appointment. All fingerprinting of international researchers must be done via an appointment. Unannounced
visitors will be turned away. Researchers will need to bring the following documents to the OPI appointment: valid passport,
valid visa, ID from school/program, a letter from the principal researcher in charge of the study indicating the researcher is part of their study, and a fingerprint payment of $135 (acceptable forms of payment include money orders or personal checks made payable to NYCDOE/DHR, credit card or debit card with a logo).
On date/time of appointment, the researchers should go to the Office of Personnel Investigation at 65 Court St., Room 200, Brooklyn, NY 11201, sign in and then indicate that they are a researcher who has scheduled an appointment with OPI staff.
An OPI staff member will collect and make copies of all documentation, ask the individual to fill out a paper background questionnaire and will bring the researcher down to the fingerprint unit to take fingerprints. A receipt of fingerprinting will be provided to the researcher.
The researcher must then provide the IRB team with a copy of fingerprint receipt. IRB staff team will reach out to OPI three business days after the researcher was fingerprinted
requesting status confirmation. OPI will respond to the IRB as follows:
<Name of researcher> was fingerprinted by the DOE and underwent our International Researcher review. Note: These researchers are allowed to be in DOE schools.
<Name of researcher> was fingerprinted by the DOE, but has not yet completed our International Researcher review. Note: These researchers are not allowed to be in DOE schools until a full security clearance is obtained.
If/when the researcher obtains a valid Social Security number he/she must go to the HR Connect
Walk-in Center at 65 Court St., Room 102, Brooklyn, NY 11201 immediately with their valid Social Security card so the Social Security number can be associated to the fingerprints.
The researcher must also inform IRB staff of the valid Social Security number, which will be entered into the IRB roster of the Personnel Eligibility Tracking System (PETS).
Top of the Document
When does fingerprinting /background information expire? The DOE maintains a database of all persons who are fingerprinted for the purpose of going into NYC Public Schools. According to current DOE policy, researchers are listed as ‘eligible’ as long as they continue to be actively involved in conducting research in NYC public schools. Researchers who are discovered to have been arrested for any reason are made ‘ineligible’ to enter schools to conduct research. Depending on the court’s disposition of the offense, a researcher’s eligibility to conduct research in schools may be restored. Top of the Document
Data Procedures What qualifies as an adequate data security plan? Data/record security is critical. Researchers should insure that all hard copy and electronic data are securely stored to prevent unauthorized access, disclosure, or loss. Hard copy records should be stored in a manner that limits access to only authorized individuals. For example, filing cabinets/areas should be locked and placed in secured/locked rooms. Electronic data should be saved on a device that has the appropriate security safeguards such as unique identification of authorized users, password protection, encryption, automated operating system patch (bug fix) management, anti-virus controls, firewall configuration, and scheduled and/or automatic backups to protect against data loss or theft. Researchers possess a strong sense of ownership for their data and consequently often manage their own computers. Laptops, Personal Digital Assistants, removable hard drives, “jump” or “thumb” drives, CDs, DVDs and other portable devices and removable media are very convenient to ensure your data is always at your fingertips. External hard drives are a cost effective and convenient way to back up your data. However all of these devices require encryption solutions if used to store Restricted or Sensitive data (e.g. identifiable information). Top of the Document
What qualifies as an adequate data disposal plan? Data disposal plans should outline when and how data collected in a study will be destroyed, including shredding of paper documents, erasing of data on computer drives, and disposal of audio- and videotapes. Federal regulations require that research data and related documents such as consent forms be kept in a secure location for a minimum of three years. Top of the Document
What is the process for accessing school- or student-level administrative records maintained by the DOE (e.g., test scores, grades, attendance) for use in a research study? Researchers may not request student- or school-level administrative records from schools where they are conducting their research. Data requests should be submitted directly to the Research and Policy Support Group. Guidelines for submitting data requests can be found at: http://schools.nyc.gov/Accountability/data/DataRequests.
Data requests do not require IRB approval; however, researchers are asked to describe their data needs in their IRB submission. Researchers requiring identifiable student data must include a list of the specific data items in their IRB parent/guardian consent form along with a check box or second signature line for parents to give explicit, active consent for the researcher to access their child’s identifiable records. Researchers do not need to wait for IRB approval to submit a data request. IRB approval for a research project does not guarantee approval for a data request or availability of the data. Requests for extant DOE data alone (without an IRB submission) do not require IRB approval. Top of the Document
When a PI obtains IRB approval, who else is allowed to access the data that has been collected? Should these people be explicitly named in the research proposal? In most cases, only the researcher and other key research personnel should have access to study data. The research proposal and consent forms must specify who will have access to collected data and the IRB must approve providing access to persons outside of the research team. Consent forms must include a signature line or check box for research participants to consent to persons outside the research team using the data. Providing access to data to persons outside the research team after a study is concluded requires re-consenting of the study participants. Top of the Document
Other Policies and Procedures When is it acceptable to use deception in a study? Rarely is it acceptable to use deception in a study. The DOE IRB would never approve use of deception in research with students. Certain types of deception in research with adults might be used when there is no other way to obtain unbiased data from respondents and when the benefits far outweigh the risks. Use of deception requires a detailed debriefing protocol to be used with respondents at the conclusion of their participation in the research, when they are informed that deception was used. Deception relating to guarantees of confidentiality or anonymity for research participants is never permitted. It is up to the discretion of the DOE IRB to determine whether deception is appropriate. Top of the Document
Are researchers allowed to collect biological samples from participants? Researchers may not collect medically-related data (i.e., saliva samples, blood samples, heart rate, height/weight, blood pressure, body mass index) from students. Data on height/weight and body mass are collected annually by the school for the NYC FITNESSGRAM Assessment. Researchers may access these data though the data request process. Top of the Document
Can researchers administer previously validated psychology/clinical tools (e.g., the Child Behavior Checklist, Beck Depression Inventory and Beck Anxiety Inventory)? Questionnaires that provide researchers with the ability to diagnose/highlight signs of a particular psychological, behavioral, or psychiatric disorder in a student (e.g., depression, anxiety, attention-deficit, and suicidal tendencies) may not be administered for research purposes. Top of the Document
Research conducted in School-Based Health Centers (SBHCs) Research conducted solely with students enrolled in SBHCs does not fall under the purview of the DOE IRB; rather, these studies are reviewed by the DOHMH’s IRB. The reason for this exception is that SBHCs’ policies on confidentiality, and parental consent are markedly different than the DOE IRB’s policies. Additionally, the DOE IRB does not include members with the medical/clinical expertise to review proposals (as required by OHRP) related to services offered by SBHC’s. Top of the Document
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IRB FAQ for Researchers June 2017
What is the IRBs policy on videotaping? In the past few years, an increasing number of research proposals submitted to the DOE IRB have included a video research component. The DOE IRB’s longstanding policy on videotaping resulted from a concern that videotaping human subjects, especially vulnerable human subjects such as children, raises special issues related to anonymity, privacy and respect for human dignity; in particular, the potential for videotaping that includes identifiable images of students to be misused, including (but not limited to) video records being reused for other research projects or displayed on public internet sites without parental consent and student assent. That said, the DOE distinguishes among (1) videotaping for public use, (2) videotaping for use in teacher training and teacher professional development, and (3) videotaping for research purposes. Requests to conduct videotaping in schools for public use must be approved by the DOE Office of Media Relations (http://schools.nyc.gov/Offices/mediarelations/ContactUs/default.htm). Videotaping for teacher training and professional development, when the video will only be viewed by the teacher and his/her mentor/coach or teachers in training, does not constitute a research procedure, although the IRB recommends that written consent be obtained. Videotaping for research purposes is rarely approved. Issues may be identified that would result in a decision not to approve videotaping. These include, but are not limited to:
videotaping for convenience of the researcher or reducing costs of data collection lack of a data analysis plan for the video records; using videotaping as a note-taking device or
fishing expedition reservations about the research design and key research questions/hypotheses subjects’ ages and other background factors greater than minimal risk to students with no clear direct or indirect benefits videographer’s technique; logistical issues lack of information about potential uses of the video records, and plans for securing and
disposing of the videotaped data (hereafter referred to as video records) Moving forward, the IRB will consider, though it may not approve, compelling reasons given by researchers for approving videotaping of students. Proposals will be reviewed on a case-by-case basis using the following criteria:
the research addresses a major problem in educational field research there is the potential for direct benefits to the subjects the research advances the DOE’s mission/goals visual information is necessary for interpretation, e.g., body language such as gaze direction,
and head orientation which can identify an intended listener in the absence of verbal signaling videotaping will capture occurrences of human behavior that either would have been vastly
altered by the presence of a human observer or, had one been present, the observer(s) would have been physically unable to hear, see, and record all that went on simultaneously;
videotaping is necessary to replicate an important study that used videotaping Videotaping teachers in classroom settings where students are present requires the teacher’s active consent plus active parental consent and student assent, even when students are not the focus of the research. Parent consent forms for videotaping in classrooms must provide the following information:
compelling reasons for using videotaping versus other methods of data collection precautions researchers will take to avoid capturing students’ images on tape, or to filter/mask
images of students that are inadvertently captured (full anonymity of videotaped subjects beyond the immediate context of the research)
arrangements that will be made for students whose parents do not consent to their being in the classroom during videotaping should not single out those students so they feel stigmatized and/or remove them from instructional activities
information on how video records will be protected from access by unauthorized persons, such as
use of high-security networks and password-protected sites for storage; disposal of video records; how long records will be kept
future uses of the video records (e.g., for teacher training/PD or presentations at academic conferences and other public venues)
As with the requirement for classroom observations, a videotaping protocol will be required for review by the IRB. Along with logistical and technical steps that will be followed, the protocol should address ethical issues such as steps that will be taken to protect students in the short and long run. The data analysis plan for a project involving videotaping should include a discussion of how video records will be analyzed and used in combination with data produced by other research methods such as questionnaires/interviews. Video data is inherently non-anonymous, however, confidentiality can be protected in many ways, such as restricting access to the video and to personal information such as the names of participants or the schools in which data were collected and restricting access to the video records, namely limiting use of the video records to research team members. The DOE IRB recognizes that at the time a proposal involving videotaping is submitted, the researcher may not be able to specify precisely what the uses of video records might be or even who, if anyone beyond the research team will be studying them (because data corpora are often shared within a research community). Under these circumstances, the IRB will grant provisional approval for data collection and will require that an addendum to the proposal be filed no later than six months after data collection is completed, if the researchers believe it is likely that data will be shared beyond their research. This would require re-consenting subjects who agreed to the videotaping without specific information about how it would be used, or subjects who were told that use of the video records would be limited to research team members and providing an opportunity for them to view (or listen to) the recordings. In some cases the IRB may request to view the video records. Additionally, when data will be shared, adequate documentation about the video must be provided to viewers, including anonymized information about research subjects, so that future users of the video will be adequately informed about the nature of the video they are analyzing and how it was collected. Video records that are electronically transmitted for the purpose of sharing them with the larger research community must be encrypted. Top of the Document
What is the IRB’s policy on randomized control trials? In developing a policy on the use of randomized control trials (RCTs), the DOE IRB considered both methodological challenges and ethical concerns. While RCTs have made contributions to the field of education, we believe RCTs are not the only way to examine causation, nor are they the one “scientific method/gold standard” with universal applicability. Randomization is considered the most powerful experimental design in clinical trials. However, a number of experts1 have questioned the applicability for behavioral research generally and specifically for education research. They have observed that highly complex organizations such as the educational system are a poor fit for the RCT model, which requires clear inclusion/exclusion criteria and interventions administered identically. Other specific methodological challenges of using RCTs in public school systems that have been observed include:
Variables can rarely be controlled tightly.
1 Ginsburg, A. and Smith, M. (2016) Do Randomized Controlled Trials Meet the “Gold Standard”? A study of the Usefulness of
RCTs in the What Works Clearinghouse, American Enterprise Institute, Washington, DC. Bhatt, R. and Koedel, C. (2010) A None-Experimental Evaluation of Curriculum Effectiveness in Math, Andrew Young School of Policy Studies, Research Paper Series No. 9-12, Atlanta, Georgia. Cartwright, N. (2007) Are RCTs the Gold Standard? Center for Philosophy of Natural and Social Science Contingency and Dissent in Science, The London School of Economics and Political Science, London, England.
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IRB FAQ for Researchers June 2017
Where student interaction is moderate to extensive, contamination of effects can compromise
randomization. Blinding – a cornerstone of clinical RCTs, is virtually impossible in studies conducted in schools. Randomization will not control for many sources of error that can impact research in schools.
Contextual factors also may affect outcomes in ways that randomization cannot fix. Interpreting results of RCTs in schools is not as simple as saying ‘it works’ or ‘it doesn’t work’,
e.g., if it works with low-income students in the rural South, does that mean it will work with middle-income students in the urban North?
The DOE IRB’s decisions are guided by the ethical principles of the Belmont Report/Common Rule:
Respect for persons – voluntariness; active informed consent/assent Beneficence–honest, comprehensive discussion of risks/benefits; commitment to maximizing
benefits while reducing risks Social justice – fair selection of subjects; fair distribution of benefits/burdens of research.
It is the IRB’s view that RCTs almost always require varying levels of compromise in honoring these principles and politically, ethically or administratively it is undesirable to deny services to a control group created for an experiment. Students and their families have a keen sense of injustice when benefits offered by their school are not distributed equally or are perceived to be arbitrarily (randomly) distributed. For this reason, studies that involve student-level randomization within a school will rarely be approved by the IRB. In a limited number of cases, the IRB may determine that randomization between schools might be an appropriate methodology for a research study. With this in mind, we have developed the following list of criteria/questions which will guide the DOE IRB’s decision to approve/not approve RCT studies conducted with students in NYC public schools:
Is there a clear scientific and policy rationale for using an RCT? Would another research methodology produce the desired outcome?
Is the margin of improvement large enough to warrant an RCT? Does the research design address an important policy or practice question which is a priority for
the DOE and participating schools, e.g., will it lead to increased school attendance, improved educational outcomes?
Does the proposal communicate clear thinking about indicators: How will improvement be measured? How will data on the indicators be collected?
Does the potential benefit to students/schools outweigh the concomitant burden to school staff of the sample size/time commitment required for an RCT?
Does the proposal communicate a deep understanding of the sample: Who is the target population? Is the sample large enough to make it really random? Is sample representative of the larger population? When will random assignment take place within schools? Following randomization, are the treatment and control groups comparable along important indicators?
Will adequate resources be available for the development/implementation phase of the program, including:
Attention and sensitivity to stakeholder perspectives/concerns: recruitment activities that give particular consideration to the position of the control group; honest discussion of what will be expected and potential risks and benefits; adequate time for control schools to decide whether it is worth it to make an active contribution to the research.
Careful piloting of recruitment/informed consent procedures; Respect for the need for tight control of the randomization process
There are several ways to mitigate the concerns around RCTs, including:
Offering the intervention to the control group at the conclusion of the study, if the intervention proved to be useful. If timing prevents offering the intervention to students in the control group (due to student matriculation), offering it to control schools the following year. If this approach is
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IRB FAQ for Researchers June 2017
not possible, due to control group students’ matriculation, an equivalent benefit, such as financial compensation, should be offered to the school.
Use of a phase-in/pipeline design. The study is run twice within the school year. Students or schools who did not receive the intervention initially would be placed in a queue to receive it if the intervention was found to be effective.
Use of a rotation design. For two groups, one group is treatment and one is control-and then, those roles switch, with the previously-treated becoming the control and the previously controlled becoming treated.
Randomization is rotated. In year one half of the schools receives a tutor for grade 3, and the other half receives one for grade 4. In year two, the schools receives a tutor for the previously untreated grade. In this way, the impact of treatment could be determined by comparing grade 3 students in schools who received a grade 3 tutor to grade 3 students in schools who received a grade 4 tutor.
Top of the Document What is considered product testing and what is the IRB’s policy? The DOE IRB defines research as data collection for the purpose of generating or testing a hypothesis/hypotheses with the goal of producing generalizable findings. Although publication of findings may result from a research study, this is not the main criterion by which we define research. Results of research, whether published or not, should be used for information purposes, not endorsements. In addition to these basic requirements, the IRB requires that a researcher provide a compelling rationale for why specific schools/subject groups are targeted to participate in the research (inclusion criteria). The IRB does not approve research where the inclusion criteria are convenience and/or cost considerations for the researcher, or subject characteristics similar to a market/audience where the researcher plans to market a product resulting from the research. Another key consideration in the IRB’s review of proposals is who benefits from the research. While many research projects approved by the DOE IRB do not directly benefit students, the research should have the potential to produce indirect benefits for future generations of students, the school system and/or the field of education research. If the purpose of the research is to validate a product, it will not be approved by the DOE IRB. Our students are in school by virtue of a compulsory education law. We are the custodians of the children in our schools; we cannot ask them or their parents to participate in research with products that have not been tested. We are not saying that schools cannot use various products; rather, we are saying ‘no’ to products being tested in schools that will ultimately benefit the researcher or an organization with which the researcher is affiliated. In the course of reviewing a research proposal we look at the following information that would help us distinguish between valid education research and data collection for the purpose of testing/marketing a product. The DOE considers many factors when determining whether a proposal constitutes product testing that will not be approved:
Is the project currently supported/endorsed by and/or being conducted in conjunction with the DOE (at the Deputy Chancellor level or above) or a specific DOE program office?
Does the DOE have an ongoing relationship with the researcher/research firm? Has the product been vetted previously for quality and effectiveness? If there is widespread utilization of the product in our schools and is the researcher able to explain
to our satisfaction how the product is being used in our schools and its effectiveness? If the answer to these two questions is “yes,” testing valuation for improvement would be legitimate.
Are other school systems using the product? Does the proposed research have a qualified researcher associated with it? Is the researcher independent, e.g., not affiliated with an organization that is likely to market the
product for gain in the future?
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IRB FAQ for Researchers June 2017
Does the product have ‘legitimators’ beyond the researcher and the institution/organization(s)
with which the researcher is affiliated? Is the organization with which the researcher(s) is affiliated a nonprofit? How will results of research with the product be used/disseminated? Is it likely the results will be
used to market the product? When the DOE IRB receives a proposal that appears to comprise testing/marketing a product, a
form will sent to the researcher requesting additional information. Top of the Document
What is the process for high school students to conduct studies in schools? Increasingly, NYC schools are offering courses in behavioral science research, providing students with the opportunity to design and carry out research projects. The DOE’s IRB affirms the importance of students learning about the principles of behavioral science research and ethical treatment of human research subjects. Based on previous experience in the IRB with research conducted by students in NYC public schools, such research does not require DOE IRB review/approval; rather, the responsibility for reviewing students’ research projects, monitoring the development of research protocols, overseeing data collection processes, and ensuring data security and disposal, should reside with a school’s research course instructors and/or a faculty research review committee/school-based IRB. The DOE IRB has developed the following guidelines to assist schools overseeing student research and data collection. These guidelines embody many of the federal regulations governing research with human subjects as well as policies and procedures that reflect the jurisdictional concerns of the NYC DOE.
Students may conduct research with other students in their own school or at other schools, provided that they submit a research proposal to their teacher outlining:
the research topic; design/methodology; risks/benefits; measures that will be taken to protect the privacy and confidentiality of research
participants; who will have access to the data; and, how the research findings will be used.
Students conducting research with other students must make it clear that participation is voluntary and participants can withdraw at any time or chose not to answer any questions with which they are uncomfortable.
Student’s conducting classroom observations should obtain the consent of the classroom teacher(s). Data collection should not distract from classroom instructional time.
Survey instruments should include a check box for students to indicate they have agreed to be surveyed, thus protecting the anonymity of respondents. When a research project involves a pre- and post-test, a list of the names of respondents to the pre-test and the ID numbers assigned to them should be stored in a secure location. At the conclusion of the post-test, all names should be removed from survey instruments and replaced with ID numbers.
When interviews or focus groups are included in a student’s research project, an assent form (for students 17 and under) or consent form (for students 18 and over) to be signed and dated by the research participant and by the student conducting the research should be provided.
The names of students participating in interviews and focus groups should be replaced with ID numbers on transcripts of interviews and focus groups to ensure the privacy and confidentiality of research respondents.
Audiotaping and videotaping should be discouraged because of the risk of misuse of the data All data collected from research participants should be reported anonymously. Student researchers should refrain from collecting information that might expose study
participants to (1) psychological risk such as discomfort, embarrassment, worry or anxiety; (2) social risk such as damage to reputation; (3) risk of breach of confidentiality or anonymity.
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IRB FAQ for Researchers June 2017
Examples of this type of information would be religious affiliation, sexual identity and behaviors, use of alcohol, drugs, illegal behaviors, and other information that might be self-incriminating.
Teachers and students should insure that all hard copy and electronic data are securely stored to prevent unauthorized access, disclosure, or loss. Hard copy records should be stored in a manner that limits access to only authorized individuals. For example, filing cabinets/areas should be locked and placed in secured/locked rooms.
Top of the Document
What is the process to interview Central staff for research purposes? Requests to conduct research with a small number of DOE officials do not have to go through IRB review. We do require that the researcher provide us with answers to the following questions:
Name(s) of individual(s) from whom you would like to collect data (e.g., interview, survey) Topics that will be covered in the interview/survey (please attach a study instrument, if available) Expected time commitment for the subject(s) A list of any publications and/or media outlets/public presentations where you intend to distribute
your findings How the district and/or the research subject(s) will be represented in any published work or public
presentations Responses to these questions, a copy of the consent form and the dates on which dates the
interviews are scheduled should be forwarded to [email protected] The IRB cannot assist researchers with identifying and recruiting Central DOE staff and cannot guarantee that they will be available for an interview. Researchers should follow recruitment strategies recommended in this document when contacting DOE officials for an interview. The interview(s) should take place at a location that is private and convenient for the interviewee. Top of the Document
