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Tracy Bourassa, Senior Director, Sponsored Program Services
Email: preaward@uconn.edu
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A Summary Report will be drafted by the IRB Monitor and sent to the PI for his/her review and responses. The report will provide a detailed summary of the audit identifying areas of improvement and recommendations for improvement. The PI and the IRB Monitor will sign the report. A copy of the signed report will be provided to the Director of Research Compliance, the PI, and the IRB Chair. When indicated, the PI will be invited to respond to each indication of non-compliance listed in the summary with a plan of corrective action for each item. This plan will be submitted to the IRB within 2 weeks of the date of the summary.
Investigators can request an overview of the consent process at any time before or during initiation of a study. During an audit of consent, the IRB Monitor will review:
If you have questions regarding the auditing process or would like to schedule a time to meet with the Post Approval Monitor for an individual or group education session please contact:
Joan Levine, MPH Post Approval Monitor
University of Connecticut
Research Compliance Services
438 Whitney Road Extension, Unit 1246
Storrs, CT 06269-1246
Tel: 860.486.7145
Fax: 860.486.1044
e-mail: joan.levine@uconn.edu
Research Integrity & Compliance Services (RICS) is committed to ensuring that all approved research is conducted in accordance with the IRB approved protocol, federal and state regulations, UConn’s institutional policies, and the ethical principles outlined in the Belmont Report. The primary goal of the Monitoring Program is to provide the most current information to investigators and students through education, training, and monitoring. Working together with Principal Investigators and student researchers, the Monitoring Program will assist with identifying needed areas of education and minimize risks to human subjects. Additionally, monitoring visits help foster communication between researchers and the IRB, and provide targeted education for faculty, staff, and students conducting human subjects research. All studies, including those approved under the Exempt Category, are subject to audit.
For-cause audits will be a priority for the Monitoring Program. However, special emphasis is placed on studies that include vulnerable populations or have activities that may place participants at greater risk than what may be anticipated in ordinary circumstances. Monitoring takes place with an emphasis on quality improvement and providing support for researchers.
Categories of Audits
Audit Notice
Except in cases where the safety of subjects is a concern, or where the IRB specifically requests an unannounced audit, written notification of an audit will be sent from RICS. Depending on the nature of the research study, an IRB member who has experience in the study topic may also be present at the audit. The Investigator will contact the Education & QA/QI Specialist to arrange a visit within the following estimated timeframes:
Elements of Audit Review
Before Audit: Investigators will receive a letter informing them that their study has been chosen for an audit. The investigator will then contact the Education & QA/QI Specialist and a time will be scheduled for the audit.
Prior to the audit, the Education & QA/QI Specialist will review the study protocol and all documentation related to the study in the IRB submission including:
Investigators can prepare for the audit by reviewing the checklist of questions below. (Please note that not all items on the checklist apply to all research studies)
Preparing for an audit
During the audit, the Education & QA/QI Specialist will briefly meet with the PI to discuss the study and the PI will provide the study files for review. The PI must make available the use of a quiet space to review the study files. The PI or designee who is familiar with the study will be available during the audit in case the Education & QA/QI Specialist has questions. As needed, during the audit, the Education & QA/QI Specialist will provide recommendations and educational support on record retention and documentation, and other compliance related issues. Documents pertaining to research will be held strictly confidential.
Review of Regulatory Compliance may include review of the following:
After the audit is complete, the Education & QA/QI Specialist will meet with the PI (and/or student investigator) and provide a brief summary of findings.
Report of Findings
A report that includes a detailed summary of the audit findings and recommendations for improvement will be sent to the PI within 10 days after the audit has been completed. The PI will be invited to respond to each indication of non-compliance listed in the summary with a plan of corrective action for each item. Findings of non-compliance will be reported to the IRB at its next fully convened meeting.
It is anticipated that in most cases serious violations involving risk of injury to participants will have already been reported to the IRB. However, if an audit demonstrates that a serious violation involving risk of injury to participants has not been reported, it will be reported immediately to the IRB Chair, Director of Research Compliance Services, and to the Vice President for Research (or his/her designee).
Audit of Informed Consent/Assent Process
Investigators can request an overview of the consent process at any time before or during initiation of a study. During an audit of consent, the IRB Education & QA/QI Specialist will review:
If you have questions regarding the auditing process, or would like to schedule a time to meet with the Education & QA/QI Specialist for an individual or group education session, please contact:
Joan Levine, MPH, CIP
Education and QA/QI Specialist
(860) 486-7145
joan.levine@uconn.edu
The IRB has an ethical obligation to review the design or other aspects of a study that may affect the scientific quality of the protocol. The following sections from internationally recognized ethical guides state that ethical research requires that:
Several sections including the following address the question.
Point 3. “The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.”
Several sections including the following address the question.
DHHS and corresponding FDA Sections (21 CFR 56.111).
In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:
Robert J. Amdur in Ch. 5-2 “Evaluating Study Design and Quality” in IRB Management and Function by Elizabeth A. Bankert and Robert J. Amdur notes the references above and offers the following guidelines to IRBs when evaluating a study’s scientific design and benefit from the perspective of risk to participants.
The IRB should use independent judgment and common sense. For example if the design of a student research project for a course is flawed but creates no effective risk to subjects, there is no ethical basis for the IRB to require revisions for approval. There are only educational reasons to suggest changes.
The IRB should NOT approve a study without requiring revisions if:
UConn IRB, Submission to the IRB, Scientific Review
Student-athletes, like all students at UConn, are a vulnerable population because of concerns with issues of coercion, undue influence and privacy. However, their involvement in research studies raises special concerns regarding recruitment and compensation for research studies since they are subject to NCAA rules and regulations that are related to their eligibility for participation in athletics.
Recruitment
Any member of the coaching staff, faculty or graduate student researchers are encouraged to contact the IRB office prior to submission of the protocol for advice to minimize the potential for undue influence, coercion, or NCAA compliance concerns. You may be advised to consider using anonymous data collection methods or an independent third party to consent participants or collect data.
If student-athletes are specifically recruited for a research study because of their status as athletes, the researchers must obtain approval from the Athletics Research Committee prior to enrollment. Written documentation of approval from the Athletics Research Committee must be provided to the IRB and indicate that they understand the research, are supportive of student-athlete participation, and, confirm that it will not jeopardize the student-athlete’s NCAA eligibility.
Studies involving student athletes should include safeguards to prevent undue influence and ensure that student athletes do not feel obligated to participate or that their participation will reflect favorably on them. Researchers should be mindful of the circumstances and settings for recruitment and consent, understanding that the presence of teammates, coaches, or athletic staff may influence decision-making. Recruitment and consent plans and materials should make it clear that participation or non-participation will not affect eligibility, playtime, or status as a student athlete. Throughout the research, it should be clear that participants are free to withdraw at any time without facing any negative consequences.
Confidentiality
If results of the research will be shared with the coach or any member of the coaching staff, sports medicine or athletic training staff or any staff person in the Director of Athletics office, the nature of the data being shared must be fully explained in the protocol application. In addition, the student-athletes must be informed of this in the consent form. NCAA rules regarding countable athletically related activities may apply in research that involves the student-athlete engaging in an athletics activity even if no athletics staff member is present. In certain situations, research may not be able to be shared with coaches if providing such information will trigger the activity to become countable. The Athletics Research Committee will advise when such a situation arises.
Compensation to Student-Athletes
Per NCAA Bylaws, a student-athlete may receive compensation from an institution for participating in a research study involving only student-athletes, provided the study is initiated and conducted by a faculty member at a member institution and the study and compensation arrangements are approved by the institutional review board of the faculty member’s institution consistent with policies applicable to other institution-based research studies.
Similarly, student athletes may be paid for their participation in research studies that recruit from the general student body or population as long as they receive the same compensation as other participants and are involved in the same manner.
Updated 8.1.2024
Advertisements and recruitment material are considered an extension of the informed consent and participant selection process. As such, recruitment of participants into a study may not begin prior to IRB approval. The IRB must approve all recruitment methods and material (flyers, letters, brochures, e-mail advertisements, radio announcements, etc.) prior to use. Materials must also be submitted for review and re-approval at the time of continuing review. The content of recruitment materials and the method for communicating it cannot create undue influence or contain misleading or exculpatory language.
The following are examples of common recruitment methods for human research studies. All recruitment methods must be described in the protocol application.
For studies that involve recruitment of patients from a medical practice or other treatment facility, it is not acceptable for investigators not affiliated with that practice or facility to directly recruit patients. The initial contact must be initiated by the physician or an employee of the practice or facility. Recruitment can take the form of a flyer posted in the waiting area or handed to potential participants by a physician or employee of the practice or facility. Due to HIPAA regulations, medical practices or treatment facilities may not give out telephone numbers or addresses of their patients.
If applicable to the study design, or required by a funding agency, the PI is responsible for tracking the ethnicity or race of participants who are recruited into studies. In such cases, investigators should ask participants to self-identify at the time of consent.
Advertisements should contain information that provides enough detail to allow the prospective participant to determine his/her eligibility and interest. Visual effects that may create undue influence cannot be used, for example, placing the phrase “GET PAID $100!!!” in all capital letters or an extra large font while the rest of the ad is in lower case or a smaller font is not acceptable.
Generally, the elements of any advertisement to recruit participants should be limited to the following:
Advertisements must display the IRB validation stamp, unless an exception has been granted by the IRB. If it is not feasible to make copies of the validated version, it is acceptable to use the exact wording of the validation stamp: “UConn IRB, Approval On (date), Approved until (date), Approved by (initials).”
Recruitment information sent by email to listservs, Craigslist, etc. must include the following statement, “This research study was approved by the UConn IRB, Protocol # __________.”
Advertisements cannot incorporate elements that:
Refer to the FDA’s regulations concerning the promotion of investigational drugs (21 CFR 312.7(a)) and of investigational devices (21 CFR 812(7)) for additional information.
A sample, recruitment flyer template is available for your reference.
Source material for this policy guidance was provided by the University of California – Irvine IRB. The UConn IRB gratefully acknowledges this support.
The UConn IRB agrees that oral history interviews are not designed to contribute to generalizable knowledge and are therefore not subject to IRB review.
The revisions to the Common Rule that went into effect in January 2019 deem the following activities not to be research under the regulations:
The Office for Human Research Protections (OHRP) protects the rights, welfare, and well-being of subjects involved in research conducted or supported by the Department of Health and Human Services (HHS) and helps ensure that such research is carried out in accordance with the regulations described at 45 CFR 46.
As noted in the UConn IRB Policy and Procedures, all research involving human participants conducted by the faculty, students, and staff of UConn, or research conducted using UConn facilities, is conducted in accordance with federal regulations, regardless of funding source. Because UConn is engaged in human subjects research that may be conducted or supported by an agency of the U.S. Department of Health and Human Services, UConn has an OHRP approved Federalwide Assurance (FWA). This FWA is our contract with OHRP whereby the University agrees to conduct all human subjects research in compliance with the HHS regulations. The UConn Storrs FWA number is 00007125.
If you go to the OHRP website you’ll see that OHRP is comprised of five divisions – Compliance, Education, Policy and Oversight, Secretary’s Advisory Committee, and International Research. The three most relevant divisions to researchers are the Compliance, Education and International Divisions.
The Compliance division is essentially the auditing arm of OHRP. If it becomes necessary for the IRB to report unanticipated problems, serious or continuing noncompliance, protocol deviations, suspensions or terminations, the Compliance division reviews the report and the corrective actions. The Compliance division then determines what, if any, additional action needs to be taken to protect human research subjects. The Compliance division may also audit the Office of Research Compliance and the UConn IRB with regard to institutional compliance with 45 CFR 46. As indicated on the OHRP website, the division “evaluates all written substantive allegations or indications of noncompliance with the HHS regulations. If complaints or concerns arise regarding an institution’s human subject protection practices, OHRP opens a formal evaluation and, if necessary, requires corrective action by the institution.” Any findings of noncompliance are issued in the form of determination letters. OHRP maintains a list of determinations of institutional noncompliance. You can access the list here – http://www.hhs.gov/ohrp/compliance-and-reporting/index.html. You will note that institutional noncompliance covers a wide range of IRB procedures involving: initial and continuing review, expedited review, informed consent, IRB membership, and IRB documentation.
The Education division is responsible for a number of initiatives including: (1) Responding to requests for clarification and guidance regarding ethical issues in biomedical and behavioral research involving human subjects and (2) Developing and conducting quality improvement activities to improve human research protection programs. The Education division developed the IRB Guidebook (http://www.hhs.gov/ohrp/education-and-outreach/archived-materials/) as well as the Human Subjects Regulation Decision Charts (http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html) which are helpful in determining whether or not the research activity requires IRB review and, if so, what level of review is required.
The International Division provides quality improvement consultation and research ethics training to domestic and foreign institutions involved in international biomedical and behavioral research. It maintains a compilation of human subjects protections laws, regulations and guidelines governing human subjects research around the world.
March 2009
Federal regulations allow specific categories of human subjects research to be exempt from continuing IRB review (45 CFR 46.104(d)). Category 1 applies to research conducted in schools and other education settings.
Research conducted in established or commonly accepted educational settings, that specifically involves normal educational practices, that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Although the regulations do not address a maximum risk level, it is implicit within the concept of exempt research that there must be very little, if any, associated risk. Please note that survey research involving children is not exempt, nor is observation of a minor’s public behavior unless the investigator does not participate in the activities being observed. (Institutional Review Board Management and Function, Bankert & Amdur, 2006).
Research exempted as normal educational practice is often conducted in public school settings which may demand that specific steps be followed in order to comply with additional state and federal laws. Although the definition in the regulations is fairly straightforward, it can create a conflict with other regulations that the IRB is obligated to follow, such as Subpart D of 45 CFR 46, FERPA (Family Educational Rights and Privacy Act), and PPRA (Protection of Pupil Rights Amendment). Subpart D specifically deals with children as a vulnerable population and most protocols that qualify for normal educational practice deal with children. If the IRB determines that a research study does not qualify for exempt status, then the extra protections for minors under Subpart D apply. Additionally, FERPA restricts researchers’ access to student records without prior written permission from parents. However, within FERPA [20 U.S.C. 1232g(b)(1)(F)], there are conditions under which student records can be disclosed without prior written parental consent if an exception applies: Organizations conducting certain studies for or on behalf of the school to develop, validate, or administer predictive tests; administer student aid programs; or improve instruction. An exception requires a written agreement (contract) to use information from a UConn student’s education record. Contact the Privacy Office at UConn early in the process to ensure requirements are met. All exceptions must be reviewed and approved by UConn’s Privacy Officer, Bruce Gelston. A copy of the written agreement must be submitted to the IRB after executed.
Investigators must contact each institution and follow that institution’s FERPA policy, in addition to the requirements of UConn IRB. Finally, PPRA outlines 8 categories of protected information for survey responses and requires that parents be afforded the right to inspect surveys before they are given to students (for more information on FERPA and PPRA, see the link at the end of this section).
45 CFR 46 does not specify that normal educational practice takes place in schools only. The IRB defines an educational setting as any setting where an educational experience takes place. For example, a public school, an after-school club or program, a Boy or Girl Scout meeting, a professional development seminar for school district personnel, or a postsecondary education setting.
The participants should include those involved in the educational experience, which most likely will include the teacher(s), student(s), and possibly the administrator(s). Participants that are indirectly involved in the educational experience may be included in the study, but they may not be exempt under normal educational practice, thus requiring additional consent procedures. For example, interviewing a principal may require that you use a consent form because this occurs outside the classroom and may not be considered normal educational practice. Participants can include populations with special educational needs, though the IRB will require demonstration of the investigator’s credentials to work with these vulnerable populations as well as clear explanation of any additional procedures to minimize risks specific to working with this population. For example, if a child is significantly cognitively delayed, obtaining assent may not be appropriate, and the investigator must describe what steps will be taken to ensure that appropriate cues are taken from the child that may indicate an unwillingness to continue with study procedures.
As noted above, the regulations define normal educational practice as “(i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.”
The IRB considers educational time to be a valuable commodity, and thus, the design of a research study that will be carried out in an educational setting should be developed with this in mind. At the minimum, the research should not waste student educational time, and may offer benefit to the individual and/or classwide educational experience. The IRB will consider the proposed methodology for the study in light of both time requirements and likelihood of benefit in order to determine whether it qualifies as normal educational practice. In all cases, the IRB will need to assess risks to all proposed participants in the study to determine the level of review required.
In some cases, it may be helpful if the PI can provide a letter verifying that the appropriate school administrator (e.g, principal, superintendent, school board) considers the proposed research study to be normal educational practice. (See Appendix A for an example).
A researcher is interested in implementing an elementary school art education curriculum designed to help students develop visual vocabulary. The curriculum involves asking children to sort cards with reproductions of various Western artists as well as additional related activities. The basic curriculum has been widely used in school settings for over 15 years. The researcher is interested in adding some contemporary artists and those from other cultures to examine whether there are any differences in children’s ability to make discriminations based on visual elements. These additions will not add significant time to the curriculum already being implemented and the assessments used in the study are typical of both length and content of current classroom assessments. Results of the study will be shared in aggregate form so that teachers can determine the benefit of including these curriculum modifications in the future.
A middle school department of science teachers begins using graphic organizers to improve instruction of English language learners. The school has an existing relationship with the local university to partner on projects of collaborative interest. Thus, the school contacts researchers to ask for assistance in developing appropriate procedures for evaluating the hypothesized improved instructional practices. Researchers plan to use the resulting data in aggregate form for purposes related to presentation and publication as well as providing individual data to teachers to inform their instructional practices.
A researcher wants to determine whether providing tangible reinforcement or verbal reinforcement will lead to greater increases in appropriate behavior and decreases in problem behavior for students identified with a serious behavior disorder. Individual students will be chosen for participation from classrooms of the same grade in consultation with the teachers. The students will be as closely matched for age and nature of the disorder, and then randomly assigned to an intervention condition. For example, one student will receive tangible reinforcement, one will receive verbal reinforcement, and the third will be the control.
Researchers are interested in developing a new assessment for math skills that involve both scoring of written prompts as well as responses involving use of manipulatives. It is expected that a new standardized, norm-referenced product will result. According to the school, the planned assessment is aligned with current curriculum and will not require students to respond to questions that would be unfamiliar. However, the development process entails having students respond to more assessment items than would be expected. In addition, in order to validate the new assessment, additional tests not currently used in the school will be administered for comparison, thus extending total testing time and number of items beyond what would be considered normal educational practice.
In research with minors, even if a protocol does qualify as normal educational practice, the IRB generally requires that parents be notified about the study via a letter sent home with the students (waiver of parental permission with notification). In some cases, it may be appropriate for the letter to be generated from an appropriate school official (e.g, principal) in conjunction with the PI (see appendix B for one example). As noted on the IRB-1 form, to justify waiving parental permission, the IRB must find and document the following:
Depending on the nature of the research, it may be appropriate to offer an ‘opt out’ option whereby parents are provided a notification form about the research study which they may sign and return an included ‘opt out’ sheet to indicate that they do not want their child and/or their child’s data to be included in the study. Note that this type of “passive” consent process still involves waiving parental permission because it is not the equivalent of informed consent.
Non-exempt Studies: Expedited and Full Board Review of Research Conducted in Educational Settings If a research study will be conducted in a classroom setting and it does not qualify for exemption, in most cases, a parental consent form must be used to obtain signed parental permission, and when appropriate, signed assent from the students. A parental permission form must be used to obtain signed permission from at least one parent. The signature of both parents is typically required only for those studies determined to be of greater than minimal risk. Depending on the age of the students, a separate assent form written at an age-appropriate level can be used, or for older students, an added signature line on the parental permission form can be used. Assent must be obtained verbally if signed assent is waived by the IRB.
If the protocol does not qualify for exemption yet it poses minimal risk to participants, it may be eligible for expedited review. If the study poses greater than minimal risk to the participants, the protocol may be reviewed at a full board meeting. If a study poses greater than minimal risk to participants, the PI must ensure that the IRB-1 includes a careful consideration of those risks with a detailed plan for managing them.
Suggestions for completing the IRB application for research in educational settings When submitting an application for research in an educational setting, the following information should be included:
For more information on FERPA, go to www.ed.gov/policy/gen/guid/fpco/ferpa/index.html.
For more information on PPRA, go to www.ed.gov/policy/gen/guid/fpco/ppra/index.html.
The IRB holds the PI responsible for the overall management of an approved study. Management of the study encompasses the ethical, technical, administrative, and fiscal elements of a project. The PI may delegate certain tasks, but retains ultimate responsibility and accountability. Principal investigators are required to:
Responsibilities of All Key Personnel
The IRB holds all study personnel (including PI and co-investigators) responsible for meeting certain obligations. Study personnel are required to:
When research involves the use of focus groups to obtain data, the participants should be given information before the focus group takes place regarding what the topic is, who the other participants / stakeholders may be, where the group will meet, and how long the session will last. It is particularly important to inform participants ahead of time when sensitive topics will be discussed (e.g., sexuality, substance abuse).
Informing Participants about Other Participants
In the consent form and during the consent discussion, participants should be informed of who may participate in the focus group. Ideally this would be done during the recruitment phase, throughout the consent discussion and in the consent form. A participant may decide that he/she does not want to participate based on the expected other participants in the group.
Example: A focus group to discuss substance abuse and availability of drugs might possibly include participants who are current and former drugs users and members of law enforcement. Because of the sensitivity of the topic, participants should be told that it is possible that law enforcement officers may take part in the group. This must also be clearly stated in the consent form. However, until the focus group actually takes place, it is not possible to know whether members of law enforcement will actually be present. Therefore, before the discussion takes place, members should be informed who is present in the focus group and given a choice as to whether they would still like to participate.
Confidentiality of the Information Shared in Focus Group Settings
In the consent form and during the consent discussion, participants should be informed that the information shared in the focus group session should not be shared with anyone outside of the group, and that the confidentiality of anything they choose to say during the session cannot be guaranteed. If the focus group is being audiotaped, participants should be instructed to maintain their privacy and confidentiality, and that of the people they talk about, they should not use names.
Informing Participants about the Focus Group Topic
In the consent form and during the consent discussion, participants should be informed of the topic that will be discussed during the focus group session. The IRB expects the PI to fully disclose the exact nature of the focus group topic area in the consent form and as part of the consent discussion. However, the cultural context must be taken into consideration when addressing this issue. The PI must provide a justification for not fully disclosing the topic, such as the one provided in the example below, in the IRB-1 protocol application. For more information on the use of deception in research, please refer to the Researcher’s Guide on the IRB website.
Example: A research study being conducted in Nepal involved running a series of focus groups to obtain village residents’ views on sex trafficking. The PI indicated that it would be counterproductive to explain the exact nature of the focus group topic since sex is considered a taboo subject in the local culture. The PI felt that by clearly stating sex trafficking as the topic, it would change the dynamics of the group and make the discussion difficult. The PI further indicated that she felt the topic of sex trade would come up spontaneously in the interview if the indirect prompts were provided. The IRB agreed to give the PI latitude on this matter, and agreed to allow the purpose of the study and the specific topic to be discussed to be described obliquely in the consent form. This was acceptable since participants were debriefed at the end of the session, and provided with the specific purpose of the study.
Audio- or Video-recording the Focus Group
In cases where the focus group session will be audio- or video-recorded, the PI must disclose use of recording devices in the consent form and as part of the consent discussion. When the focus group meets, the PI should again disclose this to each member of the focus group, and ask if they agree to be audio- or video-recorded. If being recorded is a requirement of participation in the focus group, this must be stated in the consent form. If a member of the focus group objects to being recorded, the PI can excuse the participant from the group, or agree not to audio- or video-record the session. Video editing tools that blur or block individual participants may also be used, and described in the protocol application. Participants should be given the opportunity to withdraw their consent AFTER the focus group session has ended. All of these specifics regarding video-recording must be clearly stated in the consent form.
Focus Groups Conducted in Developing/Traditional Societies
PIs must use special care in conducting focus group sessions in developing countries and in vulnerable communities. It is crucial that the PI thoroughly understand the structure of local governments and local communities in order to gain permission from a representative of the community to conduct research. As a first step, the IRB suggests that the PI obtain permission from the mayor, a tribal elder, or from a tribal council. In some cultures, it is inappropriate for men and women to be invited to discuss some or all topics in one group. Sensitivity to and knowledge of local culture must be demonstrated by the PI in the IRB application. Please refer to the Researcher’s Guide on the IRB website for more information regarding Ethnographic/Naturalistic Research.
Ethnographic research presents special challenges to investigators as it can be difficult to accurately describe the nature of the ethnographic research within the confines of the IRB-1 or IRB-5 protocol application forms. Therefore, we have created a separate form for submission of qualitative or ethnographic research, the IRB-9 form. The IRB appreciates that ethnographic research has the following special characteristics (Arwood, T., and McGough, H., 2007 PRIM&R SBER Conference):
In order for the IRB to understand these special characteristics and the nature and scope of a particular ethnographic research project, the following issues should be addressed in the IRB application form, if applicable to the research.
The research site(s) or location(s):
Risk of harm in ethnographic research is usually limited to what may result from invasion of privacy, stigmatization, or breach of confidentiality. Harm may happen to individuals and to the groups or communities to which they belong.
Sometimes individuals or whole communities do not want to remain anonymous. If this is the case, please describe why. If there are differences in the community about this, describe how this will be handled.
The importance of accurate documentation to the quality of medical care given to patients is unquestioned. It is such an accepted element of patient risk reduction in hospitals and in court rooms that the corresponding maxim is: “If it’s not written down, it didn’t happen.” NYU Medical Center website reminds its employees that in addition to its importance in providing a chronological description of patient care, and communication to other health professionals, “proper documentation also facilitates:
These concerns also apply to research with human subjects, whether it is conducted in a hospital setting where the chart is a legal document or elsewhere. It is common sense that accurately recording information is essential for providing accurate research data.
Mistakes happen; if you make a mistake, correct it right away.
Do:
Do not: