IRB Oral History Research Plan (Required)

Page of 10 JHSPH Institutional Review Board RESEARCH PLAN PI: Roni Neff, PhD, MS Study Title: Baltimore City Food System: Oral Histories IRB No.: 2626 PI Version Number/Date: November 18, 2011 Aims/objectives/research question/hypotheses: Describe the primary and secondary aims/objectives of the research, or the project’s research questions or hypotheses 1) This project aims to gather qualitative oral history data from Baltimore senior citizens about their perspectives about: historical food access, availability, quality and affordability in Baltimore; how the city’s food system has changed over time; and their ideas about how to improve the city’s food system 2) The project aims to provide training and education to student oral history interviewers Background and rationale: Summarize briefly what is already known about the issue, where there are gaps in information, and previous relevant research If applicable, describe preclinical and clinical data, current experience with procedures, instruments, drugs or devices References are not required but may be included if they are directly relevant The food system is immensely important for public’s health and welfare.  The food system can be  defined as “a system comprised of all of the processes involved in getting food from farm to table to  disposal, including production, processing, distributing, preparing, marketing, accessing, consuming,  and disposing. Food systems also involve people, farms, businesses, communities, interventions,  policies, and politics.1­4“ In order to address problems with the current food system (and related public health issues such as diet-related illnesses), it is important to understand not only the current status of the food system, but also the historical changes that have occurred over the past several decades The food system in Baltimore city is shaped by the city’s history, by its residents, by poverty and race, by the history of business in the area, by local geography and climate, by culture, and by broader national and systemic factors including industry, policy, and economics Together, these factors have created a food system of mixed levels of access to food, high availability of unhealthy foods, challenges in affording healthy and sustainably produced foods, contributing to a variety of diet-related diseases and health disparities in Baltimore City This research project involves conducting oral history interviews with Baltimore senior citizens to learn about the history of the city’s food system and their insights about today’s food system Several factors that will be explored in the interviews, such as food-related beliefs, preferences, behaviors, and cultural influences have been associated with dietary intake and related diseases such as obesity  5  Additionally, the interviews will cover issues related to food access and availability Numerous studies have documented the differential availability of healthy foods between low- and high-income neighborhoods, which may contribute to disparities in dietary intake and obesity rates. 6­9 A 2006 study published in the American Journal of Preventive MedicineError: Reference source not found examined the associations among the availability of healthy foods in Baltimore City and racial and income neighborhood composition This study concluded that predominantly black and lower-income neighborhoods have a lower availability of healthy foods than white and high-income neighborhoods due to the differential placement of types of stores as well as differential offerings of healthy foods within similar stores.Error: Reference source not found A low availability of healthy foods (i.e., scoring in the lowest tertile of the V7_13July09 Page of 10 healthy food availability index) was present in 43% of predominantly Black neighborhoods, but only 4% of predominantly White neighborhoods Conversely, a high availability of healthy foods was present in only 19% of predominantly Black neighborhoods, compared to 68% of predominantly White neighborhoods Error: Reference source not found These differences may contribute to racial and economic health disparities Additionally, in 2007, the Center for a Livable Future partnered with Operation ReachOut Southwest to identify community members’ key food and nutrition concerns and to measure the availability of healthy foods in Southwest Baltimore City 75% of the stores surveyed did not offer any fruits, and 68% did not offer any vegetables Although most of their food dollars were spent at supermarkets ($280/month), respondents reported that 46% of their food-related shopping visits were made to corner stores 83% of respondents reported they would purchase fresh produce that was grown in their neighborhood Safe and nutritious foods are not universally available or affordable in the U.S., and have become less so over the past few decades,10 due to policy and other factors at the federal, state and local levels.  Many researchers have pointed out that the U.S has seen a shift in recent decades where unhealthy foods (e.g., fast food) have become more ubiquitous, cheap, and abundant in comparison to nutritious foods, particularly in low-income neighborhoods.Error: Reference source not found, 11 Additionally, as a greater proportion of women have entered the workforce, there has been a shift toward convenience and fast foods.12 Advances in food processing and transportation have allowed restaurants and other food outlets to provide a variety of highly palatable and convenient foods at a very low cost.Error: Reference source not found As people have moved towards a greater reliance on prepared and convenience foods, fewer and fewer individuals cook, grow food themselves, or purchase locally produced food Beyond the direct health impacts of the food that is consumed, food security is threatened by the loss of regional food production 13 No published accounts of the history of Baltimore city’s food system have been identified Some archival materials are available, such as at the Maryland Historical Society, but these are not organized or archived Gaining an understanding of the city’s food system’s history can help enrich understandings of how today’s food system operates, the expectations and history of those living within the system, and can generate new ideas and support for positive interventions for change Some informants will have lived in other areas besides Baltimore for portions of their lives; the discussion of historical food systems elsewhere, and contrasts with what they have seen and learned about Baltimore’s history and present, will also enrich the findings Data collection for this project will take place within the context of an academic course: Baltimore Food Systems: A case study of urban food environments (PH.180.655) The seminar-style course will include multiple experiential education components including visits to a range of sites in the Baltimore food system For this assignment, students will receive training in oral history interviewing and human subjects issues, and will be asked to perform and document their oral history interviews in pairs Such first-hand experience is not something that can easily be taught in a classroom setting and will reinforce the quantitative and qualitative data and information provided by faculty, guest speakers and supplemental readings (See http://courseplus.jhsph.edu/index.cfm?event=showEditorSupplementHome&catalogID=12100 for further information.) Participants: a Describe the study participants and the population from which they will be/were drawn V7_13July09 Page of 10 Study participants will be older Baltimore residents residing in a senior center near the Bloomberg School of Public Health [at the time of IRB submission, we are finalizing this relationship; we will submit the information and a letter of support as soon as it is available.] Participants must volunteer to be interviewed, and thus the study sample will not reflect a random distribution from among eligible individuals b Describe any screening procedures and any inclusion or exclusion criteria To be included in the study, the individuals must be at least 65 years old and have lived in the Baltimore area for at least 25 years The senior center staff will be asked to screen out individuals who they feel may have difficulty completing the interview, including due to physical or mental health concerns, or low English language competency c Provide sample size and a clear justification as to how you arrived at your projected sample size Each year, the class will conduct up to 11 eligible interviews (There will be a maximum of 22 students, and students will conduct interviews in pairs.) In order to broaden the sample of individuals interviewed, the study will include up to 30 individuals, in interviews over the course of up to three years of the class d Describe whether identifiers will be collected Identifiers will not be collected Study procedures: b If your study involves contact, direct or indirect, with subjects, provide the following: 1) General study design and methods This study will involve collection and analysis of qualitative oral history data about Baltimore city’s food system and closely related topics Data will be collected and initially analyzed by students in the Baltimore Food Systems class over the course of up to three years Re-analysis for publication will be conducted by class faculty, teaching assistants, and former students The qualitative data will be coded and analyzed primarily using content analysis 2) Study procedures, including their sequence and timing The following activities will take place, in the order listed 1) Background training: Student researchers will learn background information about the Baltimore city food system They will receive in-class training in oral history research methods and in relevant human subjects issues including obtaining informed consent, avoiding questions that could lead to discussion of sensitive information, and allowing interviewees to skip questions or stop the interview at any time They will also be required to complete the online CITI training program and to review the study’s IRB application in full [repeated annually for up to years] 2) Recruitment: Participants will be recruited from among residents of the senior center, based on the above-described eligibility criteria A staff contact at the center will publicize the project and make available the opportunity to sign up for an interview time slot The list of interviewee names will be destroyed after the interviews are conducted [repeated annually for up to years] 3) Students will arrive in pairs to meet interviewees in a designated room at the senior center at designated times The students will only know their time slot, and will not be directly provided with the interviewees’ names [repeated annually for up to years] V7_13July09 Page of 10 4) Students will explain the course and purpose of the interview, the general content, and expected interview time frame (40-60 minutes) Oral informed consent will be obtained (see below and attached form) [repeated annually for up to years] 5) Students will take turns asking questions and taking notes Interviews will be recorded on voice recorders The class will brainstorm interview questions together, but generally speaking, questions will cover content such as the following:  How long have you lived in Baltimore?  What kinds of foods did you eat when you were younger?  Where did you get the food that you ate when you were younger?  What were those stores like?  Did you have a backyard garden?  How much time did you spend on food preparation in the past?  How has all that changed over the years?  What is good/bad about the food environment now?  What you think is needed to improve today’s food environment? Students will be instructed NOT to ask personal questions, questions likely to cause discomfort, or information that may be deemed confidential, such as income or other financial information, and to change the subject if an interviewee appears uncomfortable Class faculty will be available by phone during interview time slots and afterwards, in case the subject or interviewer has any concerns The teaching assistant will observe at least three interviews, will intervene if needed based on human subjects or other grounds, and will report back to the faculty if there are any concerns that could suggest need for further training of students [repeated annually for up to years] 6) Following the interview, interviewers will give interviewees $25 gift cards to thank them for their time These will be given even if interviewees suspend the interviews [repeated annually for up to years] 7) At the end of the interview portion of the study, student investigators will ask the participant whether they wish to receive a written transcript of the interview If the participant indicates that they want a copy of the transcript, they will be asked for their oral consent authorizing the investigators to print one (1) copy of the interview to be given exclusively to the participant In this case, no personal identifiers will be collected to connect the interviewee to the transcript A numerical code will be assigned to each participant, and the interview will be labeled only with the same code The participant will be given a printed card with the numerical code, and will be infomed that this will be the only way to receive a copy of the transcript Our contact at the site will be provided with sealed and numbered envelopes and asked to distribute them accordingly She will return any undelivered envelopes to the study team 8) Student pairs will transcribe interviews, analyze and share their findings in written and oral presentations [repeated annually for up to years] 9) Following all the data collection, broader analysis will be performed by faculty or others associated with the class, using interview transcriptions and qualitative analysis software such as Atlas.ti to identify findings from across the range of interviews These will be described in a manuscript for journal publication V7_13July09 Page of 10 3) Number of study contacts or visits required of participants Each participant will be interviewed once 4) Expected duration of the study The study data collection will be completed during the springs of 2010, 2011, and 2012 Analysis and development of a manuscript based on the findings will be completed within one year of final student data collection 5) A brief data analysis plan and description of the nature of the variables to be derived Data content will be analyzed qualitatively Transcribed interviews will be coded using software such as Atlas.ti The paper will provide some background information regarding the project, Baltimore city, and the senior center Respondents will be described in aggregate; no information would be shared that would enable identifying any individual interviewees Per the list of interview topics, respondent comments on the following themes of interest may be examined:  Where food was produced historically  Where they obtained food historically  What stores were like in their youths and across time  What they ate  How much time was spent on food preparation  How and why all these things have changed since their youths  Ideas about what is needed to make the food system healthier and more sustainable We will examine interviews for additional themes including:  Attitudes towards food including issues of trust of conventionally available foods, interest in food healthfulness, interest in local or sustainably produced foods,  Advice received regarding what one ‘ought’ to eat from medical, media, family and other sources  Race, class and justice issues  Southern and rural legacies  Food traditions and cultural factors Key additional topics and themes that arise in a grounded sense from the interviews may also be analyzed and discussed Beyond classical content analysis, we may also present some information graphically, such as information pertinent to documenting or understanding the geography and structure of the food system, or other information amenable to such presentation Finally, key quotations may be selected and shared, with careful attention to assuring that individuals cannot be identified Data Security and Protection of Subject Confidentiality a Are you applying for a Certificate of Confidentiality? No V7_13July09 Page of 10 b Identify the data security plan below that best describes how you will minimize the risk of a breach of confidentiality by checking one of the boxes on the left side of this chart If your study includes sequential phases that require different procedures, or does not fit these categories, explain in “Other” Note: Identifiers include name, address, SSN, hospital record number, etc., and other indirect identifiers (e.g., date of birth) that, when combined with other variables, may make a subject identifiable These categories reflect minimal standards; you may impose more stringent protections See the JHSPH Data Security Guidance at www.jhsph.edu/irb > Policies & Guidance > Guidance for additional information regarding best practices Hard Copy of data collection form: Indicate your choice but typing an X in the appropriate box on the left: Hard copies of data collection materials have identifiers and are locked in a secure cabinet or room with limited access by specified individuals When possible, redacted (de-identified) versions of the data collection sheets will be used for coding and analysis Hard copies of data collection materials include an ID code and not have personal identifiers However, a code linking the data to the subject’s personal information is stored separately from the data collection sheets, and is locked in a secure cabinet or room with limited access by authorized individuals Data are not collected on paper x Other (describe): Hard copies of data collection materials include an ID code and not have personal identifiers No information linking the data to the subject will be collected Electronic Databases: Indicate your choice but typing an X in the appropriate box on the left: : Note: A de-identified version of the database should be used for data analysis except in instances in which identifying information is prerequisite for coding or analysis Databases that retain identifying information require a higher degree of electronic security The study is minimal risk and data collected are not sensitive in nature No personal identifiers are included in the electronic database Any electronic documents that link IDs to identifying information are stored on a computer in accordance with JHSPH Data Security guidance Personal identifiers are included in the database The data are stored on a computer that is password protected with a secure server Transfer or storage on portable devices (e.g., laptops, flashdrives) is encrypted The devices on which this information is stored are accessible only to individuals who need access to these data No personal identifiers are included in the database but linkable identifiers exist separately and the data are sensitive in nature (e.g., substance use, mental health, genetic propensities, sexual practices or activities) such that disclosure could provide a risk to the individual The codes are stored on a computer that is password protected with a secure server Transfer or storage on portable devices (e.g., laptops, flashdrives) is encrypted The devices on which this information is stored are accessible only to individuals who need access to these data Other (describe): d Describe any plans for destroying data including if, when and how that will be done Raw data recordings will be destroyed following publication of a manuscript Recruitment process: a Describe how participants will be recruited Participants will be recruited from among residents of the Senior Center, based on the above-described eligibility criteria A staff contact at the center will publicize the project and make available the opportunity to sign up for an interview based on a list of time slots V7_13July09 Page of 10 b If relevant, address any privacy concerns associated with the recruitment process No identifiers will be collected by the researchers The subjects will be instructed not to use their own names during the interviews or in introducing themselves In student write-ups and class presentations, they may assign first names to the interviewees The sign-up sheet will be destroyed after the interviews are completed While it could be possible for the staff contact and other interviewees to see who has signed up, this is not expected to raise privacy concerns, as the final report will not present data that clearly identify any interviewees Consent process and documentation: a Describe who will obtain informed consent from participants, and how, when and where consent will be obtained Oral informed consent will be obtained by student researchers at the beginning of the interviews, in a private room where the interviews are conducted We have opted for oral rather than written informed consent so that we will not have access to any identifying information (including the participants’ signatures on a consent form) This form of consent is acceptable also because the interviews pose minimal risk to subjects b If the study will involve vulnerable populations (e.g., children, prisoners, cognitively impaired adults, non-English-speakers, etc.) describe efforts to ensure their understanding of the research and the extra protections that will be in place to ensure their voluntary participation The study is not intended to include vulnerable populations The exclusion criteria aim to screen out those with physical or mental challenges that would make it difficult to complete the interview, and those with limited facility in English language Risks: a Describe the risks associated with the study and its procedures, including physical, psychological, emotional, social, legal, or economic risks There is minimal or no risk from discussing food issues with students The main anticipated risk may be discomfort if residents discuss themes that make them uncomfortable, such as an inability to afford food Some subjects will opt to receive copies of the interview transcript via an anonymous procedure described above in 4) b) 2) 7) The only possible related risk to subjects would be if an unauthorized person opened an interview envelope, and if that person was able to figure out who the interviewee was despite the anonymity, and if the interview included sensitive information b Describe steps to be taken to minimize those risks The oral informed consent notifies interviewees that they may refuse to answer any question and may stop the interview at any time They are also assured that no personally identifying information will be shared in the write-up for journal publication Students will be further instructed not to probe about personal issues and to encourage interviewees to change the subject if a topic causes them any discomfort The risk related to providing copies of the interview transcript will be minimized through the abovedescribed measures of encouraging interviewees to avoid sensitive information and providing transcripts through an anonymous system We will also be clear with our site contact about keeping the envelopes carefully guarded until they are distributed Finally, interviewees will not be asked about their interest in V7_13July09 Page of 10 receiving transcripts until after the interviews are complete, so they will know at that point what information the transcript would contain; if there is information they not wish to have in writing out of concern for confidentiality, they could make their decisions with that in mind c Describe the research burden for participants, including time, inconvenience, out-of pocket costs, etc The interviews will last 40-60 minutes Beyond time, no other research burdens are anticipated d Describe how participant privacy will be protected during data collection if sensitive questions are included in interviews The interviews should not include sensitive questions Interviews will take place in a private room with a closed door Benefits: a Describe any potential direct benefits to participants from participating in the research (not including payment for participation) Interviewees may find it enjoyable to share their perspectives and history with younger students Some interviewees will appreciate receiving transcripts of their interviews b Describe potential societal benefits likely to derive from the research There is no known published information regarding the history of the Baltimore food system Documenting information from the interviews can provide information to address that gap, and can be valuable for generating ideas, strategies and insights about improving diets, food access, and other aspects of urban food systems 10 Payment: a Describe the form, amount, and schedule of payment to participants As thanks for participating in the interviews, interviewees will receive $25 grocery store gift cards b Include the possible total remuneration and any consequences for not completing all phases of the research The gift cards will be provided even if individuals not complete interviews 11 Plan for reporting unanticipated problems/adverse events: Describe plan for reporting to the IRB and (if applicable) to the sponsor Include plan for government-mandated reporting of abuse or illegal activity Student interviewers will be strongly encouraged to report any unanticipated problems to the faculty without risk of penalty or judgment The faculty will report these to the IRB Interviewees will be advised in the oral informed consent to avoid mentioning abuse or illegal activity 12 Other IRBs: If the research will require review by other IRBs, provide the name and contact information for each IRB and its FWA (available on OHRP’s website at http://www.hhs.gov/ohrp/assurances) NA 13 Outside collaborations: For studies that involve collaboration with non-JHSPH institutions, describe the collaboration and the roles of each collaborator, including the JHSPH investigator V7_13July09 Page of 10 This project involves collaboration with a Senior Center At the time of IRB submission, we are finalizing this relationship; we will submit the information and a letter of support as soon as it is available The senior center staff will be responsible for coordinating with JHSPH to generate a list of potential time slots for interviews, reserving the on-site room, publicizing the interview opportunity, performing basic-level screening based on knowledge of the residents, and signing up individuals for time slots JHSPH will be responsible for coordinating about potential time slots, performing the interviews, and conducting the analyses 14 Oversight plan for studies conducted at non-JHSPH sites, including international venues, for which the JHSPH investigator is the responsible PI: Explain how the study will be managed, the qualifications of study personnel managing the project, and how personnel involved with the data collection and analysis will be trained in human subjects research protections If the PI will not personally be on-site during the data collection process, provide details about the supervision of the data collection and the communication plan between the PI and study team to assure adherence to the IRBapproved research plan The PI and course co-instructor will manage the study Both have completed CITI training and have experience with oral history and qualitative research studies The course teaching assistant, who also has such experience, will also play a supporting role in management Student data collectors will be required to complete the IRB’s CITI training module and to sign a document indicating they have reviewed this IRB application prior to conducting interviews We will also offer our own training including a review of relevant human subjects information, guidance on avoiding questions that might make subjects uncomfortable, and confidentiality issues The Teaching Assistant will accompany at least three sets of interviews, and will report back to the faculty about any concerns requiring follow-up Students, interviewees (via informed consent), and the staff contact at the senior center will also be strongly encouraged to report any concerns to the faculty REFERENCES Neff, Roni A., Palmer, Anne M., McKenzie, Shawn E and Lawrence, Robert S Food systems and public health disparities Journal of Hunger & Environmental Nutrition 2009;4(3):282314 Sobal J, Khan LK, Bisogni C A conceptual model of the food and nutrition system Soc Sci Med 1998;47:853–863 von Bertalanffy L An outline of general system theory Br J Philos Sci 1950;1: 134–165 Leischow SJ, Milstein B Systems thinking and modeling for public health practice Am J Public Health 2006;96:403–405 Kumanyika S Environmental influences on childhood obesity: Ethnic and cultural influences in context Physiology and Behavior 2008;94:61-70 Franco M, Diez Roux AV, Glass TA, Caballero B, Brancati FL Neighborhood characteristics and availability of healthy foods in Baltimore American Journal of Preventive Medicine 2008;35(6), 561-567 V7_13July09 Page 10 of 10 Franco M, Diez-Roux AV, Nettleton JA, Lazo M, Brancati F, Caballero B, et al Availability of healthy foods and dietary patterns: the Multi-Ethnic Study of Atherosclerosis American Journal of Clinical Nutrition 2009;89(3):897-904 Health Eating Research (2008, July) Restaurant realities: inequalities in access to healthy restaurant choices Available at: http://www.healthyeatingresearch.org/images/stories/her_research_briefs/her %20restaurant%20realities_7-2008.pdf Story M, Kaphingst KM, Robinson-O'Brien R, Glanz K Creating healthy food and eating environments: policy and environmental approaches Annual Rev Pub Health 2008;29: 253-72 doi: 10.1146/annurev.publhealth.29.020907.090926 10 Brescoll VL, Kersh R, Brownell KD Assessing the feasibility and impact of federal childhood obesity policies Annals of the American Academy of Political and Social Science 2008;615(1):178-194 11 Drewnowski A, Darmon N Food choices and diet costs: an economic analysis J Nutr 2005;135(4):900-4 12 French SA, Story M, Jeffery RW Environmental influences on eating and physical activity Annual Review of Public Health 2001;22(1):309-335 13 Nestle M Food Politics: How the Food Industry Influences Nutrition and Health University of California Press, Berkeley, CA 2002 V7_13July09 ... adherence to the IRBapproved research plan The PI and course co-instructor will manage the study Both have completed CITI training and have experience with oral history and qualitative research studies... these to the IRB Interviewees will be advised in the oral informed consent to avoid mentioning abuse or illegal activity 12 Other IRBs: If the research will require review by other IRBs, provide... of the research The gift cards will be provided even if individuals not complete interviews 11 Plan for reporting unanticipated problems/adverse events: Describe plan for reporting to the IRB and