IRB submission

For AIR Employees: Please use this as a resource as you prepare for or complete your Project Abstract, Deliverables, Information Security, and IRB (PADII) Application. All information must be entered into http://padii.air.org and submitted by the Project Director before review can take place.

For Collaborators: Please fill out this document and return to your AIR contact. Only AIR staff have access to the PADII application and airportal.air.org links.

Yellow highlight = selected

Gray highlight = question not relevant to this study

What is the purpose of this IRB submission?

Pre-award approval. Need an IRB review for submission of a proposal to a funding agency (The anticipated proposal submission date is: )

Provisional approval. Seek to submit an IRB Control Form only to obtain a project number for a new project. I plan to submit materials for IRB review later.

Approval. (1) Seek an IRB review for a new project or (2) Seek an IRB Review for a component of an existing project.

Approval renewal. (1) Seek a periodic (i.e., annual) review in order to renew IRB approval. (2) Seek to close-out the IRB file with an IRB Final Progress Report.

Will the project, project task(s), or project component(s) involve any recruitment/data collection or secondary data analysis?

Yes - The earliest anticipated recruitment/data collection or secondary data analysis start date is (If uncertain, please just give your best guess.): 09/01/2017

Which of the following best describe this project, project task or project component? (Choose as many as apply.)

Randomized controlled intervention study (i.e., an experiment with randomization)

Program evaluation

Survey work (e.g., item development, survey administration, and/or analysis of new survey data)

Focus Groups, observations, or interviews

Analysis of extant secondary data

Cost or cost/effectiveness analysis

Consulting services

Mandatory State Assessment (If only this option is selected, please see page 7)

Development of a student test or assessment (e.g., a state assessment)

Assessment research

Scoring student tests or assessments

Equity analyses and support

Usability testing or cognitive testing

Technical assistance

Conference planning, meeting(s) or workshop(s)

Website or data system construction

IRB services for external client

Work will be performed or data will be collected outside the U.S.

Do not know; project plans insufficiently developed

Other:

Please describe the research plan for this project. This will help to give the IRB Reviewer some context for the review. (Optional)

The purpose of this survey is to increase knowledge about the factors that contribute to intimate partner violence (IPV) perpetration. This study will be a non-probability, purposive sample of 3 populations: the currently incarcerated intimate partner violence (IPV) offender population, the currently incarcerated non-IPV offender population, and the general (non-incarcerated) population. The survey will be conducted online for the general (non-incarcerated) population and in-person for the incarcerated population.

A more detailed description of the study can be found in Form A.

Will this project or project task involve systematic investigation that will develop or contribute to generalizable knowledge; that is, scientific or research findings or results that build on other research in the field in which this work will be done? (Please read guidance immediately below before answering.)

Please read carefully: Examples of generalizable knowledge include results that could or will be presented at scientific meetings or submitted to scholarly research journals based on results from the project. Examples of what in most cases would be non-generalizable knowledge include results from employment equity projects where personnel records collected for business purposes are analyzed for the sole purpose of advising a plaintiff or defendant in a court case, surveys developed to verify eligibility for specific client services, item development procedures for a state assessment, and forms used to evaluate a specific meeting or workshop.

Important: Projects that might not be thought of as research projects (e.g., assessment projects or demonstration projects) could include research activities that lead to generalizable knowledge. If so, check, “yes”.

Yes

Uncertain

Will data from living human beings be collected as part of this project through the use of printed questionnaires, web surveys, interviews, focus groups, observations, videotaping, etc.?

Yes

Uncertain

Do you plan to use human participants from any of the following populations? (Check all that apply.)

Prisoners

Pregnant women

Children under 18 years of age

Cognitively impaired children or adults

None of the above

Are you collecting data on sensitive topics such as sexual behavior, HIV status, drug or alcohol use, illegal behaviors, child or physical abuse, immigration status, etc.?

Yes

Uncertain

Will the data you are collecting allow you to ascertain an individual’s identity? (Please read guidance immediately below before answering.)

Please read carefully: Individuals’ identities can be ascertained in several ways including personal data such as names addresses, phone numbers, and identification numbers (e.g., social security and medical record numbers). In addition, audio and videotapes also enable direct identification of an individual. Finally, an individual may be identified through “deductive disclosure,” that is, the ability to deduce who someone is with high probability through the cross-classification of variables such as age, gender, and employment position where sample or cell sizes are small.

Yes

Uncertain

Will data be collected in a language other than English?

Yes

Will non-AIR staff (e.g., temporary employees, subcontractors, recruiting firms) recruit participants or collect, analyze, or have access to data you are collecting?

Yes

Are you collecting data for an education agency such as a US state, school district or school?

Yes

Is your project funded wholly or in part by the National Center for Education Statistics (NCES)?

Yes

Please read carefully: NCES has very specific requirements for ensuring the security and confidentiality of any data collected on its behalf. Many of these procedures are federally-mandated and focus on those data that may enable users to identify individual respondents, either directly or indirectly through deductive disclosure or by matching to other data sources. Confidentiality procedures include, but are not limited to, a disclosure risk analysis for any data that may be released to the public, and if necessary, implementation of disclosure limitation techniques. Exact procedures will depend on the type of data being collected, and should be developed in coordination with NCES. Your IRB submission should acknowledge understanding of federal legislation with respect to NCES data, as well as your obligation to work with NCES to develop any necessary disclosure limitation procedures. See the NCES web site (http://nces.ed.gov/statprog/2002/std4_2.asp) for more information.

Will you be collecting identifiable health information? Note: “Health” includes more than just physical health, but also mental, psychological, and emotional health.

Yes

Will this project use existing data on humans from records, transcripts, videotapes, etc.?

Yes

Uncertain

~~Check all that apply with regard to the type of data that will be used:~~

~~Publicly available data on humans~~

~~Publicly available administrative data~~

~~Data on humans collected for other purposes that are not publicly available (e.g., data from another study that are not publicly available, personnel data)~~

~~Administrative data that are not publicly available~~

~~Education records (e.g., data, files, documents or other materials directly related to a student or students and maintained by an education agency or institution)~~

~~Medical records data (e.g., from a hospital, health care provider or health insurance company)~~

~~Other – Please describe:~~ ~~ ~~

Will the existing data you are using allow you to ascertain an individual’s identity either directly or through the use of a code or key? (Please read guidance immediately below before answering.)

~~Please read carefully:~~ Individuals’ identities can be ascertained in several ways including personal data such as names addresses, phone numbers, and identification numbers (e.g., social security and medical record numbers). In addition, audio and videotapes also enable direct identification of an individual. Finally, an individual may be identified through “deductive disclosure,” that is, the ability to deduce who someone is with high probability through the cross-classification of variables such as age, gender, and employment position) where sample or cell sizes are small.

~~Yes~~

~~Uncertain~~

~~Will you be using any National Center for Education Statistics (NCES) restricted-use data (i.e., data containing individually identifiable information) for this project?~~

~~Yes~~

~~Please read carefully:~~ Individuals must obtain a restricted-use data (RUD) license before accessing any NCES restricted-use data. Individuals apply for a restricted-use data (RUD) license from NCES through qualified institutions which have met the necessary security requirements; AIR staff may obtain a RUD license through AIR. For more information on obtaining an NCES RUD license, contact AIR’s Data Security Officer. Your IRB submission should indicate that you understand procedures related to obtaining RUD licenses and ensuring the security of restricted-use data. For more information, see the NCES RUD web site: ~~http://nces.ed.gov/statprog/instruct.asp.~~

~~Will non-AIR staff (e.g., temporary employees, subcontractors, recruiting firms) analyze or have access to the existing data being used in this project?~~

~~Yes~~

Will the project include recording of still or video images or audio recording of participants?

Yes

Will your project produce any outward-facing documents that will contain art such as photography, clip art, cartoons, comic strips, illustrations, audio, or video?

Yes

Is this project classified?

Yes

Is AIR the prime, a subcontractor, or an equal partner with another organization on this project?

Prime without subcontractors

Prime with Subcontractors

Subcontractor

Equal Partner

A IR Institutional Review Board (IRB) Control Form

Form A: To Be Used When Projects or Tasks Collect Data From or Use Data About Human Participants

For Collaborators: Please fill out this document and return to your AIR contact. Only AIR staff have access to the PADII application and airportal.air.org links.

Participants

Please provide a detailed description of the human participants who will be involved in your project or task. These may be people from whom you will be directly collecting data and/or people about whom you will have extant data. Describe the characteristics of the population, including their anticipated number, age range, gender, and health and mental health status.

This study will be a non-probability, purposive sample of 3 populations: the currently incarcerated intimate partner violence (IPV) offender population, the currently incarcerated non-IPV offender population, and the general (non-incarcerated) population. All participants will be at least 18 years old and live in the United States.

We aim to collect data from 2210 respondents: 2000 general (non-incarcerated) population individuals, 105 currently incarcerated individuals who have an IPV offense record, and 105 currently incarcerated individuals who do not have an IPV offense record.

General Population Mechanical Turk (MT) Workers: Participants from the general population will be a purposive sample of Amazon’s Mechanical Turk (MT) workers. MT is a convenient, low-cost method of crowdsourcing human intelligence tasks that has been used for social science research. Individuals register as “workers” and can browse Human Intelligence Tasks (HIT) posted by “requesters.” Once a MT worker successfully completes the task, they are paid through the MT interface. CDC specifically mentioned during the proposal process that use of MT was a potential source of online survey participants from the general population.

Up to 8,600 MT workers will first complete a screening questionnaire. AIR will then choose 2,000 workers who collectively, most closely, demographically represent those of the general US population (in terms of age, sex assigned at birth, race, ethnicity, household income, and education) for invitation to complete the full survey. We will oversample individuals who identify as gay or lesbian. Studies have shown that IPV disproportionally affects this subgroup. We are oversampling to ensure that we get a large enough sample from this subgroup to achieve adequate power in our analyses. We will purposively choose participants so that our sample will be approximately:

Age: 14.5% ages 18-24 years, 43.1% 25-44 years, 29.0% 45-64 years, 13.4% 65 years and older
Sex assigned at birth: 50.8% female, 49.2% male
Race: 77.4% White, 13.2% Black, 1.2% American Indian or Alaska Native, 5.4% Asian, <1% Native Hawaiian and Other Pacific Islander, 2.5% Two or more races
Ethnicity: 17.4% Hispanic origin
Household income: 8% Under $10,000, 6% $10,000 - $14,999, 6% $15,000 - $19,999, 6% $20,000 - $24,999, 11% $25,000 - $34,999, 14% $35,000 - $49,999, 18% $50,000-$74,999, 11% $75,000-$99,999, 20% $100,000 and over
Education: 29.3% four year college graduate or more
Sexual orientation: 25% men who identify as heterosexual, 25% men who identify as gay, 25% women who identify as heterosexual, 25% women who identify as lesbian.

Incarcerated Population: Participants from the incarcerated offender population will be from 1 prison and 3 work release facilities (hereinafter referred to as “facilities”) in Indiana. It is expected that all individuals living in these facilities are 18 years old or older, most being between 26 and 50 years old. We anticipate about two thirds of our sample to be male. Our sample will be equally stratified by if the individual has an IPV-related offense record (e.g. charges for domestic battery). In general, this population likely has a higher proportion of individuals with health problems and mental illness compared to the general population. It is also likely that these individuals have experienced more trauma than that of the general population. Many individuals may have low literacy skills as well.

Identify the criteria for inclusion or exclusion of any subpopulation.

General Population Mechanical Turk (MT) Workers: Participants are eligible if they are 18 years old or older, live in the United States, are MT workers, and have a 95% or higher approval rating on their work with MT.

Incarcerated Population: Incarcerated individuals are eligible if they are at least 18 years old. All incarcerated participants must live in one of the facilities we will work with.

Explain the rationale for the involvement of any special classes of participants, such as children, children with disabilities, adults with disabilities, persons with mental disabilities, pregnant women, prisoners, institutionalized individuals, or others who are likely to be vulnerable. If none, write "None."

We will be surveying prisoners in 4 facilities in Indiana. We are conducting research on attitudes, conflict, and patterns of behavior, including violence, in intimate partner relationships with the goal of identifying factors that influence IPV perpetration. This data will be used for the long term goal of developing tailored perpetrator intervention programs.

Involving incarcerated IPV offenders allows us to collect data from individuals who, we can confirm through their criminal history, have actually perpetrated IPV. Ultimately (and after this contract) the data gathered from this survey will be used to develop a valid instrument to differentiate types of IPV perpetration. Some patterns of behavior, such as physical, emotional, or sexual violence, are more prevalent within the incarcerated population than within the general population. Surveying people who have an IPV offense record allows us to obtain data from a population who have likely experienced trauma, are at high risk of perpetrating IPV again, and who may have committed particularly severe or frequent offenses. The experience and personal characteristics of this population may be different from those of the non-incarcerated population and are valuable to identifying indicators that predict patterns of aggression. Additionally, it is a requirement of the funding to include incarcerated individuals in our sample.

This population is likely to have a larger proportion of individuals who are cognitively impaired or mentally unstable compared to the general population. All individuals have the option to refuse the survey. Interviewers will be trained to recognize signs of distress and stop/pause the survey or seek help from facility staff, if necessary.

Surveying incarcerated non-IPV offenders and the general population will allow us to collect data to identify distinguishing factors between perpetrators and non-perpetrators.

Sources and Types of Data

Identify the sources and types of data (e.g., specimens, records, or other materials) that will be obtained or used. If the project or task is collecting or using multiple sources or types of data, indicate which will be obtained specifically for this project and which will involve the use of existing data. Similarly, if the project or task is collecting or using multiple sources or types of data, indicate the extent to which each is publicly available.

Data will come from 3 sources: 1) IPV arrest history (has an IPV arrest on record or not) for individuals from the incarcerated population who consent to participate. Data will be provided by the facilities. 2) MT workers’ responses to screening questionnaire (data collected specifically for this project), and 3) all respondents’ responses to survey items (data collected specifically for this project). None of these data will be made publicly available.

Please attach a copy of each of your proposed data collection protocols.
If you do not have this information at this time and will submit it later, please select "Submit Later".

Submit Now (Attach)

Submit Later

See Attachment

You previously indicated that you will be collecting data on one or more sensitive topics (e.g. sexual behavior, HIV status, drug or alcohol use, illegal behaviors, child or physical abuse, immigration status). Please provide information about the nature of these data. (If applicable).

We will ask several questions about violence that occurred within and outside of intimate partner relationships, substance use and abuse, sexual behavior, psychological conditions, attitudes that condone violence, and adverse childhood experiences. We will ask about violence that is physical, emotional, sexual, or stalking. Our expert consultants and literature review identified these areas as important and predictive factors that contribute to perpetration of IPV. It is important to understand the details of the violent occurrence(s), the reasons for violence, and personal characteristics of individuals to appropriately distinguish between IPV perpetrators and non-perpetrators and between types of IPV perpetrators. Survey items were either taken from existing scales, modified from existing scales, or written by AIR and CDC. Items were all cognitively tested with formerly incarcerated IPV offenders and non-offenders, and participants from the general population.

You previously indicated that you will be collecting or using data that will allow you to ascertain an individual’s identity. Please provide information about the nature of these data and the extent to which they contain information such as names, addresses, identifying numbers, photographs and video or audio recordings that could be used to identify participants. (If applicable).

General Population Mechanical Turk (MT) Workers: MT workers will participate in the survey anonymously and no identifiable information or contact information will be collected. For those who volunteer to take the survey, AIR will receive their MT WorkerID, a 14 character ID (e.g. A3IZSXSSGW80FN), which we will only use to re-contact workers who are chosen for our sample.

Incarcerated Population: AIR will not have PII associated with the incarcerated population on its systems or in hard copy outside of the facility. AIR will not be doing the sampling. The prison facility staff will be drawing a quota based sample where they select the number of inmates that meet our sampling sample size targets. When AIR staff arrive onsite, the facility would provide a list of the names of sampled inmates that AIR would meet with on that day and an indication of whether they have an IPV arrest history or not. AIR will not retain copies of lists of inmates. Each person who participates in the study will be assigned a code number. Survey answers will be associated with this code number and not the individual’s name. The only form containing the individual’s name is the consent form, which only researchers will have access to.

Recruitment/Consent

For existing data (e.g. extant data) that will be used in this project, to the extent known, please describe the recruitment and informed consent procedures used to collect the data and indicate the extent to which data confidentiality was promised to participants.

General Population MT Workers: None

Incarcerated Population: The existing data collected will be the IPV arrest history (has an IPV arrest on record or not) for incarcerated individuals who choose to participate in the study. This data will be provided to AIR by the facilities. To keep track of whether the inmate is in the IPV arrest history vs non-IPV arrest history groups, AIR would record this information in an Excel spreadsheet that has all of the AIR created code numbers generated. Once the inmate has agreed to participate and signed the consent form, they would be assigned a code number. There would be columns for IPV arrest history and non-IPV arrest history and they would be marked a ‘1’ for the group they belong to and a ‘0’ for the group they do not belong to. The first question in the survey will be to enter the code number. The AIR employee would enter the code number from the spreadsheet. Then the inmate would continue with the survey. The IPV arrest history information would be merged with the survey data by the code number after data collection.

For the data you will collect, please describe your plans for recruiting participants and the consent procedures to be followed in the text block below. In particular, spell out:

the circumstances under which consent will be sought and obtained;
who will seek it;
how it will be documented;
the nature of the information to be provided to prospective participants; and
information about any monetary or other incentives offered to compensate participants for research-related inconveniences.

General Population MT Workers: First, the screener survey will be posted as a simple human intelligence task (HIT) for MT workers to complete. The HIT will provide a brief description of the screener survey, the qualifications required of MT workers for participation (at least 95% approval rating), estimated time to take the screener survey, and the reward amount (10 cents). Of those who participated in the screener survey, AIR will choose a sample to complete the full survey. These workers will be sent a request to complete a second HIT for the full survey. The HIT will again provide a brief description of the survey, the qualifications required of MT workers for participation (at least 95% approval rating), estimated time to take the survey, and the reward amount (about 3 to 5 dollars).

Sampled MT workers will be paid 3 dollars for completing the full survey and a bonus of 2 dollars if they answer at least 90% of the questions. Because this group is a worker population, the incentive scheme is designed in this way to protect AIR from receiving poor quality submissions that have only a few questions answered, while also giving participants a choice to skip sensitive questions. In justification of the incentive amounts provided to MT workers, we found that most HITs for psychology surveys and studies of family experience in young adulthood and other types of similar work provide about $0.25 for a 3-5 minute survey, $0.50 for a 5-7 minute survey and about $4-6 for a 40 to 60 minute survey. Our incentives are comparable to what other HITs offer. Previous research has shown that many MT workers do not use MT as their primary source of income and complete tasks for enjoyment or just “for something to do” that allows them to also earn money.

Both the screener survey and full survey will require respondents to read and acknowledge a consent form prior to participation. The consent form will provide information about the study purpose, who is conducting the research, how their confidentiality as a respondent will be protected, and who to contact if they have any questions about the study. Participants will be informed that the project will be receiving a Certificate of Confidentiality from CDC, which will protect the privacy of respondents by protecting research staff from being forced to release respondents’ identifying information in any civil, criminal, administrative, legislative, or other proceeding. They will be informed that their answers will be identified with a code number. Their identity will not be linked with their answers. Additionally, results from this survey will only be reported for groups of participants. Results will not be reported about specific people.

We seek to waive documentation of consent for MT workers as a consent form would be the only record linking the participant to the research. If MT workers click “Agree” to the consent page on the online survey, this will be considered to be providing consent.

Incarcerated Population:

First, selected inmates will come meet with AIR staff to talk about the study and get an information sheet. Inmates who are interested in participating are invited to schedule an appointment time to complete the survey. This could be on the same day or another day. Giving the inmates time to think about if they want to participate protects the inmate’s rights to participate by not coercing them into doing the interview the first time they learn of the study. At the scheduled appointment, AIR staff will introduce the survey and review the consent form. The individual will be given the opportunity to ask any questions. The consent form will provide information about the study purpose, who is conducting the research, how their confidentiality as a respondent will be protected, and who to contact if they have any questions about the study. We will inform respondents that participation will not affect their legal case in any way, there will be no repercussions for declining to participate, and mandated reporting will occur if child abuse is disclosed. They will be informed that their answers will be assigned a code number given by AIR and their name or Facility ID number will not be linked with anything they say. Additionally, results from this survey will only be reported for groups of participants. Results will not be reported about specific people. Individuals are required to sign the consent form if they decide to participate.

A token of appreciation in the form of a small snack (e.g. piece of fresh fruit or a candy bar) will be will be provided for participants who take the survey. The value of this incentive is attractive enough to be a reward for participants but small enough to not be coercive.

Please upload a copy of your proposed recruitment materials and consent form (and/or related documents such as consent "information sheets” or cover letters). A Word version of the informed consent checklist can be found here.

If you do not have this information at this time and will submit it later, or you are requesting a waiver or alteration of consent and thus do not have any applicable materials, please select "Submit Later".

Submit Now (Attach)

Submit Later

Please indicate if you are requesting any of the following (Select all that apply):

A waiver of documentation of consent

A waiver or alteration of consent (These are rare)

A waiver or partial waiver of HIPAA authorization (These are rare. Please complete FORM E: HIPAA)

None

Waiver of documentation of consent (if selected above)

Yes (Please indicate how your study meets each of the criteria necessary for the IRB to grant a waiver of documentation of consent: )

When an IRB has not waived the requirement for seeking prospective informed consent of the subjects or the parental permission of children who are subjects, it may waive the requirement for a signed consent form for some or all subjects if it finds EITHER:

that the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (e.g., the only thing that would link a human subject to a study of persons who are HIV positive is a consent form)…. or
that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context (e.g., drawing blood, asking shoppers in a mall about ambient lighting or temperature).

~~Waiver or alteration of consent (if selected above)~~

~~Yes (Please indicate how your study meets each of the criteria necessary for the IRB to grant a waiver or alteration of consent:~~ ~~ ~~)

~~An IRB may waive or alter the requirements of informed consent provided that ALL of the following four conditions are met:~~

~~the research involves no more than minimal risk to the subjects;~~
~~the waiver or alteration will not adversely affect the rights and welfare of the subjects;~~
~~the research could not practicably be carried out without the waiver or alteration; and~~
~~whenever appropriate, the subjects be provided with additional pertinent information after participation.~~

(Note: “Practicable” is not an inconvenience or increase in time or expense to the investigator or investigation, rather it is for instances in which the additional cost would make the research prohibitively expensive or where the identification and contact of a large number of potential subjects, while not impossible, may not be feasible for the anticipated results of the study.)

Risks/Benefits and Risk/Benefit Analysis

Describe potential risks (physical, psychological, social, legal, or other) to participants and assess their likelihood and seriousness. Describe potential benefits to participants (health-related, psychosocial, or other) or others (such as acquisition of generalizable knowledge). Where appropriate, describe alternfCAative treatments and procedures that might be advantageous to the participants. Discuss why the risks to participants are reasonable in relation to the anticipated benefits to participants and in relation to the importance of the knowledge that may reasonably be expected to result.

Some questions might be uncomfortable or embarrassing to answer for participants. The benefits to participation are that participants will help contribute to the body of knowledge about IPV perpetration, which may help to create more effective and tailored perpetration intervention programs. This study is one step towards helping to prevent intimate partner violence in the future.

General Population MT Workers: If there was a breach in confidentiality and workers’ identities were released, their answers to the survey could cause problems with their job or personal relationships. There is also a risk of individuals revealing something that is potentially incriminating to themselves when answering questions about illegal activities. The survey also asks several sensitive questions which may be psychologically and emotionally difficult for respondents.

Incarcerated Population: The participants’ identity could be discovered through deduction if data about their names, Facility ID, facility, criminal history, and sex were released. If the participants’ identify was discovered and answers or comments were shared in connection with their name, this could cause problems with their job or personal relationships. There is also a risk of individuals revealing something that is potentially incriminating to themselves when answering questions about illegal activities. The survey also asks several sensitive questions which may be psychologically and emotionally difficult for respondents.

Protections for Participants

Describe the procedures for protecting against or minimizing potential risks to participants (including risk of physical harm and risks arising from breaches of confidentiality such as harassment, ostracism, psychological harm, civil liability, criminal prosecution, loss of employability and financial loss), and assess their likely effectiveness. Where appropriate, discuss provisions for ensuring necessary medical or professional intervention in the event of adverse effects to the participants. Also, where appropriate, describe the provisions for monitoring the data collected to ensure the safety of the participants. Note that Project Directors are responsible for insuring that all project staff have completed appropriate training regarding the protection of human participants. Information about staff who have and have not completed accepted training may be obtained from the IRB Administrator (IRBAdministrator@air.org). If any IRB reviews will be conducted at any partner organizations, please include information about this here.

We will inform participants that if they disclose information that leads us to believe there is child abuse or elder/disabled abuse occurring, we are mandated by law to report this to authorities.

General population MT workers: The participant will have the opportunity to pause the survey and will be provided clear instructions on how to end the survey, if desired. If possible, a pop up will be programmed to appear to ask if the participant if they are OK if they remain on a question for a certain period of time. Contact information for help lines or support organizations will be provided at several points during the survey.

MT workers are given an overall approval rating based on the quality of their work they submit. If a worker submits work that is rejected by the requester, their approval rating will go down. MT workers will be informed that, if they consent to take the survey, they will receive 3 dollars for taking the survey and a bonus of 5 dollars if they complete at least 90% of the questions. They are able to skip any questions or stop the survey at any time and will still receive 3 dollars. Skipping questions or stopping the survey will not affect their approval rating in any way.

All data will be temporarily stored on the survey software’s secure server and will be securely transferred to a FISMA compliant server for storage. The online survey software’s servers, databases, and web presences will be HIPAA compliant and employ multiple forms of security features. Their security protocols are designed to protect the data as well as the confidentiality of research participants.

Incarcerated population: Participants will be informed that they may refuse to answer any questions or stop the interview without penalty. Surveys will be conducted individually in a private, quiet room. Because the survey topic is sensitive in nature, interviewers will be trained to recognize signs of distress and will be instructed to ask participants if they are OK and pause/stop the interview if needed. Participants will also be given information about who to go to within the facility if they need support.

Participants might feel uncomfortable if facility staff know who chooses to participate in the survey. They may feel like they have to participate or else they will be punished. In the information sheet and when the study is introduced, we will stress that participation is voluntary and that there are no repercussions for not participating. Only essential facility staff will know that we are conducting a survey. Non-essential staff will only be informed that some inmates have an appointment. They will not know the purpose of the appointment nor the fact that inmates were able to choose to participate or not. Additionally, we will have a memorandum of understanding (MOU) in place to address roles and responsibilities of facility staff, especially in regard to confidentiality.

The consent form will be the only document that contains the inmates’ names. All paper consent forms will be stored in a secure, locked, location. No personally identifiable information will be included in the survey data file. Participants will only be identified by a code number. Researchers will not have access to the list inmates who participate in the study after data collection is complete. The survey data collected through the survey software will be stored on the software’s secure server. Data will be uploaded to the survey software servers daily, or as soon as possible, and taken off of the iPad. The online survey software’s servers, databases, and web presences will be HIPAA compliant and employ multiple forms of security features. Their security protocols are designed to protect the data as well as the confidentiality of research participants. After data collection, data will then be transferred to a FISMA compliant server for storage. AIR staff will be in possession of the iPads and monitor their use at all times. All iPads will be password protected and stored in locked storage containers when not in use. At night, iPads will be stored in a locked, secure location at AIR’s Indianapolis office.

Furthermore, during informed consent and at the conclusion of the appointment, inmates will be given information about available resources within the facility should they need support after participation in the survey. Some survey questions may be triggering and prisoners might need mental health resources after. Inmates may also need support if they want to discuss the survey or their participation after AIR interviewers have left the facilities.

Please list key personnel for this project:

The IRB will not be able to issue an approval for your work until you and all of your key personnel have completed training in the protection of human research participants. AIR policy and the terms of our Federalwide Assurance state that staff who collect or analyze data from living humans must complete training in the protection of human research participants. Key personnel who have not completed the training will receive an email notifying them to do so. Certificates of completion can be uploaded into PADII via the “Check My Certification” link on the left dashboard.

Melissa Scardaville

HarmoniJoie Noel

Alison Huang

Roger Jarjoura

Nathan Zaugg

Konrad Haight

Screener Survey Consent Form

Consent Form: MT General Population Sample

What is this survey about? What will you ask me to do?

This is a screener survey to collect demographic information from some Mechanical Turk workers. We will ask you to answer questions about yourself. If your background matches the needs of our survey, we will send you another Human Intelligence Task (HIT) directly. The HIT will be a request to complete a full survey about problems in relationships between intimate partners.

This screener survey will take about 5 minutes. You will receive 10 cents for doing the screener survey. If your background matches the needs for our full survey, you will receive up to 5 dollars for taking the full survey.

Who is conducting the screener survey?

The American Institutes for Research (AIR) is conducting this survey. AIR is a research organization based in Washington, DC. The survey is funded by the Centers for Disease Control and Prevention (CDC), a government agency.

Do I have to take the screener survey?

No. It is your choice whether to do the screener survey or not. If you decide to do the screener survey, you can stop taking it at any time. You do not have to answer any questions that you don’t want to. There are no penalties and your approval rating will not be affected if you decide to skip any questions, if you do not complete the screener, or if you chose to start the screener survey and change your mind later.

What are the risks and benefits if I take the screener survey?

There are few risks to taking the screener survey. You may feel uncomfortable answering some of the questions on the survey. You may, skip questions that you are uncomfortable answering or stop taking the survey at any time.

The benefits to taking the screener survey are that if your background matches the needs of our full survey, you will have the chance to earn up to 5 dollars for completing the full survey in another HIT.

How will you protect my privacy?

We know how important it is to keep your information private. We will take all steps to keep your information confidential. Your answers will only be identified by a code number given to you by AIR. Your WorkerID, which will only be used to send you the next HIT if you are eligible, is only known by project team researchers. Your WorkerID will not be linked with any of your answers. Additionally, results from this screener survey will only be reported for groups of participants. We will never report results about specific people.

What if I want more information?

If you have additional questions or concerns about this survey, please contact the director of the survey at AIR, Melissa Scardaville, Ph.D. at (404) 260-1046.

If you have concerns or questions about your rights as a participant, contact AIR’s Institutional Review Board (which is responsible for the protection of people taking this survey) toll free at 1-800-634-0797 or c/o IRB, 1000 Thomas Jefferson Street, NW, Washington, DC 20007.

Please click the “Agree” button if you agree to take the screener survey

Clicking the “agree” button means that you are agreeing to take this screener survey. This means that you have read and understood the information on this form and you are willing to take the survey under the conditions we described.

A IR Institutional Review Board (IRB)

Form E: To Be Used Where HIPAA May Apply

For Collaborators: Please fill out this document and return to your AIR contact. Only AIR staff have access to the PADII application and airportal.air.org links.

Whenever a project uses extant medical or health insurance records, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) may apply. The Privacy Rule and the Security Rules for the protection of individually identifiable health information are pertinent to AIR projects. Please carefully read the sections below and answer the questions that follow to determine how HIPAA affects your project and what kind of IRB review is required.

HIPAA and the Standards for Privacy
In response to a congressional mandate in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the U.S. Department of Health and Human Services (HHS) issued the regulations Standards for Privacy of Individually Identifiable Health Information . For most covered entities, compliance with these regulations, known as the Privacy Rule, was required as of April 14, 2003.

HIPAA and the Standards for Security
The HIPAA Security Rule provides administrative, physical, and technical safeguards for protecting electronic protected health information (EPHI). EPHI is any PHI that is created, stored, transmitted, received or disposed of in electronic format.

The final Security Rule adopting HIPAA standards for security was published in the Federal Register on February 20, 2003 and became effective April 20, 2005. Like the Privacy Rule, the Security Rule applies to covered entities. However, the obligations imposed by the Security Rule may also apply to those who receive EPHI from covered entities in accordance with a BAA or DUA.

The Security Rule describes how to implement administrative, physical, and technical safeguards designed to protect the confidentiality, integrity, and availability of EPHI.

Confidentiality is the assurance that EPHI data is shared only among authorized persons or organizations.

Integrity is the assurance that EPHI data is not changed unless an alteration is known, required, documented, validated and authoritatively approved. It is an assurance that the information is authentic and complete, and that the information can be relied upon to be sufficiently accurate for its purpose.

Availability is the assurance that systems responsible for delivering, storing and processing of EPHI data are accessible when needed and by those who need it both during normal operations and during a business disruption/emergencies.

EPHI is any PHI that is created, stored, transmitted, received or disposed of in electronic format.

Identifiable Health Information Excluded from HIPAA

Education Records: The definition of PHI under HIPAA specifically excludes identifiable health information in "education records" subject to the Family Education Rights and Privacy Act (FERPA, 20 USC 1232g). FERPA provides privacy protections for such records when held by federally funded educational institutions. See FERPA Intranet page of this website for additional information.

Employment Records: The definition of PHI under HIPAA also excludes employment records for covered entities for activities related to their employment function. However, in their health roles, they create records containing what is defined as PHI for any employees for whom they provide health services. Refer to http://privacy.med.miami.edu/glossary/xd_employment_records.htm for additional information related to this exclusion.

Comparison of the HIPAA Privacy and Security Rules
The Privacy Rule focuses on the right of an individual to control the use of his or her personal information. It covers the confidentiality of PHI in any form or medium including electronic, paper and oral. Confidentiality is an assurance that the information will be safeguarded from unauthorized disclosure. The physical security of PHI in all formats is an element of the Privacy Rule. The Privacy Rule is enforced by the Office for Civil Rights of the Department of Health and Human Services (HHS).

The Security Rule focuses on administrative, technical and physical safeguards specifically as they relate to electronically protected health information. The Security Rule has more specific and comprehensive security controls than those specified in the Privacy Rule for electronic data. Protection of EPHI data from unauthorized access, whether external or internal, stored or in transit, is all part of the HIPAA Security Rule. The Centers for Medicare & Medicaid Services (CMS) has been delegated authority to enforce the non-privacy provisions of the HIPAA Regulations, including the HIPAA Security Rule.

Relevance to AIR Projects
HIPAA applies to the use of PHI by covered entities for treatment and payment. AIR is not a covered entity, but is responsible for meeting the covered entity’s obligations under the HIPAA Privacy and Security Rules when it receives PHI from a covered entity to conduct projects. HIPAA applies to both research and non-research projects conducted by AIR.

Non-Research Projects

When AIR contracts with a covered entity to conduct non-research work that requires access to PHI, AIR enters into a Business Associate Agreement with the covered entity. The BAA specifies AIR’s obligations to adhere to the terms of the Privacy and Security Rules. For example, if AIR contracts with a health insurer to conduct a direct social marketing campaign that informs its members about weight control, the insurer must reveal to AIR the names of its beneficiaries. Health insurance enrollment information is PHI because it is used to pay claims. Because the insurer is contracting with AIR to conduct a normal business operation, it will require AIR to enter into a BAA before releasing the data.

Research Projects

Research organizations are not themselves covered entities, unless they are also health care providers and engage in any of the covered electronic transactions. Researchers, who are not workforce members of covered entities, may be indirectly affected by the Privacy Rule if covered entities supply their data. When AIR needs to acquire PHI to conduct research, it enters into a Data Use Agreement with the covered entity that agrees to provide the PHI. This might be the client, another organization. The DUA specifies the uses to which AIR may put the data, the actions it will take to protect the privacy and security of the data, and actions it will take to inform the covered entity supplying the data in the event of a breach of privacy or security. For example, if AIR is surveying Medicare beneficiaries for CMS as part of a research project, and samples from a list of Medicare beneficiaries supplied by CMS, it must enter into a DUA, because CMS is a covered entity. If the project requires PHI from hospitals, AIR must enter into a DUA with each hospital that agrees to provide the PHI. Because research is not a normal business operation, the DUA, rather than the BAA, is the appropriate agreement.

Important PHI Definitions
1. PHI includes any of the following 18 data items in electronic, paper, or oral form:

Names
Geographic subdivisions smaller than state
Dates more specific than year
Telephone numbers
FAX numbers
Email addresses
Social Security Numbers
Medical Record Numbers
Health Plan beneficiary numbers
Account numbers
Certificate/license numbers
Vehicle identifiers
Device identifiers
Web URLs
IP addresses
Biometric identifiers such as finger or voice prints
Full face photograph or image
Any other number, code or characteristic that can be linked to identity by the researcher.

2. A “de-identified data set” cannot contain ANY of these 18 data items.

3. A “limited data set” may not contain the above 18 data items, except for dates more specific than the year and location more specific than the state; note that street name, street number, and P.O. Box number may not be included in a limited data set, but county or zip code can be included.

Use and Disclosure of PHI for Research
The Privacy Rule permits covered entities to use or disclose PHI for research purposes either with an individual's specific written permission, termed an “Authorization,” or without it, if certain conditions are met. A covered entity is permitted to use or disclose PHI for research purposes if one of the following conditions is met:

Obtains the individual's Authorization for the research use or disclosure of PHI as specified under section 164.508 of the Privacy Rule.
Obtains satisfactory documentation of an Institutional Review Board (IRB) or Privacy Board waiver of the Authorization requirement that satisfies section 164.512(i) of the Privacy Rule. To grant a waiver, the IRB or Privacy Board must find that the research meets all of the following conditions:

No more than minimal risk;
Adequate plan to protect identifiers;
Adequate plan to destroy identifiers ASAP;
Written assurances that PHI will not be disclosed for purposes other than approved;
Research could not practicably be conducted without the waiver;
Research could not practicably be conducted without using PHI ;
Waiver will not adversely affect rights or welfare of subjects; and
When appropriate, subjects will be provided information later.

The covered entity supplying the data and the researcher receiving the data must enter into a Data Use Agreement (DUA) specifying how these conditions have been met.

Obtains satisfactory documentation of an IRB or Privacy Board's alteration of the Authorization requirement as well as the altered Authorization from the individual.
Uses or discloses PHI for reviews preparatory to research with representations from the researcher that satisfy section 164.512(i)(1)(ii) of the Privacy Rule (e.g., to review medical records to determine if research is feasible).
Uses or discloses PHI for research solely on decedents' PHI with representations from the researcher that satisfy section 164.512(i)(1)(iii) of the Privacy Rule.
Provides a limited data set and enters into a Data Use Agreement with the recipient as specified under section 164.514(e) of the Privacy Rule.
Uses or discloses information that is de-identified in accordance with the standards set by the Privacy Rule at section 164.514(a)-(c) (in which case, the health information is no longer PHI).
Uses or discloses PHI based on a permission that predates the applicable compliance date of the Privacy Rule (generally, April 14, 2003), i.e., an express legal permission to use or disclose the information for the research, an informed consent of the individual to participate in the research, or a waiver by an IRB of informed consent to participate in the research. See the Privacy Rule at section 164.532(c).

The Common Rule and HIPAA have similar, but somewhat different requirements for privacy, confidential, and security. For example, procedures that are considered adequate to protect confidentiality under the Common Rule may not be adequate under the HIPAA Privacy and Security Rules. The definition of a “de-identified” data set under HIPAA differs from the definition of an “anonymous” data set under the Common Rule. Thus, a project that is exempt under the Common Rule because the data are anonymous may require a waiver of authorization under HIPAA because the data are not de-identified.

For a more detailed explanation about research and the Privacy Rule and for more information about the various sections referred to above, please visit the government’s official website for the following document on the use of PHI for research: http://www.hhs.gov/ocr/hipaa/guidelines/research.pdf. You might also want to visit: http://privacyruleandresearch.nih.gov/healthservicesprivacy.asp, a site from which much of the information here was drawn.

The specific standards and implementation procedures related to the Security Rule safeguarding EPHI also can be located on AIR’s intranet here: http://airportal.air.org/Services/CSO/Web%20Pages/HIPAA%20Security.aspx. Included in this website are useful references and links that should provide additional background related to implementation of the Security Rule.

Except for the exclusions noted above (employment and/or education records), will this project or task use Protected Health Information (PHI) or Electronic Protected Health Information (EPHI)?

Yes, this project will collect EPHI

Yes, this project will collect PHI (non-electronic)

Yes, this project will collect both EPHI and PHI

Unsure (Please describe the nature of your data and indicate why you are unsure if it is PHI or not: )

Since you are using EPHI, a written information security plan needs to be developed. Please upload a plan for ensuring the confidentiality and security of the information you will be collecting and/or using. For plan preparation, please refer to the below link that provides specific guidelines and helpful templates on developing an information security plan that includes security measures associated with accessing, storing, and transmitting data. (~~http://airportal.air.org/services/cso/Web%20Pages/IRB.aspx~~)

It is recommended that you develop your data security plan in coordination with the AIR Chief Security Officer and/or IT Data Security Officer (IRBSecurity@air.org), as they will be notified when you upload your plan and asked to approve it.

~~Submit now (Attach)~~

~~Submit later~~

*Security plan will be attached

Since you are using identifiable health information, a written information security plan needs to be developed. Please upload a plan for ensuring the confidentiality and security of the information you will be collecting and/or using. For plan preparation, please refer to the below link that provides specific guidelines along with a helpful template on developing an information security plan that includes security measures associated with protecting PHI. (~~http://airportal.air.org/services/cso/Web%20Pages/IRB.aspx~~)

~~Submit now (Attach)~~

~~Submit later~~

~~Which of the following actions are you requesting from the IRB?~~

~~Approval to obtain the individual's authorization for the research use or disclosure of~~

~~PHI as specified under section 164.508 of the Privacy Rule~~.

~~Approval of a waiver of the individual’s authorization requirement and the use of a DUA that~~

~~satisfies section 164.512(i) of the Privacy Rule. (Attach)~~

~~Approval to alter the Authorization requirement and obtain altered Authorization from~~

~~the individual.~~

~~Approval to use or disclose PHI for reviews preparatory to research under section~~

~~164.512(i)(1)(ii) of the Privacy Rule.~~

~~Approval to use or disclose decedents' PHI for research under section 164.512(i)(1)(iii)~~

~~of the Privacy Rule.~~

~~Approval to use a limited data set and a DUA under section 164.514(e) of the Privacy~~

~~Rule.~~

Approval to use or disclose information that is de-identified in accordance with the standards set by the Privacy Rule at section 164.514(a)-(c) (in which case, the health information is no longer PHI).

~~Approval to use or disclose PHI based on a permission that predates the applicable~~

~~compliance date of the Privacy Rule (generally, April 14, 2003).~~

~~Updated 5.19.2010~~

File Type	application/msword
Author	Opt1m1st1c1
Last Modified By	Reidy, Dennis (CDC/ONDIEH/NCIPC)
File Modified	2017-03-06
File Created	2017-03-06

Project Name or Project Number	CDC IPV Metric
Project Director/ designated staff responsible for overseeing the execution of this security plan	Melissa Scardaville
Project Director review date (last review date)	July 26, 2016

	Brief Description of Each Data Type [Example Input Here]	Security Category


3	General Population Screener Survey: This file will include Amazon’s Mechanical Turk worker’s responses to demographic questions. Respondents will only be identified by a WorkerID number. No contact information will be collected.	Low
4	Mechanical Turk (MT) WorkerID: This file contains the WorkerIDs for those who completed the screener survey. This file will be used to re-contact workers who are chosen from the sample. Respondents will only be identified by a WorkerID number.	Low
5	Raw Survey Data: This file will include all respondents’ responses to the survey. Respondents will only be identified by an ID number given to them by AIR. No contact information will be collected.	Low
6	Clean Survey Data: This file is a cleaned version of the raw survey data, which includes all respondents’ responses to the survey. Respondents will only be identified by an ID number. No contact information will be collected.	Low

Data Type (From Section 3 above)	Sending Organization	Receiving Organization	Type File Sharing (Enter no. below)

MTurk WorkerIDs	Mechanical Turk	AIR	8 – using open source software (CRAN-R and MTurkR)
Clean Survey Data	AIR	CDC	Surgeon General Report project server
Types of File Transfer/Sharing (edit as needed): 1 - AIR Secure FTP (SFTP) is projected to be used to transfer files 2 - AIR Secure web portal/SharePoint is projected to be used to transfer/share files 3 - AIR inSync file sharing (Druva) 4 - External organization hosted file sharing/transfer 5 - Email (see section C2. Below) 6 - Mail (non-electronic) (see section C2. Below) 7 – Hand Carry/courier service 8 - Not known at this time

Role	Name	Phone/Email
Project Security Representative	Melissa Scardaville	404-260-1046
AIR Chief Information Security Officer	Robert McMahon, Sr.	202.403.5777
IT Enterprise Architecture & Engineering	Cory Schultheis	650.843.8180
AIR Education Unit Data Management (Chicago or Naperville Research Data)	Shaheen Khan	630.649.6585

Date	Document History Log	Author/Editor
6/8/16	Original security plan created	Huang, Alison
1/27/17	Update with new plan so AIR does not have PII in its possession.	Noel, HarmoniJoie

Windows Network Share (full path)
AIR SharePoint Location

Server Name
Network Share/Drive path

IRB submission

Attachment C - IRB Application Full Protocol.doc

Understanding Relationship Dynamics and Conflict Survey--Formative Study

IRB submission

OMB: 0920-1206

Development of Standardized Measure to Assess Disparate Contextual Forms of Intimate Partner Violence

Table of Contents

S creening Questionnaire

Form A: To Be Used When Projects or Tasks Collect Data From or Use Data About Human Participants

Screener Survey Consent Form

Screener Survey

Consent Form-Incarcerated Population

Consent Form-MT Population

Form E: To Be Used Where HIPAA May Apply