CU IRB
Revised September 2015 / 1

Data Plan Exemplar, Specific Pointers on Protecting Confidentiality, and Consent Form Exemplar

DATA PLAN EXAMPLE THAT CAN BE USED AS A MODEL:

[A data plan addresses how data will be captured, protected, and shared with others. Some specific pointers / guidelines in data security are given as bullet lists at the end of the Data Plan Example. You can copy and use this text if you want to use it as a model, but make this personal to your study and your data plan.]

This study requires the collection of personal identifying information. First, this will be in the consent form process. The consent form will have the name of the individual. This form will be kept in a separate file that is locked and away from the rest of the study information/data/questionnaires. However, we need other PII for this study, and this must be entered into our main database. The principle investigator and data entry manager will have access to this data. The name and address of the participant is needed in the records because this is a follow-up study and the principle investigator needs to be able to work with the participant over different days. Also, because we are doing tests where we must give the participant the results of the test and/or our study result, we need to retain the name and address (and such direct identifying information) for three years after the study. During the active research, due to the need to enter the data, both the data entry manager and the principle investigator will have the identifying information. After the active research, for three years after the research, the principle investigator will have this PII. The direct PII will only be stored on computers that are either 1) the principle investigator’s computer or 2) at the institution Concordia University – Portland. After three years, this PII will be deleted by the principle investigator.

The study also requires PII that is indirect, so that put together it is possible that some person could infer the identity of the participant. For example, we must have the street name in our records because this study includes understanding the geographic distribution of the XX . We assure that we will protect this information, limit the access/storage/use of this information to the absolute minimum in use and duration of use. Although we need such data for the data analysis, the results of each specific person is not necessary to be known. Therefore, all data analysis will be done on data sets that have been de-identified (and all related computing resources, such as flash drives or thumb drives or printed material). There will be no identifying information in publications and/or reports, written and/or oral. We will not show, display, or discuss PII, videos, photos or recordings, maps at a resolution closer than a street level, institution of work-place with job titles of the participants, or any such information that could reasonably allow someone outside of this investigation to identify a participant in this study.

As described above, regarding the direct PII, there will be only be 1) the consent form and 2) one data set solely controlled by the principle investigator and the data entry manager. The indirect PII is needed for data analysis by key investigators (names are listed as key investigators in this protocol), but this data will be limited in its use and duration of use. Data analysis that is conducted by anyone other than the key investigators will be done only on a data set that has been de-identified: that is, the data set will have no PII or data that could be reasonably linked to PII. Three (3) years after the active research has completed, as long as there is not a pressing reason (dictated by the institutional review board and/or the federal government – such as the FDA or study sponsor - determining that there is a reason we must remain able to re-contact the participants) all PII will be detected and only anonymized data will remain.

Study data, even if it does not include the PII itself, will be handled and stored using responsible research conduct data security measures. This includes the investigators never emailing study data unless it is de-identified, always using a password protected computer, always logging out of the computer when not in active use by the investigator (and only the investigator uses that computer), and storing data only on firewall protected computing resources. For example, any flash drive (or thumb drive) that is used in order to refrain from emailing data will be a flash drive that is password protected.

However, even with responsible data security procedures, there is some risk of this information inadvertently being disclosed (e.g., a data breech, a computing device being lost or stolen). Therefore, we will describe the type of data we will need/collect/store. The data TYPE is as follows

  • Type-1: not applicable – one or more investigator must have PII
  • Type-2: We will have data from questionnaires that include personal issues, such as history of past bedwetting, present feeling about peer pressure, and assessment of food insecurity (using the standard food insecurity scale ). This data is linked to PII because we are geographically studying this data, and therefore must use the location of residence at the level of a zip-code, but likely not lower than the level of the street.
  • Type-3: Because our study includes some school record data (for example, grade point average along with results on this school’s placement tests), and because the school we are studying is funded in part by the US Department of Education, we have data that is protected under the FERPA Regulations (see, However, this data is not going to be geographically analyzed and the data will only be analyzed if the parents along with the study participant give specific consent to obtain this data from the school, and so provide us with a request that the school gives us this information. Only the principle investigator will have access to this information (as described above).
  • Type-4: We have no needs, no plans and no anticipated reasons to observe or record a participant’s(s’) Type-4 level personal data. If we were to inadvertently come to know (or be exposed to) Type-4 data that would need to be considered in our study (or if we came to know something that could cause imminent harm to the participant, which must be reported according to state laws), we would immediately report this to the Concordia University – Portland IRB as an unanticipated event.

Ways to Protect Confidentiality

If it is essential to collect and link identifying information (e.g., subjects' names) to subjects’ responses (e.g., questionnaire answers), researchers must do their best and may need to be creative to provide the utmost confidentiality of subject data. The following are examples of practices that may be implemented to increase the level of confidentiality:

  • Use study codes on data documents (e.g., completed questionnaire) instead of recording identifying information and keep a separate document that links the study code to subjects’ identifying information locked in a separate location and restrict access to this document (e.g., only allowing primary investigators access);
  • Encrypt identifiable data;
  • Remove face sheets containing identifiers (e.g., names and addresses) from survey instruments containing data after receiving from study participants;
  • Properly dispose, destroy, or delete study data / documents;
  • Limit access to identifiable information;
  • Securely store data documents within locked locations; and/or
  • Never email data files or other documents that have identifying information; and
  • Assign security codes to computerized records.

What does confidential data mean, and how is it different than anonymous data?

Anonymous data are recorded so that the information can never be linked to the subject who supplied it. Confidential data are recorded so that the information is not immediately identified with the subject who supplied it, but such a link is possible. Confidential data are usually “coded”- that is, the subject is assigned a unique identifier that will be used to identify the data.

Maintaining confidentiality of information collected from research participants means that only the investigator(s) or individuals of the research team can identify the responses of individual subjects; however, the researchers must make every effort to prevent anyone outside of the project from connecting individual subjects with their responses. A study should not collect identifying information of research participants unless it is essential to the study protocol.

Examples of Identifying Information

  • Name
  • Addresses at a level lower than a zip code (>20,000 persons)
  • Employer's name or address, if small employer, or Employers name and department or position title if large employer (>100 employees)
  • Household member names or addresses
  • Date (e.g., birthdate, date of death, or other person-specific trackable date – for example, accident date if that accident is in a newspaper)
  • Phone / fax numbers
  • E-mail addresses
  • IP addresses that are static (that is, unless the network uses dynamic assignment)
  • Social security numbers
  • Member / account numbers
  • Voiceprints
  • Fingerprints
  • Full face photos & comparable images

Study Codes

The use of study codes is an effective method for protecting the confidentiality of research participants. Study codes may be used on data collection instruments in place of identifying information to protect participants' responses / data when data documents are stored or out in the open. Also, in the event that a data document is lost, stolen, etc. having the data protected by a study ID will prevent anyone who may view the data from determining the participant's identity.

How to Use Study Codes

If you need to link individual participants with their responses / data, if feasible, assign each participant a study ID prior to collecting data. On a separate document / file type each participant's name along with their unique study ID (e.g., 001). Store this document separately from data documents.

When you are ready to collect data, insert each participant's unique study ID onto their data document, or provide each participant with his/her unique study ID and ask him/her to insert the ID onto his/her data document.

How to Use Study Codes for Online Surveys

Provide each participant with his/her unique study ID on his/her invitation document (e.g., email requesting participation). Ask the participant to insert that code into a specified field on the online survey.

Mass Recruitment

If you cannot assign each participant his/her own study ID (e.g., large number of participants - mass recruitment), yet need to link individual participants with their responses / data, request that participants generate their own study ID. For example, you could provide participants with instructions such as:

  1. What are the first two initials of your high school's name? ____
  2. What day of the month were you born? ____
  3. What is the last letter of your first name? ____
  4. Combine your responses from 1-3 in order here (e.g., FA19A) : _____ (this is your study ID)
  5. Insert your study ID into question #1 of the attached survey.

Participants may then use this study ID for all survey instruments they complete. This will allow researchers to match survey instruments for longitudinal studies.

Methods to work on data in data files or collaborating with other investigators

ITS/STS – please help me write some of your suggestions for encryption software / websites and other resources such as the new server you are installing.

CONSENT FORM WORDING ABOUT DATA, CONFIDENTIALITY, AND DATA PLAN:

[Individuals must understand what type of information they are giving you for you to conduct your research. Provide examples of the kinds of data collected during the study, explain that you will keep it confidential by taking precautions, such as only using computers with special passwords and protections.]

Consent Form

STUDY:

Community Centers as a Barometer for Identifying the

Range of Stress Types and Levels

INVESTIGATORS:

Principle Investigator Dr. XXX XXXXXConcordia University – Portland

Co-investigatorMr. XXX XXXXPortland Area Community Center

You are invited to be in a research study of how this community center can improve the benefits and different programs we give you, your family, and the community.

You are being asked to volunteer, which is to consent, to being in this study because you came to the community center two times last month. We expect 200 individuals to be asked, like you, to participate in this study. No one will be paid to be in this study. Please, read this form and ask questions. You can ask questions now or later. But, we want you to know about the study before you volunteer.

WHY ARE WE DOING THE STUDY?

One important need the community has is knowing how much worry about food – having too much food or having not enough food – is part of our everyday life. This study will see if some stress is good and helps in school’s testing and helps in doctor’s testing results and if some stress is bad. We think some stress can be beneficial to us and some stress can cause problems. We hope to improve our program’s recreation and fellowship schedule and report to education and public health programs how they better detect and understand stress in our everyday life.

WHAT HAPPENS IN THE STUDY?

To be in the study, you must agree to talking with us and letting us take basic physical measures over a three month period of time. We will talk with you every month for 30 minutes, talking once every month for three months. In each visit with you, we will ask you to volunteer and give data (information). For example, volunteer means you will

  • Let us take your blood pressure, weight and other basic measure common in a nurse visit
  • Answer questions on teaching material and the benefits of your community center class
  • Answer questions about your activities, habits, and diet and how you feel about this
  • Explain what causes you to feel stress or not sleep well

One part of the study asks you to tell your school and doctor to give us a little information. The ONLY information we ask for is

  1. School test results for your grade point average and school placement exam from last year and this year.
  2. Doctor test results of your blood pressure test results from last year and this year

We need this information because it will help us know if the school or the doctor had information that would be related with the answers that you give us when we visit you. This information will help us and give you benefits.

☐ Check box if you say “Yes” to asking your school to give us this information: #1.

Your school’s name is: ______We will give you a form to give to your school.

☐ Check box if you say “Yes” to asking your doctor to give us this information: #2.

. Your doctor’s name is:______We will give you a form to give to your doctor.

WHAT ARE THE BENEFITS of volunteering to this study?

The benefit you get is to let us learn how to better serve you, your family and your community to build programs that can detect good and bad types of stress. You will have a benefit in participating in this study because talking with our investigator can be fun and can relieve stress. The study will benefit your family and others, because this study will help us and other cities and states improve their service to people of all different lifestyles and stress levels.

WHAT ARE THE RISKS of volunteering to this study?

You might feel uncomfortable or shy when answering some questions. This is normal and you can expect this. We get many different answers of all kinds of answers from all different people. There is no right or wrong answer. If you want to stop and talk about something else or play cards, we can do that. After we talk, if you remain uncomfortable or have stress due to our talk, you can call or write us (the principle investigator: Dr. First Last, at 999-999-9999, who works at Concordia University in Portland). You can also call or email a counselor in this community center who will talk with you at no cost to you (Counselor First Last, Community Hall, Portland, telephone 888-888-8888).

The questions and tests for this study are similar to questions your doctor or teacher asked you in the past. For example, if you went to the doctor, the doctor might ask why you are having trouble sleeping. We do not think you have any risk while you volunteer in this study. If you want to stop answering the questions or taking the tests, you can stop. This will not cause any problems and we will be happy to see you enjoy the community center in other ways.

WHAT IF I WANT TO STOP, OR TAKE AWAY CONSENT SOME PART OF THE STUDY?