TEMPLATES, VERBIAGE & CHECKLIST

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Data Security Policy

Researchers often use their own personal computers to conduct the research. The IRB understands that the researchers will inform us they have protection on their computer and that they have password protection enabled on the user’s login. However, antivirus protection is not completely safe. The IRB also cannot expect researchers to only use their personal machine for research only during their research time period. Furthermore, if their laptop were to be left somewhere or if family members were to get onto the machine, the research data wouldn't be that safe and secure. Lastly, the researcher will often have to keep some data after research is completed for a long duration of time.

In order to know that the data is safe and to avoid all of these problems, the IRB suggests using an encrypted flash drive and storing all data related to the research on that drive. 

Suggested Verbiage:  

Once the data are collected, they will be stored on the researcher’s flash drive with encryption.  This flash drive will be accessible only to the researcher, using a strong password known only to the researcher.  No other individuals will have access. 

Anonymity in Online Survey Tools

Most online survey tools offer an anonymity option. You will need to demonstrate an understanding of your tool's anonymity options and provide a link to the tool's anonymity procedure.

Suggested Verbiage:  

To ensure the anonymity of the survey participants, in using [your online survey tool], the researchers will not be collecting IP addresses.  Here is the link in [your online survey tool] that provides information on how to turn off the function of collecting IP addresses: [insert link] This function will be utilized when building the survey.

Informed Consent in Online Survey Tools

Most online survey tools offer an informed consent option. You will need to demonstrate an understanding of your tool's anonymity options and provide a link to the tool's anonymity procedure.

 In collecting informed consent, the online survey tool provides the ability to place a page before the survey where informed consent information is provided.  Survey participants can read this information, and when they are ready, they can click Yes to move to the survey.  If they do not wish to participate after reading this information, they can click No. The process will end, and they will not move to the survey.

Templates for informed consent forms are linked below.

Example: Survey Monkey

Purdue University Global Consent for Participation in Research

Click here to download the template

Assent Form Templates

NOTE:  Informed Consent from parents/guardians is always needed in addition to assent from the child.

When children or minors are involved in research, assent of the child or minor and the permission of the parent/guardian are required.

While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent to or dissent from participation. Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if the research: 

1. does not involve interventions likely to be of benefit to the subjects; and

2. the child can comprehend and appreciate what it means to be a volunteer for the benefit of others.

The IRB must determine for each protocol whether all or some of the children are capable of assenting to participation, depending on such factors as the nature of the research and the age, status, and condition of the proposed subjects. 

Assent Process

The assent process, while not legally binding, should involve explaining to the child, in an age-appropriate manner, the following:

• what is going on in the proposed study;

• why the study is being done;

• what will happen to them during the study; and 

• that if they object, the research will be terminated and they will not be punished or scolded.
  
  

As children develop, they should gradually become the primary guardians of personal health and the primary partners in medical decision-making, assuming responsibility from their parents or guardians. Just as is the case with informed consent, the emphasis in obtaining assent should be on the interactive process in which information and values are shared and joint decisions are made.

Developing Assent Forms

The child should be given an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity, and condition. This explanation should include a discussion of any discomfort or inconvenience the child may experience if they agree to participate.

Investigators should submit both an informed consent form for parents and a separate assent form for the child to read and sign. An assent form should be written as simply as possible (e.g. at an approximate 6th grade reading level) and cover the following points:

• What the study is about;

• Why the child qualifies for the study;

• The voluntary nature of the study;

• The procedures that will be done;

• Potential benefits & potential risks;

• An assurance that he/she will be treated the same whether or not the child agrees to join the study;

• An invitation to ask questions; and

• Assurance that the child may withdraw from the study after discussing it with parents/guardians.

Click here to download the template for older children

Click here to download the template for younger children

Retention of Signed Informed Consent Documents

There are two options.  Please include the suggested verbiage for your chosen option in your Research Summary Plan.

Keeping original hard copy signed informed consent forms

Once the informed consent documents are signed, they will be collected and placed in a sealed envelope.  Anyone who has not signed a consent form will leave the room.  The class will begin at that point.  When the researcher is back at her office, the sealed envelopes of signed informed consent documents will be filed in a locked cabinet, and the researcher will be the only person with the key/access.  This data will be stored for a minimum of 3 years.  The original documents will be shredded.

Keeping signed informed consent forms in an electronic file

Once the informed consent documents are signed, they will be collected and placed in a sealed envelope.  Anyone who has not signed a consent form will leave the room.  The class will begin at that point.  When the researcher is back at her office, she will scan the signed informed consent documents into an electronic file, and she will shred the originals.  These files will be stored on the researcher’s flash drive with encryption.  This flash drive will be accessible only by using a strong password known to the researcher.  The researcher will be the only person to have access.  This data will be stored for a minimum of 3 years.  The subject files will be double deleted.