Templates and Suggested Verbiage
Data Security Policy - IRB recommendations (9/16/15)
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 really avoid all of these problems, the IRB suggests using a flash drive and storing all data related to the research on that drive. No data has to be stored on the machine, and it is completely portable so if the researcher’s machine was ever compromised with malware or the internal hard drive decided to crash, the research is still safe. Flash drives also can come with encryption software that would encrypt the data located on the flash drive in case the researcher left it anywhere. Most flash drives, even the cheapest ones (around $10) can be quite durable. Furthermore, flash drives are not susceptible to as much malware as the internal hard drive. Meaning if the computer hard drive did have malware infected on the machine, it would not affect the flash drive.
Flash drives are extremely affordable, more reliable, and the best choice for storing all research data. Here is a sampling of some professional, cost-effective flash drives that encrypt data on the drive: http://www.amazon.com/s/ref=nb_sb_noss_2?url=node%3D1292110011&field-keywords=flash+drive+encrypted&rh=n%3A172282%2Cn%3A541966%2Cn%3A1292110011%2Ck%3Aflash+drive+encrypted
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 by using a strong password known to the researcher. The researcher will be the only person to have access.
Anonymity in Survey Monkey
NOTE: All online survey tools do offer this option. The information below applies to Survey Monkey only, as it’s used most often. If you are using a different survey tool, please be sure to search in that tool for how to apply this there.
Suggested Verbiage: To ensure the anonymity of the survey participants, in using Survey Monkey, the researchers will not be collecting IP addresses. Here is the link in Survey Monkey that provides information on how to turn off the function of collecting IP addresses – this will be utilized when building the survey: https://help.surveymonkey.com/articles/en_US/kb/How-do-I-make-surveys-anonymous
Informed Consent in Survey Monkey
NOTE: All online survey tools do offer this option. The information below applies to Survey Monkey only, as it’s used most often. If you are using a different survey tool, please be sure to search in that tool for how to apply this there.
In collecting informed consent, Survey Monkey 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, and the process will end, and they will not move to the survey. Here is a link in Survey Monkey that provides information on how this is done:
Purdue University Global Consent for Participation in Research
Retention of Signed Informed Consent Documents
There are two options. Please select one (as appropriate) and include the suggested verbiage below 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.
Alternatively, this verbiage may be used instead:
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.
Assent Form Template
NOTE: Informed Consent from parents/guardians is always needed as well.
Introduction
When children or minors are involved in research, we require the assent of the child or minor and the permission of the parent(s).
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 children can comprehend and appreciate what it means to be a volunteer for the benefit of others.
The IRB must determine for each protocol - depending on such factors as the nature of the research and the age, status, and condition of the proposed subjects - whether all or some of the children are capable of assenting to participation.
Assent Process
The assent process, while not legally binding, should involve taking the time to explain to a child, at whatever age they can begin to understand, what is going on in the proposed study, why the study is being done, what will be done to them, 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. Just as is the case with informed consent, the emphasis on obtaining assent should be on the interactive process in which information and values are shared and joint decisions are made.
Develop 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 discomforts and inconveniences the child may experience if he or she agrees to participate.
Investigators should submit an informed consent form for parents and a separate assent form for the child (i.e., at about a 6th-grade reading level) to read and sign. An assent form should be written as simply as possible and cover the following points:
● What the study is about
● Why he/she 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 he/she agrees to join the study
● An invitation to ask questions
● Assurance that he/she may withdraw from the study after discussing it with his/her parents
Click here to download the template
Assent Form Template (for small children)
NOTE: Informed Consent from parents/guardians is always needed as well.
(This is the same as the regular assent form; however, the signature options are different since small children will not be able to sign their names.)
IRB Training
The Purdue University Global IRB is obligated to adhere to the terms of its Federal Wide Assurance with OHRP, which strongly recommends that the designated IRB establish educational training and oversight mechanisms (appropriate to the nature and volume of its research) to ensure that research investigators, IRB members and staff, and other appropriate personnel maintain continuing knowledge of, and comply with, the following: relevant ethical principles; relevant federal regulations; written IRB procedures; OHRP guidance; other applicable guidance, state and local laws; and institutional policies for the protection of human subjects.
Furthermore, OHRP recommends that a) IRB members and staff complete relevant educational training before reviewing human subjects’ research; and b) research investigators complete appropriate institutional educational training before conducting human subjects’ research.
Compliance with the training standard may be met by completion of any ONE of the following:
Completion of the CITI basic course in Social/Humanistic/Behavioral Research (14-15 modules (plus HIPPA module for those who are part of the nursing team and/or health sciences teams, respectively); OR
Completion of the PHRP CBT; OR
Provision of a certificate from another institution that provides a similar certification.
Following are details on each of the three abovementioned training options. For research investigators or IRB members who have not received any IRB training or have training that is outdated, certification can be obtained by completing either Training Option # 1 (CITI Basic Course in SBR) or Training option #2 (PHRP CBT).
Training Option #1: CITI Basic Course in Social/Humanistic/Behavioral Research (SBR)
Accessible from: https://www.citiprogram.org/default.asp
Stringent adherence to the directions in the instruction set is strongly recommended. If a person does not follow the instructions, and therefore, ends up taking a course other than the basic course in SBR, which as noted above, has 14-15 modules, then it is that person’s responsibility to take the correct course.
Certification in a “Refresher” course or a “Responsible Conduct in Research” course, or any course other than the basic course in Social/Humanistic/ Behavioral research will not be accepted. When in doubt, the IRB staff should be contacted for further direction in taking the basic SBR course.
Training Option #2: PHRP Computer-Based Training (CBT)
Accessible from: https://phrptraining.com/#!/
The very first page of the PHRP CBT Website includes clear and brief instructions for registering and completing the training. The training is straightforward and brief in comparison to the CITI training.
Training Option #3:
A certificate from another institution providing similar certification as Training Option #1 or Training Option #2 will also be accepted. However, one limitation applies. We will not accept training documentation that is outdated (i.e., more than 7 years old). Stated differently, 7 years is how far back the IRB will accept documentation of IRB training.