David Allbritton, Psychology LRB
Updated Nov. 24, 2015
As you prepare your proposal or claim of exemption, try to address the issues below that the IRB frequently mentions in reviews. It could save you some time on revisions.
Frequent IRB Comments and Revision Requests:
1. Since the student subjects will receive subject pool credit for participation, please amend the Information Sheet to specifically indicate the amount of credit (1 credit, 0.5 credits, etc.) the students will receive for participating.
2. Will you be using the Experiment Management System for hosting your survey or will you be using an external online survey host (i.e. Quickdata, Qualtrics, Survey Monkey)? Please visit this website for additional web survey details: Psychology Researchers.
3. Web-based Studies. When conducting research using the psychology subject pool for recruitment, and when the survey is completed through a survey program that is outside of the SONA system, a number of steps in the research methods need to be clarified in the application and materials provided to the subjects.
a. How the subjects get the credit for participating. Indicate the process for capturing the subject pool numbers (participant codes in Sona Systems web-based experiment scheduling system) so that you can provide the subject credit within the Sona system. Most online surveys create a separate page at the end of the survey in which the subjects enter the subject pool number. This page is not linked to the survey responses, so that the survey responses remain anonymous. If not using this method, what other method is being used? [note: edited by DA]
b. Where will the instructions for getting credit be posted for the subjects? In the info sheet? At the end of the survey? After the debriefing script?
c. How and when will the information sheet (consent) text be provided to the subject? Does the SONA system list the URL and then will the URL go directly to the info sheet and they click I agree to move to the survey itself, or will the info sheet be on the same page as the survey?
d. Since you will be using an external online survey system such as Qualtrics, please visit this website Pyschology Researchers for further information about how to grant students credit. This is a helpful link for Psychology researchers. (http://csh.depaul.edu/departments/psychology/research/intro-psych-research/Pages/researchers.aspx)
4. Anonymous vs. de-identified: In the plan of work: Clarify if the measures will be linked to the subject in any way (i.e. a code or other indirect identifier) or if the data will be recorded in a totally de-identified manner. This also relates to Step VIII item A 5 which says the anonymous data will be kept…. The data is not anonymous since you know the names of the people and the research is completed in-person, but you can record it in a de-identified manner.
5. In the application, please list out how much credit each student will receive, how they will obtain the credit, and that only participants 18 years and older can participate. The application should be your protocol with all the necessary details listed (a stand-alone document).
6. Please submit the actual page that captures the students’ information in order to grant them credit for completing the survey. You mention it will be the last page (separate from the survey); however, there is no such page at the end of the survey.
7. When will the information sheet be presented to the students? Will this be the first page of the survey? Will this be a separate page (if so, you will need to add a link to the survey)?
8. Since the survey is open-ended, please add to the instructions a reminder to students to not include names or identifying information in the responses, to preserve anonymity.
9. Please provide a description of the study that will be listed on the website when recruiting subjects via the psychology subject pool. All recruitment materials need to be submitted to the IRB for review prior to using.
10a. NOTE: This one seems to represent a new, stricter interpretation of what can qualify for exemption than we have seen in the past:
Upon further review of the activities presented in your research, it does not seem that your study falls under the exempt categories, specifically, Category 2: “involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation”
a. Your research involves a survey measures, as well as a video, additional paragraphs to read, and additional measures regarding their beliefs. If your research only involved the survey measures, or educational (cognitive tests) as well as the surveys, it would fall under the exempt category 2. Remember that to meet the criteria for exemption, all the research activities must fit into the narrow confines of the exempt categories.
10b. NOTE: Deception usually requires expedited review rather than exemption, but not always:
There are differing opinions about whether a study like this would qualify for an exemption or would need to be reviewed under the expedited guidelines. We have determined that your study falls within exempt category 2: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. The questions in your survey are benign in nature and the deception is minor and not the focus of the study.
10c. NOTE: More discussion of the criteria for exemption:
As a reminder, we have determined that your study qualifies for an exemption .... Specifically, your study falls within category 2: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. This determination that your study qualifies for an exemption was made based on a number of factors:
a. Your study is completed anonymously online, so there is no risk that a subject’s personal information or identity will be linked to the survey.
b. Looking at you actual survey, the questions carry benign risk: you are not asking them to divulge potentially embarrassing or incriminating information or cause damage to reputation, financial standing or employability.
c. Studies that meet the criteria of the exempt categories do not require informed consent containing all the elements of consent, as technically they are exempt from the informed consent requirement. At DePaul we use an information sheet to provide the information that an informed consent document normally would to the subject in agreement with the Belmont principle of Respect for Persons and voluntary participation.
11. Awarding credit for Lab Studies for Intro Psych Participants:
The plan of work should include a description of the plan for collecting the Psychology Subject Pool numbers for the subjects who complete the study and how you will provide them credit given that this is a lab study versus one completed directly within the subject pool system.
Information from David Allbritton regarding the process: For lab studies, when a student signs up the researcher sees only their system code listed by that time slot. When the researcher goes to award credit, she clicks on a time slot and then selects "credit, no-show" etc. from a menu. Again, only the student's system code is visible. So to award credit, the researcher must know either the time of the appointment (if only one person was scheduled at a time) or the participant's code (if more than one person was scheduled at a particular time). So what researchers should probably say is: "When the participant arrives at the lab we will record their random system-assigned participant code number (or whatever you would rather we call that) on a list that is not linked to their data. We will then use that code number to award the participant credit in the experiment signup system, since participants are identified to us in the system only by code number and not by name." So it is basically the same system we use for externally-hosted web-based studies, except it is a "list" of participant codes rather than a "database" of codes. So probably all studies should say pretty much the same thing about recording the codes in a list/database and using them to award credit.
12. Intro Psych Subject Pool credit is considered an inducement:
Step VI item F of application, inducements: Revise to yes and indicate the amount of credit that will be provided for participation in the research. In the compensation section of the consent form, also indicate the number of credits being provided for participation.
13. Will the IP address of the subject be captured by the survey program and be made available to you? If you obtain the IP address the surveys are not anonymous. Most survey programs have settings where you can indicate you do not want the IP address in the data set.
[For example, see this document on how to change settings in Qualtrics to avoid recording IP addresses: https://docs.google.com/document/d/1Ngo3cLTL_nyPFTLNYM3Rh6MtYXi9Q4xuuEzntfas5sk/edit?usp=sharing
Look for the item about “collecting fully anonymous data with Qualtrics”]
13b. Language has been added by the IRB to your information sheet to state that IP addresses will not be collected. Please make sure to adjust the settings of you Qualtrics survey to not collect IP addresses.
14. In the consent document: Under “Can I decide not to participate?” Please add the following statement: “If you decide not to participate you will not receive 1.0 credits towards the Intro Psych research requirement.” (assuming this is true). Another statement should be placed in this section saying “Your decision whether or not to participate will not affect your grades or standing here at DePaul University.” [note: edited slightly for clarity - DA]
15. In the consent: Please change "You will be given a copy of this sheet for your records" to "You may print out a copy of this sheet”. Make appropriate changes to all versions of information sheet. [note: This is for online studies that have an online consent process.]
16. Since we received all study documents in one large scanned PDF, we are unable to make these revisions for you. Please send all revised documents as stand-alone WORD documents, especially all recruitment items and the consent documents, as we need to be able to manipulate them. [DA note: We are changing our LRB instructions in light of this to no longer encourage putting everything in one pdf file]
17. Do you have any examples from previously approved IRB protocols?
Consent form examples: https://docs.google.com/document/d/1qeqwenVkxvzLTjvqdIjIgcVSmUYZj0fF2nx3DypoxIw/pub
18. Storing data.
The IRB does not require that data be destroyed. As a measure to protect the confidentiality of research data, the IRB does require that the data be de-identified as soon as possible in the research process. Data that is de-identified may be kept indefinitely. If there is a reason that data must be kept in an identifiable manner, the IRB does not disapprove of this, but would require a justification as to why you need to retain identifiable data and would want to ensure that protections are in place to protect the confidentiality of the data.
19. Who can bypass the LRB and submit directly to the IRB? [PI must be faculty]
For future reference, you submitted this application bypassing the LRB review process because your faculty sponsor had submitted IRB applications before. This is an incorrect interpretation of the revised LRB policy. The revised policy indicates persons who do not need to go to the LRB are seasoned faculty researchers who have submitted before to the IRB. In this case a student (you) is the PI of this study and you have not submitted to the IRB before and all students regardless of whether they have submitted before or not are required to submit their protocols to the LRB before the IRB.