Survey re safety of prepared foods.

[SilverLining]

We have been asked to post a link to an anonymous survey by a PhD grad and a PhD candidate from Virginia Tech. They are conducting a survey regarding people with food allergies and their means of determining if a prepared food is "safe" for them or not.

https://www.surveymonkey.com/s/RYV5FWK

[PurpleCat]

Why don't they want to say who they are?

[Anna Champion]

I am a current PhD graduate and I am conducting the survey. We are not trying to remain anonymous, the survey is anonymous so people taking the survey do not have to identify themselves if they don't want to!

[guess]

I believe her point is why is it missing the IRB basics for human test subjects such as to guarantee informed consent, any compensation implied or not given, the approval, the ability to opt out, etc. Has this received IRB approval?  If so please share.

[SilverLining]

Sorry. I worded it, and apparently poorly. 

Personally, I appreciate that those who fill in the survey can remain anonymous.

[guess]

A couple of items, ones that I'm not hanging around for.  Sorry.  Schedule.

Candidate or graduate?  Are you currently working under academic pursuits through the university as part of your program or at the behest of the university because a professor of yours has been contracted out by said uni to perform market research, and as a graduate assistant you are turning the work over? 

Have you graduated (not ABD but defended, graduated) and now doing this work in the employ of a for profit operation?

Who is we?  And, why?  I'd personally be satisfied with the IRB# although that would not necessarily meet the standard of informed consent for everyone.

Here's a clear example from another graduate student who properly disclosed for the purposes of informed consent. 

Hello Peanut allergic parents,
I am a mother of a 17 year old peanut/tree nut allergic son.  I am taking a graduate class (yes, I am a much older student) and my project is a small research study to find out if there is a correlation between pregnancy issues and peanut allergic children. Please, please take a moment to complete this simple 13 question survey!!!!!!!
The URL is: https://www.surveymonkey.com/s/X6Y2HC6Here is additional study information:
IRB STUDY #1310501940

INDIANA UNIVERSITY STUDY INFORMATION SHEET FOR

The Relationship between Food Allergies and Pregnancy Issues Study

You are invited to participate in a research study of investigating a relationship between pregnancy issues and peanut/tree nut allergies in children. You were selected as a possible subject because you have a child with food allergies. We ask that you read this form and ask any questions you may have before agreeing to be in the study.

The study is being conducted by Lisa Cortese, a graduate student at School of Engineering and Technology at IUPUI under the supervision of Professor Eugenia Fernandez at the School of Engineering and Technology at IUPUI. It is an unfunded study.

STUDY PURPOSE

The purpose of this study is to determine a possible correlation between pregnancy issues and children with peanut and tree nut allergies.

PROCEDURES FOR THE STUDY

If you agree to be in the study, you will complete an online survey. Please complete one survey for each peanut and or tree nut allergic child in your household

CONFIDENTIALITY

The survey does not ask for any personally identifiable information. Efforts will be made to keep your individual responses confidential. We cannot guarantee absolute confidentiality. Your responses may be disclosed if required by law.

PAYMENT

You will not receive payment for taking part in this study.

VOLUNTARY NATURE OF STUDY

Taking part in this study is voluntary. You may choose not to take part or may leave the study at any time. Leaving the study will not result in any penalty. Your decision whether or not to participate in this study will not affect your current or future relations with Indiana University or Purdue University.

CONTACTS FOR QUESTIONS OR PROBLEMS

For questions about the study, contact the researcher Lisa Cortese-Allie at 317-490-8884or lcortese@iupui.edu.

For questions about your rights as a research participant or to discuss problems, complaints or concerns about a research study, or to obtain information, or offer input, contact the IU Human Subjects Office at (317) 278-3458 .

[Anna Champion]

Just to further clarify, I am a graduate of the PhD program, no longer affiliated with the University and conducting this market research for a proposed business endevour NOT affiliated with any federal or state funded program/monies. An IRB is not needed. The surveymonkey allows you to stay anonymous if you choose to take the survey. If you have reservations, please feel free to abstain.

[guess]

Do you have any CITI training for human subject research?  It would be the standard outside of academic pursuit.  An absence of affiliation with a university does not obviate the need for informed consent.  Responsibilities to human subjects is not limited to anonymity.

If you are in the employ of a company I'm not sure why you're leveraging your PhD and university if it's not at all affiliated.  It would have been better to disclose up front your current position.

We have been asked to post a link to an anonymous survey by a PhD grad and a PhD candidate from Virginia Tech. They are conducting a survey regarding people with food allergies and their means of determining if a prepared food is "safe" for them or not.

Company name that is asking for our data?  Please.  I'm well informed of my right to opt out.  I'd like to know what I'm opting in for. 

https://www.citiprogram.org/index.cfm?pageID=418&id=74

Human Subjects Research - SBE Guide (November 2014)

CITI Program's web-based Human Subjects Research - SBE content is now available in a book entitled, Human Subjects Research (HSR) Guide for Social, Behavioral, and Educational Research.

Highlights:

    Discusses issues that arise in the context of SBE research involving human subjects
    Allows you to review and reference core concepts, regulations, and guidelines
    Comes in a convenient print format
    Provides a compilation of modules from our online HSR - SBE course

[Anna Champion]

I am honestly not trying to "leverage" anything. The original fb admin asked about my background and the recent PhD is what I have to say. I am NOT employed by a company I have just literally graduated and have an idea for a product and would like to know if anybody else would find it useful. I have CITI training through my University but please don't think I'm leveraging that. I am just a person with Celiac that thought of an idea. This is not data that I will publish or use individual responses. For all intents and purposes that I have researched, it does not require specific training to ask a question.

Please, do NOT answer if you are uncomfortable.

[guess]

Ms. Champion, this is about informed consent - not my comfort zone.  When you are asked about the background for the sole purpose of making a decision to participate it should not be treated as a trick question designed to vex you.

In that spirit I leave this to the others so that they can make decisions for themselves and understand their rights in research including surveys per the example I posted previously.  That is the gold standard.  For the record I *did* participate in that survey as I know how hard it is for graduate students to generate responses for their work.

[Office for Human Research Protections (OHRP)

§46.116 Informed Consent Checklist - Basic and Additional Elements

I'll cross-post to the research thread later.

[Anna Champion]

I don't mean to sound like I'm trying to hide anything or that I was vexed. I stated above exactly what I was asking the questions for. It was meant for something as simple as a fb question and answer and was not meant to stir up human research subject debate. I understand now that is your profession, but I'm just not understanding how I can be any more transparent than I have been. I have a product idea and I'd like to know if anybody else with allergies would be interested in it and what kind of prices they would be willing to pay for it. I'm not sure what you want me to do.

[SilverLining]

One question I was surprised was missing from the survey (well, a two-parter actually)

How often do you eat at restaurants (of any kind)?
Would a product like this mean you might eat out more often?

~~~

Personally, I don't eat in restaurants.
A product like this, if it were accurate and not to expensive, might result in me eating out more. I can't say for certain...but probably.