The “Second Scientist” Protocol

Project Proposal Guidelines 3

For All Projects 3
Guidelines for Projects involving humans (no-hypothesis) 4
Guidelines for Projects involving humans and a hypothesis. 4

Templates to Use for Convening an IRB 5

So you want to run an experiment, collect some data, or do large scale education projects…
This document will help you to figure out how to run your project safely and with the appropriate
level of review.

First things first, can you answer yes to any of the following?
Are you going to share data outside of your classroom? Are you dividing students into groups
and then give them different experiences? Is this something that has not been done before?
Does this involve any animals (dead or alive) with a spinal cord? Are you going to kill or cause
pain to anything? Are you using any chemicals listed as mutagens or poisons?

Step 1: The First Few Set of Questions.

Are you a student or a teacher? If you are a student most of this will have to be written.
1. Are the people doing the experiments or ​projects​ going to be exposed to anything
dangerous or controlled (​by​ the FDA or DEA)?
2. Are you doing experiments on humans or collecting data from humans?
3. Where​ are you hoping to share this information?

Step 2: Learn the three levels of review.

1. No permission needed!
Go for it! (e.g. A teacher doing something inside their classroom)

2. Second Scientist/Expert
You are most likely good to go, but you should run this by at least two scientists/experts.
If you are teacher, you count as the first scientist.

3. IRB. Institutional Review Board

These projects usually involve questions of ethics and require different levels of further
involvement by counselors (if there is a potential danger to students), administrators (if
 something dangerous is happening in the school), the CFO (if there is a question of
legality), and/or an external scientist (someone who is objective and not a part of the
school).

These projects will usually involve a proposal and then a review by a convened IRB.
The second scientist can help you to convene the IRB. We have people “on-call” for just
this purpose, the Nueva Science Collective. All IACUC or IRB communication should all
happen in writing or via email.

Step 3: Determine the Level of Review that you Need.

Take a look at the grid that is on the next page. Look to the left and see if your project involves
any of the listed items. Look to the right and you should be able to see what level of review that
you need.
Project Proposal Guidelines

For All Projects

1. Name of the Teacher Sponsoring your project. Or the name of the teacher writing this
proposal.

2. Looking at the grid, determine who you need to talk to and list them here.
 3. Where are you planning on running your experiment? Where are you planning on
storing the items that you are going to use in your experiment?

4. What is a basic description of your project?

5. What is the value of the project?

6. What other projects have you studied to make sure that this project will be successful?
Other papers, posters, conversations with other scientists. Please list any protocols that
you are using in this section.

7. What are any of the potential harms to the people running the experiment?
Are there any dangerous chemicals? Could you get bitten? Could you get lost?

8. What steps are you taking to make sure that you are mitigating the risks?

9. What are you doing this experiment on? And what is the potential harm to the people
that you are experimenting on? Please consider all possibilities (e.g. consider the
impact of getting both a positive or negative result)

Guidelines for Living Organisms (All Non-Human Vertebrates)

1. Does this involve the loss of life or pain to the vertebrate? If so, why is the loss of life or
pain necessary?

2. If there is loss of life, please explain the method you are using to euthanize (all
euthanizations at Nueva require double methods) Gas is not a method of euthanasia.

3. What steps have you taken to ensure that you are using the fewest animals and least
pain that you can? E.g. look at previous published experiments.

Guidelines for Projects involving humans (no-hypothesis)

There are two types of human experiments and you need to figure out which one you are doing.
Is this a hypothesis-driven experiment, with groups who experience different interventions? If
you are doing a hypothesis-driven experiment you are probably going to do different things to
different groups of students and that requires a few more considerations.

1. Are you using people under the age of 18?

If so, did you consider whether or not you need parental permission? If you are doing
something new, the answer is yes, you are going to need to at least notify the parents.

2. Did you get people’s permission before you gathered any data?

3. Are you taking steps to ensure anonymity?

4. Are you taking as little as you can: Take as little information as you can from people. If you
don’t need their names, don’t collect them.

5. If you are taking names, are you taking steps to protect your data? Don’t store it on
the cloud. Generate codes for students and store those codes in different places than
there data. This is a real good time to ​run questions by the tech department.

Guidelines for Projects involving humans and a hypothesis.

1. Have you satisfied the requirements for informed consent?

You must explain your experiment to the people being tested. You must explain what
the groups in your experiments are.

There is a link here for more information:

https://research-compliance.umich.edu/informed-consent-guidelines

2. Have you satisfied the requirement for plain language when communicating with the
people in your group?

3. Is there a potential harm to one group? How do you mitigate this harm.
For example: If you are trying out a new amazing Spanish teaching module, you may
want to have a group that uses the module and another group that doesn’t. It is
unethical to deprive students of a learning opportunity (that you think will work).
Templates to Use for Convening an IRB

Hi Administrator!

We were hoping that you could serve on an institutional Review Board (iRB). It would take
you no longer than 10 minutes. I know that your time is very valuable, so feel free to pass
this on. One of the kids suggested that you might enjoy being a part of this.

The Background:

One of our research groups is going to need iRB approval to proceed. Our iRB/IACUC
protocol recommends that we run a protocol by an internal scientist, external scientist,
administrator​, and counselor. You are one of those, and we would really appreciate it if
you could participate.

If you agree, you will get a two-page proposal in a few days. The proposal will outline the
design of the proposed experiment, the reported value of the experiment, possible danger,
and the mitigation of that danger.

Instructions for Proposal Review:

Please consider the experiment from the point of view of your role. For example, as a
counselor, you are considering the health and mental impact of the study. You have three
options when replying. ​You can "approve", "approve with suggestions", or "require
modifications".​ If you respond with the two latter, please explain what you would like to
improve and suggest a way to improve them. The "require modifications" option effectively
stops the experiment.

Some people are confused about why there isn't a "NO" option. In essence, there is. If you
want to answer "no" or "disapprove" you simply point out the part of the project that you
think is most egregious and require a modification.

For example:
I require a modification to the experiment that you propose. You cannot use human
subjects in this experiment.

Response to this Email

In response to this email please simply reply "I accept" or "I cannot"

Thank you.