Massanutten regional governor’s school 2009 – 2010 student research handbook table of Contents

Risk Assessment Form (Form 6)

Adapted from International Rules for Precollege Science Research

www.societyforscience.org/isef/

REQUIRED for ALL research projects using hazardous chemicals, activities, or devices before experimentation begins.

Student Name: __________________________________________________________________________________

Title of Project: __________________________________________________________________________________

To be completed by the Student Researcher in collaboration with the Qualified Off-site Mentor.

All questions must be answered, additional pages may be attached

1. List/identify the hazardous chemicals, activities, devices, or microorganisms that will be used.
2. Identify and assess the risks involved.

3. Describe the safety precautions and procedures that will be used to reduce the risks.

4. Describe the disposal procedures that will be used, if applicable.

5. List the source(s) of safety information/guidelines.

To be completed and signed by the Qualified Off-site Mentor.

I agree with the risk assessment and safety precautions and procedures described above. I certify that I have reviewed the Research Plan and will provide direct supervision.
_____________________________ _____________________________ _________

Off-Site Mentor’s Printed Name Off-site Mentor’s Signature Date

____________________________ _____________________________

Institution Position

_____________________________

Phone or e-mail

Informed Consent for Students Form (Form 7)

Adapted from International Rules for Precollege Science Research

www.societyforscience.org/isef/

REQUIRED for ALL research projects involving human subjects before experimentation begins.

Student researchers must provide important information about the project to participants. Participants and their parents must be notified of what activity the participant will be engaged in, how data will be collected and used, any potential risks and/or side effects, and how confidentiality will be maintained.
All participants and their parents must complete an informed consent form similar to that shown below.

To be completed by Human Subject (prior to participation):
 yes  no I have read and understand the conditions and risks above and I consent to voluntarily participate in this research study.

 yes  no I realize that I am free to withdraw my consent and to withdraw from this study at any time without negative consequences.

 yes  no I consent to the use of visual images (photos, videos, etc.) involving my participation in this research.
_________________________________ ______________

Signature Date

To be completed by Parent/Guardian (prior to participation for all students):
 yes  no I have read and understand the conditions and risks above and consent to the participation of my child in this research study.

 yes  no I have received a copy of any survey or questionnaire used in the research.

 yes  no I consent to the use of visual images (photos, videos, etc.) involving my child in this research.
_________________________________ ______________

Signature Date

Collecting Human Subject Research Data via the Internet

Adapted from International Rules for Precollege Science Research

www.societyforscience.org/isef/
Studies that collect data via use of the Internet require special consideration from the PRB. The use of the Internet and e-mail for data collection will pose challenges in collecting a) anonymous data, b) obtaining informed consent, and c) ensuring that participants are of the appropriate age to give informed consent. The research plan (Form 3) must explicitly address how these challenges were evaluated and addressed.
It is permissible to develop a process of obtaining informed consent that is conducive to Internet research. Researchers will want to provide information to potential participants about the purpose of the study and nature of their participation, potential risks, the voluntary nature of the study, and the participant’s right to withdrawal from the study at any time. A sample informed consent for adult participants is shown below. The text in italics provides an example of appropriate wording. If privacy and/or confidentiality are of particular concern, an alternative to asking participants to provide their name is also demonstrated.
Recruiting and utilizing participants who are under the age of 18 for a research study conducted on the Internet is permissible under the following two conditions:

1. 
   The parent/legal guardian must give consent through a traditional Form 7. In this situation, parents/guardians review and sign a Form 7 before the minor completes the online or e-mail survey.
   
2. 
   The student researcher must obtain consent from individuals taking the survey. The researcher must provide information to potential participants describing the nature of the study and what the participant will be asked to do, informing the participant of his/her right to withdrawal at any time and indicating that by typing I AGREE or checking a box on the survey that he/she agreed to participate in the study.
   

Sample Internet Informed Consent Text for Adult Participants
In order to decide whether or not you should agree to be part of this study, you should understand enough of its risks and benefits to make an informed decision. This process is known as informed consent. This consent from gives you detailed information about the research study. Once you understand the study, if you still wish to participate, you will be asked to electronically sign this informed consent form.
Title of Study:

Name and Contact Information of Student Researcher and Off-site Mentor (if applicable):

Purpose of Study:

Duration: My participation in this study will include the completion of this online survey.

Procedures: During the course of this study, I will be asked to complete this online survey.

Potential Risks/Discomforts:

Potential Benefits:

Confidentiality: All responses to this survey will be kept confidential. Your name or identity will not be linked in any way to the research data.

Right to withdraw: I understand that my participation is voluntary and that I may refuse to participate, or I may discontinue at any time.

Individuals to contact: If I have question about my participation in this study, I can contact:

I have read this form and I understand it completely. All of my questions regarding this form or this study have been answered to my satisfaction. I agree to participate in this research study.
I understand that by typing my name in the box below I am signing this form and therefore am providing informed consent for this study. OR By typing the words I AGREE in the space below and by completing the attached suvey I am giving my consent to participate in this research study.

Vertebrate Animal Form (Form 8)

Adapted from International Rules for Precollege Science Research

www.societyforscience.org/isef/

REQUIRED for ALL research projects involving vertebrate animals conducted in a

Non-Regulated Research Site before experimentation begins.
Student Name: __________________________________________________________________________________

Title of Project: __________________________________________________________________________________

To be completed by the Student Researcher in collaboration with the Qualified Off-Site Mentor.

All questions must be answered, additional pages may be attached

1. Common name (or Genus, species) and number of animals used.

2. Describe completely the housing and husbandry to be provided. Include the cage/pen size, number of animals per cage, environment, bedding, type of food, frequency of food and water, how often animals is observed, etc.

3. What will happen to the animals after experimentation?


To be completed by the PRB BEFORE experimentation
Level of Supervision required for agricultural, behavioral, or nutritional studies:

• 
  Off-site mentor is required. Please have applicable person sign below and complete Qualified Off-Site Mentor Form (Form 5).
  
• 
  Veterinarian is required. Please have applicable person sign below and complete Qualified Off-Site Mentor Form (Form 5).
  
• 
  Veterinarian and Qualified Scientist are required. Please have applicable persons sign below and complete Qualified Off-Site Mentor Form (Form 5).
  

The PRB has carefully reviewed this study and find it is an appropriate research study that may be conducted in a non-regulated site.

_____________________________ _____________________________ _________

School Division Personnel Printed Name Signature Date

To be completed by Off-site Mentor, Veterinarian, and/or Qualified Scientist.

(More than one form may be needed, duplicate as necessary)

• 
  I certify that I have reviewed this research and animal husbandry with the student before start of experimentation.
  
• 
  I certify that I accept primary responsibility for the care and handling of the animals in this project.
  
• 
  I certify that I will provide veterinary medical care/nursing in case of illness or emergency.
  
• 
  I certify that I will directly supervise the experiment.
  

_____________________________ _____________________________ _________

Printed Name Signature Date





Vertebrate Animal Form (Form 9)

Adapted from International Rules for Precollege Science Research

www.societyforscience.org/isef/

REQUIRED for ALL research projects involving vertebrate animals that is conducted in a

Regulated Research Institution before experimentation begins.

Student Name: __________________________________________________________________________________

Title of Project: __________________________________________________________________________________
To be completed by the Off-Site Mentor, Veterinarian, or Qualified Scientist
1. Was this a student-generated idea or was it a subset of your work?

2. Have you reviewed the Massanutten Research Handbooks relevant to this research project?  yes  no

3. What laboratory training, including dates, was provided to the student?

4. Species of animals used: ___________________________________Number of animals used: __________

5. USDA Pain Category designated for this study: ________________________________________________

6. Describe, in detail, the role of the student researcher in this project: procedures and equipment they will be involved with, oversight to be provided, and safety precautions to be employed. (Attach extra pages if necessary.)

7. Attach a copy of the Regulated Research Institution IACUC Approval.
Potentially Hazardous Biological Agents Risk Assessment Form (Form 10)

Adapted from International Rules for Precollege Science Research

www.societyforscience.org/isef/

REQUIRED for ALL research projects involving micro-organisms, rDNA,

fresh/frozen blood and body fluids before experimentation begins.

Student Name: __________________________________________________________________________________

Title of Project: __________________________________________________________________________________
To be completed by the Student Researcher in collaboration with Qualified Off-Site Mentor.

All questions are applicable and must be answered, additional pages may be attached.

1. Identify potentially hazardous biological agents to be used in this research project. Include the source, quantity, and the bio-safety level risk group of each micro-organism.

2. Describe the site of experimentation including the level of biological containment.

3. Describe the method of disposal of all cultured materials and other potentially hazardous biological agents.

4. Describe the procedures that will be used to minimize risk. (personal protective equip, hood type, etc.)

5. What final bio-safety level do you recommend for this project given the risk assessment you conducted?

To be completed by the Qualified Off-Site Mentor
1. What training will the student receive for this project?

2. Do you concur with the bio-safety information and recommendation provided by the student researcher above.  yes  no If no, please explain.

_____________________________ _____________________________ _________

Qualified Off-Site Mentor Printed Name Signature Date


To be completed by Off-Site Mentor
 This project was reviewed and approved by the appropriate institutional board before experimentation at a BSL-1 or BSL-2 laboratory and complies with the Massanutten Research Handbook. The required institutional forms are attached.

 The institution does not require approval for this type of study. The student received proper training. Attached is a letter from an institutional representative certifying the above

______________________________________

Off-Site Mentor Printed Name

_________________________ ___________

Signature Date

Human and Vertebrate Animal Form (Form 11)

Adapted from International Rules for Precollege Science Research

www.societyforscience.org/isef/

REQUIRED for ALL research projects involving fresh/frozen tissue, primary cell cultures,

blood and blood products before experimentation begins.

If the research involves living organisms, please ensure that the proper human or animal forms are attached.

Student Name: __________________________________________________________________________________

Title of Project: __________________________________________________________________________________

To be completed by the Student Researcher

1. What tissue(s), organ(s), or part(s) will be used?

2. Where will the above tissue, organ, or part be obtained (identify each separately):

3. If the tissue is obtained from a source within a research institution, please provide information regarding the vertebrate study from which the tissue was obtained. Attach a copy of the IACUC certification with the name of the research institution, the title of the study, the IACUC approval number, and the date of IACUS approval.

Funding Request (Form 12)
REQUIRED for ALL research projects requesting funding from Massanutten Regional Governor’s School
Student Name: __________________________________________________________________________________

Title of Project: __________________________________________________________________________________

List any research project items for which you would like to request funding. For each item include the quantity needed, cost per item, projected total cost, and distributor. Requests may be entirely funded, partially funded, or may not receive funding at all. Requests submitted prior to December 18^th will receive preferential treatment.

Item	Distributor	Quantity Needed	Cost Per Unit	Total Cost

Justification for the need of these items:

Projected date that items are needed: ___________________________________

______________________________________________________ ___________________

Student Signature Date