IRB Example Forms and Research Paperwork A step by Step guide on filling out the paperwork required for irb submissions

Checklist for Adult Sponsor Form (1)

Checklist for Adult Sponsor Form (1) Contd.

Student Checklist 1A

Student Checklist 1A (Continued)

Approval Form 1B

Student Approval Form 1B (Continued) To be completed before state fair

Qualified Scientist Form (2)

Qualified Scientist Form (2) Continued

Risk Assessment Form (3)

Risk Assessment Form(3) Continued

Risk Assessment Form(3) Continued

Human Participants Form (4)

Human Participants Form 4(Continued)

Human Informed Consent Form

Human Informed Consent (Continued)

Research Plan The Research Plan/Project Summary should include the following: a. RATIONALE: Include a brief synopsis of the background that supports your research problem and explain why this research is important and if applicable, explain any societal impact of your research. b. RESEARCH QUESTION(S), HYPOTHESIS(ES), ENGINEERING GOAL(S), EXPECTED OUTCOMES: How is this based on the rationale described above? c. Describe the following in detail: • Procedures: Detail all procedures and experimental design including methods for data collection. Describe only your project. Do not include work done by mentor or others. • Risk and Safety: Identify any potential risks and safety precautions needed. • Data Analysis: Describe the procedures you will use to analyze the data/results. d. BIBLIOGRAPHY: List major references (e.g. science journal articles, books, internet sites) from your literature review. If you plan to use vertebrate animals, one of these references must be an animal care reference.

Sample Research Plan September 5, 2016 Jane Doe Science Project – IRB Approval Process The rationale of this experiment is to test to see if the typical amounts of chlorine in Oakcreek city water and in home swimming pools have an effect on plant growth in the environment.  Small doses of chorine are added to drinking water to kill harmful bacteria making it safe to drink.  Chlorine is added to swimming pools to also kill harmful bacteria growth.   High levels of chlorine, however, can cause irritation to eyes, mucous membranes and skin and very high levels of chlorine could be harmful.  Since so many people drain water from chlorinated pools out into the environment and surrounding vegetation and also use unfiltered city water to water gardens, this experiment will test to determine what levels of chlorine actually affect plant growth.  Are the levels of chlorine commonly found in water in Oakcreek city water and home swimming pools high enough to stunt or affect the quality of growth in plants? 

The hypothesis of this experiment is that the bean plants watered with the highest levels of chlorinated water will not germinate or grow as well as the bean plants watered with little or no chlorine.  The research question for this experiment is, “How will the amount of chlorine in water affect plant growth?” The engineering goal of this experiment is to determine what specific amounts of chlorine in water will affect plant growth.  The results of this experiment will inform people about the possible hazards of draining chlorinated water from swimming pools into the environment. The expected outcomes of this experiment are that the bean plants watered with the highest levels of chlorine in the water will have fewer germinated seeds and stunted plant growth compared to the bean plants watered with lower or no levels of chlorine in the water. This is based on the rationale that very low levels of chlorine in water can be beneficial to killing harmful bacteria and higher levels of chlorine can have harmful effects.

PROCEDURES:  Gather materials:  4 plant beds, potting soil, bean seeds, exposure to sunlight, distilled water, watering cans, chlorine granules. Fill 4 plant beds equally with the same potting soil mixture in an outdoor area with equal exposure to sunlight. Plant 12 bean seeds, one inch deep and equal distances apart, in each of the 4 plant-beds. Water each of the 4 Plant Beds with 1 cup of a water solution twice daily at 8am and 5pm. Water Plant Bed #1 with 1 cup of distilled water (with no chlorine added) once daily at 8am.  Water Plant Bed #2 with 1 cup of chlorinated water mixture equivalent to typical Oakcreek City Water (1.4 parts per million chlorine per gallon of water).  Water Plant Bed #3 with 1 cup of chlorinated water mixture equivalent to typical home swimming pool (5 parts per million chlorine per gallon of water). Water Plant Bed #4 with 1 cup of chlorinated water mixture equivalent to a public chlorinated swimming pool (10 parts per million chlorine per gallon of water).  Repeat step 4 daily for 30-60 days. Record number of seeds that germinated at the end of each week. Record the height of bean plants in millimeters at the end of each week. Record any visual observations such as browning or curling leaves.

The potential risks of using chlorine are irritation to human eyes, skin or mucous membranes if touched.  The safety precautions that will be used are to wear safety goggles and gloves when handling the chlorine granules.  An adult will create the chlorine/water solutions following the student’s directions on chlorine to water concentrations. To analyze the data/results, the number of seeds that germinate in each seed bed will be counted and the height of the plants that grow will be measured in millimeters.  Visual observations about curling or browning of leaves will be documented as the plants grow.  The predicted data is going to be that the plants that are watered with the most highly-chlorinated water will have less seeds that germinate and that the plants that do grow will be stunted in growth compared to the plants watered with less or no chlorine.    The articles that were used in research include: reference.com, HortScience magazine, Chlorine.americanchemistry.com/safewater, ehow.com, InspiredLiving.com, ScienceLab.com, Oakcreek City Water data

Hazardous chemicals and activities: The risk assessment is that Dichloroisocyanuric Acid Sodium Salt (MSDS) can be hazardous in case of skin contact (irritant), eye contact (irritant), of ingestion, of inhalation (lung irritant). Prolonged exposure may result in skin burns and ulcerations. Over-exposure by inhalation may cause respiratory irritation.    The chemical concentrations that will be used in this experiment are: 1.4  parts per million, 5 parts per million, and 10 parts per million of chlorine granules in water. The safety precautions and procedures that will be used to minimize risk of injury are: An adult will mix the chlorine/water solutions to be used by the student for watering the seedbeds.  The adult will be using eye goggles and gloves to avoid contact with the chlorine granules. The methods of disposal are to place empty containers of chlorine granules in plastic garbage bags and placed in trash bins which are collected weekly by the city.  

Sample Human Participants Research Plan a. Participants: Describe age range, gender, racial/ethnic composition of participants:40 students will be asked to participate in the study to see if their performance on a test will be affected when they chew gum. Most of the students will be between the age range 12-14. The ideal participant population will have a 1:1 ratio of boys to girls. At least 10% of the participants will be represented by African Americans, Hispanic, Asian and Caucasian races. b. Recruitment: Where will you find your participants? How will they be invited to participate? Students will be asked if they would like to be participants through morning announcements, fliers that will be passed out in science class and asking students during lunch time in the cafeteria.

c. Methods: What will participants be asked to do c. Methods: What will participants be asked to do? Will you use any surveys, questionnaires or tests? What is the frequency and length of time involved for each subject? Participants will be asked to take a 30 question math test on day 1 without the use of gum and then will be asked to take the same test on day 2 this time they will be given a piece of chewing gum. There will be a week in between day 1 and day 2 of testing. This is so that students don’t just memorize the answers. The test should not take longer than 45 minutes each time. No other questionnaire or surveys will be used.

d. Risk Assessment: What are the risks or potential discomforts (physical, psychological, time involved, social, legal, etc.) to participants? How will you minimize risks? List any benefits to society or participants. If students are willing to be part of the study then they will be give the pre filled consent forms to be signed by the parents. The consent form will also contain the name of the product and the ingredients will be listed as it appears on the product so parents have all necessary information to make an informed decision about letting their students participate. Parents will be able to identify potential allergens and will then give permission for their students to be part of the experiment or deny the same. This will lower the risk of students being allergic to ingredients found in the product. Students will also be required to stay seated the time it takes for them to do the test so that will help minimize the risk of choking. They will be given only one piece of gum. Benefits: If the results support the hypothesis that there will be an increase in student performance as chewing gum reduces test anxiety, then it will give students a way to deal with test anxiety on standardized tests.

e. Protection of Privacy: Will identifiable information (e. g e. Protection of Privacy: Will identifiable information (e.g., names, telephone numbers, birth dates, email addresses) be collected? Will data be confidential/anonymous? If anonymous, describe how the data will be collected. If not anonymous, what procedures are in place for safeguarding confidentiality? Where will data be stored? Who will have access to the data? What will you do with the data after the study? All identifiable information will replaced with a student number and group number. So for example: Jane Doe from Math Period 2 will be changed to #5 Group Red. All identifiable information will be stored in a secure place with the adult sponsor. No other personal information will be gathered. In order to guarantee the anonymity of the test subjects only the color of the group and the student number will be used throughout the study and in the analysis of the results. Only the adult sponsor and the researcher will have access to the information which will be shredded at the end of the year.

f. Informed Consent Process: Describe how you will inform participants about the purpose of the study, what they will be asked to do, that their participation is voluntary and they have the right to stop at any time. Participants will receive a letter when they sign up to be a participant which will outline the purpose of the study and in that students will be explicitly told that their participation is voluntary and that they can choose to opt out of the study at any time.

Vertebrate Animal Form Click to add tet C to a Vertebrate Animal Form Fill in Student(s) name(s) and the Title of the project. Either on the form or on a separate piece of paper, fill out the answers to the questions to be completed by the student researcher , be sure to answer all of the questions.

Thoroughly answer questions on form 1. Felis catus 2. This cat is a housecat that has free roam of the house. The cat is also a pet. The cat likes to sleep in his cat bed, but he also likes sleeping on th couch, pillows and laundry baskets etc. The cat is fed via free feeding. This is that cat has access to food and water whenever he would like it. The cat will observed during meal times. 3. After experimentation, the cat will continue to live it's life as a housecat. 4. N/A 5. N/A

Send into the SRC When a Vet is required, this form and a form 5B will need to be filled out by the veterinarian. The rules website (page 12) will determine if you need a vet. https://member.societyfor science.org/document.d oc?id=632

Potentially Hazardous Biological Agents Risk Assessment Form Answer all questions thoroughly with your mentor or teacher

Potentially Hazardous Biological Agent Risk Assessment Form Mentor or Qualified Scientist should fill out this part. (Rules below page 15) https://member.soci etyforscience.org/d ocument.doc?id=6 32

Human and Vertebrate Animal Tissue Form Answer these questions thoroughly with the help of your mentor. https://member.so cietyforscience.org /document.doc?i(d =632 See rules page 18

Human and Vertebrate Animal Tissue Form This needs to be filled out and signed by the Qualified Scientist