Where could student researchers and/or student subjects find additional resources? (2023)

All researchers, including faculty, students, and staff, conducting human subjects research are required to complete the online Human Subjects Training available through CITI (Collaborative Institutional Training Initiative) at citiprogram.org. This training is required for all types of IRB applications.

CITI certification must be renewed every three years. CITI certification must be kept current throughout human subject research; from participant recruitment to data analysis. Each course has a number of modules that must be completed with an overall score of 80%. CITI issues a “Certificate of Completion” for each completed course. See instructions for CITI training below.

Please upload a copy of the diplomas of all researchers involved in the research project (including student assistants) to IRBNet.If you are a student, please upload your graduation certificateandYour study advisor.

CITI training instructions:

1. Go to https://about.citiprogram.org/en/homepage/.

2.If you are a new user, you need to create an account. If you are a returning user, enter your username and password. To create an account, click Register and follow the on-screen instructions. Be sure to link your account to California State University San Marcos and provide your university email address.

3. Once logged in, click Add Course or Update Learner Groups. You should see this option under the California State University San Marcos shell.

4. Scroll down and answer questions 1 through 4. If you are not conducting laboratory animal research, leave question 2 blank. Based on this questionnaire, most students and teachers will use the "Social and behavioral science - basics/refresher" Course.

**If you are an undergraduate researcher or a faculty member of the School of Education,You must also select 'Social and Behavioral Responsible Behavior of Research Course' to Question 3. This course is mandatory and student submissions that do not include this additional certificate will not be processed until it is included.**

5. Click on the course name that appears under the California State University San Marcos shell to begin the training. Each course can last up to 4 hours. You can unsubscribe at any time and come back later to work on the modules listed under each course.

6. When you have successfully completed and 'passed' the courses, click 'Print report' for each course, save the report as a PDF and upload it to IRBNet with your application.

IMPORTANT:If you are a graduate student in the joint doctoral program with UCSD and are passing through their IRB office for your dissertation, you must add UCSD as your institution and follow their instructions for CITI.

Examples of projects that qualify as “human participatory research” are:

• Participants in physical activities (eg, physical exertion, use of substances, medical procedures)
• Psychological, educational and opinion studies (e.g. surveys, questionnaires, tests)
• Studies in which the researcher is the subject of research
• Testing of student-designed inventions, prototypes, or computer applications by human participants other than student researchers or single adult guardians/adult sponsors/QS/DS when testing requires an adult tester.
• Data/record review projects containing data that is not anonymized/anonymized (e.g. records containing name, date of birth, phone number or other identifying variables)
• behavioral observations
  • involve an interaction with the observed person(s) or where the researcher has changed the environment (e.g. putting up a sign, placing an object).
  • occur in non-public or restricted-access environments (e.g. day-care centers, medical practices)
  • involve the recording of personal data.

Rules

1. Student researchers must complete ALL elements of the Human Participants section of the Research Plan/Project Summary Instructions and assess and minimize the physical, psychological and privacy risks to their human participants. See risk assessment information on page 11 and onlineRisk Assessment Guidefor additional guidance.

2. Student research involving human participants must be reviewed and approved by an Institutional Review Board (IRB) (see page 5) before any interaction (eg, recruitment, data collection) with human participants can begin. It is the responsibility of the IRB to assess potential physical and/or psychological risks of the project and to decide whether the project is appropriate for student research and safe for the student researcher and participants.

a. Projects conducted in the school, home, or community that are not affiliated with a Regulated Research Organization (RRI) must be reviewed and approved by the school's IRB prior to student recruitment and/or interaction with human participants can begin. The School IRB must assess the risk and document its risk determination on Form 4.

b. Projects conducted at a Regulated Research Organization (RRI) (e.g. university, hospital, medical center, government laboratory) must have IRB approval from the RRI. A copy of the IRB approval for the project must be obtained. A letter from an adult mentor and/or qualified scientist is not sufficient documentation of the RRI IRB review and approval process.

3. The student must comply with all school or RRI IRB regulations before beginning any interaction with human participants (e.g., recruitment, data collection).

• a. If the IRB requires a QualifiedScientist (QS), Form 2 must be completed by the QS prior to any interaction with human participants. The school's IRB will review this completed form before approving the project.
• b. If the IRB requires a Designated Supervisor (DS), Form 3 must be completed prior to any interaction with human participants. The school's IRB will review this completed form before approving the project.
• c. See Rule #4 below for procedures required to obtain informed consent/consent and/or parental permission.

4. Participation in research may only begin after research participants have voluntarily given their informed consent/consent (in some cases with parental permission). Adult research participants may give their own consent. Research participants under the age of 18 and/or persons who are unable to consent (e.g. persons with developmental disabilities) give their consent if their parent/guardian gives permission.

The school's IRB determines whether parental consent/consent/permission can be a) oral or implied or b) must be in writing. See risk assessment information on page 11 and onlineRisk Assessment Guidefor further explanations on the declaration of consent.

1. Informed consent requires that the researcher provide the participant (and parent or guardian, if applicable) with full information about the risks and benefits associated with participating in the research study, which will then enable the participant and parent or guardian to make an informed decision about it to meet whether or not to participate.
2. Participants must be informed that their participation is voluntary and that they are free to withdraw from participation at any time (i.e. they may participate or refuse to participate without adverse consequences of non-participation or discontinuation of participation).
3. Informed consent must not involve coercion.
4. If written parental consent is required and the study includes a survey, the survey must be attached to the informed consent form.
5. The student researcher may request that the IRB waive the requirement for written parental consent/permission in their research plan if the project meets certain requirements. See the IRB Waivers section for more information on situations in which the IRB may waive written parental consent and/or written informed consent.

5. The research study must comply with any privacy laws (e.g., the U.S. Family Educational Rights and Privacy Act (FERPA) and the U.S. Health Insurance Portability and Accountability Act (HIPAA)) if they apply to the project (e.g., the project contains medical information).

6. Students are prohibited from independently diagnosing disease, administering medication, and/or performing medical procedures on human participants.

• a. A student may only observe and collect data for analysis of medical procedures, drug/treatment efficacy, and diagnosis of disease under the direct supervision of a licensed healthcare provider/professional.
• b. This healthcare provider/professional must be named in the IRB-approved research plan/protocol. The IRB must also certify that the student is not in violation of the relevant practice law (medicine, nursing, pharmacy, etc.) of the state or country where he/she is conducting the research.
• c. Entrants are prohibited from providing diagnostic or medical information to Entrants without the direct supervision and involvement of a physician. This includes posting diagnostic apps on public websites or app stores without proper FDA approval.

7. Student researchers may NOT publish or display in any report any information that directly identifies the human participants or through identifiers (including photographs) associated with the participants without the written consent of the participant(s) (Public Health Service Act, 42, U.S.C. 241(d)).

8. All published instruments that are not in the public domain must be managed, evaluated and interpreted by a qualified scientist in accordance with the requirements of the instrument publisher. Any use and distribution of the test must be in accordance with the publisher's requirements, including obtaining legal copies of the instrument.

9. Studies involving the collection of data via the Internet (eg, email, web-based surveys) are acceptable, but researchers should be aware that there are challenges in collecting anonymous data, obtaining a Informed consent and ensuring that participants are of appropriate age to give informed consent.

• a. Studies involving the use of minors in conducting online surveys must have informed consent and the minor's parent/guardian must provide written parental permission before the survey can be given to the minor. The procedures for obtaining parental permission must be described in the research plan.
• b. In order to maintain the confidentiality of participants, it is extremely important that IP addresses and the data provided are protected. Precautions must be described in the research plan.

For suggestions on how to comply with points 9a and 9b above, see the online survey consent procedures.

10. After initial IRB approval, a student with proposed changes to the research plan must repeat the approval process and regain approval before resuming interaction (recruitment, data collection) with human participants.

11. After experimentation and before the competition, the Affiliated Fair SRC will verify compliance with all rules.

12. The following forms are required:

• a.Adult Sponsor Checklist (1), Student Checklist (1A), Research Plan/Project Summary and Approval Form (1B)
• b. Human Participant Form (4) for projects screened by School IRB or IRB Approval Documentation by an RRI and any applicable consent forms and surveys
• c.Regulated Research Institution Form (1C), falls zutreffend
• d.Qualified Scientist Form (2), if applicable
• e. Risk assessment (3), if applicable

IRB Written Informed Consent/Parental Permission Waiver

The IRB may waive the requirement to document written parental consent/consent/permission when the research involves minimal risk and anonymous data collection and is one of the following:

1. Research incorporating normal pedagogical practices

2. Research on individual or group behavior or characteristics of individuals where the researcher does not manipulate the behavior of participants and the study does not involve more than minimal risk.

3. Surveys, questionnaires, or activities determined by the IRB to involve perception, cognition, or game theory, etc., that DO NOT involve the collection of personal information, invasion of privacy, or potential for emotional distress.

4. Studies involving physical activity where the IRB determines that there is no more than minimal risk and where the likelihood and magnitude of harm or discomfort anticipated in the research are no greater than those typically anticipated occur in DAILY LIFE or when engaging in routine physical activities.

If there is any doubt as to the appropriateness of waiving written parental consent/consent/permission, it is strongly recommended that documentation of written parental consent/consent/permission be obtained.

Involvement of the human participant in student-designed inventions, prototypes, computer applications, engineering/design projects, and product testing

Student-created inventions, prototypes, computer applications, and engineering/design projects that involve testing of the invention by a human participant require attention to the potential risks to the person(s) testing or trying out the invention/prototype.

1. Review and pre-approval by the IRB is required when the student-designed invention, prototype, application, etc. will be tested by human participants other than the student researchers or single adult guardians/adult sponsors/QS/DS when the testing is a requires adult tester. This includes surveys conducted for potential use, verification of the invention or consumer product and/or opinions on the project/product.
2. Human participants testing an invention, prototype or project involving a medical diagnosis or intervention (as defined by the FDA or the Medical Practices Act) must comply with rule 6 of the Human Participant Rules regarding the Prohibition of Medical Procedures and Be supervised by a healthcare professional with appropriate credentials and specialization in the area of ​​the medical diagnosis or intervention being studied.
3. A risk assessment form 3 is required for any student-designed invention, prototype, or consumer product project that involves human testing.

Excluded studies (do not require IRB pre-approval or human participant paperwork)

Some human studies are exempt from IRB pre-approval or additional human participant forms. Exceptional projects for ISEF and affiliated fairs are:

1. Student-created inventions, prototypes, computer applications, or engineering/design projects where the student is the only person testing the invention, prototype, or computer application and testing does not pose a health or safety hazard. It is recommended to fill out a risk assessment form (3). The use of human participants (other than the student researcher himself) for this test requires review and approval by the IRB.
2. Data/record review studies (e.g., baseball statistics, crime statistics) where the data is derived from pre-existing datasets that are publicly available and/or published and do not involve human interaction or the collection of data from a human participant for the purpose of student research research project.
3. Behavioral observations in unconstrained, public settings (e.g., mall, public park) where all of the following are true:
   a. the researcher has no interaction with the observed persons
   b. the researcher does not manipulate the environment in any way and
   c. The researcher does not collect any personally identifiable information.
4. Projects in which the student receives pre-existing/retrospective data in ade-identified/anonymousFormat that meets both of the following conditions:

• a. the professional providing the data certifies in writing that the data has been adequately anonymized prior to disclosure to the student researcher and will comply with all privacy and HIPAA laws, and
• b. the affiliated trade fair SRC ensures that the data has been appropriately anonymized by examining the written documents of the person(s) in charge.

Human participant & IRB resources

Use this information to determine the risk level of a study involving human participants.

All projects with human participants are considered risky.

There is minimal risk if the likelihood and magnitude of harm or discomfort anticipated in the research are (in and of themselves) no greater than those a potential participant would typically encounter in everyday life or while performing routine physical or psychological examinations or tests.

More than minimal risk exists when the possibility of physical or psychological harm or harm related to a breach of confidentiality or an invasion of privacy is greater than what would normally occur in everyday life. Most of these studies require documented informed consent or minor consent with parental or guardian permission (if applicable).

1.Examples of greater than minimum physical risk

• Movement that is not common in everyday life
• Ingesting, tasting, smelling, or applying a substance. However, ingestion or tasting projects that involve commonly available food or drink are assessed by the IRB, which determines the level of risk based on the nature of the study and local norms.
• Exposure to potentially hazardous substances.

2.Examples of more than minimal psychological risk

• A research activity (eg, survey, questionnaire, viewing stimuli) or experimental condition that could potentially result in emotional distress. Some examples are: answering questions about personal experiences such as sexual or physical abuse, divorce, depression, anxiety; Answering questions that may lead to depression, anxiety, or low self-esteem; or viewing violent or upsetting video images.

3.privacy concerns

• The student researcher and the IRB must consider whether an activity could have potentially negative consequences for the participant due to an invasion of privacy or a breach of confidentiality. Protecting confidentiality requires measures to ensure that identifiable research data is not disclosed to the public or unauthorized parties.
• The level of risk can be reduced by protecting confidentiality or collecting strictly anonymous data. This requires the collection of research in a way that makes it impossible to link research data to the person who provided the data.

4.The risk group
If the research study includes participants from any of the following groups, the IRB and student research must consider whether the nature of the study requires special protections or precautions:

• Any member of a natural risk group (e.g. pregnant women, mentally handicapped, economically or educationally disadvantaged people, people with diseases such as cancer, asthma, diabetes, AIDS, dyslexia, heart disease, psychiatric diseases, learning disabilities, etc.)
• Special groups protected by federal regulations or guidelines (e.g. children/minors, convicts, pregnant women, students who receive benefits under the Disability Education Act (IDG).

More detailed information on risk assessment can be found in the online risk assessment guide and consent process for online surveys.

Sources of information: Human participants

1. Code of Federal Regulation (CFR), Title 45 (Public Welfare), Part 46 – Protection of Human Subjects (45CFR46)
http://ohsr.od.nih.gov/guidelines/45cfr46.html

2. Dunn, C. M. und Chadwick, G. L., Protecting Study Volunteers in Research, 3. Auflage (2004). Boston, MA: Thomson Centerwatch. ISBN 1-930624-44-1.
Can be purchased from:
www.amazon.com

3. NIH Tutorial “Protecting Human Research Participants”
http://phrp.nihtraining.com/users/PHRP.pdf

4. Belmont Report, April 18, 1979
www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

5. Standards for educational and psychological testing. (1999). Washington, DC: AERA, APA, NCME.
www.apa.org/science/programs/testing/standards.aspx

6. American Psychological Association
750 First Street, NE Washington, DC 20002-4242
Phone: 202-336-5500; 800-374-2721
www.apa.org

Information for students:
www.apa.org/science/leadership/students/information.aspx
Information about publications:
www.apa.org/pubs/index.aspx

7. Pedagogical and psychological tests
Test center for the APA Science Directorate
Phone: 202-336-6000
Email:
www.apa.org/science/programs/testing/index.aspx

8. Children's Online Privacy Protection Act of 1998 (COPPA) (15 U.S.C. §§ 6501-6506)
www.ftc.gov/privacy/coppafaqs.shtm

How can faculty researchers avoid being forced into student subjects?

Answer and Explanation: One way to avoid coercion on research subjects isProvide each subject with a letter when he or she signs the informed consent form. The letter should state that participation in the study will not affect class grades.

Which research example with prisoners would be allowed?

What example of research involving prisoners would be allowed under the regulations?Examining age at first arrest as a predictor of adult criminal history. Testing of age at first arrest is the correct answer.

What type of IRB review does not require IRB approval but does require IRB determination?

"Excluded" human subject researchis a subset of research involving human subjects that does not require extensive IRB review and approval because the only research activity involving human subjects falls into one or more specific exception categories as defined by the Common Rule.

What is the IRB accused of?

An IRB is a committee charged withProtecting the rights and welfare of human subjects in research. An IRB reviews and monitors research plans, including protocols and instruments, for risks to human participants.