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 training instructions:
  • IRB Written Informed Consent/Parental Permission Waiver
  • Excluded studies (do not require IRB pre-approval or human participant paperwork)
  • Sources of information: Human participants
  • How can faculty researchers avoid being forced into student subjects?
  • Which research example with prisoners would be allowed?
  • What type of IRB review does not require IRB approval but does require IRB determination?
  • What is the IRB accused of?

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.

(Video) Tracking Study Participants - How to create and maintain a subject log for your research study.


consent form
Involving human participants in student-designed inventions, prototypes, computer applications, and engineering/design projects
risk assessment
sources of information

The following rules were developed to help pre-college student researchers comply with federal regulations for professional scientists and to protect the welfare of both human participants and student researchers. Health and well-being are top priorities when students engage in research with human participants.

According to the Code of Federal Regulation 45, CFR 46, a human participant is a living individual about whom a researcher obtains (1) data or samples through human intervention or interaction, or (2) identifiable private information.

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.


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).

(Video) Writing Videos for Kids: How to Evaluate Sources for Reliability

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.

(Video) A Beginner's Guide to Start Homeschooling: Tips and Resources from Kids Freeze Dance

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)

(Video) Use Google Scholar for academic research: Google Scholar search tips & tricks

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:

3. NIH Tutorial “Protecting Human Research Participants”

4. Belmont Report, April 18, 1979

5. Standards for educational and psychological testing. (1999). Washington, DC: AERA, APA, NCME.

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

Information for students:
Information about publications:

7. Pedagogical and psychological tests
Test center for the APA Science Directorate
Phone: 202-336-6000

8. Children's Online Privacy Protection Act of 1998 (COPPA) (15 U.S.C. §§ 6501-6506)

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.


What are additional protections researchers can include in their practice Citi? ›

Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include: A, Keeping the key linking names to responses in a secure location. B. Destroying all identifiers connected to the data.

Which of the following must occur before researchers can start research with children? ›

Parental Permission

Because a child cannot legally provide consent for research on his or her own behalf, permission by at least one parent or legal guardian is required before a minor is enrolled research study. Research involving no more than minimal risk requires permission from at least one parent/guardian.

Which example of research with prisoners would be available under the regulations? ›

Which example of research with prisoners would be allowable under the regulations? Examining age at first arrest as a predictor of adult criminal history. Examining age at first arrest is the correct answer.

Which type of IRB does not require approval? ›

“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.

What are five protections that researchers must make sure that research participants receive? ›

In practice, these ethical principles mean that as a researcher, you need to: (a) obtain informed consent from potential research participants; (b) minimise the risk of harm to participants; (c) protect their anonymity and confidentiality; (d) avoid using deceptive practices; and (e) give participants the right to ...

What are some best practices for researchers to protect research data? ›

What are Some Best Practices for Researchers to Protect Research Data?
  • Remain Current with Cybersecurity Practices. ...
  • Install Anti-virus Software. ...
  • Install a Firewall.
  • Update and Patch Operating System. ...
  • Data Classification. ...
  • System Authentication and Security. ...
  • Data Backup Options. ...
  • Data Encryption.

What is the first thing a student must do to begin the research process? ›

Step 1 – Identify a question or problem.

The first step in the research process is to develop a research question. This can be a problem that needs to be solved, or some piece of information that is missing about a particular topic. Answering this question will be the focus of the research study.

What are the major ethical considerations researchers need to consider in research with children? ›

Ethical considerations
  • Can I ensure children will not be harmed by involvement in the research?
  • How will I respond if children become distressed or upset?
  • What information do children need to provide authentically "informed" consent?
  • Is parents' consent always required for children to participate in research?

What needs to be done when conducting research with minors researchers? ›

In general, parental or guardian permission should be sought before seeking the assent of a child, particularly in more than minimal risk research, unless the requirement for obtaining parental or guardian permission can be waived.

What researchers conducting studies with human subjects must do to protect their participants and why? ›

One of the key aspects of protecting individuals participating in research is making assurances to those participants regarding how their personal information will be protected. This includes protecting participants' privacy, keeping information confidential, and/or allowing the participant to remain anonymous.

What are some examples of programs utilized for inmate rehabilitation? ›

Pre-Release Community Programs
  • Male Community Reentry Program (MCRP)
  • Custody to Community Transitional Reentry Program (CCTRP)
  • Alternative Custody Program (ACP)
  • Community Prisoner Mother Program (CPMP)

Why is it important to protect human subjects in research? ›

It is of central importance because we are ethical people, and society has set up regulations to assure minimum ethical standards in protecting subjects. Protecting subjects is also critical to society's research goal, since research subjects will not volunteer if the fear of harm becomes a major issue.

What are the 3 types of IRB? ›

There are five types of IRB review: (a) exempt, (b) expedited, (c) full, (d) continuing, and (e) limited. An exempt review doesn't require monitoring by the IRB. Exempt categories are outlined by the Department of Health and Human Services in 45 CFR 46.101(b).

What are the 3 types of review the Institutional Review Board offers? ›

IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full.

What IRB means? ›

Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials | FDA. The .gov means it's official.

What are 5 things researchers should do to ensure their work is ethical? ›

Five principles for research ethics
  • Discuss intellectual property frankly. ...
  • Be conscious of multiple roles. ...
  • Follow informed-consent rules. ...
  • Respect confidentiality and privacy. ...
  • Tap into ethics resources.

What are the 4 main ethical concerns that researchers face? ›

These include anonymity, confidentiality, informed consent, researchers' potential impact on the participants and vice versa.

What is one example of why researchers must take into consideration the benefits of their research? ›

An empirical article contains new knowledge or insight. What is one example of why researchers must take into consideration the benefits of their research? A study should only be conducted if the study's benefits outweigh the risks.

Where do you store research data? ›

In general, regulation requires that all raw data be kept for a minimum of 3-years after study completion. If the research plan includes long term retention of PII (in paper or electronic form), then all data files should be stored securely in a safe or locked file cabinets in a secure building.

How do researchers protect your information when storing data? ›

Methods for keeping data confidential range from using routine precautions, such as substituting codes for participant identifiers and storing data in locked cabinets, to more elaborate procedures involving statistical methods (e.g., error inoculation) or data encryption.

How do you secure data collection for research? ›

Securing Research Data
  1. Encrypt data. ...
  2. Limit access to only those that require it and have been identified within an approved IRB protocol.
  3. Conduct periodic access reviews. ...
  4. Follow Minimum Use guidelines. ...
  5. Do not e-mail PHI or PII without encryption.
  6. Ensure you have a strong password and change it regularly.

Where is the best place to conduct the research? ›

Discover 10 research sources you should consider, including the Internet.
  • of 10. The Internet. Hero Images / Getty Images. ...
  • of 10. Libraries. Bruce Bi / Lonely Planet Images / Getty Images. ...
  • of 10. Books. ...
  • of 10. Newspapers. ...
  • of 10. Magazines. ...
  • of 10. Documentaries and DVDs. ...
  • of 10. Government Offices. ...
  • of 10. Museums.
Mar 3, 2019

What are the methods used in research? ›

Most frequently used methods include:
  • Observation / Participant Observation.
  • Surveys.
  • Interviews.
  • Focus Groups.
  • Experiments.
  • Secondary Data Analysis / Archival Study.
  • Mixed Methods (combination of some of the above)
Sep 21, 2018

What to consider when doing research with children? ›

Consider whether the research poses any risk of harm to the children or researchers involved. Research shouldn't involve any greater stress than is commonly experienced in day-to-day life. In research about children's experiences, the main risk is the potential to trigger or cause emotional or psychological distress.

What are the most important ethical requirements for researchers? ›

Principles of research ethics
  • Respect for persons - autonomy and protecting those with diminished autonomy. ...
  • Beneficence and non-maleficence. ...
  • Justice. ...
  • Informed consent. ...
  • Confidentiality and data protection. ...
  • Integrity. ...
  • Conflict of interest.

Where can I find ethical considerations in research? ›

Ethical Considerations
  • Research participants should not be subjected to harm in any ways whatsoever.
  • Respect for the dignity of research participants should be prioritised.
  • Full consent should be obtained from the participants prior to the study.
  • The protection of the privacy of research participants has to be ensured.

What is the best way to get involved in research at your college as a student? ›

The most straightforward way to get an undergraduate research position is to send emails to professors. A simple look at a professor's profile on their department website will tell you if you're interested in the research their lab does.

How do high school students get involved in research projects? ›

The simplest way to get involved in research as a high school student is to join an existing research project. Every college and university has lab facilities because all faculty are required to conduct research and publish it as part of their job description.

What is the importance of conducting research for you as a student give 3 examples? ›

Studies reveal that research helps restore and protect memory and enhances mathematic and problem-solving skills. Therefore, it prepares the mind for a better understanding of concepts and theories. A person's learning capacity is improved and they can perform better in comparison who is reluctant to research.

What to do when conducting a research on human subjects? ›

Finally, neither the risks nor the costs of any research study should outweigh the likely benefits.
  1. Respect for persons. ...
  2. Beneficence. ...
  3. Justice. ...
  4. Think about issues of responsible conduct. ...
  5. Make sure the use of human subjects is both justifiable and necessary. ...
  6. Informed Consent. ...
  7. Elements of an informed consent document.

How do researchers ensure protection of human subjects participants? ›

Institutional review boards (IRBs) have the federally mandated responsibility to review research involving human subjects to ensure that a proposed protocol meets the appropriate ethical guidelines before subjects may be enrolled in the study.

What document must Researchers provide to human subjects before they agree to participate in the research project? ›

An informed consent document is typically used to provide subjects with the information they need to make a decision to volunteer for a research study. Federal regulations (45 CFR 46.116 ) provide the framework for the type of information (i.e., the "elements") that must be included as part of the consent process.

What kind of resources would you recommend to family members that have someone incarcerated? ›

Talk it Out
  • Read a book written by a former inmate or their family members.
  • Find a community group for inmate families in your local area.
  • Search for an online group of like-minded people.
  • Become a member of a social media group for wives/husbands/loved ones of inmates.

What are the programs you deem to include to further enhance the effective rehabilitation of every probationer? ›

Correction and Rehabilitation of Penitent Offenders
  • Individual and group counseling. ...
  • Moral, Spiritual, Values Formation. ...
  • Work or Job Placement/Referral. ...
  • Vocational/Livelihood and Skills Training. ...
  • Health, Mental and Medical Services. ...
  • Literacy and Education. ...
  • Community Service. ...
  • Client Self-Help Organization.
Feb 8, 2023

How do educational programs help prisoners? ›

Prison education also breaks down racial and ethnic barriers that are often a cause of tension and violence in prisons, significantly improves relations between staff members and the incarcerated, and dramatically enhances the prisoners' self-esteem.

What is an example of an IRB? ›

Some examples include informed consent, adequate staff training and experience, debriefing, and monitoring adverse effects on participants.

What types of studies need an IRB? ›

FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).

What are the levels of research review? ›

Most reviews fall into the following types: literature review, narrative review, integrative review, evidenced based review, meta-analysis and systematic review.

What are the different types of reviews? ›

What are the different types of review?
  • Systematic literature reviews (SLRs) ...
  • Rapid reviews. ...
  • Umbrella reviews or Overview of reviews. ...
  • Scoping reviews. ...
  • Literature reviews or narrative reviews.
Jun 28, 2022

What are the three kinds of sources that can be included in the review of related literature? ›

Primary, Secondary, and Tertiary Sources.

What are the four major types of reviews? ›

Over the years, numerous types of literature reviews have emerged, but the four main types are traditional or narrative, systematic, meta-analysis and meta-synthesis.

Who approves research studies? ›

In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

What particular types of individuals might need additional protections in research studies? ›

There are some groups who have been identified by the federal regulations as “vulnerable populations”: pregnant women and fetuses, minors, prisoners, persons with diminished mental capacity, and those who are educationally or economically disadvantaged.

What protections are there for participants in a clinical research study? ›

Researchers must provide patients with an informed consent form. This is a document with essential information that patients need before deciding if they want to participate. The consent form is usually a paper or online document that you must read and sign before enrolling.

What protections and information should be given to research subjects? ›

The purpose of the study. Foreseeable risks/discomforts to the individual. Potential benefits to the individual or others. Confidentiality protections for the individual.
Informed Consent
  • Voluntariness.
  • Comprehension.
  • Disclosure.

How can a researcher ensure the protection of the research participants? ›

One of the key aspects of protecting individuals participating in research is making assurances to those participants regarding how their personal information will be protected. This includes protecting participants' privacy, keeping information confidential, and/or allowing the participant to remain anonymous.

Which protection of human subjects in research means that researchers must ensure that the responses given by participants do not reveal their identities? ›

Confidentiality refers to a condition in which the researcher knows the identity of a research subject, but takes steps to protect that identity from being discovered by others.

Why is it important that researchers protect human subjects? ›

It is of central importance because we are ethical people, and society has set up regulations to assure minimum ethical standards in protecting subjects. Protecting subjects is also critical to society's research goal, since research subjects will not volunteer if the fear of harm becomes a major issue.

Why human subjects research protection is important? ›

The decision to conduct a study with human subjects carries both ethical and regulatory responsibilities to protect the welfare and interests of those subjects, to design the study so as to minimize risks to subjects, and to obtain adequate training for protecting the interests and welfare of the research subjects.

What rights of the participants must be observed by the researcher? ›

As a participant in a research study, you have the right:

To refuse to be in the study at all, and to stop participating at any time after you begin the study. To be told what the study is trying to find out, what will happen to you, and what you will be asked to do if you are in the study.

What ethical principles must Researchers adhere to protect the rights of participants? ›

Principles of research ethics
  • Respect for persons - autonomy and protecting those with diminished autonomy. ...
  • Beneficence and non-maleficence. ...
  • Justice. ...
  • Informed consent. ...
  • Confidentiality and data protection. ...
  • Integrity. ...
  • Conflict of interest.

How do you protect vulnerable subjects in research? ›

Protections for these persons should focus on devising a consent procedure that will adequately insulate prospective subjects from the hierarchical system. Such a procedure might involve having persons other than the investigator approach potential participants.

What is a document that provides guidance in protection of human subjects in research studies? ›

The "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," known as the Belmont Report, describe the ethical principles on which the regulations are based.

What ethical issues should be considered when conducting research to protect human subjects? ›

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

What are the three basic ethical principles for research involving human subjects? ›

Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.

What's something you can do as a researcher to ensure participants are fully informed during the informed consent process? ›

Researchers must give prospective participants all the information necessary for them to make an informed decision about participating in the research. Of note: The information must be provided in plain language that the participants will easily understand. A reading level of grade 6 to 8 is generally recommended.


1. Medical Myths: Reiki and Energy Healing
(Student Doctor Ben)
2. Operations research - subject introduction for all management students
(srinath ramaswamy)
3. Materials And Their Properties
4. How To Choose A Research Topic For A Dissertation Or Thesis (7 Step Method + Examples)
(Grad Coach)
5. CCP's Jack Ma Problem: Xi Jinping Ruined Ma's Life
(Business Basics)
6. Stop searching for your passion | Terri Trespicio | TEDxKC
(TEDx Talks)
Top Articles
Latest Posts
Article information

Author: Prof. Nancy Dach

Last Updated: 12/04/2023

Views: 5993

Rating: 4.7 / 5 (57 voted)

Reviews: 80% of readers found this page helpful

Author information

Name: Prof. Nancy Dach

Birthday: 1993-08-23

Address: 569 Waelchi Ports, South Blainebury, LA 11589

Phone: +9958996486049

Job: Sales Manager

Hobby: Web surfing, Scuba diving, Mountaineering, Writing, Sailing, Dance, Blacksmithing

Introduction: My name is Prof. Nancy Dach, I am a lively, joyous, courageous, lovely, tender, charming, open person who loves writing and wants to share my knowledge and understanding with you.