The IRB reviews proposed human research studies to ensure compliance with federal (45 CFR 46 et seq.) and state (22VAC40-890-10 et seq.) human research regulations. The essence of regulatory compliance is ensuring the protection of the rights, welfare, and wellbeing of clients, staff or others who volunteer to participate in research. This is accomplished through IRB oversight of the research plan and the informed consent process.
Human research is designed to address research questions or hypotheses using:
- surveys,
- administrative personally identifiable information (PII),
- focus groups,
- interviews, or
- observation.
Emphasis is on research activities that will be conducted for the purpose(s) of:
- a demonstration project,
- increasing understanding about program effectiveness,
- discovering evidence based practice(s),
- identifying client outcomes that can be broadly applied (affects other clients in other regions, states, etc.)
- sharing data/outcomes/analyses that may influence behavior, practice, policy, theory, or future research design,
- presenting at regional, national, or international meetings,
- publishing in an academic journal or other media
In contrast, examples of internal activities specific to an agency that are not human research and do not require IRB review includes:
- quality improvement,
- internal reports specific to an agency program,
- in-house program evaluations (e.g. training evaluations, HR surveys, staff satisfaction surveys, use of administrative data for program monitoring or performance, etc.),
- Accreditation studies, or
- Press inquiries.
The proposed research could involve activities conducted or authorized by any of the following:
- VDSS
- Local departments of social services
- VDSS-licensed facilities; or
- VDSS-authorized contractors
Questions or IRB applications should be submitted to irb@dss.virginia.gov
Information for Research Participants
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Subsection 1: Questions to ask before you agree to participate in a research study
The federal government's Office for Human Research Protections (OHRP) suggests some questions that you should ask before you agree to participate in a research study:
- Why is the research being done?
- What will be done to me as part of the research?
- How will I benefit from the research?
- Could the research hurt me?
- What will the researcher do with my information?
- Will the research cost me anything?
- How long will the study last?
- What happens if I decide to leave the study early?
- Who should I call if I have a question about the research?
For resources designed to help you better understand research and find the information to help you decide whether to participate in research click this link: www.hhs.gov/about-research-participation
Subsection 2: Bill of Rights for Research Participants
As a research participant, you have the right to:
- Be free of pressure from anyone else when deciding if you wish to take part in a study
- Make up your mind about taking part in a study without being rushed
- Be told what question, topic, or issue is being studied
- Be told what will happen and what the procedures are
- Be told about the potential risks or discomforts, if any, of the research
- Be told if you can expect any benefit from taking part and, if so, what the benefit might be
- Be told if there will be no direct benefit to you
- Ask questions about the study at any time before, during or after the study
- Refuse to take part in the study at any time
- Quit after the study starts, without any penalty
- Receive a copy of your Informed Consent Form to keep.
Do you have a question, concern or complaint about your involvement in a research study or your rights as a research participant? If so, please feel free to contact the VDSS IRB or the VDSS research participant's Ombudsman.
Procedures
IRB Operations
- Commonwealth of Virginia Laws Relevant to Human Subjects Research and Informed Consent (PDF)
- Guidance for Research Funded by DOE and NIDDR (PDF)
- Guidance for Research Funded by DOJ (PDF)
- IRB Member Responsibilities and Conflicts of Interest (PDF)
- Initial Review Checklist for IRB Members (DOCX)
- Limited Review Checklist for IRB Members (DOCX)
- Procedures for Recording Minutes at Convened Meetings (PDF)
- Reliance Agreements (PDF)
Review Types
- Continuing Review (PDF)
- Disclosure Standards for Research Determined Exempt (PDF)
- Study Closure (PDF)
Informed Consent
Children as Research Participants
Quick Start for Investigators
Forms
- Adverse Event Reporting Form (DOCX)
- Continuing Review Form (DOCX)
- Exempt Status Study Closure Form (DOCX)
- Exemption from VDSS IRB Review Request Form (rev. 9/2022) (DOCX)
- Modification to Approved Study (rev. 10/2022) (DOCX)
- Request for Initial Review (rev. 10/17/2022) (DOCX)
- Request for Waiver of Informed Consent (DOC)
- Request for Waiver of Informed Consent (PDF)
- Study Close-Out Report (DOCX)
Resources and Reports
- ASQ Consent Form Template (02-22-2016) (DOCX)
- HHS Human Subject Regulations Decision Charts: 2018 Requirements (Web page)
- HHS Human Subject Regulations Decision Charts: 2018 Requirements (Download) (PDF)
- HHS Informed Consent Guidance (Web page)
- HHS Regulations for Protection of Human Subjects in Research (45 CFR 46) (Web page)
