Human Research Protections Program (HRPP)

WVSOM is committed to working with human subjects in an ethical manner. WVSOM holds a Federalwide Assurance with the Office of Human Research Protections (FWA00007632).

Before any research projects with human subjects can proceed, an Institutional Review Board (IRB) must approve any research project involving the use of human subjects including social-behavioral, educational or bio-medical research. Investigators should contact the IRB chair for details regarding IRB submission. The WVSOM IRB will only review research projects that have received Institutional approval from the ORSP (completion of ORSP-1).

All individuals engaging in human subjects research must have appropriate training and be approved by the IRB prior to engaging in human subjects research (HSR). Being "engaged" in HSR means interacting with humans for research purposes, including recruitment purposes. "Engaging" in HSR also includes viewing, utilizing, or analyzing private, identifiable data, even if you do not interact with human subjects.

HRPP Policy & procedure

Training

Keep an eye out for faculty development sessions through-out the year. The Office of Assessment and Educational Development will post such trainings on their website.  Additionally, WVSOM conducts training with individuals, groups, and through on-line resources. 
To schedule an individual training session, please contact irb@osteo.wvsom.edu.  WVSOM's online training software is through CITI.  At a minimum, all WVSOM personnel interacting with human subjects will need to affiliate with WVSOM and complete a Human Subjects Research course appropriate to the protocol.  This may either be the Biomedical course or the Social, Behavioral, Educational course.  Additional courses may be required, and will be indicated in the Institutional research project approval email, or in the response to the request to add additional personnel.

Protocol Applications

  • WVSOM utilizes an electronic protocol application system. For access to the electronic system, contact the  IRB Administrator.
  • For step-by-step instructions on how to use the electronic system, contact the IRB Administrator.
  • Additional training on the electronic application system and sample forms are available on my.wvsom.edu under the Research tab.

FAQs

What do I need to include in my protocol to have it be approved?

The federal government oversees research with human subjects, in order to ensure the ethical treatment of all persons participating as subjects. IRBs were established to review research protocols involving human subjects to ensure the following criteria are met:
  • Risks to subjects are minimized
  • Risks to subjects are reasonable in relation to the benefit to the subject or to society in general
  • Selection of subjects is equitable
  • Informed consent will be sought from each subject or their representative
  • Informed consent will be appropriately documented or waived
  • The research plan makes appropriate provisions for data monitoring, when appropriate
  • The research plan has adequate provisions to protect the privacy of subjects and the confidentiality of the data, when appropriate
  • When subjects are likely to be vulnerable or subject to coercion or undue influence, appropriate protections are in place

For more detailed information, contact the IRB or read the Revised Common Rule.

What are the general timelines for review?

  • Exempt-WVSOM does administrative review of these types of studies within 1 week of receipt, to ensure they meet the federal criteria for exemption.
  • Expedited-The WVSOM IRB reviews studies that fall into this category withing 3 weeks of receipt.
  • Full-The WVSOM IRB must convene the full board to review studies that fall into this category. The board is convened within 1 month of the initial submission.
  • Note that is it not uncommon for clarifications to be requested once the protocol has undergone initial review. In these cases, the timeline to approval is lengthened based on how long the PI takes to compose their response. Once the protocol is resubmitted, the above described timelines apply again.

What is an exempt study?

An exempt study is a human subjects research project that is exempt from the Revised Common rule
In order to be eligible for exempt review, studies MUST be minimal risk. Studies that may meet the criteria for exempt review include:
  • Research on normal educational practices or effectiveness of instructional design. Educational studies designed to randomize assignment to intervention groups are NOT considered exempt
  • Research involving educational tests, surveys, interviews, or observation of public behavior
  • Research involving benign behavioral interventions (e.g. solving puzzles, group activities, etc.)
  • Some types of research with identifiable information or biospecimens already collected for other purposes
  • Taste and food quality evaluation

For a complete description of exempt research, go to the Revised Common Rule, section 46.104(d).

What is an expedited study?

An expedited study is a human subjects research project that undergoes expedited review.

In order to be eligible for expedited review, studies MUST be minimal risk. Studies that may meet the criteria for expedited review include:

  • Collection of blood samples through certain procedures and only if limited to certain amounts
  • Prospective collection of biological specimens by non invasive means (e.g. skin cells through skin swab, saliva collection, etc.)
  • Collection of data through noninvasive procedures routinely employed in clinical practice, excluding x-rays or microwaves (e.g. EKG, MRI)
  • Collection of data from voice, video, digital, or image recordings made for research purposes
  • Continuing review of previously approved research in certain cases (Check with the IRB)

For a complete description of expedited review categories, click here. (https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-r...)

What is a full board study?

A full board study is one that is reviewed by the convened IRB.

Any greater than minimal risk studies will be reviewed by the full IRB.

Any studies not falling into the above categories (exempt or expedited) will be reviewed by the full IRB. Any IRB member may request an expedited study to undergo full board review.

What are the basic elements of the Informed Consent?

Informed consent is not just a document, it is a process for ensuring subjects have all information that a reasonable person would need to make a decision about participating in the research. Basic informed consent must include a discussion of the following, and the informed consent document should reflect this information:
  • A statement that the study involves research, an explanation of the purpose of the research, expected duration of the subject's involvement, a description of the procedures, and identification of any experimental procedures
  • A description of any reasonably foreseeable risks or discomforts
  • A description of any benefits the subject may reasonably expect to gain
  • A disclosure of appropriate alternative procedures/treatments (if any)
  • A description of confidentiality of the records
  • An explanation of whether any compensation or medical treatment is available if injury occurs as a result of participation in the research
  • A description of who to contact for answers to pertinent questions
  • A statement that participation is voluntary and refusal to participate or withdrawing will not cause penalty to the subject
  • If it involves collection of identifiable private information or identifiable biospecimens, a description of effects of removal of identifiers (see 45 CFR 46.116(9)(i and ii))
  • In addition, informed consent should not include any exculpatory language, it should be concise and focused, and be presented in a way that facilitates the subject's understanding of the research and what is being requested of them.
  • There may be additional required elements to informed consent, depending on the nature of the study or the study procedures.

    Does the IRB conduct post-approval monitoring or audits?

    Yes, the ORSP oversees any post-approval monitoring. The ORSP may also conduct audits, random or for-cause, to ensure continuing compliance with approved protocols. Information from these audits or monitoring is provided to the IRB for review.

    When is continuing review required?

    Continuing review is required at least annually, but may be required more regularly. The default Federal rules indicate the following do not require continuing review:
    • Research eligible for expedited review
    • Exempt research requiring limited IRB review
    • Research for which all interventions are completed, and now only includes analyzing data (even if identifiable
    • Research for which all interventions are completed and now only includes accessing follow-up clinical data from clinical care procedures

    Note that the IRB may override any of these defaults and do continuing review. The basis for such a decision will be documented in your approval letter.

    Can other IRBs review my WVSOM research project?

    The WVSOM does permit other IRB's to review WVSOM research projects. In order to permit this, WVSOM must have an active IRB Authorization Agreement (IAA) with the Institution whose IRB will be reviewing the research. WVSOM has several agreements in place, including one with Marshall, WVU, and CAMC. WVSOM requires a copy of the IRB approval letter prior to WVSOM personnel engaging in research.  Your WVSOM research project still requires institutional review (through the ORSP-1 process).  If you want another IRB to review your project, you must contact the WVSOM IRB to discuss.

     

    Contacts

    Diana Bird
    Office of Research and Sponsored Programs
    Administrative Assistant Senior
    (304) 647-6289
    Peter Feltman, MS
    Office of Research and Sponsored Programs
    Research Integrity and Compliance Administrator
    (304) 647-6284
    Jandy Hanna, PhD, MSB
    Professor, Biomedical Sciences
    IRB Chair
    (304) 647-6366
    James W. Nemitz, PhD
    Office of the President
    President
    (304) 647-6200
    Revised Common Rule
    45 CFR 46
    Office of Human Research Protections