Human Research Protection Program (HRPP)

The HRPP is a comprehensive program that affords protections for all human research participants. This website is designed to provide its users with the most up to date information related to conducting research with human participants at Regional Health.
 
Human Research Protection Program (HRPP)
The HRPP was developed to ensure the rights, safety and welfare of all subjects recruited or enrolled in research projects, regardless of funding source. The program also ensures that all personnel involved in research activities understand and comply with the ethical standards of research. The HRPP coordinates oversight by incorporating all aspects of compliance related to human subjects research.

Contact Information

Regional Health Institutional Review Board
PO Box 6000
Rapid City, SD57709-6000
Phone: 605-755-9037
Email: rhirb@regionalhealth.org
 
Institutional Review Board
The Regional Health Institutional Review Board (RH IRB) is a committee which meets monthly to review research involving human subjects in order to ensure all projects conform to federal and institutional regulations and policies.
 
Investigators and Research Staff
The range of research activities at Regional Health is broad and deep.  There are 3 Regional Health Study Sites which seek to expand human knowledge through analysis, innovation and insight.

Purpose of HRPP and IRB

Human Research Protection Program (HRPP)

The purpose of the Human Research Protection Program (HRPP) and Grants Review Committee will be to assess and monitor the quality, effectiveness, and efficiency of research and grant administration. The purpose of this committee’s assessments is to identify standards of excellence and potential areas for improvement in order to promote a solid foundation for proper grant administration and the conduct of human subject research, to ensure compliance and the safety and protection of research participants.

Regional Health Institutional Review Board (RH IRB) 
The purpose of the RH IRB is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines.  The RH IRB is established under the authority of the Food and Drug Administration for the purpose of protecting the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of Regional Health. The IRB is intended to protect the rights and welfare of subjects by reviewing clinical investigations regulated by the FDA under sections 505, 507, and 520 of the Federal Food, Drug and Cosmetic Act. In addition, the RH IRB will review all clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including food and color additives, drugs for human use, medical devices for human use, biological products for human use and electronic products.  RH IRB also reviews and approves Community Initiated Research (CIR) such as local physician research, clinic research, and student research.

RH IRB

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The purpose of the IRB is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines.

DOWNLOAD PDF for the 2018 Meeting Schedule and if there are questions to please call the RH IRB Office at (605) 755-9028.

The Value of AAHRPP Accreditation 

The primary purpose of AAHRPP accreditation is to strengthen protections for research participants. Each accreditation advances that objective and helps build public trust and confidence in research. The benefits of AAHRPP’s comprehensive approach extend beyond participants to the research enterprise as a whole. Perhaps the greatest value is to those organizations that earn the privilege of displaying the AAHRPP seal. For them, attaining AAHRPP accreditation has proved to be both the right and the smart thing to do. The vast majority find that AAHRPP accreditation provides an excellent return on their investment. Equally important, the value of AAHRPP accreditation endures and is reinforced through reaccreditation.
 
 AAHRPP-accredited organizations:

  • Earn the respect and meet the expectations of their peers. Long regarded as the gold standard, AAHRPP accreditation is becoming the norm for quality research programs. All major U.S. independent institutional review boards (IRBs) are AAHRPP accredited. More than 60 percent of U.S. research-intensive universities and 65 percent of U.S. medical schools are either AAHRPP accredited or have begun the accreditation process. Increasingly, organizations that have not earned AAHRPP accreditation are being asked, “Why not?”
  • Play a leadership role in collaborative efforts. AAHRPP accreditation instills trust among research partners and, therefore, is becoming a requirement for collaboration. AAHRPP-accredited organizations often insist that accreditation status be a determining factor in decisions on external IRB review.
  • Gain a competitive edge with sponsors and other funders, who recognize that AAHRPP-accredited organizations have more efficient operations, provide more comprehensive protections, and produce high-quality data. Virtually all sponsors require independent IRBs to be AAHRPP accredited. Some sponsors also consider accreditation status when choosing investigative sites.
  • Reduce the risk of non-compliance. AAHRPP accreditation signifies that an organization has built the necessary infrastructure for a quality human research protection program (HRPP). AAHRPP-accredited organizations tend to have more streamlined, effective policies and procedures. These organizations also typically keep better records and are more likely to avoid costly shutdowns and problematic inspections.
  • Enhance their standing with U.S. federal agencies, which are more likely to target non-accredited organizations for inspections. Federal agencies have begun seeking AAHRPP accreditation for their own HRPPs. The central IRB of the National Cancer Institute earned AAHRPP accreditation in December 2012.
  • Benefit from a common commitment to continuous quality improvement.AAHRPP-accredited organizations share innovative practices and collect data to help establish benchmarks and assess quality improvement. AAHRPP compiles and distributes these data to aid organizations, sponsors, government agencies, and participants in identifying and promoting high-quality practices.

Goals, Principles, and Standards 
The goals of accreditation are to:

  • Improve the systems that protect the rights and welfare of individuals who participate in research.
  • And communicate to the public the strength of an Organization's commitment to the protection of human research participants.

To help promote these goals, AAHRPP has adopted nine overarching principles for protecting human research participants, which serve as the foundation for the AAHRPP Accreditation Standards for Human Research Protection Programs. The AAHRPP Accreditation Standards themselves describe what Organizations can do to consistently act on these principles by applying them to the diverse organizational and cultural contexts in which research is conducted and reviewed.

Ethical Guidance

Codes and Policies for Research Ethics
Given the importance of ethics for the conduct of research, it should be no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics.

Many government agencies, such as the NATIONAL INSTITUTES OF HEALTH (NIH), the NATIONAL SCIENCE FOUNDATION (NSF), the FOOD AND DRUG ADMINISTRATION (FDA), the ENVIRONMENTAL PROTECTION AGENCY (EPA), and the US DEPARTMENT OF AGRICULTURE (USDA) have ethics rules for funded researchers.

Other influential research ethics policies include the AMERICAN CHEMICAL SOCIETY, THE CHEMIST PROFESSIONAL’S CODE OF CONDUCTCODE OF ETHICS (AMERICAN SOCIETY FOR CLINICAL LABORATORY SCIENCE)  AMERICAN PSYCHOLOGICAL ASSOCIATION, ETHICAL PRINCIPLES OF PSYCHOLOGISTS AND CODE OF CONDUCTSTATEMENTS ON ETHICS AND PROFESSIONAL RESPONSIBILITY (AMERICAN ANTHROPOLOGICAL ASSOCIATION)STATEMENT ON PROFESSIONAL ETHICS (AMERICAN ASSOCIATION OF UNIVERSITY PROFESSORS), The BELMONT REPORT, the NUREMBERG CODE and the WORLD MEDICAL ASSOCIATION'S DECLARATION OF HELSINKI.
 
The following is a rough and general summary of some ethical principles that various codes address:

Honesty
Strive for honesty in all scientific communications. Honestly report data, results, methods and procedures, and publication status. Do not fabricate, falsify, or misrepresent data. Do not deceive colleagues, research sponsors, or the public.

Objectivity
Strive to avoid bias in experimental design, data analysis, data interpretation, peer review, personnel decisions, grant writing, expert testimony, and other aspects of research where objectivity is expected or required. Avoid or minimize bias or self-deception. Disclose personal or financial interests that may affect research.

Integrity
Keep your promises and agreements; act with sincerity; strive for consistency of thought and action.

Carefulness
Avoid careless errors and negligence; carefully and critically examine your own work and the work of your peers. Keep good records of research activities, such as data collection, research design, and correspondence with agencies or journals.

Openness
Share data, results, ideas, tools, resources. Be open to criticism and new ideas.

Respect for Intellectual Property
Honor patents, copyrights, and other forms of intellectual property. Do not use unpublished data, methods, or results without permission. Give proper acknowledgement or credit for all contributions to research. Never plagiarize.

Confidentiality
Protect confidential communications, such as papers or grants submitted for publication, personnel records, trade or military secrets, and patient records.

Responsible Publication
Publish in order to advance research and scholarship, not to advance just your own career. Avoid wasteful and duplicative publication.

Responsible Mentoring
Help to educate, mentor, and advise students. Promote their welfare and allow them to make their own decisions.

Respect for colleagues
Respect your colleagues and treat them fairly.

Social Responsibility
Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy.

Non-Discrimination
Avoid discrimination against colleagues or students on the basis of sex, race, ethnicity, or other factors not related to scientific competence and integrity.

Competence
Maintain and improve your own professional competence and expertise through lifelong education and learning; take steps to promote competence in science as a whole.

Legality
Know and obey relevant laws and institutional and governmental policies.

Human Subjects Protection
When conducting research on human subjects, minimize harms and risks and maximize benefits; respect human dignity, privacy, and autonomy; take special precautions with vulnerable populations; and strive to distribute the benefits and burdens of research fairly.

Participants Rights 

Research Participant’s Bill of Rights 
It is important that the purpose and procedures of the research study are fully understood and that consent is offered willingly. A subject in a research study, or someone who is asked to give consent on behalf of another person for such participation, has the right to:

  1. Be informed of the nature and purpose of the research.
  2. Be given an explanation of all procedures to be followed and of any drug or device that will be used.
  3. Be given a description of any risks or discomforts, which can be associated with the research study.
  4. Be given an explanation of any benefits, which can be associated with the research study.
  5. Be informed of any risks and benefits of the appropriate alternative procedures, drugs, or devices in the research study.
  6. Be informed of any medical treatment, which will be made available to the participant, if complications should arise from the research study.
  7. 7. Be given an opportunity and encouraged to ask questions concerning the research study or procedures involved.
  8. Be made aware that participants can quit the research study at any time.
  9. Be given a copy of the signed and dated written consent form, if requested.
  10. Not be subjected to an element of force, fraud, deceit, duress, coercion, or any influences in reaching the decision to consent or to not consent to participate in the research.

If you have questions regarding your rights as a research subject, you may contact the Regional Health IRB office at (605) 755-9037 or 1-877-861-4865.  To discuss problems, concerns, questions, offer information, or provide suggestions or input to someone who is not involved with the research study, you may call Customer Service and Patient Relations at (605) 755-8134.

    Education

    Before a Principle Investigator can submit a protocol for IRB Review and Approval the PI must have demonstrated and submitted documentation of training – Collaborative Institutional Training Initiative (CITI) or National Institutes of Health (NIH).  If the PI does not have training documented contact the RH IRB Office for the sign-on information for CITI Training.

    INFORMATION ON CITI TRAINING

    HIPAA

    18 IDENTIFIERS OF PHI
    HIPAA recognizes that health-related information is often so rich in content that it can never be made truly anonymous, but that the risk of re-identification of an individual is greatly decreased by removing certain elements from data. Health information lacking these elements is said to be de-identified and may be used or disclosed without restriction under the HIPAA Privacy Rule (the health information is no longer PHI).

    To de-identify PHI, remove the following list of 18 identifiers of the individual and of the individual’s relatives, employers, or household members:

    1. Names
    2. All geographic subdivisions smaller than state
    3. All elements of dates except year – e.g. date of birth, date of death, admission date, discharge date, all ages over age 89.
    4. Telephone numbers
    5. Fax numbers
    6. E-mail addresses
    7. Social security numbers
    8. Medical Record numbers
    9. Health plan beneficiary numbers
    10. Account numbers
    11. Certificate/license numbers
    12. Vehicle identification, serial, or license plate numbers
    13. Device identifiers and serial numbers
    14. Web Universal Resources (URLs)
    15. Internet Protocol (IP) address numbers
    16. Biometric identifiers, including finger and voice prints
    17. Full face photographic images any comparable images
    18. All other unique identifying numbers, characteristic, or code

    HIPAA allows for the use of a Limited Data Set for Research and Public Health
    A “limited data set” is a limited set of identifiable patient information as defined in the Privacy Regulations issued under the Health Insurance Portability and Accountability Act”. A “limited data set” of information may be disclosed to an outside party without a patient’s authorization if certain conditions are met.

    • First, the purpose of the disclosure may only be for research, public health or health care operations.
    • Second, the person receiving the information must sign a Data Use Agreement (DUA).

    DUAs are contractual documents used for the transfer of nonpublic data that is subject to some restriction on its use. DUAs serve to outline the terms and conditions of the transfer. Specifically, DUAs address important issues such as limitations on use of the data, obligations to safeguard the data, liability for harm arising from the use of the data, publication, and privacy rights that are associated with transfers of confidential or protected data.  The understanding established by a DUA can help avoid later issues by clearly setting forth the expectations of the parties (provider and recipient). Having a signed DUA in place may be a required precondition to transfers of certain data, or it may simply be a good idea. Determining whether a DUA is required is necessarily context dependent. When a DUA is required, it must be study specific – i.e. data cannot be transferred pursuant to “master” or blanket sharing agreements.

    The agreement needs to be reviewed and approved by the RH Legal Department through the normal contract control process.

    Helpful Links

    Association for the Accreditation of Human Research Protection Program, Inc. (AAHRP): HTTP://WWW.AAHRPP.ORG/
     
    Food and Drug Administration: HTTP://WWW.FDA.GOV/
     
    Office for Human Research Protections (OHRP): HTTP://WWW.HHS.GOV/OHRP/
    OHRP Educational Videos: HTTP://WWW.HHS.GOV/OHRP/EDUCATION-AND-OUTREACH/ONLINE-EDUCATION/VIDEOS/INDEX.HTML
    OHRP YouTube Videos: HTTPS://WWW.YOUTUBE.COM/PLAYLIST?LIST=PL5965CB14C2506914
     
    Collaborative Institutional Training Initiative (CITI): HTTPS://WWW.CITIPROGRAM.ORG/
    National Institutes of Health (NIH): HTTPS://CRT.NIHTRAINING.COM