Articles (51)

Office of Human Research Ethics SOP 0101: UNC-Chapel Hill Human Research Protections Program

The University of North Carolina at Chapel Hill (UNC‐Chapel Hill) fosters a research environment that promotes the respect for the rights and welfare of individuals recruited for, or participating in, research conducted by or under the auspices of the Organization.

Office of Human Research Ethics SOP 0201: Quality Assurance

The University of North Carolina at Chapel Hill (UNC-Chapel Hill) performs Quality Assurance and Improvement activities for the purposes of monitoring the safety of ongoing studies and measuring and improving human research protection effectiveness, quality, and compliance with organizational policies and procedures and applicable federal, state, and local laws.

Office of Human Research Ethics SOP 0301: Education & Training

Recognizing that a vital component of a comprehensive human research protection program is an education program for all individuals involved with research subjects, we are committed to providing training and an on-going educational process for IRB members, the staff of the IRB and HRPP Office, investigators and members of their research team, related to ethical concerns and regulatory and organizational requirements for the protection of human subjects.

Office of Human Research Ethics SOP 0401: Institutional Review Board

The University of North Carolina at Chapel Hill has established an Institutional Review Board (IRB) to ensure the protection of human subjects in research conducted. All non‐exempt human subject research conducted under the auspices of the UNC‐Chapel Hill must be reviewed and approved by the UNC‐Chapel Hill IRB or another designated IRB prior to the initiation of the research unless it has been determined that the UNC‐Chapel Hill is not engaged in the research (See SOP 101.2.6).

Office of Human Research Ethics SOP 0501: Human Subject Research Determination

All non‐exempt human subjects research must be reviewed by the IRB. The first step in determining whether research must be reviewed is to determine whether it meets the regulatory definition of human subjects research.

Office of Human Research Ethics SOP 0601: Exempt Studies

All research using human subjects must be approved by the University of North Carolina at Chapel Hill (UNC‐Chapel Hill). However, certain categories of human subject research are exempt from IRB approval. Exempt research is subject to review for determination of exemption status. At the UNC‐Chapel Hill exemptions are reviewed IRB Staff, and granted by an IRB Chair or designee.

Office of Human Research Ethics SOP 0701: IRB Review Process

The IRB will review and ensure that University of North Carolina at Chapel Hill (UNC-Chapel Hill) research involving human subjects meets all required ethical and regulatory criteria for initial and continuing review and any modifications of approved research. The IRB may conduct their review using the following review methods: Expedited Review and Review by Convened IRB.

Office of Human Research Ethics SOP 0801: Institution, Investigator, or Sponsor-Initiated Holds

An “Institutional-, investigator- or sponsor-initiated hold” refers to a voluntary action by the institution, investigator or sponsor of the study to place some or all research activities associated with that study on hold. Institutional, investigator or sponsor holds may be the result of interim data analysis, inadequate drug availability, response to a DSMB report/recommendation, pre-planned stopping point or other information.

Office of Human Research Ethics SOP 0901: Multicenter Research and Reliance Process

All non-exempt human subject research conducted under the auspices of the UNC-Chapel Hill must be reviewed and approved by the UNC Chapel Hill IRB or another designated IRB prior to the initiation of the research unless it has been determined that UNC-Chapel Hill is not engaged in the research.

Office of Human Research Ethics SOP 1001: Documentation of Records

The University of North Carolina at Chapel Hill (UNC-Chapel Hill) prepares and maintains adequate documentation of the IRB’s activities. All records are accessible for inspection and copying by authorized representatives of the FDA, OHRP, sponsors, and other authorized entities at reasonable times and in a reasonable manner.

Office of Human Research Ethics SOP 1101: Obtaining Informed Consent from Research Subjects

No investigator conducting research under the auspices of the University of North Carolina at Chapel Hill (UNC-Chapel Hill) may involve a human being as a subject in research without obtaining the legally effective informed consent of the subject or the subject’s legally authorized representative unless a waiver of consent has been approved by the IRB in accordance with Section 2.9 of these procedures.

Office of Human Research Ethics SOP 1201: Vulnerable Subjects in Research

When some or all of the participants in a research conducted under the auspices of the University of North Carolina at Chapel Hill (UNC-Chapel Hill) are likely to be vulnerable to coercion or undue influence or have diminished decision-making capacity, the research must include additional safeguards to protect the rights and welfare of these participants.

Office of Human Research Ethics SOP 1301: FDA-Regulated Research

FDA regulations apply to research that involves a FDA-regulated test article in a clinical investigation involving human subjects as defined by the FDA regulations. For FDA-regulated research, the IRB must apply the FDA regulations at 21 CFR 50 and 21 CFR 56. If required by organizational policy or a FWA, 45 CFR 46 must also be applied.

Office of Human Research Ethics SOP 1401: Reporting New Safety Information

Regulations require an organization to have written procedures for ensuring prompt reporting of changes in research activity; unanticipated problems involving risk to subjects or others; and any instances of serious or continuing non-compliance to the IRB, organizational officials, and applicable federal agencies.

Office of Human Research Ethics SOP 1402: Management of New Safety Information

This procedure establishes the process to manage New Safety Information. This procedure begins when OHRE receives New Safety Information (regardless of whether the information is reportable). This procedure ends when the New Safety Information has been resolved administratively or the Principal Investigator (PI), Institutional Official, and if applicable, Federal Regulatory Agencies have been notified of final determinations made by the convened IRB.

Office of Human Research Ethics SOP 1403: Questions, Concerns, or Complaints from Research Participants or Third Parties

UNC-CH is committed to protecting the rights, safety and welfare of research participants. Consistent with this commitment, this SOP establishes the procedures for handling questions, concerns or complaints from subjects or third party.

Office of Human Research Ethics SOP 1501: Investigator Responsibilities

Investigators are ultimately responsible for the conduct of research. Investigators may delegate tasks to appropriately trained and qualified members of their research team. However, investigators must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibilities.

Office of Human Research Ethics SOP 1601: Sponsored Research

It is the University of North Carolina at Chapel Hill (UNC-Chapel Hill) policy that any sponsored research conducted under the auspices of the Organization is conducted in accordance with federal guidelines and ethical standards. The following describe the procedures required to ensure that all sponsored research meets this requirement.

Office of Human Research Ethics SOP 1701: Participant Outreach

The University of North Carolina at Chapel Hill (UNC-Chapel Hill) is committed to ensuring that educational opportunities are offered to research participants, prospective research participants, and community members which will enhance their understanding of research involving human participants at the UNC-Chapel Hill and provide them the opportunity to provide input and express concerns.

Office of Human Research Ethics SOP 1801: Health Insurance Portability and Accountability Act (HIPAA)

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) required the creation of a Privacy Rule for identifiable health information. While the primary impact of the Privacy Rule is on the routine provision of and billing for health care, the Rule also affects the conduct and oversight of research.

Office of Human Research Ethics SOP 1901: Information Security

The University of North Carolina at Chapel Hill (UNC-Chapel Hill) has established standards and safeguards to protect patient’s information and to ensure compliance with federal and state information security regulations.

Office of Human Research Ethics SOP 2101: Individual Conflict of Interest in Research

Consistent with the University of North Carolina at Chapel Hill’s research, teaching and public service missions, the University encourages faculty, staff and students to engage in appropriate outside relationships, including but not limited to private industry and the nonprofit sector.

Office of Human Research Ethics SOP 2102: IRB Member and Consultant Conflict of Interest

This policy outlines the responsibilities of IRB members for making known any potential or perceived conflicts of interest (COI) concerning protocols reviewed by the IRB. No IRB member may participate in the review of any research project in which they have a COI, except to provide information, as requested. It is the responsibility of each IRB member to disclose any COI related to a study submitted for review and to recuse him/herself from the deliberations and vote by leaving the room.

Office of Human Research Ethics SOP 2201: Research Subject to the U.S. Environmental Protection Agency Regulations

Environmental Protection Agency (EPA) policy requires that researchers submit IRB determinations and approval to the EPA human subjects research review official for final review and approval before the research can begin. For research not conducted or supported by any federal agency that has requirements for protecting human research subjects and for which the intention of the research is submission to the EPA, the EPA requirements for protecting human research subjects apply.

Office of Human Research Ethics SOP 2301: Research Subject to US Department of Education Regulations

The following special considerations apply to all research involving human subjects supported or conducted by the U.S. Department of Education. These considerations are in addition to those found in 45 CFR 46 Subparts A-D.

Office of Human Research Ethics SOP 2401: Research Subject to US Department of Energy Regulations

When following Department of Energy (DOE) regulations, the IRB reviews and approves the ““DOE Institutional Review Board Template for Reviewing Human Subjects Research Protocols that Utilize Personally Identifiable Information (PII)” submitted by the researchers to verify compliance with the DOE requirements for the protection of personally Identifiable Information.

Office of Human Research Ethics SOP 2501: Case Reports Requiring IRB Review

In general, an anecdotal report on one or a series of patients seen in one’s own practice and a comparison of these patients to existing reports in the literature is not research and does not require IRB approval. Going beyond one’s own practice to seek out and report cases seen by other clinicians creates the appearance of a systematic investigation with the intent to contribute to generalizable knowledge and therefore is considered research and would require IRB approval.

Office of Human Research Ethics SOP 2601: Certificate of Confidentiality

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.

Office of Human Research Ethics SOP 2701: Community Partnerships in Research

Community based research (CBR) is research that is conducted as an equal partnership between academic investigators and members of a community. In CBR projects, the community participates fully in all aspects of the research process. Community is often self-defined, but general categories of community include geographic community, a community of individuals with a common problem or issue, or a community of individuals with a common interest or goal.

Office of Human Research Ethics SOP 2801: Data or Biological Sample Repositories

A repository is a collection of data or biological specimens whose organizers: Receive data or specimens from multiple sources; Maintain the data or specimens over time; and Control access to and use of data or specimens by multiple individuals and/or for multiple purposes, which may evolve over time

Office of Human Research Ethics SOP 2901: Family History Research

Family research typically involves obtaining information from one family member (called a proband) about other family members (third parties). For a detailed description of family history research, see SOP 2901

Office of Human Research Ethics SOP 3001: Genetic and Stem Cell Research

Genetic research studies may create special risks to human subjects and their relatives. These involve medical, psychosocial, legal and economic risks, such as the possible loss of privacy, insurability, and employability, change in immigration status and limits on education options, and may create a social stigma. Knowledge of one's genetic make-up may also affect one's knowledge of the disease risk status of family members.

Office of Human Research Ethics SOP 3101: Research in Educational Settings

Research conducted in established or commonly accepted educational settings that involve normal educational practices as well as research involving the use of educational tests, survey procedures, interview procedures, or the observation of public behavior is eligible for exemption from the Common Rule. However, such research sometimes raises special concerns to which the IRB must be especially attentive.

Office of Human Research Ethics SOP 3201: Internet Research

The vast amount of social and behavioral information potentially available on the Internet has made it an important tool for researchers wishing to study the dynamics of human interactions and their consequences in this virtual medium. Researchers can potentially collect data from widely dispersed populations at relatively low cost and in less time than similar efforts in the physical world.

Office of Human Research Ethics SOP 3301: Mandatory Reporting

While any person may make a report if they have reasonable cause to believe that a child or elder was abused or neglected, North Carolina law mandates that certain persons who suspect child or elder abuse or neglect report this.

Office of Human Research Ethics SOP 3401: Multi-Site Studies Where UNC-Chapel Hill is the Lead Site or Coordinating Center

This scenario arises when: UNC-Chapel Hill is the lead coordinating center responsible for overall study conduct; or A UNC-Chapel Hill employee serves as principal investigator for the entire multi-site study, (unless coordinating function located elsewhere as in some NIH-sponsored groups), or UNC-Chapel Hill is the sponsor (initiates contracts with and disburses funds to other sites).

Office of Human Research Ethics SOP 3501: Oral History

A decision whether oral history or other activities solely consisting of open ended qualitative type interviews are subject to the policies and regulations outlined in an institution's FWA and DHHS regulations for the protection of human research subjects (45 CFR 46) is based on the prospective intent of the investigator and the definition of "research" under DHHS regulations at 45 CFR 46.102(d)

Office of Human Research Ethics SOP 3601: Pilot Studies

A pilot study is typically defined as an initial or smaller-scale investigation or a study to either test out new experimental designs (including survey or instrument development) or methods of treatment. Pilot studies are synonymous with feasibility studies, where the investigation proposed is planned to identify various issues to determine that the larger study of the same subject matter has the greatest potential to successfully test the intended research hypotheses.

Office of Human Research Ethics SOP 3701: Qualitative Research

Qualitative studies, which may involve such methods as participant observation, case studies, unstructured interviews, focus groups and various other descriptive techniques, raise special issues for the IRB. Qualitative research investigators usually have a well-articulated plan for their research, often have one or more reasonably specific hypotheses to be tested, and can describe in general terms the techniques they intend to employ.

Office of Human Research Ethics SOP 3801: Research Involving Coded Private Information or Biological Specimens

All activities involving the collection of human biological specimens for research purposes, as well as the research use of specimens collected for clinical care, must be conducted under the terms of an IRB approved research protocol. The collection and use of human biological specimens (either identifiable or de-identified) must comply with all applicable laws and regulations for research involving human biological specimens or superseding requirements.

Office of Human Research Ethics SOP 3901: Research Involving Deception or Withholding of Information

Some research designs may require the withholding of information from human subjects. Research involving deception or withholding of information must be reviewed by the IRB with common sense and sensitivity. The withholding of information by researchers is different from the practice of deception, in which researchers provide false or misleading information to subjects.

Office of Human Research Ethics SOP 4001: Research Involving Potentially Addictive Substances

With respect to cigarettes and alcoholic beverages, IRBs and researchers should be aware that under North Carolina state law these substances may not be distributed to or used by minors.

Office of Human Research Ethics SOP 4101: Research Involving Radiation

Studies involving the use of radiation, such as those requiring patients to be X-rayed, are not eligible for expedited review, even if all of the other procedures in the study have been deemed to pose no more than minimal risk.

Office of Human Research Ethics SOP 4201: Research Using Existing Data and Materials

Each separate human subjects research study requires IRB review and approval of the specific proposed study, regardless of whether the data set or research materials have been previously compiled.

Office of Human Research Ethics SOP 4301: Review Involving Data from Voice, Video, Digital or Image Recordings

If researchers wish to utilize data from voice, video, digital or image recordings, they must take a variety of special precautions. First, the researcher must obtain appropriate permissions from subjects who will not have their anonymity protected due to the very nature of the data being collected.

Office of Human Research Ethics SOP 4401: Survey Research

The IRB should pay particular attention to the following issues in survey research: Possibility of undue influence in administration of the survey; Possibility of deductive disclosure based on demographic information garnered from subjects (subject confidentiality and privacy must be protected); The setting of the survey and the issues raised by such a setting; and The mode of obtaining consent, especially when implied consent is to be used.

Office of Human Research Ethics SOP 4501: The UNC-Chapel Hill Students and Employees as Research Subjects

Generally, researchers at UNC-Chapel Hill may not solicit by direct appeal to students, employees or trainees in that researcher’s department or class in an effort to recruit subjects for a study. Such direct and targeted solicitation (which should be distinguished from the dissemination of information such as is done in mass distribution emails) takes place within a power dynamic that could be construed as coercive by the potential subjects being solicited.

Office of Human Research Ethics SOP 4601: Trainee or Student Projects Involving Human Subjects Research

Learning how to conduct ethical human subject research is an important part of a student’s educational experience. Research activities that are designed as part of a course requirement for purposes of learning experience only and are not “designed to develop or contribute to generalizable knowledge” may not require IRB review and approval if all of the following conditions are true...

Office of Human Research Ethics SOP 4701: Transnational Research

The IRB will review all transnational research involving human participants to assure adequate provisions are in place to protect the rights and welfare of the participants. Approval of research is permitted if “the procedures prescribed by the foreign institution afford protections that are at least equivalent to those provided in 45 CFR 46.”

Office of Human Research Ethics SOP 4801: Pregnancy Testing Requirements

The UNC IRB has developed this SOP to describe a series of consistent, deliberate steps to mitigate fetal exposure to risk in clinical research studies among women of child-bearing potential (CBP).

Office of Human Research Ethics SOP 4901: Management of Incidental Findings in Research Imaging

There is the inherent risk that incidental findings (IF) may be discovered on research- directed imaging procedures. These IFs may or may not be of clinical significance. The incidence of detected abnormalities when imaging varies depending on a number of factors including age of subjects, health status, the technology used and the expertise of the individual reviewing the image.