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Managing Human Subjects Research Projects: A Tool Kit for Project Managers

3. Regulatory Guidelines for Human Subjects Research

Prior to the initiation of research, the project manager should review the federal regulatory guidelines and procedures that govern all human subjects research in the United States. Additionally, the project manager should contact the institution's Office of Protection for Research Subjects and attend research ethics training prior to the initiation of any research activities. This section provides an introduction and overview to federal regulations for human subjects research. All project managers should contact their organization's Office of Protection for Research Subjects for institution-specific guidance on interpreting federal human subjects research guidelines, attending training and submitting and maintaining Institutional Review Board (IRB) approval.

3.1 The Federal Institutional Review Board (IRB) Guidebook

Federal regulations for the protection of human subjects are available on the United States Department of Health and Human Services web site. See the Office for Human Research Protections for a detailed list of documents that may help tailor the research for IRB approval that is specific to an institution (http://www.hhs.gov/ohrp/).

The federal IRB Guidebook (http://www.hhs.gov/ohrp/irb/irb_guidebook.htm) will assist you in understanding how members of the IRB make decisions about initial submissions, continuing review and amendments.

3.2 The Office for Human Research Protections (OHRP) Policy Guidance

The OHRP is the oversight office for federally-sponsored research studies. Many institutions also apply these policies to non-federally funded research. Therefore, it is important to understand the regulations under which specific institutions operate, in order to know which of the resources provided in this section are relevant to any non-federally funded research conducted at your institution. Listed in this section is a brief sample of topics included on the OHRP Web site.

Databases and Data Storage

This is a link to guidelines that will assist in the acquisition and storage of paper and electronic data and biological samples.

Decision Charts

This is a great tool for understanding whether the activity being planned is considered human subjects research. Be sure to seek confirmation from your IRB before moving forward.

Engagement in Research

This link will assist you in determining whether partnering institutions, agencies or organizations are actually "engaged" in research. The OHRP has detailed guidelines on which activities are considered "engagement." This determination will be the factor in deciding whether that institution, agency or organization needs a Federal Wide Assurance (FWA) number. To obtain a FWA, institutions, agencies and organizations must apply to the OHRP.

Common Rule

The Common Rule is a code of federal regulations concerning the public's welfare and the uses of personal health information. It is one of the primary rules that governs human subjects research. Understanding the Common Rule will ensure proper conduct of human subjects research.

Institutional Review Board (IRB)

The Institutional Review Board (IRB) is the governing body of human subjects research within an institution. The IRB typically consists of members of the scientific community, as well as individuals from other fields and lay individuals. The IRB meets on a regular basis and decides what protocols will be allowed to be implemented at the institution. The IRB also decides annually what protocols will be allowed to continue, using a process called "Continuing Review." Below are links to information about various research activities for which the IRB provides oversight.

Informed Consent

Informed consent is not simply a form to be filled out by research participants, but an important process to be completed for every research project. Information must be presented to enable persons to voluntarily decide whether or not to participate as a research subject. It is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act. The procedures used in obtaining informed consent should be designed to educate potential research subjects in language that they can understand. Therefore, informed consent language and its documentation (especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits) must be written in "lay language" (i.e., language that is understandable to the people being asked to participate). Written information is used to document the basis for consent and is provided to subjects for future reference. The informed consent document should be revised when deficiencies are noted or when additional information will improve the consent process. For more details, see (www.hhs.gov/ohrp/policy/ictips.html).

Repositories (see also Tissue Storage/Repositories)
This is a link to guidelines that will assist in the acquisition and storage of paper and electronic data and biological samples. (This link is the same as that provided previously under Databases and Data Storage.)

3.3 Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Researchers in medical and health-related disciplines require access to many sources of health information - from archived medical records and epidemiological databases to disease registries, tissue repositories, hospital discharge records, and government compilations of vital statistics and health records. The HIPAA Privacy Rule was implemented to further protect participants' personal health information. The U.S. Department of Health and Human Services and the National Institutes of Health maintain a web site devoted to the explanation and documentation of HIPAA. A 93-page document (45 CRF Parts 160 and 164: Standards for Privacy of Individually Identifiable Health Information, Final Rule) entitled The Privacy Rule - Final Modification is located at http://privacyruleandresearch.nih.gov/. Also located on the web site are links to:

The link to the Center for Medicare & Medicaid Services HIPAA information (provided above) is a great resource that provides a decision tree to assist organizations in determining if they are considered a covered entity as defined by the Privacy Rule. Importantly, not all researchers have to comply with the Privacy Rule. It is best to consult with the IRB at your institution to determine their rules and regulations regarding researchers and the Privacy Rule. Federal information for researchers on how to interpret the privacy rule is available at: http://privacyruleandresearch.nih.gov/pr_02.asp.

Research Repositories, Databases, and the HIPAA Privacy Rule

This web site provides detailed information about HIPAA Privacy Rule and its use when working within research repositories and databases (http://privacyruleandresearch.nih.gov/research_repositories.asp).

3.4 Working with the Office of Protection for Research Subjects at Your Institution

Most research institutions have offices for research subject protection or regulatory affairs. These groups are responsible for upholding the rights of research subjects and participants. They also are responsible for reviewing protocols regularly and providing oversight to ensure that participants are being treated ethically and that the research is being conducted responsibly. Project managers work closely with these offices to make sure that the research is being conducted in accordance with regulatory guidelines that govern human subjects research. Project managers should become very familiar with the rules and regulations set forth by this office within their own institution.

3.5 Attending Ethics and Human Subjects Training

One way for the project manager to ensure that he or she is familiar with the rules and regulations that govern human subjects research is by attending human subjects trainings offered at his or her respective institution. Most research institutions offer on-line training.

3.6 Submitting and Maintaining IRB Approval

IRB approval must be renewed annually. Most research institutions have standard procedures for submitting and maintaining IRB approval for a study, including forms that should be completed and the number of copies of the application that must be submitted based on the study's review status (i.e., full or expedited review; see IRB section).

3.7 Identifying and Reporting Adverse Events

Identifying and reporting adverse events is very important. An adverse event is broadly defined as any unfavorable or unintended sign (including an abnormal laboratory finding, symptom, or disease temporally associated with the use of an investigational product or participation in the study), whether or not it is considered related to participation in the research. In a survey study, an example of an adverse event is if a person mentions he or she has had thoughts of committing suicide, or a person is unusually agitated by a line of questioning. These should be reported to the IRB within the time-frame specified by the institution at which the adverse event has occurred. Most research institutions have an Internet-based adverse event submission form.

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