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TABLE OF CONTENTS
GLOSSARY TERMS
INTRODUCTION
All research projects with human subjects conducted by faculty, staff and students associated with the University of Houston must receive approval from the institutional review board (IRB). The information in this Procedures Manual is designed to assist you with this process. For more information about basic ethical questions in the conduct of research, you are encouraged to read the Belmont Report [http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm] .
A brief review of relevant documents is provided here to help investigators better understand the reason for ethical review of research involving human participants, the primary ethical principles that govern such research, and the statutory basis for enactment of these principles. This manual contains information that should assist UH researchers in the preparation of an acceptable application for review of a project that involves human subjects.
1.1 Historical Background
The history of research involving human participants includes a great many instances of inhumane and unethical treatment. The Nuremberg trial s document s one such episode involving the unethical behavior of German doctors and scientists during World War II.
The United States possesses its own unique history of abuse. The worst example of human subject violations in the United States was the Syphilis Study conducted in Tuskegee, Alabama by the U.S. Public Health Service from 1932 to 1972. Approximately 400 poor and uneducated African American men were enrolled in a study designed to follow the natural course of syphilis. There was no informed consent process. In fact, at no time were they informed that they had the disease nor were they offered any treatment after penicillin was found to be effective. In another example, children at the Willowbrook State School, a New York state school for “mentally defective” youths, were purposely infected with the hepatitis virus between 1963 and 1966. During this time, the school claimed that they were overcrowded and closed the school to enrollment of new clients. Parents were allowed to enroll their child only if they agreed to allow their child to participate in the research project.
Also, behavioral and social science researchers have exposed other humans to severe trauma and psychological stress in the name of scientific research. The participants in Stanley Milgram's studies on obedience in the early 1960s were told that continued participation in the study required that they shock another person at increasingly intense voltages. Participants were unaware that the third party was actually a confederate collaborator who was “faking” a reaction to electrical shock.
1.2 Codes of Research Ethics
Codes of research ethics have been developed to address the disregard for human safety and dignity reflected in the aforementioned projects reflect . The Nuremberg Code of 1947 was the first international code of research ethics. The first principle established that “The voluntary consent of the human subject is absolutely essential.” The code clarified that the potential subject should “...have the legal capacity to give consent” and “...should have sufficient knowledge and comprehension ... to make an understanding and enlightened decision.” This basic concept continues to serve as the basic foundation for ethical research involving human participants. [http://www.hhs.gov/ohrp/references/nurcode.htm]
Other codes followed. In 1964, the World Medical Association adopted the Declaration of Helsinki. This code established the concept of ethical review by an independent board. It also recognized a distinction between therapeutic and non-therapeutic research. [http://www.wma.net/e/policy/b3.htm] The American Psychological Association established the first ethical code addressing social and behavioral research in the U.S. in 1972. Based on examples of unethical or questionable behavior, the APA developed ten basic principles for human subjects research. These principles were the first to recognize the principle of confidentiality. Today, most professional organizational have ethical codes that provide guidance on human subjects research. Also, many journals now require that authors state adherence to appropriate ethical principles and guidelines in their research.
The U.S. Department of Health, Education and Welfare (DHEW) issued ethical guidelines in 1971 through the National Institutes of Health. In 1973, an ad hoc advisory panel issued the final report of the Tuskegee Syphilis study. This report concluded that, “Society can no longer afford to leave the balancing of individual rights against scientific progress to the scientific community.” The following year, Congress passed the National Research Act and codified the DHEW guidelines into federal regulations at 45 Code of Federal Regulations ( CFR ) 46 (also known as the Common Rule) [http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm] . The Act also established the National Commission for the Protection of Human Subjects to identify the basic ethical principles that now underlie the conduct of biomedical and behavioral research involving human subjects. Known as the Belmont Report, the report was published in 1978 and identified three basic ethical principles:
- Respect for Persons (autonomy) – This principle acknowledges the dignity and freedom of every person. It requires obtaining informed consent from all potential research subjects (or their legally authorized representatives).
- Beneficence – This principle requires the investigator to maximize the benefits and minimize the harms or risks associated with the research. Research-related risks must be reasonable in light of expected benefits.
- Justice – This principle requires equitable selection, recruitment and fair treatment of human research subjects.
The three principles were the underpinnings of the Common Federal Policy for the Protection of Human Subjects. Sixteen federal departments and agencies, including the Department of Health and Human Services, the National Science Foundation, The Department of Education, and the Department of Energy, have adopted the current version. The current version was published in 1991and guides the decisions of IRBs. The regulations further require that every institution at which federally funded research is conducted adhere to the principles of the Belmont Report and set forth in writing its ethical principles, policies, and procedures. The University of Houston's agreement to abide by the Belmont Report and by 45 CFR 46 (called a Federalwide Assurance) is approved by the federal agency that oversees ethical issues in human research.
1.3 Administration of Research Ethics – Federal
The Office for Human Research Protection (OHRP) is the federal office responsible for the oversight of research involving human participants and is part of the Department of Health and Human Services. Audits conducted by OHRP at several institutions have resulted in the temporary suspension of all research activities involving human subjects. Additional information about this agency is available at [http://www.hhs.gov/ohrp/] .
1.4 Administration of Research Ethics – University of Houston
The Office of the Vice President for Research is responsible for the administration of research ethics at the University of Houston. The office oversees the Office of Research Policies, Compliance and Committees, which includes the institutional IRBs. For additional information, visit our web site at www.research.uh.edu , click on “Human Subjects.”
1.5 IRB Authority
The IRB has the authority to :
- approve, require modifications in, or disapprove all research activities involving human subjects at the University of Houston ;
- observe or monitor ongoing research as is necessary to protect human subjects ; and
- to suspend or terminate approval of previously approved research.
Although the Vice President of Research, deans, department chairs and other University officials may have the authority to disapprove research activities approved by the IRB or to set more stringent requirements on research protocols, research disapproved by the IRB cannot be conducted.
THE IRBs AT THE UNIVERSITY OF HOUSTON
2.1 The Institutional Review Boards' Charge
The institutional review boards (IRBs) at the University of Houston are the Committee for the Protection of Human Subjects (CPHS) and the Social Sciences Committee for the Protection of Human Subjects (SSCPHS). The scope of the IRBs' charge is broad. Generally, any University research that involves humans, human tissue, surveys of human subjects, or human subjects' records requires IRB review and approval, regardless of funding source. This purview extends to all student research projects. The specific charge to the IRBs is to give consideration to:
• the potential risks to the subjects;
• the anticipated benefits to the subjects and others;
• the importance of the knowledge that may reasonably be expected to result; and
• the informed consent process to be employed.
The basis for the CPHS charge is found in the Code of Federal Regulations (CFR). Although protection of human subjects is a concern of all agencies that sponsor research, regulatory leadership is vested in the Office for Human Research Protection (OHRP) and the Food and Drug Administration (FDA). The OHRP has general responsibility for the protections of humans as subjects in research, and the FDA regulates the use of drugs and medical devices in experiments.
OHRP regulates compliance of institutions primarily through “assurances.” A Federalwide Assurance is a legally binding agreement between the institution and the OHRP. The University's assurance outlines our responsibilities and explains the steps the University will take to meet the federal regulations for research on human subjects.
2.2 Membership and Structure of the IRB
The University of Houston has two institutional review boards. The Social Sciences Committee for the Protection of Human Subjects (SSCPHS) supports protocols from the departments of Anthropology, Economics, Political Science, Psychology, and Sociology. This IRB has three members who represent expertise of these research areas, one community representative, and one non-science representative. The Committee for the Protection of Human Subjects (CPHS), which is responsible for all other program areas, is composed of ten members. Included are five faculty members, one community representative, one non-science representative, one graduate student representative, and two medical doctors. Additional members may be appointed if the required expertise is not available on the IRB (i.e., the additional membership required to review research involving prisoners).
In accordance with 45 CFR 46.110(b), each IRB has a related subcommittee consisting of the chairman and one other committee member. The subcommittee can only review research activities that fall under one of the expedited categories published in the Federal Register (63 FR 60364-60367, November 9, 1998). The list is also provided on the CPHS web site.
The committees strive for a balance of men and women and representation from diverse ethnic groups. Appointment is based on the expertise required, familiarity with applicable laws, regulations, and relevant standards of professional conduct and practice, and knowledge of vulnerable or special populations. Diversity in experience and expertise enables the IRBs to evaluate a wide range of research.
2.3 The Office of Research Policies, Compliance and Committees (ORPCC)
The Office of Research Policies, Compliance and Committees is part of the Division of Research and provides administrative support to both IRBs.
2.4 IRB Meetings
Convened meetings are scheduled monthly, September to August. The schedule is set in the summer for the following academic year and published on the IRB's web site [www.research.uh.edu] , click on “Human Subjects”]. The deadline for submission of materials for full IRB review is three weeks prior to the scheduled meeting. Members are sent applications and other materials for review approximately one week prior to the scheduled meeting. Members are expected to review all materials prior to the meeting.
The IRB meets in executive session. The Chair may permit persons not affiliated with the IRB to attend meetings, upon request. Investigators or their collaborators are not permitted to be present at IRB meetings during deliberations on their research. However, the IRB may decide to invite investigators to the meetings to answer questions about their research.
2.5 IRB Policies
The IRB's policies are drafted by the IRB chairs, or designees, and approved by a majority of members present at a convened IRB meeting at which a quorum is present. The policies may be changed or revised as warranted by the majority of the IRB at a convened meeting.
When warranted and appropriate in specific situations, the IRB may waive any of its policies and procedures if: (1) the waiver is not inconsistent with federal regulations and (2) the waiver does not increase the risks to participants in research
2.6 Conflict of Interest
No IRB member may participate in the review of or vote on any initial or continuing application, revision, or other matter involving research in which he or she has a conflict of interest. A conflict of interest is assumed to be present when the member is the Principal Investigator, faculty sponsor, or member of a funded project on any research being reviewed by the IRB or when the member has a financial interest in the sponsor of research under consideration.
Members shall excuse themselves from discussions at IRB meetings of an application or other matter in which they have a conflict of interest. This is recorded in the minutes. Members may provide information requested by the IRB prior to or after formal deliberations.
The Chair excuses him- or herself from reviewing applications for expedited review and revisions or continuations when a conflict of interest is present. The Chair may appoint another IRB member to act as chair during the review of such applications or research activities. This is noted in forms indicating the IRB's actions.
All IRB members are encouraged to avoid the appearance of a conflict of interest that would compromise their ability to make a fair, impartial, and ethical decision on any IRB matter and to excuse themselves from decision-making in such instances.
WHAT IS SUBJECT TO REVIEW?
3.1 Definition of Research
Research is defined by the federal regulations as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” [45 CFR 46.102(d)] This definition may include qualitative and quantitative research studies, surveys, case studies, experiments, interventions, analysis of specimens, demographic and epidemiological research, program evaluations, oral histories, secondary analyses of documents and records, and other methods associated with biomedical, behavioral and social sciences. Research is characterized by the intent to share knowledge with others in professional, scholarly, or scientific publications and/or forums.
3.2 Definition of a Human Subject
A human subject is defined in the federal regulations as a “living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable in order for obtaining the information to constitute research involving human subjects. [45 CFR 46.102(f)]
a. Third Parties – In the course of their research, investigators sometimes collect information about persons other than the participant who has provided informed consent to be part of a study. For example, medical histories often collect information about conditions and diseases among a person's relatives or sociological, anthropological, or psychological research may obtain information about people's experiences and perspectives on others in their lives. Persons who are not primary subjects of research, but about whom information is collected are sometimes referred to as “third parties” or “secondary subjects.” Many IRBs and the OHRP have examined the issue of: when do third parties become “human subjects” from whom informed consent must be obtained?
Investigators have an ethical responsibility to avoid exposing any persons to unnecessary risks or undue harms, whether or not they are research subjects . Information collected about third parties generally should be recorded in a manner that protects their identities, and special steps must be taken to safeguard confidentiality in the case of sensitive information that could cause harm to persons unless this jeopardizes the rights and welfare of the research participants.
The IRBs will consider on a case-by-case basis the circumstances under which third parties should be considered research subjects. In reaching this determination, the IRB will consider the following factors: (1) the amount of private information collected about third parties; (2) the sensitivity of that information; (3) the ability of investigators to maintain the confidentiality of third parties; (4) the welfare of the originally designated research subjects; and (5) the right of the originally designated research subjects to provide information on their personal life experiences. Third parties normally are not considered research subjects from whom consent must be obtained unless information obtained about them pertains to their personal behavior unrelated to the interests and experiences of the originally designated research subjects.
b. Expert Opinion – Faculty, staff and students sometimes solicit the opinions of experts through phone or face-to-face interviews, surveys, and panel discussions. Experts are persons who, by virtue of their training or expertise, have information and knowledge in a substantive area beyond that of the average person and who regularly share this information and knowledge through consultation, teaching or public speaking, or publications and written reports. For IRB purposes, experts are not human subjects when asked to provide information and opinions within their areas of expertise. Communications with experts on non-private information do not require IRB approval.
c. Autobiography or “Auto-ethnography” – In sociology, anthropology and related disciplines, postmodern ethnography, autobiography, or auto-ethnography is a narrative method in which the investigator and “subject” are one and the same. That is, the investigator reports on his or her own experiences and perspectives. In this form of narrative reporting, the investigator is not considered a research subject, and IRB approval is not required.
3.3 Scope of Review
IRB review and approval is required for any research involving human subjects that:
• is conducted by University faculty, staff, or students;
• is performed on the premises of the University;
• involves University students, faculty, or staff;
• satisfies a requirement impose s d by the University for a degree program;
• is performed with , or involves the use of , facilities or equipment belonging to the University.
3.4 Research Conducted by “Affiliated Faculty”
Research conducted by “affiliated faculty” – faculty members who hold clinical appointments – is subject to the University's guidelines for research on human subjects and must be submitted for IRB review. Any research project that is conducted by or under the direction of any employee or agent of this institution, in connection with his or her institutional responsibilities, requires IRB approval.
3.5 Research Projects in which the Researcher is a Consultant
University IRB review is required as stated above unless the researcher has a strict consulting relationship in which:
• the researcher is hired on his or her own time; OR
• the researcher holds no rights in the work; and AND
• neither the researcher nor the University retains any data; and AND
• the researcher does not utilize University space, materials and supplies, and secretarial and staff support.
3.6 Research Conducted by Students – The Faculty Sponsor's Responsibility
Theses/dissertation projects, senior honor theses, independent study research projects, and other similar projects must be submitted independently to the IRB by the student-researcher. Faculty sponsors must instruct students on the ethical conduct of research and help them prepare the application for IRB approval. Students should:
• understand the elements of informed consent;
• develop a readable consent form following the samples ( www.research.uh.edu , click on “Human Subjects”);
• plan appropriate recruitment strategies for identifying potential subjects;
• establish and maintain strict guidelines for protecting anonymity or confidentiality; and
• allow sufficient time for IRB review and completion of the project.
To ensure that the University's guidelines will be followed, the faculty sponsor is required to sign the student's application for IRB approval. The faculty sponsor's certification section of the application states, “ I hereby certify the accuracy of this application and attest to the scientific merit of the proposed project. I accept the responsibility for the conduct of this research and for the protection of human subjects as required by law and institutional policy.” After IRB approval, faculty sponsors must take an active role in ensuring that projects are conducted in accordance with the IRB's requirements.
3.7 Research Conducted in University Courses
Many research methods courses at the University of Houston require students to complete projects as a way of teaching research methods and skills. Institutional review boards at institutions of higher education vary according to whether they require student projects to be reviewed and approved. The University of Houston's IRB does not require student projects conducted in research methods courses to be reviewed if the purpose of these projects is educational in nature and will not be published or used in future research . Activities not intended to provide generalizable knowledge are not subject to IRB review. However, the instructor of the course is ultimately responsible for the protection of human subjects.
Students are not permitted to continue projects conducted for a research methods course after the semester has ended without IRB approval.
Students in graduate methods courses, in particular, sometimes use projects to refine their research interests and provide a foundation for a thesis or dissertation. A project initially conducted to learn research methods may yield data that the student subsequently wishes to use to contribute to knowledge. In order to use these data for theses, dissertations, or other research purposes, students must either: (1) demonstrate that individuals provided informed consent for the project at the time, through procedures approved by the instructor; or (2) obtain consent from the individuals to use previously collected information according to procedures approved by the IRB (i.e., an application for exemption, expedited review, or full IRB review). Instructors of methods courses requiring student projects are encouraged to send a memo to the IRB administrator listing the students and their research projects and indicating that the projects were conducted under the instructor's supervision and in accord with procedures approved by the instructor. The administrator will provide a memo verifying that the student projects did not require IRB approval.
Student projects in courses are subject to IRB review if they are designed at least partially to provide data for research and publication purposes. For example, instructors may enlist students to assist in data collection or analysis for their own research or may design seminars in which a goal is for students to collaborate in research that will be submitted for publication. These projects constitute research and must be submitted to the IRB for approval beforehand before the project can begin.
3.8 Research Conducted at Another Institution
Prior to participation in a research project at another institution, the University-researcher must obtain approval of the project by the relevant IRB at University of Houston and all relevant institutions. For example, a University researcher engaged in research with Baylor College of Medicine must secure approval from the IRBs at both institutions.
Changes in protocol or consent forms required by the IRB at the other institution should must be brought to the attention of the IRB at the University of Houston.
3.9 Research Conducted at UH by Investigators from Other Institutions
University of Houston officials and faculty are sometimes approached by investigators at other institutions for cooperation in their research. For example, department chairs or deans might be asked to assist in the distribution of surveys to faculty or students. This research does not fall under the purview of the IRB unless: (1) University facilities and resources will be used; (2) University officials are actively engaged in or actively cooperate with or encourage participation in the research; or (3) University officials, faculty, staff, or students intend to use the findings or results of these studies for their own purposes.
Investigators from other institutions are advised to contact the Research Compliance Specialist for additional information on the required procedures.
3.10 Research as Part of Multicenter Clinical Trials
Approval of a proposal document at the national level is not sufficient to bypass approval at the local level. Researchers who conduct multicenter clinical trials sponsored by the National Institutes of Health (NIH) or the National Cancer Institute (NCI), for example, should include protocols and consent forms approved at the national level with their applications to the IRB. Although the documents should be identified as having been approved by a national IRB, the local IRB must review the material as it would any other submission.
Only the local IRB is vested with the authority to review and approve projects to be conducted at a given institution familiar with the particular circumstances of its research setting and is able to weigh critical considerations such as state and local laws, professional and community standards, institutional policies, and the needs of different patient and subject populations.
If changes are made to documents approved by the national IRB, the investigator must notify that IRB. The University IRB will rarely make substantive changes in the protocol or study plan and more likely to request that the wording of a consent form be changed to reflect local standards or to include specific language required by the University.
3.11 Research in Foreign Countries
Research conducted by University investigators in foreign countries remains under the purview and guidelines of the University IRB. While we cannot impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct or consent process.
While human subjects in foreign countries merit the same level of protection as subjects in the United States, acceptable practices vary from place to place. Different traditions, mores and institutions may require different research protocols, particularly regarding informed consent, recruitment practices, and documentation. Special attention must be given to local customs, culture, and religious norms in drafting written consent documents.
Documentation of “local approval” is a prerequisite to IRB approval at the University. This approval should be from the local equivalent of the University IRB, local experts or community leaders. Researchers should provide sufficient information regarding the language and culture of the country in question. Researchers proposing international research should allow additional time for this review process.
3.12 Research at a Pilot or Feasibility Stage
Investigators sometimes conduct pilot studies designed to develop or refine research procedures and instruments. Although data collected through pilot or feasibility studies (including those involving only one human subject) may not be used in research reports and publications, pilot studies represent part of the research process that leads to the development of or contribution to generalizable knowledge. Therefore, these studies require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in the “Application to Conduct Research using Human Subjects.” Ordinarily the data collected from subjects as part of a pilot/feasibility study are not used for study findings. The consent document should clearly identify the project as a pilot study.
Experts reviewing draft research procedures or instruments are not considered human subjects, and IRB approval is not required for this.
3.13 Research Involving Secondary Use of or Archival Data
Federal regulations extend to the use of existing or “archival” data if it was originally obtained from persons who would meet the definition of a human subject. Exempt category 4 states, “Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.”
This might include (but is not limited to) student test scores, academic achievement scores, attendance and/or discipline records, data previously collected in a research project, census records, etc. The application must indicate that the data is publicly available (with a description of how it is obtained) or provide a letter from the person s who is the owner or the keeper of the data indicating that permission has been granted for the use of the data in a research activity. Also, the data must be in existence at the time the application is submitted to the IRB.
3.14 Research Involving Tissue/Blood Samples
Research that is conducted on "waste" or "extra" human tissue or fluids must be submitted for review.
"Waste material" is material that is collected originally for clinical or diagnostic purposes only but is no longer needed. "Extra material" is material that is collected above and beyond what is needed for a clinical or diagnostic procedure. It is collected during the same procedure, but solely for investigational purposes.
The IRB may determine that research on waste material qualifies as exempt from full review. If the subject's consent to the clinical procedure outlines research use of the material as well, a separate consent form may not be required. Collecting and using "extra material" requires subjects' written consent and full IRB review.
3.15 Research Involving Deception
The IRB discourages deception in any form of experimental procedure. If an investigator believes that deception is necessary to conduct the research and is the only way to answer the research question(s), he or she must provide a detailed rationale to the IRB and ensure that psychological, social, and other risks will be minimized. Before approving deception in research, the IRB will require a procedure to be put into place that provides for a debriefing process, with the participant being given a statement to sign indicating that debriefing has occurred and that he or she understands that deception occurred and how.
3.16 Research Involving the Internet
For Internet research, investigators must protect the privacy and confidentiality of participants and obtain their informed consent. Investigators may not be required to obtain consent of persons to record information or communications in public Internet forums in which people do not have a reasonable expectation of privacy. For example, an investigator would need to obtain consent of people to record communications in a private listserv, but would not be required to do so in a public chat room with unrestricted access. In communications with persons in public or private Internet forums, investigators must not conceal their identities as investigators or mislead people about their purposes. Investigators must not communicate directly on the Internet with persons whom they believe are minors without their parents' permission.
In electronic surveys or interviews, investigators must take reasonable steps to protect people's privacy and confidentiality, taking into account the sensitivity of questions asked of them. For interviews or surveys on non-sensitive topics, e-mail is generally acceptable. Interviews or surveys on sensitive topics should be conducted on a secure Web site.
3.17 HIPPA and Research
The Health Insurance Portability and Accountability Act of 1996 was adopted with the goal of improving the efficiency and effectiveness of the healthcare system. It also carries with it an associated Privacy Rule that can significantly affect the way researchers obtain, use and disclose protected health information (PHI) in research involving human subjects. The minimum standard necessary requires that only the minimum amount of information needed for any specific purpose be used or disclosed. NOTE: HIPPA IS IN ADDITION TO, NOT INSTEAD OF, UNIVERSITY IRB POLICIES. WHEN HIPPA AND HUMAN SUBJECT PROTECTION REGULATIONS APPLY, BOTH SETS OF REQUIREMENTS MUST BE FOLLOWED.
Under certain circumstances, the Privacy Rule allows a covered entity to use or disclose PHI for research without an individual's authorization. Therefore, the IRB's role, under HIPPA, is to act on requests for a waiver or an alteration of the Privacy Rule's Authorization requirement. The IRB may grant a Waiver of Authorization for studies meeting ALL of the following criteria:
• The use or disclosure involves no more than minimal risk to a subject's privacy, based on at least the following principles:
- A plan to protect identifiers
- A plan to destroy identifiers at the earliest opportunity that is consistent with the goals of the study, unless there is a health justification for retaining identifiers or retention is otherwise required by law
- Adequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by the study or law enforcement agencies.
• The research could not be practicably conducted without the waiver.
• The research could not be practicably conducted without access to and use of PHI.
If a waiver is obtained, please note that the following procedures must also be in place:
• The investigator must identify and justify what identifiable information is needed.
• Disclosures of PHI outside UH must be tracked. The purpose of this tracking requirement is to provide patients, upon their request, with a list of where information about them was released for research and certain other non-treatment purposes without their knowledge. The following information must be tracked for each disclosure:
- Name of individual
- Date of disclosure
- Name of person/entity that received the information
- Brief description of PHI disclosed
- Brief statement about the purpose of the disclosure
- Disclosures must be made available to the individual upon request for 6 years following the disclosure
• Any changes to a waiver (for example, the addition of new sources of PHI) must be approved by the IRB.
HOW TO APPLY FOR REVIEW
4.1 The IRB Process
The IRB reviews a proposal first by assessing the risks and benefits of research participation. After determining that the research benefit outweighs the risks involved, the IRB turns to the consent process to ensure that potential subjects are fully aware of the risks and benefits and that they participate in the project voluntarily. The consent is a key element in the review. The IRB will also determine whether or not the scientific questions addressed in the protocol have adequate merit to justify the involvement of human subjects.
After reviewing all materials, the IRB may opt to approve, table, or reject the application. The IRB may require revisions in the protocol. After the investigator revises a project, the IRB reviews the project again to see whether its concerns have been adequately addressed.
To fully protect subjects, the IRB must approve a project before investigators start to work on it – even before they begin to recruit subjects, since recruitment strategies are part of the review. Although there are different types of review, many projects require “full” committee review. The initial full review will occur according the published submission deadlines. All IRB actions are communicated in writing to the investigator by the IRB staff. If the investigator is a student, the letter is addressed to the investigator in the care of the faculty sponsor.
4.2 Primary Types of Review
The IRB reviews research projects according to the risk to subject and at one of three levels defined in federal regulations:
- full convened IRB review,
- expedited, IRB review, and
- administrative review for exemption from full IRB review.
The IRB will determine the level of review.
4.3 Full Review
A project that involves greater than minimal risk or does not qualify for exempt/expedited review requires approval from an IRB panel composed of members qualified to review research in that field. Research that requires full committee review includes:
- research that involves greater than minimal risk;
- non-exempt research that involves children or other vulnerable populations;
- research that involves experimental drugs or devices;
- research that involves invasive procedures; and
- research that involves deception.
Survey research that involves sensitive questions or information about sexual practice s or illegal behavior is subject to full review, in keeping with federal guidelines. A dditional, a ny survey or interview that is likely to be stressful for the subject requires full committee review. The IRB administrator will make this determination.
The administrative staff screens all applications before they are assigned to an IRB panel. If incomplete, the application is returned to the investigator . The IRB reviews only complete applications (see 4.1). After review, the IRB will act on the application. Possible committee decisions include:
- approved as submitted;
- approved with minor requests for minor changes;
- approved with contingencies (conditions that must be met before final approval is granted) – most common decision;
- deferred pending receipt of additional information or major revisions; or
- disapproved.
All non-exempt research is subject to continuing review at least annually [refer to 6.0 Continuing Review].
4.4 Expedited Review
To qualify for expedited review, a research project must be limited to the activities that are federally approved for expedited review and incur no more than minimal risk for participants, or be a minor change in previously approved research that involves no additional risk to the research subject.
The activities approved in the federal regulations for expedited review are:
- Clinical studies of drugs and medical devices, only when condition (a) or (b) is met. (a) research on drugs for which an investigational new drug application (21 CFR Part 312) is required. (*Note: research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.); or (b) research on medical devices for which (i) an investigational device exemption application (21 CFR 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with cleared/approved labeling.
- Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children (as defined by the HHS regulations as “persons who have not attained the legal age for consent to treatments or procedures involved in this research, under the applicable law of the jurisdiction in which the research will be conducted), considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently that 2 times per week.
- Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at a delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skill cells collected by buccal scaping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
- Continuing review of research previously approved by the convened IRB as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.
- Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and additional risks have been identified.
The researcher must demonstrate in the application how the proposed project activities fall into one or more of these categories. To apply for expedited review, investigators complete the Application to Conduct Research using Human Subjects and indicate that they are requesting expedited review in the appropriate section.
The IRB administrator will ensure that all of the elements essential for review, including consent forms and supporting documentation, have been submitted. The administrator will then forward the application for review and approval by either the CPHS subcommittee or the full committee, depending on the submission deadlines. Following review, the subcommittee will approve the application (perhaps with contingencies) or forward it to the full committee for review.
In accordance with 45 CFR 46.110(c), the applications approved under the expedited procedures by the subcommittee are reported to all members of the full committee. The full committee shall receive a copy of the minutes from the subcommittee meeting listing the protocols that were reviewed and the decision.
4.5 Administrative Review for Exempt Status
While research that involves only minimal risk to human subjects is sometimes exempt from full IRB committee review, it is still subject to review. Investigators do not have the authority to determine whether research involving human subjects is exempt from full review [45 CFR 46.101(b) and (c)]. Researchers must file an application requesting that the IRB determine exempt status for a project. Exemptions are approved for a specific research project conducted by specific investigators. Departments cannot receive blanket exemptions for unspecified research (e.g., surveys, public observations) to be conducted in the future.
Projects that involve contact with subjects may still qualify as exempt. In general, the federal guidelines for research on human subjects allow a project to be exempt from full review only if the research involves no risk to the subject and the procedures are limited to the following criteria:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if: (i) the human subjects are elected or appointed officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
The application form is available from the Division of Research office or its Web site. Copies of the written consent form should be filed with the application or justification for a waiver of written documentation should be provided. See 45 CFR 46.117.
The IRB administrator will decide whether the project qualifies as exempt, and confirms the decision in writing. If the project does not qualify as exempt, it will be submitted to the appropriate committee based on the posted Submission Deadlines. Again, the investigator will be notified in writing.
Exemptions are approved for a maximum of five years after approval. To continue research after that time period, investigators must apply for another exemption.
4.6 Appeal of IRB Determination
Investigators who have been required to make revisions in their applications or whose applications have been disapproved may request further information regarding its reasons from the IRB or may ask the IRB to reconsider its decision. Such requests must be made in writing and will be considered by the IRB at the next convened meeting, if submitted according to the published deadline for submission of materials to the IRB. At its discretion, the IRB may invite investigators to meet with the IRB or a subcommittee of the IRB to collect additional information or to explain the reasons for its decision. The IRB will provide investigators with a written explanation of its reasons or its decision upon reconsideration. The IRB's decision will be final, and no further appeal can be made.
4.7 Application Forms and Original Signatures
All forms that an investigator must file with the IRB to apply for review are available with specific instructions on the Web at www.research.uh.edu (then click on “human subjects”), or from the Office of Research Policies, Compliance and Committees. The RPCC staff can help researchers determine which application is appropriate for a project. The forms available are:
- Application to Conduct Research using Human Subjects
- Application for Revision to a Currently Approved Protocol
- Application for Renewal
A signature page provides space for the signature of the principal investigator and co-investigators. An original signature certifies that the investigator will be actively involved in the research project and has made a commitment to protect the research subjects according to the federal regulations and institutional policies. Faculty sponsors must sign all student research proposals. Department heads (or college deans) must sign all faculty, staff and student proposals. [Note: Signature from the department head (or college dean) is not required for applications requesting exempt approval.] Signatures must be original.
All other documents submitted to the IRB (such as interim reports, requests for revisions, adverse events reports, renewal applications) also require original signatures. Staff signatures will not be accepted. The principal investigator remains ultimately responsible for the protection of subjects.
Finally, before submitting the application with original signatures, investigators must:
- retain a copy of all submitted materials for their own records; and
- attach the appropriate number of copies required:
- for full IRB review (CPHS – Committee 1) – original plus 9 copies of the application, appropriate consent documents, interview questions and/or questionnaires, and any additional information.
- for full IRB review (SSCPHS – Committee 2) – original plus 5 copies of the application, appropriate consent documents, interview questions and/or questionnaires, and any additional information.
- for expedited review (both Committee 1 and 2) – original plus 2 copies of the application, appropriate consent documents, interview questions and/or questionnaires, and any additional information.
4.8 Preparing the Application
To submit a project to the IRB for review, an investigator must complete the application form according to detailed instructions and enclose supporting material as required.
A fully complete application form will include:
- an up-to-date version of the appropriate application form (available at www.research.uh.edu);
- answers to every question on the form;
- appropriate attachments to the application;
- a lay abstract describing the purpose of the study;
- a description of the study population, criteria for inclusion/exclusion, the number of subjects, and the process of identifying potential subjects, and any other plans related to the section selection of subjects;
- a description of the tasks that subjects will be asked to perform;
- a full description of the anticipated risks and benefits of participating in the student study ;
- an explanation of how risks will be minimized;
- documentation of provisions to care for subjects in case of accident or injury (if applicable);
- a full description of procedures for maintaining confidentiality;
- a description of the process by which informed consent will be obtained from the appropriate individuals;
- documentation of any required approvals or applications for approval from other committees and/or from cooperating agencies;
- all supporting materials and documents, including protocol, interview schedules, solicitation letters, advertisements, and any survey instruments; and
- appropriate original signatures, including the faculty sponsor's signature for student research, and the department head/college dean (when applicable).
The application form will serve as background information for all future reviews of the study. For this reason, “see protocol” or “see attached” are not adequate responses to any application question. The application is designed to provide the IRB with sufficient information about the proposed research activity to make the following determinations prior to approval:
- Risks to participants are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose them to risks.
- Risks are reasonable in relation to anticipated benefits, if any, to participants and the importance of knowledge that may reasonably be expected to result.
- Selection of subjects is equitable. In making this determination, the IRB takes into account the purposes of the research and the setting in which the research will be conducted and is particularly cognizant of the special problems of research involving vulnerable populations, including children, prisoners, pregnant women, persons with impaired decision-making capabilities, and economically or educationally disadvantaged persons.
- Informed consent is sought from each prospective participant or the participant's legally authorized representative and is appropriately documented.
- When appropriate, the research plans make adequate provisions for monitoring the data collected to ensure the safety of participants.
- When appropriate, there are adequate provisions to protect the privacy of participants and confidentiality of the data.
- For participants who are likely to be vulnerable to coercion or undue influence, additional safeguards are included to protect their rights and welfare.
No form can address adequately the wide diversity of research at the University of Houston. Principal investigators should use the form to convey the nature and specifics of the project proposed and attach appendices as necessary.
4.9 Designating the Principal Investigator
The IRB recognizes only one Principal Investigator (PI) for each project. The PI must be a faculty member, student or staff member at the University of Houston. On research conducted by students, a faculty member must serve as the sponsor and assume responsibility for exercising appropriate oversight of the student's research.
The PI, including the faculty sponsor in the case of students, must personally review and sign all applications, revisions, renewals, and other documentation submitted to the IRB. The PI is responsible for identifying key personnel involved in the conduct of research, monitoring their activities, informing the IRB of proposed changes, adverse events, and responding in a timely fashion to inquiries or requests from the IRB.
All official correspondence is addressed to the PI. In the case of student researchers, correspondence is addressed to the student, care of the faculty sponsor. All correspondence is sent via campus mail.
Any change in the PI or in the PI's status that affects the project must be communicated to the IRB. [See section 6.2 Making Changes to Research Protocols.]
4.10 Summary of Proposal: Rationale and Methods
Investigators must provide a summary of their proposed research in non-technical terms. For any risks associated with human research to be warranted, and hence, for research to be ethical, studies must have scholarly or scientific merit. Any study that does not have the potential to contribute to knowledge or that is fundamentally flawed in its methods cannot be approved by the IRB. When research is not flawed, but could be strengthened in the opinion of IRB members, the IRB may provide recommendations to investigators that they may follow at their discretion.
Investigators should summarize the rationale for the research, including the research questions the study is intended to answer or the knowledge to be contributed by the study in the lay summary. This section should not be used to describe the methods in the proposed research.
Investigators must describe the nature of the intervention or interaction with potential participants or the nature of private information to be collected and analyzed. Both the general methodological tradition (e.g., qualitative versus quantitative) and specific methods (e.g., participant observation, interviews, surveys) should be described. The IRB examines applications to ensure that the research methods are appropriate given the research rationale and questions.
The investigator must provide information on specific procedures, the nature and number of interventions or interactions with participants, and the analytical procedures. Researchers using participant observation or anthropological field work methods should be specific regarding where and among whom observations will be recorded and how they will identify themselves. The IRB discourages covert participant observation in which the investigator conceals his or her identity as a researcher and will require a clear justification for this approach. The investigator must demonstrate that the researcher could not be conducted overtly and that participants will not be harmed or exposed to undue risk.
4.11 Specifying the Number of Research Subjects
The application must specify the number of study subjects to be recruited and tested the number to participate , grouped by age, gender, and population diversity. Exceeding the recruitment limits approved by the IRB is a violation of the protocol. The IRB must give prior written approval for any increase in subjects.
The IRB is changed charged with the protection of human subjects from the earliest contact for possible recruitment. All subjects who go through the recruitment process screening must be accounted for, even if they fail or decline participation. When calculating the number of subjects in research design, please include a number large enough to account for this group.
If it is difficult to predict how many subjects will be eligible or be attracted to a study, the optimum number should be specified. Responses such as “don't know” or “as many as we can recruit” to questions about the number of subjects are not acceptable.
Multicenter studies, in which data will be pooled and recruitment may vary, present a special problem for investigators. The application should provide information about the total picture, including both the number of subjects to be studied at the University of Houston or by University researchers and information on overall recruitment goals.
4.12 Women and Minorities in Study Populations
Research benefits and burdens should be distributed fairly. If an individual or group is denied access to a clinical trial that might be beneficial, or if some people are singled out to bear the burden of risks associated with a study, the requirement for fairness is not met.
In accordance with the policies of the National Institutes of Health, the IRB requires applicants for federal funds to provide data regarding the subject populations by gender and minority group. Studies with the potential to address issues relevant to both genders must recruit both genders, and include minority groups in a study population wherever feasible. Researchers must justify the exclusion of any group of individuals. The IRB makes exceptions if there is adequate scientific justification for exclusion, such as when a disease predominates in one gender or the focus of the research question is on a specific group.
4.13 Students or Employees as Research Subjects
Though the researcher must be careful to avoid potentially coercive behavior, the very nature of the relationship with the subject can create the appearance of coercion. For this reason, researchers should be aware of the potential for coercion that exists when a research subject is also a student, employee, colleague, or subordinate of the researcher. Therefore, researchers should avoid using their own students or employees as research subjects.
If there is sound scientific reason to include their own students, researchers should:
- ensure that students clearly understand that participation will not influence class standing, grades or other benefits under the control of the researcher.
- limit the use of extra credit points as a reward for participating; points should be used only when the research is closely tied to the course subject matter and should not raise a student's grade by a whole step (for example, from a B to an A). Students should be offered an alternative assignment of a non-research nature that entails the comparable level of time as the research activity. Students who participate in part, but not all of the research should be offered partial credit for participation according to the amount of time spent (an alternative assignment comparable in time must be offered to enable students to receive full credit).
- avoid using class time to recruit subjects or complete study instruments.
Researchers who select colleagues or subordinates as research subjects must be able to provide a rationale other than convenience for recruitment and must show that the recruitment method does not imply penalty or compromise by refusing to participate. Recruitment through bulletin board advertisements or by a third party is preferable.
A detailed description of how students and colleagues will be recruited and how coercion will be avoided must be included in the information submitted to the IRB.
4.14 Children as Subjects
All research that involves minor subjects is subject to the application of 45 CFR 46 Subpart D. In all cases, inclusion or exclusion of children is reviewed for appropriateness as defined in the regulation.
In general, if research involves greater than minimal risk, children can be included in the study population only if there is direct personal benefit to the child. This restriction applies to research in both the health sciences and the social sciences. A research protocol that involves anything more than minimal risk and that offers no potential benefit to the subject cannot include children unless all conditions of 45 CFR 46.406 are met. Investigators claiming this provision in 45 CFR 46.406 should be prepared to provide justification.
4.15 Prisoners and Institutionalized Persons
All research that involves prisoners is subject to | 
