- Review Process
- Reporting and Modification
Prior to any involvement of human subjects, all human subjects research must be reviewed and approved by the HSRB. The HSRB reviews a proposal by first assessing the risks and benefits of research participation. After determining that the research benefit outweighs the risks involved, the HSRB turns to the consent process to ensure that participants are fully aware of the risks and benefits and that they understand that their participation is voluntary. The consent process and form is a key element in this review.
For all projects, an application with relevant attachments must be submitted to the HSRB for review. The application asks for information about the investigator(s), the nature of the research, the funding source, targeted subject groups, how subjects will be recruited, how informed consent will be obtained, how confidentiality will be protected, and the risks and benefits of the proposed research.
Upon completion of the review, a letter will be sent to the responsible project investigator authorizing initiation of the project or containing stipulations that must be met before approval is granted. When the investigator revises a project, the HSRB reviews it again to see whether the concerns have been adequately addressed. A project may undergo several reviews.
The involvement of human subjects, including recruitment, may begin only after stipulations have been satisfactorily addressed and formal, written approval is given. Although there are different types of review, many projects require "full" committee review. In most cases, the initial review will occur within two weeks of submission if the application is complete. All HSRB actions are communicated in writing to the responsible project investigator by the HSRB chair or reviewer. Approval is good for one year. The HSRB conducts continuing reviews of non-exempt research at intervals appropriate to the degree of risk, but at least once per year. A research completion report should be filed with the HSRB within 2 months of the completion of all research activities.
Research projects are reviewed at one of two levels, according to the HSRB's determination of the project's potential risk to human subjects and the federal guidelines that define categories of review. The level of review is determined only by the HSRB. The levels are:
We strongly recommend that investigators informally consult with the HSRB to confirm exempt status and to ensure human subjects protections are handled appropriately. Research involving more than minimal risk is not exempt, and certain minimal risk projects might not be exempted if, in the opinion of the HSRB, the research contains procedures that should be periodically re-reviewed. Also, if an investigator thinks she or he might want to publish or present their research outside of Metropolitan State University, HSRB review is required.
All human subjects research, whether exempt or not, must be conducted in accordance with Metropolitan State University policies, federal guidelines, and ethical principles set forth in the Belmont Report. Unless it will involve prisoners, pregnant women, people not competent to provide informed consent, or fetuses as subjects or certain activities involving children, or use of personal records (e.g., health care information, drug and alcohol treatment records, psychiatric treatment records, educational records) protected by the Federal Privacy Act and other federal and state laws, research may be exempt from the HSRB review if the only involvement of human subjects will be in one or more of the categories below.
The following is excerpted from Policy 2060, Metropolitan State University.
"Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from review and do not need to be submitted to the HSRB. All other research with human subjects must be submitted to the HSRB for review.
- Research conducted in established or commonly accepted educational settings, involving normal educational practices such as:
- research on regular and special education instructional strategies; or
- research on the effectiveness of, or the comparison among, instructional techniques, curricula or classroom management methods.
- 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 through identifiers linked to the subjects.
- Research activities, conducted by University personnel and intended for internal use only, that are designed to assess, evaluate or otherwise examine:
- University courses, services, and programs;
- procedures for obtaining benefits or services at the University;
- possible changes in or alternatives to services, programs or procedures; or
- possible changes in methods or levels of payment for benefits or services under those programs.
- Research activities that are conducted within an established University course and are directed solely toward the learning of research methodology and procedures. Exceptions that are subject to review include capstones, thesis, or other research activities that are conducted beyond the boundaries of the supervisory classroom environment and involve human subjects who are not registered members of the course.
It is expected that appropriate measures will be taken to preserve subjects' anonymity and/or confidentiality and that subjects will be informed that their participation is voluntary and no coercive strategies will be used in order to gain subjects' compliance."
NOTE: All non-exempt research is subject to continuing review at least annually. If research involves significant risk to subjects, the HSRB may require more frequent review and may ask to be kept apprised of all research activity.
The terms "Expedited" and "Minimal Risk Review" refer to a specific type of review in which an HSRB review is required but review by a full committee is not required. An expedited review procedure consists of a review by the HSRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the HSRB. Research eligible for review by "expedited procedures" is generally that in which direct contact with human subjects is minimal or non-existent. Although minimal risk review is conducted by expedited procedures, this does not mean that it takes less time than review by a full committee. Because it is only available to eligible activities, anything submitted for expedited review must be reviewed not only for its adherence to usual ethical and regulatory requirement, but to ensure that it does not exceed the permissible minimal risk categories. Consequently, a minimal risk review may take as long, if not longer, to review than a full review.
To qualify for expedited review, research must be limited to federally approved activities. See Health and Human Services Source: 63 FR 60364-60367, November 9, 1998, for a full listing. The researcher must demonstrate in the application how the proposed project falls into one or more of the categories.
An Expedited Review requires the following:
Research activities that present no more than minimal risk to human subjects AND involve (as pertinent)
- Noninvasive measurements
- Archival/previously collected data that does not contain identifiers
- Survey, interview, focus group, or programmed evaluation methodologies.
The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review expedited or full utilized by the HSRB. The criteria apply to both initial and continuing HSRB review.
A project that involves greater than minimal risk requires approval by the full HSRB 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 (e.g. prisoners, pregnant women, people not competent to provide informed consent)
- research that involves experimental drugs or devices
- research that involves invasive procedures
- research that involves deception
- research that involves sensitive questions or information about sexual practice or illegal behavior
- any survey or interview that is likely to be stressful for the subject
It is expected that human subjects research at Metropolitan State University will satisfy the following conditions (from Title 45 Code of Federal Regulations, Part 46):
- Minimize Risk:(46.111) Research procedures should be designed so that the probability and magnitude of physical, psychological or social harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Any possible risks imposed must be weighed against the scientific importance and the potential benefits of the research.
- Confidentiality: (46.111) Research procedures shall not disclose confidential information, including names and/or salient individual identifying characteristics, to other than the investigator(s) and their research staff. Further, adequate provision must be made to protect the confidentiality of information that is to be retained over an extended period of time.
- Informed Consent: (46.116 and 46.117) Participants will be clearly informed as to the purpose of the study, risks and benefits associated with participation. No investigator may involve a human being as a subject in research unless the investigator has obtained informed consent of the subject or the subject's legally authorized representative.
The HSRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the HSRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the HSRB's action and shall be reported promptly to the investigator and the Provost and Vice President for Academic Affairs.
Double-sided copies: Sometimes investigators try to save paper by photocopying the application and materials in double-sided format. This creates several problems, and therefore, the Committee does not accept double-sided materials for review.
Consent forms: Often consent forms omit required elements of informed consent and are written in technical language that subjects do not understand. Use everyday language and avoid technical terms and professional jargon as much as possible. Use short words and short sentences. Avoid the passive voice. Include consent forms for all groups of adult subjects, and assent forms for minor subjects. Include all required elements of consent.
Protection of privacy: the two biggest problems are how subjects are approached to participate in the research and how the confidentiality of data is protected. Subjects should be approached to take part in the research by someone with whom they have had prior contact. This person explains the study briefly and requests permission to release the potential subject's name to the investigator. These so-called "intermediaries" may include the subject's health care provider, teacher, friend, leader of an organization, etc. The important thing is that the person's involvement in the research is entirely voluntary and they were not coerced in any way to participate, nor did they feel compelled to participate for reasons other than their own desire to partake in the research process. Their privacy should be protected by removing identifiers as quickly as possible and by secure storage procedures.
Including all necessary information: Please carefully read and follow the How to Apply instructions and include all requested attachments.
Translations: When materials (whether approach, recruitment or consent forms or procedures, or questionnaires, surveys or other study procedures or materials) are to be administered in a language other than English, the materials should ideally be submitted in the target language(s), accompanied by English translation(s) that accurately represent the materials one actually intends to use. The following points should be considered.
- Approach, recruitment and consent materials are often revised as a result of review. It is often better to submit English versions for initial review, and explain that translations will be submitted after English versions have been approved. However, because translation sometimes requires re-thinking and revision, it may be that the approved English versions no longer correspond to the actual materials. If this occurs, it is important to submit new English versions for review and approval.
- Similarly, questionnaires and interview material to be used in several languages may require adaptations that make each translation a separate version. In such cases, it may be necessary to submit an English translation of each version.
Issues arising from use of materials in several languages can become complex, and must often be handled on a case-by-case basis. When submitting an application involving use of translated materials, it is generally helpful to address the issues preemptively, in the application itself. Addressing the issues at the time of application can help reduce delays in screening and review.
Once the HSRB has approved a project, it must be carried out as planned. Any changes in subject population, recruitment plans, research procedures, measures/instruments, study location, consent process, or major research personnel must be approved by the HSRB prior to implementation. You may submit the request via email to the HSRB (firstname.lastname@example.org). Enacting changes without prior approval constitutes a protocol violation.
Researchers planning a change to research already approved by Metropolitan State's HSRB must submit a letter to the HSRB that includes the following
- name and HSRB approval number of the study
- description of the proposed change
- explanation of why the change is needed
- description of the implications for subjects
- revised consent documents, if the change will affect the subjects
- revised interviews, instruments, etc. (if changed)
Minor changes are handled by administrative action or expedited review. Changes that affect the risk/benefit ration may require full review. Implementation of the change must wait for the HSRB's approval.
Adverse events are unexpected problems whose nature, severity, and frequency are not described in the information provided to the HSRB or to subjects. Examples include unexpected complications for a subject, missteps in the consent documentation, or breaches of confidentiality. Adverse events must be reported to the HSRB within 10 working days of the event. The RPI is responsible for completing and submitting an "adverse event report" to the HSRB office. The report must discuss:
- the facts of the case, including the date and a description of the subject
- whether the event is related to the study's procedures or to the subject's situation (e.g., underlying disease or condition)
- the steps that have been taken to address the problem
- whether the event is likely to recur
- whether the event provides new information about the study's risks that should be conveyed to participants, and if so, attach a revised consent form.
Researchers must maintain a file of all documents concerning the use of human subjects in research for at least three (3) years. The documents that researchers must have on file are as follows:
- a copy of the original application submitted to the HSRB
- the HSRB response and/or notice of approval or approval renewal
- copies of all other correspondence with the HSRB.
Original signed consent forms must be kept in a secure location within Metropolitan State University property and separate from all other research and correspondence files. HSRB records are subject to inspection by federal authorities. Sanctions for incomplete or nonexistent records include suspension of funding, fines, and exclusion from future funding.