Research Integrity and Compliance
Human Subjects
Frequently Asked Questions
GENERAL QUESTIONS
REVIEW OF RESEARCH
FEDERAL FUNDING
ASSESSING RISK
- What makes research "minimal risk" rather than "no risk" or "at risk"?
- What is an example of risk of physical harm?
- What is an example of risk of psychological harm?
- What is an example of risk of social or economic harm?
- How does anonymity differ from confidentiality?
- What is an example of risk from inadequate protection of confidentiality?
- What can be considered "benefits" when weighing the risk/benefit ratio for participants?
INFORMED CONSENT
- What kinds of information need to be included in a consent form?
- What is the difference between informed consent and written consent?
- When can the requirement for written consent be waived?
- Is consent from participants required for the use of pre-existing data?
- For research with school-age children, do both the parent and the child have to give consent?
- How can consent be obtained from children or from persons with an impaired ability to understand a consent form?
- When is it possible to withhold information about the purpose of the research or to give misleading information about the purpose of the research?
- Can participants be asked to waive the possibility of initiating legal action against the researcher or the institution?
SUBMISSION REQUIREMENTS
APPROVALS
- What should a researcher do if changes are requested when an application is reviewed?
- In what situations does a researcher need to contact the IRB after research has been approved?
- How long does an approval last?
- What does a researcher need to do if the project has not been completed when the approval expires?
RECORDKEEPING
HISTORICAL DOCUMENTS
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GENERAL QUESTIONS
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What is human subjects research?
Answer: "Research" refers to a systematic investigation designed to develop or contribute to generalizable knowledge. This generally implies collection and analysis of data the researcher hopes to report in a scientific publication or at a professional meeting, although some departments review any research done by their students. "Human subjects research" involves the participation of human beings as subjects in such an investigation. See Research Covered by CPHS Policies on page 2 in Policies and Procedures. What special knowledge is expected for persons doing human subjects research? Answer: In addition to any professional, ethical, and methodological standards specific to the subject area being investigated, researchers also need to understand federal and university policies that apply when conducting human subjects research. Some basic information is covered in these Frequently Asked Questions. There is more extensive information in the Policies and Procedures. Researchers can verify their understanding of these issues by taking a short test, available soon on this web site. For now, this test will be voluntary, but it is likely to become a requirement in the near future. |
| REVIEW OF RESEARCH | |
| What human subjects research is subject to review? Answer: Research conducted by Sacramento State employees or students, and research conducted by others involving the use of University students or other resources, must be reviewed. This includes research that has already been approved at another institution. See more specific information in Research Covered by CPHS Policies on page 2 of Policies and Procedures. Please contact a member of the committee if there are any questions. What human subjects research can be reviewed at the department level? Answer: Research conducted by students that does not involve risk to the participants can be reviewed by a departmental committee if that committee has been approved by the CPHS and applies the same standards the CPHS would use. (However, collaborative projects in which students participate as researchers but a faculty member is the primary investigator must be reviewed by the CPHS.) See Role of the Institutional Review Board on page 1 of Policies and Procedures. Does research with pre-existing data require review? Answer: If the data are available without restriction to the general public, such research does not require review. If access is limited, for example to persons with certain qualifications or to persons who pay a substantial fee, the research may require review. One key issue is whether the data contain personally identifiable information when acquired by the new researcher. What is the meaning of "expedited" review? Answer: This simply means that the research will be reviewed, at least initially, by less than the full committee. It does not necessarily mean that the review process will be faster, or that the review will be less rigorous than one done by the full committee. See Review Process for Applications on page 5 of Policies and Procedures. What kinds of research are "exempt"? Answer: Some examples include research in established courses on the effectiveness of instructional techniques, observational research on adults (but not children or minors) when the observations are recorded in a way that does not allow individual participants to be identified, reviews of pre-existing records or surveys that are completely anonymous to the researcher, and studies which evaluate public service or benefit programs. For other possibilities, see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html and look for Federal Policy §46.101(b). Who determines that research is "exempt"? Answer: The research must be reviewed by the CPHS (or, for student research, by an authorized departmental committee) to determine whether it is exempt. The researcher cannot make this decision. |
| FEDERAL FUNDING |
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| Why do federal policies (45 CFR 46) affect research not funded by federal agencies? Answer: Most institutions, including Sacramento State, have agreed to follow federal regulations for all research involving human subjects when they obtained an assurance of compliance with requirements for federally funded research. See Role of the Institutional Review Board on page 1 of Policies and Procedures. What additional special knowledge may be required when applying for federally funded research? Answer: Researchers applying for major grants should investigate more extensive training programs, such as Human Participant Protections Education for Research Teams, available at http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp. Completion of this free, two-hour web-based course satisfies the NIH human subjects training requirement for obtaining federal funds. |
| ASSESSING RISK | |
| What makes research "minimal risk" rather than "no risk" or "at risk"? Answer: Research is "minimal risk" when the probability and magnitude of harm or discomfort anticipated for participants is no greater than what might be encountered in daily life or during the performance of routine physical or psychological examinations or tests. See the various descriptions for Level of Risk on page 6 of Policies and Procedures. What is an example of risk of physical harm? Answer: One example would be the possibility of pain and/or bruising when a blood sample is taken from a vein. There are many other possible examples. See Level of Risk: Physical Harm on page 6 of Policies and Procedures. What is an example of risk of psychological harm? Answer: Questions about sensitive topics, such as sexual orientation, could be stressful either when asked in an interview or when included as part of a questionnaire. Many other situations can have a risk of psychological harm. See Level of Risk: Psychological Harm on page 6 of Policies and Procedures. What is an example of risk of social or economic harm? Answer: Requesting employee evaluations of their supervisors when the identity of the participants could be linked to their responses would be one example. Again, there are many other possible examples. See Level of Risk: Social and Economic Harm on page 7 of Policies and Procedures. How does anonymity differ from confidentiality? Answer: Anonymous data do not contain names or any other information that could identify a specific person. Such anonymity can be assured when there is no linkage between any list of participants in the study and the data collected from them. Confidentiality is simply a promise by the researcher to protect the data, which may or may not have identifiers in it, from being obtained or misused by others. Researchers are generally obligated to keep their data confidential, even if they are unable to collect it anonymously. What is an example of risk from inadequate protection of confidentiality? Answer: This is a crucial topic and a complex one. For example, asking demographic questions that are not essential for the purpose of the research may unnecessarily allow some participants to be identified by their responses to those questions even if the research is otherwise anonymous. See Level of Risk: Inadequate Protection for the Confidentiality of Research Data on page 7 of Policies and Procedures for more information on this topic. What can be considered "benefits" when weighing the risk/benefit ratio for participants? Answer: When research includes any element of risk, the committee is obligated to evaluate the extent of the risk and whether participants will receive any personal benefit sufficient to justify that level of risk. A "personal benefit" is something specific to the person (such as an opportunity to receive special training or an individual assessment of a particular health risk) that goes beyond any inducement (such as payment or entry in a raffle) offered as an incentive to participate. Sometimes the most honest answer is that participants will receive no direct benefit (other than the satisfaction of contributing to research that may eventually benefit others). |
| INFORMED CONSENT | |
| What kinds of information need to be included in a consent form? Answer: This is a complex topic and a crucial one. Any information that could reasonably affect a person's willingness to participate in the research must be disclosed. See Informed Consent (on page 7) and the examples of several consent forms for adults and an assent form for a child in Appendices C-1 through C-5 (on pages 22-28) of Policies and Procedures. Also see Appendix C: Constructing a Consent Form (on pages 20-21) for additional commentary about consent forms. More information is also available by using the link for Informed Consent at http://www.hhs.gov/ohrp/faq.html. What is the difference between informed consent and written consent? Answer: Informed consent is the process of communication between the researcher and the participant in which all information that could affect willingness to participate is made clear and agreement to participate is obtained. Written consent is the evidence that this communication process has been accomplished. When can the requirement for written consent be waived? Answer: The essence is that the potential participant must be protected better by not signing a consent form than by being asked to provide written consent. Other considerations also apply. See Informed Consent on page 7 of Policies and Procedures. Is consent from participants required for the use of pre-existing data? Answer: In some instances, yes – for example if consent was not previously given, the data contain personally identifiable information, and such personal identifiers are not removed from the data before they are acquired. For research with school-age children, do both the parent and the child have to give consent? Answer: Parental consent is required, and the children must also give their assent to participate. For very young children, this could be just a brief verbal description of the activity and asking the child's willingness to participate. A short written consent form in simple language would be appropriate for somewhat older children, and still older children could be given a more extensive written consent form that is closer to the one given to the parents. More information on this situation is available by using the link for Research with Children at http://www.hhs.gov/ohrp/faq.html. How can consent be obtained from children or from persons with an impaired ability to understand a consent form? Answer: The key requirement is to use language that will be understandable to the person and to take sufficient time to be sure that the person understands the nature of the research and any risks before requesting agreement from the person to participate in the research. See the example of an assent form for a child in Appendix C-2 (on page 23) of Policies and Procedures. For other situations with vulnerable populations, consult Subparts B, C, and D of the Federal Policy at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. When is it possible to withhold information about the purpose of the research or to give misleading information about the purpose of the research? Answer: Only when this would not affect the willingness to participate in the research, and the misinformation or withheld information is provided afterward. It is not appropriate to withhold information that would affect willingness to participate merely because such information might affect how participants respond during the research. Can participants be asked to waive the possibility of initiating legal action against the researcher or the institution? Answer: No. Federal Policy does not allow any language that would make a participant waive any legal rights. |
| SUBMISSION REQUIREMENTS |
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| Where can a researcher obtain an application form to request human subjects review? Answer: The application form, as well as the Policies and Procedures manual, is available at http://www.csus.edu/research/humansubjects. These can also be requested from the Office of Research Administration. What materials need to be attached to an application for review in addition to the consent form? Answer: Applications must include any materials that will be used with participants, such as consent forms, screening measures (e.g., health questionnaires), tests, surveys, and interview questions. Lengthy documents such as research proposals or grant applications should not be included, as the committee will not be able to read them. The relevant information from such documents should be summarized in response to questions on the application form. When should an application be submitted? Answer: The deadlines for having an application reviewed at the committee’s monthly meeting are listed at http://www.csus.edu/research/humansubjects. These deadlines are usually two weeks before the date of the meeting to allow time for the applications to be distributed to committee members and time for those members to review all of the applications before the meeting. Please be sure that all applications are complete and are submitted by the deadline. Incomplete applications will be returned for the missing information, and late submissions will not be reviewed until the following month’s meeting. The committee does not meet in January or during the summer months, so please plan accordingly. |
| APPROVALS | What should a researcher do if changes are requested when an application is reviewed?
In what situations does a researcher need to contact the IRB after research has been approved?
How long does an approval last?
What does a researcher need to do if the project has not been completed when the approval expires? |
| HISTORICAL DOCUMENTS | What fundamental principles in the 1979 Belmont Report have become basic guidelines for conducting human subjects research?
What was the major impact of the Declaration of Helsinki (1964) on the behavior of American scientists? Answer: Journal editors began to insist that any research submitted for publication must have been conducted according to ethical standards. Click here to see a 19-minute video segment on the "History of Research Ethics".
What was the significance of the 1966 article by Beecher on "Ethics and Clinical Research"? Answer: It clearly showed that unethical research had occurred not just in other countries but also in the United States. Click here to see a 19-minute video segment on the "History of Research Ethics". |