Human subjects policies + procedures
The policies, procedures and guidance resources on this page will help you protect electronic health information, treat paid research participants ethically, develop compliant recruitment materials and be aware of federal regulations that govern the conduct of human subjects research.
Policies + guidance
The Health Insurance Portability & Accountability Act (HIPAA) is the federal legislation that governs the uses and disclosures of protected health information in order to protect individuals’ privacy. HIPAA’s Privacy Rule establishes the conditions under which health information, regardless of the form or medium of that information, maintained by covered entities and by business associates performing services on behalf of covered entities, may be used or disclosed. HIPAA’s Security Rule addresses the security of protected health information in electronic form only. The following document addresses the Security Rule as it applies to KU-Lawrence investigators who are not themselves in covered health care components of the university, but who receive or collect electronic protected health information while acting as a business associate of the covered entity.
This document also includes agreements, authorization forms, checklists and a risk-management certification that must be signed and submitted by project directors/principal investigators for relevant projects.
The Human Research Protection Program acknowledges that it is occasionally necessary to use deception or incomplete disclosure in a research design in order to protect or strengthen the scientific integrity of an investigation. Deception occurs when participants are deliberately given false information about some aspect of the research study. Incomplete disclosure occurs when participants are not given complete information about their experience in the research study.
HRPP considers such research to not meet the general requirement for informed consent as stated in the Code of Federal Regulations (45 CFR 46.116.a.1). The Code of Federal Regulations, however, does provide for instances in which informed consent can be altered or waived (45 CFR 46.116.d.1‑5).
Investigators proposing research to HRPP that involves deception or incomplete disclosure must include in their submission materials the following elements:
- Justification for the deception or incomplete disclosure. Explain:
- How the research presents no more than minimal risk to the participants.
- How the use of deception/incomplete disclosure will not adversely affect the rights and welfare of the subjects.
- Why the research cannot be practicably carried out without the use of deception/incomplete disclosure.
- The process to debrief participants (Who will debrief them/when/where etc.)
- Information pertaining to the study procedures and debriefing. Within the consent form:
- Provide a truthful and accurate explanation of the purpose of the study to the extent possible without giving too much of the study away.
- Make sure that consent form language does not contain misinformation, is not being used as part of the deception, and is not used as a means for manipulating subjects' behavior.
- Include a statement regarding debriefing such as “Some research requires that the full purpose of the study not be explained before you participate. We will give you a full explanation at the end of the study.” OR “After completing the study you will receive detailed information regarding its nature.”
- Debriefing statement or script. Participants are appropriately debriefed when:
- The participant is informed that deception/incomplete disclosure took place.
- There is an explanation of how the participants were deceived/how information was omitted.
- There is an explanation of why deception/incomplete disclosure were necessary in order to carry out the research.
- There is an explanation as to what was actually being studied (i.e. purpose, hypothesis, aim) in lay terms and without the use of jargon.
- There is an explanation of how the results of the deception/incomplete disclosure will be evaluated.
- The subject is reminded of his/her rights to withdraw from the study at this time.
- The participant is thanked for taking the time to participate in the study.
- The participant is given the opportunity to withdraw his/her consent for use of audio/video recordings (When applicable).
- Special considerations for online research
- An explanation/assessment is offered of whether a deception paradigm used in in-person research poses additional risk in an online format.
- The use of an online debriefing script is appropriate and does not create any foreseeable risk to subjects.
- If the deception is likely to create risk to participants, there is an explanation of how it is guaranteed that participants will receive the debriefing statement.
Full committee review
Please note that the above elements do not constitute an exclusive list. When appropriate, HRPP may request that additional elements of information be provided to each subject. Furthermore, HRPP may require full committee review for studies involving deception or incomplete disclosure that present certain risks or require Board member expertise.
HRPP may require full committee review if one or more of the following items are not met:
- There is no way the study could be done either without, or with a lesser degree, of deception.
- The study does not use a new and unknown deception paradigm.
- There are no possible risks that may have been overlooked in the description of the study.
- The deception is not associated with more than minimal risk.
- The deception used does not involve a therapeutic intervention, or other clinical or diagnostic intervention.
- There are no reasons to believe that when leaving the study, participants may have lingering bad feelings or high arousal as a result of participating in the study.
- There is not an unreasonable delay between a participant’s involvement and the delivery of the debriefing.
- There are no reasons to believe that, when the study and debriefing are complete, the participants may still perceive the deception as having been a betrayal of trust, somehow unfair, and/or leave them feeling denigrated in any way.
- Participants are debriefed in person OR where internet methods are employed, the use of an online debriefing script is appropriate and does not create any foreseeable risk to subjects.
- The researcher can guarantee that all participants receive appropriate debriefing.
Thousands of individuals are paid for participating in biomedical and behavioral research funded either by federal departments and agencies or private institutions. Although payments are usually monetary, both patients and normal healthy volunteers may be offered other rewards in lieu of or in addition to money. Free medical care, extra vacation time, and academic rewards (in the form of a research credit or a letter of recommendation) are examples of alternative rewards.
Regardless of the form of remuneration, the issues for IRBs remain the same. The Human Research Protection Program must consider whether paid participants in research are recruited fairly, informed adequately, and paid appropriately. Taking into consideration the subjects' medical, employment, and educational status — and their financial, emotional and community resources — HRPP must determine whether the rewards offered for participation in research constitute undue influence.
One of the primary responsibilities of HRPP is to ensure that a subject's decision to participate in research will be truly voluntary, and that consent will be sought only under circumstances that provide the prospective subject sufficient opportunity to consider whether to participate and that minimize the possibility of coercion or undue influence.
Clear cases of coercion (i.e., actual threats) are readily identifiable; it is more difficult to recognize undue inducement. An offer one could not refuse is essentially coercive (or "undue"). Undue inducements may be troublesome because: (1) offers that are too attractive may blind prospective subjects to the risks or impair their ability to exercise proper judgment; and (2) they may prompt subjects to lie or conceal information that, if known, would disqualify them from enrolling — or continuing — as participants in a research project.
Application and consent form
If you intend to pay participants, your application should describe — in the Abstract section of the application and in the Payments section of the consent form — how much and on what schedule and conditions.
HRPP must attempt to make sure that prospective subjects realize that their participation is voluntary, and that choosing not to participate will not adversely affect their relationship with the institution or its staff in any way. To make this determination, HRPP should know who the subjects will be, what incentives are being offered, and the conditions under which the offer will be made.
Appropriateness of incentive
Determining the appropriateness of the incentive is another matter. For research that requires subjects to undergo only minor inconvenience or discomfort, a modest payment will usually be adequate. Reimbursement for travel may also be provided. In more complex research projects, IRBs tend to base their assessment on the prevailing payment practices within their institution or general locale (payment for time and effort).
Volunteers are often compensated for their participation according to an established fee schedule, based upon the complexity of the study, the type and number of procedures to be performed, the time involved, and the anticipated discomfort or inconvenience. Standard payments may be established for each tissue or fluid sample collected, depending on the type of sample (blood, urine, or saliva) and the time (day or evening) the sample is to be collected. Alternatively, subjects may be paid an hourly rate or a fixed amount, depending on the duration of the study and whether the study requires admission to a research ward. Extra payments are usually provided for a variety of additional inconveniences (for example, the imposition of dietary restrictions).
Payments may vary according to a number of factors, and, therefore, IRBs may need to become familiar with the accepted standards within their community as well as the anticipated discomforts and inconveniences involved in a particular study to judge appropriateness of payments. Some institutions have a ceiling on the amount an individual may earn in any one study or during a given length of time (for example, per year, per semester). Researchers must also consider the method of delivering payment to participants, providing it is appropriate and does not put participants at additional risk (i.e., breach of confidentiality, safety, etc.).
One of the most perplexing problems for IRBs is how to assess the appropriateness of payment offers for experiments that involve the assumption of risk or significant discomfort. On a practical level, it is probably impossible for an IRB to determine what amount of money or type of reward would unduly influence a particular individual to accept a given degree of risk. Although our society generally accepts the premise that those assuming risk deserve reward, the application of this rule in establishing payment for subjects in biomedical and behavioral experiments is still being debated. The appropriateness of proposed payments is a matter each institution must address in formulating its policies.
IRB members tend to approach the problem of assuming risk for pay from one of two positions. One side argues that normal healthy volunteers are able to exercise free choice, and that — because judging the acceptability of risk and weighing the benefits is a personal matter — IRBs should refrain from imposing their own views on potential subjects. On this view, IRB responsibility should be confined to ensuring that consent is properly informed. Other IRB members argue that the IRB should protect potential subjects from inducements that may affect their ability to make an informed, voluntary choice. It should be noted that, in this context, incentives need not be financial to cause problems. Free health care for persons with limited resources and major medical problems may be a significant inducement to participate in research (even if the research activity is nontherapeutic). There is no consensus as to whether this kind of inducement is unacceptable. In assessing this potential problem, IRBs might consider whether only the destitute agree to volunteer or if people who can obtain good medical care on their own agree to participate as well. IRBs may need to monitor subject recruitment to make such determinations.
Points to consider
- Are all conditions in keeping with standards for voluntary and informed consent?
- Are the incentives offered reasonable, based upon the complexities and inconveniences of the study and the particular subject population?
- Are there special standards that the IRB ought to apply to the review of research in which volunteers are asked to assume significant risk?
- Should the IRB monitor subject recruitment to determine whether coercion or undue influence is a problem?
Accounting and tax considerations
The University of Kansas requires that consent forms for participants who are to be paid through funding include the following statement in the Payments section: "Researchers may ask for your social security number in order to comply with federal and state tax and accounting regulations."
For tax purposes, there are two types of subjects: U.S. citizens/permanent residents or non-U.S. citizens. Payments to non-U.S. citizens are subject to additional review to determine if the individual is eligible to receive payments and to determine tax liability. Contact KU Office of Research accounting services for assistance.
Gift certificates are considered the same as monetary payment and require the same advisory wording in the consent form.
Lotteries or drawings
Offering the chance of winning a prize for participation constitutes gambling, according to Kansas statute. Three elements make an activity illegal under Kansas statute when all three are present: 1) chance, 2) consideration, and 3) prize. Therefore, to make an activity legal, eliminate one of those elements — such as consideration — by allowing anyone to submit their name on a ticket or form for a drawing for a prize without having to complete the survey or questionnaire. Otherwise, the act of completing the survey is the consideration that allows only those who participate in the study and complete the survey to have a chance for the prize. The other option is to eliminate the reference to the drawing in your information statement.
Some institutions have adopted policies regarding the recruitment and payment of volunteers. In general, they attempt to minimize the possibility of coercion or undue influence by requesting that subjects be recruited by open, written invitation rather than by personal solicitation. Institutions try to ensure that the consent document contains a detailed account of the terms of payment, including a description of the conditions under which a subject would receive partial or no payment (for example, what will happen if they withdraw part way through the research).
The KU Office of Research encourages paying research subject incentives through the Greenphire “ClinCard” System whenever possible to increase confidentiality of participant information and to streamline the payment and reporting process for compliance with government, KU and KUCR requirements.