Whether reviewed by the expedited process or the full Committee, the following factors are considered in reviewing protocols submitted to the Human Subjects Committee:
Risks are minimized
The protocols are carefully reviewed to ensure that procedures are consistent with the federal regulations and that they do not expose subject to unnecessary. No doubt, many projects can and will contain risks, both direct and as a result of inadvertent disclosure of confidential data, but the risks should be fully acknowledged and a management plan developed and described in the protocol. Common risks include the following:
· The potential for participants to experience stress, anxiety, guilt, or trauma that can result in genuine psychological harm.
· The risk of criminal or civil liability or other risks that can result in serious social harms, such as damage to financial standing, employability, insurability, or reputation; stigmatization; or damage to social relationships.
· The risk of individually identifiable private information that the research has collected being disclosed (“leaked”) resulting in a breach of confidentiality that could harm subjects
If you cannot foresee any risks such as those indicated or others in your research project, please indicate in your protocol that the risks to participants are “minimal.”
Risks are reasonable
No matter what the level of risk, the protocol is reviewed to determine that the risks are reasonably justified by the anticipated benefits (if any) to the subjects themselves, and in a larger sense, to society.
Selection of subjects is equitable
In evaluating the criteria and procedures for recruitment of subjects detailed in the protocol, the Committee seeks to determine that burdens and benefits of the research are equitably distributed. Whether you use a random sampling method, solicit responses to a survey, or target certain individuals for data collection, be sure to explain the rationale for your choice, particularly if you choose to exclude certain populations. Keep in mind that this choice may also influence the generalizability of the research results.
Informed consent procedures are in place and documented
The Committee evaluates the procedures by which informed consent is to be obtained, directly from prospective participants or from their legally authorized representatives. It must be both legally effective (meaning that a reasonable person would have been given sufficient information on the risks and benefits to make an informed judgment as to whether to participate) and effectively documented. Pay particular attention to any situations that could be perceived as coercive of the subjects’ participation. Subjects under the age of 18 are considered minors, and must give “assent”, along with a fully documented informed consent from a parent or guardian.
Data safety and confidentiality
The protocol must include a plan for monitoring and storing the collected data to ensure subject protection and privacy. A strategy for reports of adverse events must be in place.
Privacy of subjects and confidentiality of data
The Committee will evaluate the likelihood of harm that could result from disclosure of collected information outside of the research team along with its nature and size. Proposed methods to anonymize, code, or encrypt the data will be considered along with storage facilities, limitations to access, and other relevant factors.
Additional safeguards for vulnerable subjects
If your research includes children, prisoners, pregnant women, persons with mental disabilities, or economically or educationally disadvantaged individuals, the Committee will evaluate safeguards you have put in place to protect their rights and welfare.