Research Participants • Legal and ethical issues relevant to nursing research

Any kind of breach done with regards to the legal aspects has the likelihood of becoming an issue for litigation. The usual legal concerns associated with nursing research can be split into three:

Ownership of Data:

This can be a legal issue for nursing research that is the topic of a contract and can also come about as a result of rivaling research grants.

Professional Indemnity:

This covers the instance where a nursing researcher is gathering research data in a place that is outside their work setting; the aspect of indemnity has to be taken into account. This is more often than not attained by having a contract between the researcher and the health care facility such as a hospital (Eaton, Cullen, and McMahon, 2014).

Privacy legislation:

In detail, ethics committees have to understand the manner in which the information and data of the participants will be kept confidential and also the manner in which these participants will be selected and recruited. The procedures of selection therefore necessitate the researcher to publicize the research study and the participants to agree to their participation (Research Participant Website, 2015).

When undertaking research that encompasses human beings, the researchers are bound by ethical rules and regulations. The main ethical principles that have been taken into account include the following:

1. Justice

This takes into account the aspect of impartiality in research studies. Concealing a benefit that an individual is entitled to devoid of any substantial reason or placing undue influence on a participant shows lack of justice. There is need for justice during selection and recruitment as they have to be taken into consideration fairly and equitably. In addition, there ought to be fair treatment of all individuals irrespective of age, gender, race, and social status.

2. Benevolence

This basically encompasses the need for the researcher to cause no harm, damage or injury, or to minimize them as much as possible and make the most of the benefits for the participants. In essence, the researcher of the study is expected to establish examinations that will decrease the level of harm and at the same time generate the highest level of benefits. The researcher is expected to put a stop to the study if any harm or injuries are perceived during the study.

3. Respect for Individuals

This takes into account two ethical problems. For starters, research participants ought to be treated as independent agents. A self-directed individual is adept of evaluating choices and making decisions relating to individual objectives. The second issue is that an individual with moderated independence ought to be protected. This denotes to safeguarding those unable of evaluating the information required in decision making. For instance, children are not self-directed individuals and therefore there is need for consent (Research Participant Website, 2015).

• IRB guidelines

The Institutional Review Board (IRB) uses a number of guidelines with regards to the protection of participants in a study. These are outlined as follows:

1. Protection against risks that might impact the participants ought to be maximized:

i. By employing procedures which are in line with the appropriate research design.

ii. Whenever suitable

2. Risks to participants are practical and rational with respect to expected benefits, if any, to participants, and the significance of the awareness that may sensibly be anticipated to come about. The IRB has a duty to think through only those risks and benefits that might come about from the research.

3. How the participants are selected ought to be fair and impartial. In undertaking this kind of assessment, the Institutional Review Board ought to take into account the main aim of the research study and the setting in which the study will be conducted.

4. Informed consent will be pursued from every potential participant or the participant's lawfully ratified representative.

5. Informed consent will be properly documented.

6. When fitting, the research plan makes satisfactory provision for governing and considering the data gathered to guarantee the safety of the participants.

7. When fitting, there are satisfactory provisions to safeguard the privacy of participants and to sustain and preserve the confidentiality of data.

8. When a number of the participants or all of them are probably going to be susceptible there should be extra protection incorporated in the research study to safeguard the rights and well-being of these participants (Research Participant Website, 2015).

• Procedures of protection for all participants

1. Risk / Benefit Assessment

This is one of the procedures employed to protect research participants.

It is fashioned to determine whether the benefits of being a participant in a research study go hand-in-hand with the...

Costs include not just financial, but also emotional, social, and also physical costs. It considers whether the risk/benefit proportion is suitable.
This aspect ought to be considered with regards to whether the risks to study participants correspond with benefits to society and the nursing field with regards to the quality of proof given. The overall guideline is that the magnitude of risk to be taken by the participants in the study ought to never surpass the probable benevolent benefits of the knowledge to be attained

There are a number of potential benefits to the participants of the study. These include the following:

i. The participants gain accessibility to an intervention which could in other aspects be unavailable to them if they were not part of the study

ii. The participants have luxury in having the ability to discuss and talk about their issue with an approachable and impartial individual iii. They also gain additional knowledge regarding themselves or their ailments either through prospect for self-examination and self-reflection or through direct communication with researchers

iv. The participants benefit from escaping from their regular routine and also having the enthusiasm and pleasure of being in a study

v. The participants also have the pleasure and contentment that the information and data that they provide might be of assistance to others who have similar problems and conditions

vi. The participants also profit from the incentives they attain and any stipends given during the research period

There are a number of potential risks to the participants of the study. These include the following:

i. Risk of physical harm and injury which encompasses unexpected side effects

ii. Fatigue and also physical anxiety and distress iii. There are also social risks; for instance, the risk of there being negative impacts on personal relationships, the risk of stigma within the society, loss of privacy, and also financial costs.

iv. There is also the risk of emotional and mental distress emanating from fear of the unknown, self-examination, embarrassment, and also fear of ultimate consequences.

2. Informed Consent

This is a predominantly significant procedure for protecting participants and their right to freedom and sovereignty.

It implies that the participants have enough information concerning the research study, have the ability to understand such information and have the autonomy of free choice, allowing them to approve or decline partaking voluntarily.

3. Confidentiality Procedures

Research participants have the right to anticipate that any information or data they give out will be kept in the most stringent confidence. The right of the participants to have privacy is safeguarded through different confidentiality procedures.

Anonymity is the most safe and sheltered means of protecting confidentiality. This takes place even when the researcher is not able to connect participants with the data that they provide. For instance, if questionnaires were circulated to a group of nursing home occupants, and were handed back devoid of any categorizing data on them, answers would be anonymous.

There is also the aspect of confidentiality even with the lack of anonymity. When secrecy is not possible, an assurance of confidentiality ought to be executed. It is a promise that any data participants make available will not be openly reported in a way that pinpoints them and will not be made available to others. This implies that research data and information ought not to be made public to strangers, nor with individuals known to the participants such as relatives and doctors, unless the participant gives the researcher unequivocal consent to do so.

4. Debriefings

This refers to the level of communication with the participants of the research study, once the information gathering is complete with regards to different aspects of the study.

It encompasses meetings subsequent to data collection to allow participants to give any queries or issue complaints

This is particularly significant when the collection of data has been hectic and worrying and when ethical guidelines had to be altered. For instance, if there was any trickery employed in the explanation of the study

5. Referrals

This encompasses the provision of contact data or details for local service providers who can be of help with regards to any issue that would be of help to the participants.

• Special considerations for at-risk populations

When making considerations for the approval of a research study, the IRB deliberated on issues such as the participants who have been selected, privacy, risk benefit analysis, and undue influence. The decisions which are made are directed and channeled by the ethical principles essential to human research study as shown in the Belmont Report (as cited in United States, 1978). There are special considerations given to at-risk populations. This special consideration is done to safeguard the well-being of…