social psych

SECTION H: Consent/Assent

Describe the following:

1) How will consent/assent be obtained place. (e.g., signing a consent form in person, online consent form as front page for online survey, etc.)

2) If applicable, what procedures are in place to reduce coercion (e.g., if extra credit is offered, what non-research alternatives are available to students who do not wish to participate in research).

3) If participants are vulnerable populations, explain how you will follow research ethics guidelines for obtaining consent. (If applicable).

4) If a request for a waiver of consent or waiver of documentation of consent is being sought for this proposal, describe here how the request comports with Federal guidelines as outlined in 45CFR46-listed criteria for a waiver found at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116 .

1) Consent of the study participants is important, and this is achieved through signing a consent form in person. The issue of seeking consent in person is essential for this crucial study where the legitimacy and transparency of the participants is essential through face to face interview as well as focus groups. Consent plays an important role in making sure that the participants understands what is important and what is required of them since the onset of the data analysis processes to the end and assure for their privacy and confidentiality. Consent makes the study credible because the information shared can be used for the desired purpose after the participants approves the use of their information to meet study objectives.

2) The procedures that are in place in reducing possible coercion during seeking the consent of the participants include’

· There is the need to discuss with the participant concerning the possibility of feeling coerced to resolve it and avoid them from falling victims of coercion.

· Obtaining consent from the participant and family members is important in eliminating possible coercion.

· The compensation for the participants of the study should not be monetary incentives to prevent coercive effects.

· The researcher should make clear declaration about the study but not influence the audience for research participation.

· Reminding the participants always that their participation is fully voluntary.

· Offer an opportunity to the participants to take their time to make decision whether to participate or not.

· Providing the participants about possible alternatives to their participation to make sure that their support for the study is voluntary.

The alternative technique for the students who are not interested in conducting a research study in the field is to use the secondary sources of the already conducted studies and make an assessment to collect relevant data for analysis.

3) In the case of vulnerable populations, informed consent would require more consideration where family members are involved in the process of consent to make sure that the participant makes the right decision. The confidentiality for the vulnerable population is important because an exposure of the information to the public might affect them. In relation to the context of domestic violence the vulnerable population might find the topic critical and might affect their health and there is a need to involve their doctor or therapist if it is possible to obtain their consent for the study.

4). The request for a waiver of consent or the waiver of documentation is practical and relates with the federal guidelines in a manner that our research has no more than minimal risks to the participants involved. Our research information collected from the participants cannot be documented without the request of a waiver. The waiver cannot adversely affect the rights and the welfare of the participants.

SECTION I: Risks to Subjects

IRBs must evaluate the risk-benefit ratio of proposed human subject research. In approving a protocol, IRBs must determine that the benefits outweigh the risks and that risks to subjects are minimized.

Research risk is the probability of harm occurring as a result of participation in research. In non-technical language, address the following:

1) The types of risks (e.g., physical, psychological, social, economic, legal, etc.) the subject may reasonably encounter. Include any likelihood that questions may be sensitive or stressful to the participants.

2) Estimate the frequency/likelihood and magnitude of those risks (cite relevant literature, if available).

3) Describe the procedures/process which will be used to reduce or minimize risks:

a. How the data will be safeguarded (e.g., data is anonymous, assigning pseudonyms, aggregate reporting, etc.).

b. How will subjects be explicitly informed if data will NOT be anonymous (Put “N/A” if using anonymous data)

c. What actions would you take if a participant gets hurt or upset?

1) The risks that the subject might encounter are psychological and social risks during the interview when collected necessary data for the study. The psychological risk would occur on the issue of domestic violence because it is a matter of people who were close before, especially the victims that would feel the pain of remembering what transpired during the incident. Social risks are also another challenge during the interview and focus groups especially for the perpetrators of the violence that agree to take part in the study after reforms. The perpetrators would feel guilty and gets the challenge of socializing with people thinking that they might hurt someone close to them. There is a likelihood that the questions in the research interview would be especially sensitive, raising the emotional mood.

2) The frequency for the likelihood for the risk is 3:4 (Bonomi et al., 2016)

3) The risks would be minimized through subjecting the participants to consultative discussion and assure them that their information is relevant in order to change society. The participants are also informed to share information or answer questions that they are comfortable with because the process is voluntary. The participants are also assured for their privacy when necessary.

a) The data is safeguarded through assigning pseudonyms to make sure the information is not attached to any participant.

b) In a scenario where the data in question is considered anonymous the subjects are informed before the interview that they should respond with a not applicable N/B for the interviewer to move to the next question.

c)The immediate action after the participant feeling upset is to cheer them up by engaging in positive discussion, informing them that their participation would help to prevent this type of domestic violence in the future where the information would create societal awareness. In addition, I would apologize by reminding them about the past and console with them that sharing the issue would assist them in healing.

SECTION J: Deception/Incomplete Disclosure

If you cannot adequately state the true purpose of the study to the subject in the informed consent, deception/ incomplete disclosure is involved.

1) Describe the deception/incomplete disclosure of information to the subjects.

2) Explain why such deception/incomplete disclosure is necessary.

3) Explain the debriefing process, or explain why there will not be a debriefing process.

1) There would be incomplete disclosure to the participants about the study processes and procedures specifically for the other participants that engage in the data collection process to make sure they share accurate data.

2) Incomplete disclosure is a necessary to make sure that the participant avoid biasness especially when they learn that the perpetrators of domestic violence also participated in the study and might interfere with the decision to volunteer or give credible information.

3) There would be no debriefing process even though this is considered [art of consent but it may affect the victims of domestic violence negatively knowing that they were betrayed during the interview. There is a need to just let the participants remain with the partial disclosure of the necessary information for the consent and avoid other additional disclosure that might be detrimental rather that beneficial.

SECTION K: Benefits

Describe any direct benefits participants could potentially receive (excluding compensation for participation). If there are no direct benefits, explain what other potential benefits are gained from the research (benefits to society). This cannot be left blank.

There would be no compensation for the participants since the process is fully voluntary and the main objective of engaging them in the study is to create an awareness and education to the society using the research information. The society would benefit in understanding the causes and factors contributing domestic violence and rectify them transforming the society for the good.

SECTION L: Subject Incentives/Compensations

SECTION M: Additional Information

Each participant of the research is interviewed independently to make sure that issues of bias on their feedback is avoided.

SECTION N: Investigator Assurances

As a PI or Co-PI, I certify the following:

· I have reviewed this protocol submission and acknowledge my responsibilities as Principal Investigator.

· The information in this submission accurately reflects the proposed research.

· I will not initiate this study until I receive written approval from the IRB.

· I will promptly report to the IRB any unanticipated problems and adverse events, as well as any findings during the course of the study that may affect the risks and benefits to the subjects.

· I will obtain prior written approval for modifications (amendments) to this protocol including, but not limited to, changes in procedures and/or changes in personnel.

· I have completed the CITI Social and Behavioral Investigator Training Module and have read the Belmont Report.

· All research personnel involved in the study have been appropriately trained in human subjects’ protection. I accept responsibility for assuring adherence to applicable Federal and State research regulations and APUS polices relative to the protection of the rights and welfare of the subjects enrolled in this study.

· I have obtained, or will obtain, all necessary permissions from study sites.

· Unless given Exempt Status, I understand that this study is subject to continuing review and approval by the IRB which will occur at least yearly.

I will promptly report to the IRB any unanticipated problems and adverse events, as well as any findings during the study that may affect the risks and benefits to the subjects.