Research Proposal Samples In Zambia

[Rolando Kumar]

TheAbdul Latif Jameel Poverty Action Lab (J-PAL) is a global research center working to reduce poverty by ensuring that policy is informed by scientific evidence. Anchored by a network of more than 900 researchers at universities around the world, J-PAL conducts randomized impact evaluations to answer critical questions in the fight against poverty.

Institutional Review Boards (IRBs) review research involving human subjects to ensure that participants are protected from potentially harmful research. This resource provides an overview of the roles of IRBs and ethics guidelines. It also includes practical tips for researchers preparing IRB proposals, including an annotated informed consent checklist, guidance on timeline planning and responding to common concerns of IRBs, and handling unanticipated events. Researchers who are already familiar with the roles of IRBs and obtaining human subjects training certificates may wish to begin at the section "Preparing the proposal."

Research involving human subjects obtains information through interventions or generates identifiable private information (including bio-specimens). Identifiable information means that the identity of the subject may readily be ascertained or associated with an individual. Private information refers to behavior taking place in a context in which an individual can reasonably expect no observation, recording, or information that the individual provided for a specific purpose and can reasonably expect will not be made public (e.g., a medical record).

The "Common Rule" is the popular term for the Federal (US) Policy for the Protection of Human Subjects, 45 CFR part 46, which outlines the criteria and mechanisms for IRB review of human subjects research. The revised Common Rule went into effect January 21, 2019. All new protocols submitted after January 21, 2019, are required to comply with the revised requirements. It is up to individual IRBs, however, whether to apply the previous or revised version of the regulations to ongoing studies that were submitted before that transition date (DHHS OHRP 2019a).

The principles of ethical research are detailed in IRB training. These principles, described below, are formulated in the Belmont report (DHHS OHRP 2017). For a more detailed overview of the role of ethics in social science research, see our resource on ethical conduct of randomized evaluations.

Research subjects need to be given a chance to independently decide and volunteer to participate in the study given knowledge of all aspects of the study that concern them: procedures, costs, risks, and benefits. Derived from this principle is the obligation for researchers to:

Researchers should consider the burdens and risks of the research in all aspects, including the length and effort of the survey, possible embarrassment from answering questions, psychological burden on subjects and surveyors, and risk of personal data being exposed. In medical research, beneficence is interpreted very strictly; for example, researchers must end a trial and begin treating the whole study population if it becomes clear that the treatment significantly increases welfare.

Note: The rules of beneficence (not doing harm and minimizing possible harm) should be applied not just to the subjects of your research but all human actors involved, for example your surveyors (who need to be protected from, e.g., psychological harm from conducting very difficult interviews, say, with torture survivors). They apply to both the study procedures (e.g., how burdensome the interview process is) and any interventions you conduct (e.g., how burdensome the policy is).

Researchers should ensure that a just distribution of burdens and benefits governs the selection of the sample, subjects, and treatment recipients. The justice principle requires that the benefits of research don't go only to one group and the burdens to another.

It may appear that simply randomly assigning a program to some people but not others falls under the definition of "injustice" above. Do the phrases "when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly" and "equals ought to be treated equally" rule out randomized designs? An article by Glennerster and Powers (2016) discusses this question in some detail. The relevant part starts on p. 12 of the ungated version.

Weighing the general benefits of research against individual costs is the key task of an IRB. However, you should, of course, also ask yourself this question. You should only go ahead with study procedures after you have made every effort to minimize the burden on your subjects and any other affected parties, and made sure that you don't find your own research ethically questionable. A first check as to whether a given research protocol is problematic or not might be introspection: Would you feel upset, treated unfairly, or subjected to considerable potential for harm in your own study? Knowing all the details of the study, would you choose to participate?

Only if you are sure that you can justify the research to yourself should you turn to the matter of describing your research protocol, and its acceptability from an ethical standpoint, to the IRB. Having thought through these questions will help you design procedures that truly minimize the burden on subjects and anticipate questions from the IRB. We will discuss some common concerns and issues that you should consider and be able to address further below in the section "Responding to common concerns of IRBs."

Plan when to submit your IRB application by calculating backwards from the piloting and study start. Typically, the procedure is that an IRB officer reviews the application first for completeness and then a Board member receives it. For full review, the proposal is then discussed at the next Board meeting; otherwise the decision is made by the Board reviewer. If you are not entirely sure if you will need a full review, plan for the full review and also budget for needing to resubmit.

IRBs often require researchers to furnish signed DUAs before approving a study protocol, and data providers often require IRB approval before signing a DUA. Research teams may request provisional approval from one party, making clear to all parties the process and constraints, to find a path forward. Research teams can facilitate the process by proactively and frequently communicating with the IRB and data partners.

Consent procedures for research involving minors are more complicated, so you should check with your IRB on the specifics. Depending on the age of the child (typically seven or older) children have to give assent to study procedures that involve them, though the method of obtaining assent will vary depending on age. In addition, parent(s) have to consent to research involving their children. If the study involves more risk, both parents' consent may be required. MIT requires that research involving minors have written informed consent of a parent as well as the suitably documented assent of the minor, if the child is over seven years old.

The revised Common Rule includes a new "Key Elements" section and a rearrangement of content that is designed to facilitate a potential subject's decision of wheter to participate. Under the revised 2018 Common Rule, the requirements for informed consent have changed, with the addition of:

There are exceptions to the need for written consent. These may be important if the written consent procedure deters or prevents subjects from participating in the research. Examples could be subjects who cannot read, who do not want to be linked with their study answers, or who are in a rush and do not want to sign unfamiliar documents before studying them carefully.

In our experience, for studies involving young students, where getting every parent to consent would be impossible, typically the head of school consents for all students. Examples of such scenarios include boarding schools or when it is likely parents will not all read or return the forms and when the study consists of non-invasive research such as math games conducted on school time. For high school students involved in educational interventions, both students and the head of school (or parent) provide legal binding consent.

An important provision of US law is a so-called Certificate of Confidentiality, which prevents law enforcement from accessing research data by subpoena for the purpose of criminal persecution.5 The National Institutes of Health offers helpful resources on what a certificate of confidentiality is and answers some frequently asked questions about how it works. The law on certificates of confidentiality was originally conceived to allow research on illegal drug use by Vietnam veterans without compromising subjects or deterring them from participating. These certificates can help a researcher protect their subjects and assure subjects of the confidentiality of their responses. For some background, see for example Wolf et al. (2015, 76 pages).

MIT has useful guidelines on providing and communicating adequate information and ensuring comprehension when obtaining informed consent. In particular, the language researchers use in their consent forms should be simple and clear. They include the following:

Subjects should get a copy of the consent form with this information. They should also receive a link to the local university's IRB office in case they have concerns they do not want to voice to the study researchers, e.g., If you feel you have been treated unfairly, or you have questions regarding your rights as a research subject, you may contact the Chairman of the Committee on the Use of Humans as Experimental Subjects, MIT, Room E25-143b, 77 Massachusetts Ave, Cambridge, MA 02139, phone +1-617-253-6787."

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