Alteration of Consent

An alteration of consent is when the [IRB [. . . approves] a consent procedure that omits some or alters some or all of the elements of informed consent]. The IRB may grant alterations to your informed consent form if specific criteria are met. In this article we will discuss these specific criteria, along with examples of when an alteration of consent may be granted.

 

For a waiver of informed consent to be granted the following criteria must be met;

  • The research involves no more than minimal risk.
  • The research could not be carried out practicably without the waiver. (*Please note this cannot simply be because it is more convenient for the researcher to not obtain consent.)
  • The waiver will not adversely affect the rights and welfare of the subjects.
  • When appropriate, the subjects will be provided with additional information about their participation.

 

Below are examples of when an alteration of consent may be granted, pending the above is met;

  • In research that involves deception or in cases where subject knowledge of the purpose of research may alter their responses. You may need to omit some information from participants in order to answer your research question. E.g. they are told they are completing a survey on overall happiness but in reality you are looking to see if the room temperature has an effect on a person’s mood
  • Where medical records or biospecimens are being reviewed and identifiers will not be kept with the data.
  • When obtaining consent from a large number of individuals in a retrospective chart review is not practical
  • In research examining public benefit or service programs not regulated by the FDA that looks at or evaluates procedures for obtaining benefits or services, changes or alternatives to these programs, or changes in methods or levels of payment for these programs.

 

To read more about alteration and waiver of consent and when they apply, please refer to CFR at § 46.116.f(2). If you would like to talk through waiver of consent and your study, please feel free to reach out to the Solutions IRB administrative team, at reviews@solutionsirb.com or 1-855-226-4472.

 

Author: Cora Crawford

Who are Prisoners in Research?

Prisoners are classified as a vulnerable population per CFR 46 Subpart C. A question an IRB sometimes faces is exactly who are prisoners? While the answer seems clear, some grey areas do exist with this vulnerable population.

The prisoner definition per §46.303 states, “…any individual involuntarily confined or detained in a penal institution.” Based upon this definition an individual being held in a prison or jail is a prisoner. However, what about individuals on a work release program or staying in a halfway house as part of their reintegration back into society; should we consider those individuals ‘prisoners’ when they are the study population?

Individuals on a work release status that requires them to return to the facility at night are prisoners since they are still considered detained. Individuals residing in a halfway house require a more in-depth understanding of the release conditions to the halfway house to determine a ‘prisoner’ status.

The full definition per §46.303 specifies that individuals being detained in other facilities that, “…provide alternatives to criminal prosecution or incarceration in a penal institution…” meet the criterion of being prisoners. Therefore, if failure to return to the halfway house at night or leaving without permission would result in the individual being returned to an incarceration facility, the answer is yes, they are prisoners. However, if the individual can leave the halfway house without penalty, technically they should not be considered a prisoner for research purposes.

It is important to note that individuals serving sentences under some form of community corrections (probation/parole) are not considered prisoners under the CFR definitions, however similar special considerations such as the risk of coercion need to be considered. These will be discussed in future articles.

Author: Ron Wallace, PhD

Waiver of Consent

The IRB may grant a waiver of informed consent in certain instances. (Not to be confused with a waiver of consent documentation, where consent other than written consent is obtained, please see our article Waiver of Documentation of Consent if you would like more information). A full waiver of consent completely waives the requirement to obtain informed consent. However, in order for a full waiver of informed consent to be granted there are certain criteria that must be met. In this article we will discuss the specific criteria, along with examples of when a waiver of informed consent may be granted.

 

For a waiver of informed consent to be granted the following criteria must be met;

  • The research involves no more than minimal risk.
  • The research could not be carried out practicably without the waiver.
  • The waiver will not adversely affect the rights and welfare of the subjects.
  • When appropriate, the subjects will be provided with additional information about their participation.

 

Below are examples of when a waiver of consent may be granted, pending the above is met;

  • Retrospective chart reviews
  • Studies of existing pathology specimens
  • Public observation studies

 

If you have questions regarding your study and if a waiver of consent may apply, you can refer to the CFRs at § 46.116.f. If you would like to talk through things please feel free to reach out to the Solutions IRB administrative team, at reviews@solutionsirb.com or 1-855-226-4472.

By: Cora Crawford

General Elements of Consent

Welcome to the start of our Informed consent article series! Solutions IRB is excited to bring you weekly articles covering the different types of consent, informed consent, waiver of consent documentation, waiver or consent, alteration of consent and broad consent. For this initial article we are going to go over the basic elements of informed consent described in the CFRs as well as elements that Solutions IRB look for.

CFR Informed Consent Elements

  1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
  2. A description of any reasonably foreseeable risks or discomforts to the subject;
  3. A description of any benefits to the subject or to others that may reasonably be expected from the research;
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject;
  8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
  9. One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
    1. A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
    2. A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Things Solutions IRB requires/looks for.

  1. Two forms of contact for the PI/research team
  2. A statement similar to the following. “If you have questions about your rights as a research subject, you may contact Solutions IRB at (855) 226-4472 or participants@solutionsirb.com.”
  3. Solutions IRB’s contact information listed after the PI’s
  4. A consenting statement at the end of the consent form, such as “by clicking continue you give your consent to participate” or “By signing you consent to participate”
  5. If audio recorded during the interview, and a statement that they can or cannot participate if they do not agree to be audio recorded.
  6. If a study will have audio or video recordings, a check box to agree to be audio recorded during the interview, and a statement that they can or cannot participate if they do not agree to be audio recorded.
  7. Clear withdrawal instructions, e.g, how, who to contact, what happens to their data if they withdraw.
  8. If applicable, how will participants receive payment, e.g. electronic email, or by mail?
  9. If applicable, in what form will compensation be received, e.g. cash, or by gift card?
  10. If applicable, When will potential participants receive compensation?
  11. If applicable disclosure of any conflicts of interest
  12. Consent forms must be paginated
  13. Must be at an appropriate reading level for the population, general population is an 8th grade reading level.

We are excited to bring this series to you! If you have any questions please reach out to us at reviews@solutionsirb.com or 855-226-4472.

Author: Cora Crawford

Minimizing Risk

It is the responsibility of IRB members to thoroughly review a research plan and decide whether to approve a protocol. When reviewing research Solutions IRB’s guidelines address three ethical principles that are fundamental to human subject protection, these being: respect for persons (respect for the right of self-government), beneficence (do no harm, maximize benefits, and minimize harms), justice (equal distribution of research burdens and benefits).

An IRB assures that adequate safeguards are incorporated into research design such as: frequent monitoring, the presence of trained personnel who can respond to emergencies, or coding of data to protect confidentiality are examples. For a study to be deemed minimal risk, the probability and magnitude of harm or discomfort in that study must be no greater than those ordinarily encountered in daily life.

Any study may contain diverse types of risk, such as: physical risks, psychological risks, social/economic risks, loss of confidentiality, and legal risks. Researchers are expected to take steps to minimize any potential risks. These include:

  • Using procedures that are consistent with sound research design
  • Not exposing subjects to unnecessary risk
  • Using procedures already being performed on the subjects for diagnostic or treatment purposes.
  • Prescreening to identify and eliminate high-risk participants,
  • Providing participants with as much information as possible during informed consent and debriefing.

Researchers must be sure that any risks involved in the research are reasonable in relation to the protocols anticipated benefits.

Authors: Ayn O’Reilly and Bridgette Moralez

Protocol Deviations

While protocol deviations are not defined by the Code of Federal Regulations (45CFR46 or 21CFR50), for Solutions IRB, a protocol deviation occurs when the activities occurring within a study stray from the Institutional Review Board-approved protocol. Deviations may be minor or major. They may be known to the PI prior to their occurrence or after they occur. Some deviations can be prevented through good protocol and consent form writing. If a deviation should happen in your study, there are specific steps that you should follow to report it quickly to the IRB.

Some deviations are minor, such as a subject signing the consent form wrong, or a survey being administered differently than was originally described. Generally, deviations like these can be quickly dealt with. Major deviations may require revisions to the study protocol, or other study documents, some may even raise the overall level of risk in the study, or rise to the level of an adverse events or noncompliance.

Some protocol deviations are known to the researcher before they occur (for example, providing life-saving treatment to a subject who becomes seriously ill while participating in study activities); others are only discovered after the fact (a signature was left off of a consent form). Whether the deviation is known prior to its occurring or after does not necessarily impact how serious that deviation is.

Not all potential protocol deviations can be anticipated ahead of time, some can be addressed through good protocol writing that anticipates where problems might occur. For example, if multiple office visits are required in the protocol, the researcher will want to make sure that the timing of such visits is reasonable. Potential deviations can also be avoided by creating a clear and comprehensive consent document. When a researcher wants subjects to complete multiple surveys, that needs to be explained in detail. Finally, many deviations can be avoided through adequate training of the research team. Make sure all of your people understand what is expected of them and what the details for the study are.

When a protocol deviation happens, it is very important to report the deviation to the IRB. This should be done as soon as it is identified, or within 5 business days of knowledge of the event. Please follow these steps:

  1. Log into your profile and access your protocol ID.
  2. Scroll to the bottom of the page and you should see a “protocol deviation” tab.
  3. Select the tab, then select “new protocol”
  4. Fill out the necessary information.
  5. Once this is all completed, Solutions IRB will review the submission
  6. Solutions IRB will walk you through any remaining processes.
  7. In some instances, you may be instructed to make certain changes—for example to your consent form, or more education for your staff may be required.
  8. Finally, the Chair will send a notification that the Protocol Deviation has been acknowledged.

Authors: Ayn O’Reilly & Josephine Rudy

Tips to Effectively Submit Revisions with Solutions IRB

Once your study has been pre-reviewed or reviewed by a Solutions IRB reviewer, the designated research team members will receive an email with any required revisions. There are some important steps that now need to be taken to effectively submit your revisions.

First, all documents that require edits need to be revised using a tracking function. You will then submit the track change copy and the clean copy of each edited document. The digital Solutions IRB application also has a track change button that needs to be selected so the edits are recorded. This aids in the reviewer’s comparison of the old and new documents, to ensure the requested edits are made.

Second, submit a response letter that identifies that each edit was made, gives explanation, or provides clarification to the reviewer’s concerns. This document will save the back-and-forth conversation that tends to happen when clarification is not given, or documents are not provided but the reviewer is unsure why. This should be added to the study with your other revised documents.

Lastly, when all revisions are submitted, please check the “Submit Revisions for Review” checkbox above your study title in the Axiom Mentor system. This notifies your reviewer that you are ready for them to review your revisions. Without checking this box, they will not be notified, and the review timeline is extended. Please also ensure that all revisions are made, and all requested documents are uploaded properly. This will save time in the review process.

If you have any questions for your reviewer or the administrative team, please feel free to send us a message in the Axiom Mentor system by clicking the “Messages” button on the right-hand side of your study page. This is the quickest form of communication with your reviewer and goes directly to them. We look forward to working with you on your study soon!

Change may be good, but it needs to be reported to the IRB

Recognizing when to submit an amendment is crucial. An amendment is viewed as ANY change to what was previously approved to an existing approved Institutional Review Board (IRB) protocol. Some examples for when to submit an amendment are, but not limited to change in: document content/format, study personnel, recruitment material, tests, consent form language, survey questions, and inclusion/exclusion criteria. All changes must be approved by the IRB through an amendment prior to implementation, except when necessary to eliminate apparent immediate hazards to the human subjects. After the decision has been made to implement change in an already approved protocol, it is important to address: what steps need to be followed? What must the amendment contain? What other information should be noted?

To submit an amendment with Solutions IRB start by choosing the application you would like to amend by logging into your Axiom account and selecting “My Applications” within the IRB tab. Scroll to the amendments section at the bottom of the application and use the grey “Create New Amendment” button. Once you have chosen the appropriate sections to modify click the “Create Amendment” button. Next, you will need to click on the button, “Post Modification Form” and select “Add/Edit Answer.” Choose the type of changes you are making and provide detail for the changes. While in the amendment section, upload the documents needed by clicking the top red and white striped context menu. All modified protocols, consent forms, recruitment materials, and any other items that may have been added or modified for the study should be uploaded. Corresponding track changes versions of these documents will need to be provided for our records to aid in the review, along with clean copies for final approval. Lastly, be sure to hit the grey “Submit” button on the left-hand side of the amendment.

It is important to note, failure to report any changes within an amendment will result in a protocol deviation with additional fees to follow. Depending on level of risk or seriousness in failure to report, there is the possibility for an investigation, suspension or even termination. If implementation without approval occurs and is later found during an annual check-in, it could delay continuation of the protocol. Once submitted it is important to wait for the IRB Approval Notice before implementing any proposed modifications, unless as described above and the amendment is needed for patient safety. Keep in mind, it is acceptable to continue with the currently approved protocol during the review process of an amendment.

Deception in Research

Generally, Institutional Review Boards (IRBs) require investigators clearly and accurately inform human subjects about research during the recruitment and consent process. Human subjects are defined as a living individual about whom an investigator conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information (§46.102(f) Definitions). Researchers must disclose the purpose of the study, benefits, potential risks and a description of what participants will be asked to do. Additional protection and safeguards may be needed for vulnerable populations. There are however, some instances in which deception or incomplete disclosure is allowed.

  • Deception occurs when the researcher provides false information to subjects about the research.
  • Incomplete disclosure is defined as the withholding of information about the purpose of the study.

The IRB considers several factors when reviewing studies using deception or incomplete disclosure. There must be a clear justification for the use of deception, why it is needed, and whether it is possible to conduct the research without it. Participants cannot be deceived about significant aspects of the research that would affect their willingness to participant or that would cause them physical or emotional harm. In most cases, a debriefing is required including a detailed description of the deception.  

There are instances in which the only way the research can be conducted is with deception or incomplete disclosure. Research examining the placebo effect may use deception. The American Psychological Association provides guidelines for the use of deception in research under Standard 8.07. The use of deception in research is allowable under certain conditions and carefully considered during the IRB review.

Role of Culture and Issue of Autonomy and Informed Consent

Role of Culture and Issue of Autonomy and Informed Consent

Author: Alice Yick Flanagan, Ph.D.

When conducting research with other cultural groups and those from racial and ethnic minority groups, it is important for researchers to take into account how culture impacts conducting ethical research. The definition of the term “culture” is complex because it is multilayered and not necessarily static but dynamic. Culture can be defined as the group’s value systems which comprises of the sanctioned behaviors and rules of conduct (Gordon, 1964; Lum, 1999). It also involves language, ways of thinking, worldviews, attitudes and religious, social, institutional, community, and familial beliefs that are passed from generation to generation within a group (Hodge, Struckerman & Trust, 1975; Sue, 1981).

 

In this blog, we will focus on the how culture can color the issue of autonomy and how it applies to informed consent. The Belmont Report identifies three main principles to guide ethical research. Let us focus on the first principle which is respect for persons. According to the Belmont Report, “respect for persons incorporates at least two ethical premises: first, individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.” When conducting ethical research, this translates to the principle that the individual can exercise self-determination and make decisions whether he/she wants to participate. The individual should not in any way feel he/she was coerced into participation. Therefore, the informed consent form is meant to communicate all the information for the research participant to make an informed decision about his/her participation in the study. For those who are not able make such decisions, mechanisms must be in place to protect these individuals.

 

In Western societies such as the United States, self-determination and autonomy are held paramount. That is because Western societies emphasize first-order autonomy, which promotes self-determination (Hanssen, 2004). However, there is another category of autonomy: second order autonomy, where decision-making is group oriented. Typically, this will apply to more collectivistic cultures, and the decision-maker is designated by the group (Hanssen, 2004). For example, often times, with research that involves Native Indian tribal groups or indigenous groups, the community leader, elders, grandparents and/or other relatives have to provide the consent versus the individual (Ruiz-Casares, 2014). In Asian immigrant groups where they adhere to traditional and patriarchal norms, there may be a male designated family member who needs to be consulted when making major decisions (Chittem & Butow, 2015).

 

The informed consent form might have different cultural meanings. In some cultures, for example, putting a signature on a piece of paper implies that the activity is associated with a major life circumstance or legal matter (Rashad, MacVane & Haith-Cooper, 2004). Requiring research participants in certain cultural groups to put a signature on a consent form may also implicitly convey a lack of trust especially if they feel that a verbal consent is adequate (Lloyd, Johnson, Mughal, Sturt, et. al., 2008; Rashad et. al., 2004). Sometimes, asking immigrants to sign a consent form may be off putting to them because they are afraid that the signature can be traced to the fact that they are illegal residing in the country, fearing deportation (Piamjariyakul, Myers, Werkowitch & Smith, 2014).

 

How do these concepts apply to researchers aiming to conduct ethical and culturally sensitive research? Here are some thoughts:

 

  1. Consult with cultural brokers who can provide you with culturally relevant information to inform your decisions about specific sampling and data collection procedures.
  2. Are there specific gatekeepers in the community that you need to identify and obtain permission to conduct the study? Do they serve as the person who provides consent for the entire group?
  3. Does it make sense to request a waiver of a signature for the consent form from your IRB? If so, make sure you provide the IRB information about the cultural context and the reasons why you are requesting this waiver.
  4. Does it make sense for you to request a waiver for consent given the local cultural context? If so, make sure you provide the IRB information about the cultural context and the reasons why you are requesting this waiver.
  5. Avoid as much technical jargon in the consent forms as possible so that it does not sound like a legal document. As much as possible, make it reader friendly.

 

 

 

 

References

Chittem, M. & Butow, P. (2015). Responding to family requests for nondisclosure: The impact of oncologists’ cultural background. Journal of Cancer Research & Therapeutics, 11(1), 174-180.

 

Gordon, M.M. (1964). Assimilation in American life. New York, NY: Oxford University Press.

 

Hanssen, I. (2004). An intercultural nursing perspective on autonomy. Nursing Ethics, 11(1), 28-41.

 

Hodge, J.L.; Struckmann, D.K. & Trost, L.D. (1975)/ Cultural bases of racism and group oppression. Berkeley, CA: Two Riders Press.

Lum, D. (1999). Culturally competence practice. Pacific Grove, CA: Brooks/Cole.

Piamjariyakul, U; Myers, S; Werkowitch, M. & Smith C.E. (2014). End-of-life preferences and presence of advance directives among ethnic populations with severe chronic cardiovascular illnesses. Journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology, 13(2), 185-189.

 

Ruiz-Casares, M. (2014). Research ethics in global mental health: Advancing culturally responsive mental health research. Transcultural Psychiatry, 51(6), 790-805.

 

Sue, D.W. (1981). Counseling the culturally different: Theory and practice. New York, NY: John Wiley & Sons.