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.

Do We Have a Moral Obligation to Conduct Prisoner Research?

Perspectives from an IRB Prisoner Research Representative

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In the scientific community, the pendulum of opinion concerning prisoner research has swung from conducting research without concern for harm, using prisoners as guinea pigs for a wide variety of studies, to conducting little research on prisoners due to potential for coercion, to conducting research on prisoners that is restricted to issues and circumstances that are encountered by the subjects because they are prisoners. During the same time the philosophy of corrections within the criminal justice community has evolved from one of retribution, deterrence and incapacitation—a focus on punishment and keeping offenders away from society—to one of rehabilitation, reintegration, and restorative justice—a focus on treating the offender and bringing him or her back into society. It is at the juxtaposition of these two shifts that we must discuss not simply whether it is permissible for researchers to conduct research on prisoner-subjects but whether it is, in fact, a moral obligation to do so.

Prisoners are a vulnerable population as defined by the Code of Federal Regulations (http://www.hhs.gov/ohrp/archive/irb/irb_chapter3.htm#e3 ). The Code stipulates that the following types of research can be conducted using prisoners as subjects:

  1. study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects . . . ;
  2. study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
  3. research on conditions particularly affecting prisoners as a class . . . ;
  4. research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. . . (http://www.hhs.gov/ohrp/policy/prisoner.html)

 

There is a long and unpleasant history of research with prisoners as subjects. Malaria experiments were conducted at correctional institutions during the 1940s. Research concerning hepatitis, dermatology, and the polio vaccine were conducted using prisoners during the 1950s. From the 1960s through the 1970s drug testing was conducted on inmates. This is just a brief example of the sorts of studies that inmates were subjected to—often without any sort of informed consent. (http://www.ahrp.org/history/chronology.php)

If for no other reason than this history of abuse of prisoners in research, it is necessary to have protections in place for modern studies involving prisoners. As a vulnerable population, prisoners are often limited in their participation in research to those studies that only concerns their circumstances as prisoners. Further, because of the extra effort that it takes to include prisoners in any study—submitting to a full IRB review of the potential study, inclusion of extra measures to insure subject protection, not to mention difficulty obtaining permission from correctional authorities to access the population in question—they are often excluded from consideration for research altogether.

While the extra safeguards required to conduct research utilizing a prison population has been seen as necessary to protect prisoners from the exploitation and degradation they often suffered at the hands of researchers when there were no safeguards; this has also served to limit the voice in research given to individuals who find themselves as prisoners and to view them as nothing more than their status as prisoners. While we certainly must research those conditions, circumstances, and interventions that prisoners are subjected to because of their status as inmates, we should also strive to include them in the wider body of research that acknowledges that while a person may in fact be a prisoner at a given moment in time, he or she is more than that status as inmate. Perhaps the current protections in prisoner have become too paternalistic and through that paternalism we are actually harming the population that we strive to protect. Rather than treating them as individuals—are we at times treating them as no more than their current social station—prisoner.

Aldridge (2012) argues that although there are a variety of challenges to research with vulnerable populations, those challenges can, at least in part, be resolved through participation and voice. So while involving prisoners only in research that pertains to their current status as individuals under the control of the criminal justice system may serve to protect them from abuse by the scientific community, it also limits their voice in scientific research and reduces them to nothing more than their set of circumstances—to less than individual human beings with a perspective worth hearing and a contribution to be made. This limits the study of individuals in prison to members only of that prison community and not as members of the many other communities that they may belong to—male or female; young or old; minority or non-minority; mother or father; survivor of trauma; and so forth.

In the field of criminal justice, there are six philosophies of corrections: retribution, deterrence, incapacitation, rehabilitation, reintegration, and restorative justice. The first three (retribution, deterrence and incapacitation) focus more on the punitive aspects of corrections. The latter three philosophies (rehabilitation, reintegration, and restorative justice) focus more on the positive aspects of corrections and would not only espouse allowing prisoners to participate in research but encouraging them to do so.

Rehabilitation has as its goal making the offender “better,” it views crime and criminality somewhat like a disease and rehabilitation is the cure. Under the philosophy of rehabilitation, the correctional system must do more than simply housing, feeding and attending to the medical needs of the prisoners. Prisoners are often subjected to a variety of different interventions (consisting of programs and therapies) to rehabilitate them. If we are going to subject prisoners to any intervention, then we are morally bound to discover if the interventions are producing the desired benefit. If we have not scientifically investigated these interventions then we are, in fact, blindly experimenting on those prisoners. Prisoner participation in research, therefore, is necessary in the philosophy of rehabilitation.

Reintegration sees crime as estranging the criminal from society and the reintegrative approach seeks to heal the estrangement and help the offender to become a fully participating member of society again. When we exclude prisoners from research because of their status as prisoners, we allow that estrangement to grow. A reintegrative approach would view the opportunity to participate in worthwhile research involving a full range of topics that touch the human condition (not limited to prison-related topics) as both necessary and desirable.

Restorative justice takes rehabilitation and reintegration a step further. Restorative justice sees criminal behavior as a break in the relationship among the criminal, society and the victim and has as its goal the repair of that relationship. If we seek to restore the prisoner to society, to repair that relationship, then prisoners must be encouraged to be fully participating members of the larger society. Each prisoner should be allowed to make an individual decision to participate in research or not—and not have the opportunities to engage in society curtailed by limiting options for research participation.

In conclusion, not only should we involve prisoner-subjects in our research but we must involve prisoner-subjects in our research. We should involve prisoner-subjects in research that investigates their circumstances as prisoners and those interventions that are designed to assist them within the criminal justice system. We must involve prisoner-subjects in research that explores the full range of circumstances of the human condition because treating prisoners as fully human involves full inclusion in research.

 

 

 

References

Aldridge, J. 2012. “Working with Vulnerable groups in social research: dilemmas by default and design.” Qualitative Research. 1-19.

OHRP Guidance on the Involvement of Prisoners in Research http://www.hhs.gov/ohrp/policy/prisoner.html (date accessed: January 16, 2015)

(http://www.ahrp.org/history/chronology.php)

Maintaining Neutrality and Objectivity: Outsourcing the IRB

dreamstime_xl_40028525Competitive organizations constantly seek ways to streamline costs and utilize resources effectively. For organizations involved in research, outsourcing the Institutional Review Board (IRB) to an external IRB can provide significant savings.

 

All IRBs must comply with Department of Health and Human Services and the Federal Drug Administration regulations in the review and approval of research. The federal regulations provide standards that define the structure and composition of the IRB and the policies and procedures to be followed.

 

The composition of the IRB requires a minimum of five members. The members must have the expertise and experience to conduct reviews and apply the federal regulations. The board should also have diversity of race, gender, culture and sensitivity. At least one member must be a non-scientist. Finally, if an IRB reviews research involving vulnerable categories of research, representatives knowledgeable with these populations should be included on the board.

 

Organizations with a limited number of studies to review face unique challenges. The composition of the IRB must be maintained as described above. Ongoing training of the board should be provided as part of best practice. The timeline of completion can also be a challenge. If an online system is not used, recordkeeping becomes more complicated with opportunities for errors and delays. Bringing together the board members for full reviews may not be easy if the reviewers have other obligations in the organization. Busy clinicians, educators, and evaluators may be unable to complete the reviews in a timely manner.

 

Outsourcing provides benefits for small and large organizations involved in research. A primary benefit is the removal of internal politics from the review. Another benefit is the elimination of unnecessary delays. Outsourcing can also assist with an accurate tracking and recordkeeping system of research studies reviews.

 

Solutions IRB, a private external IRB, uses a state-of-the-art online submission and tracking system. Solutions IRB completes exempt and expedited reviews within 24-48 hours of submission, and convened board reviews are completed within 72 hours of submission. Solutions IRB also provides a free pre-review for all studies to verify documentation is complete. Solutions IRB consists of highly experienced, well-trained reviewers who can provide an objective review of all studies submitted while complying with the required regulations, standards, policies and procedures.

 

If you would like more information on the benefits of outsourcing your IRB please contact us at info@solutionsirb.com.

 

Protecting Participant Data

Evaluators and researchers must take steps to protect data collected from participants/patients. Individually identifiable information may not always be collected, however, if it is, a plan for the protection of the data is needed. This is one way to demonstrate respect for our participants.

Evaluators and researchers often ask what does a plan for protecting the information include? Below are a few examples often used to protect data.

  • Assign study participant identification codes to instruments, questionnaires, surveys, etc. Keep a list of the identifiable information linking individuals to their codes in a separate location with restricted access. Only personnel with the appropriate training/education should have access to the data. This is usually the principle investigator/evaluator, coordinator, or research assistant.
  • An acceptable data security plan must provide that all electronic transmissions of PHI or PII over the internet (including by email), file transfers or other data transfer modalities, will be encrypted;
  • Remove cover or face sheets containing identifiers (e.g., names and addresses) from survey instruments containing data after receiving them from study participants;
  • At the end of the study or when you are no longer required to keep the data properly dispose, destroy, or delete study data / documents (simply deleting data from a computer or disk is not sufficient, additional steps must be taken to permanently remove it from the hard drive);
  • Securely store data documents within locked locations and/or assign security codes to computerized records;
  • If the data will be stored on a multi-user server the specific server name and IP address should be included with the protocol. Also, include who has access to the server and the security of the server;
  • No data containing PHI or PII may be stored in external organization storage, such as Google Docs, unless the organization has appropriate legal documentation approved in advance to do so.

What happens if despite all steps to protect the data, a breach occurs? Any loss of or breach of security relating to research data containing PHI or PII must be reported to the IRB as an Unanticipated Problem Involving Risks to Subjects or Others; and (2) also to the study Sponsor (if applicable).

Examples of security breaches include: (1) lost or stolen desktops, laptops, USB drives, CD/DVD/Zip drives, etc. with stored data; (2) a compromised account which is used to look up data (e.g., unauthorized user has had access to the account); (3) a compromised work station or server that contains data; and (4) accidental disclosure of data to unauthorized recipients (e.g., sending data to an incorrect email address).

Protection of study data must be followed at all stages of research, using the methods described above are examples of ways to guard against threats to both privacy and confidentiality. The information in this blog posting provides some examples, but each study is different. Solutions IRB is happy to consult with evaluators and researchers during the planning phase to develop an appropriate data protection plan.

 

Conducting research with children and FERPA

As the school year begins, research and evaluation including schools and children often increases. The following information is intended as a review of Family Education Rights and Privacy Act (FERPA) for researchers and evaluators working with this population. A future blog will address the Protection of Pupil Rights Amendment

FERPA protects the privacy of student records, regardless of the age of that student. When a student reaches age 18 or transfers from a secondary school to a post-secondary institution, the rights afforded to parents in elementary and secondary schools transfer to the student him or herself.

Under FERPA, parents or eligible students are afforded the following rights:
• Review student educational records for that school
• Request corrections to records they believe are inaccurate
• Request a formal hearing, in the event that records are not corrected or amended as requested
• Provide written permission for the release of any information from an education record

Schools are allowed to disclose records without parent or eligible student consent to the following parties or under the following circumstances (34 CFR § 99.31):
• School officials with legitimate educational interest;
• Other schools to which a student is transferring;
• Specified officials for audit or evaluation purposes;
• Appropriate parties in connection with financial aid to a student;
• Organizations conducting certain studies for or on behalf of the school;
• Accrediting organizations;
• To comply with a judicial order or lawfully issued subpoena;
• Appropriate officials in cases of health and safety emergencies; and
• State and local authorities, within a juvenile justice system, pursuant to specific State law.

Under FERPA, schools have the right to disclose directory information without parent or eligible student consent. Directory information is determined by the schools, and the school must tell parents and eligible students exactly what is included in that school’s directory information, allowing them time to review and make a decision about whether they will allow their directory information to be disclosed. Directory information may include information such as student name, address, phone number, date or year of birth, telephone number, dates of attendance, and honors or awards. Disclosing directory information for a student where it has been prohibited is a violation of FERPA. Schools are also required to provide annual notification about student rights under FERPA, and to annually allow parents and eligible students to withdraw their permission to have directory information shared.
Research that involves the use of school records must adhere to FERPA regulations, and must take care to ensure that all appropriate and explicit consents to use, review, or report information from student records beyond directory information has been obtained.

Family Educational Rights and Privacy Act (FERPA). (n.d.). U.S. Department of Education. Retrieved on 18 June 2013 from http://www.ed.gov/policy/gen/guid/fpco/ferpa/index.html

Informed Consent Quick Tip #2- Exculpatory Language

Preparation of the informed consent form can be a challenge for researchers and evaluators. Inclusion of exculpatory language is not permissible according to OHRP. What does this mean? According to 45 CFR 46.116 and 21 CFR 50.20 participants language  that provides a waiver or release or appearance of making the sponsor, researcher or others free from malpractice, negligence, blame fault or guilt. Frequently, the inclusion of exculpatory language is not intentional on the part of the evaluator. As practitioners, this type of language and release may be required. For this reason, adjusting the language may not be intuitive. OHRP has provided examples of language which can be used.

Examples of Acceptable Language

• Although future research that uses your samples may lead to the development of new products, there are no plans to provide financial compensation to you should this occur.

• I voluntarily and freely donate any and all blood, urine, and tissue samples to the [name of research institution] for the research described above.

• Although the results of research, including your donated materials, may be patentable or have commercial value, you will have no legal or financial interest in any commercial development resulting from the research.

• Tissue obtained from you in this research may be used to establish a cell line that could be patented and licensed. There are no plans to provide financial compensation to you should this occur.

• By consenting to participate, you authorize the use of your bodily fluids and tissue samples for the research described above.

• Because of hospital policy, the hospital is not able to offer financial compensation should you be injured as a result of participating in this research. However, you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research, including the hospital.

• Because of hospital policy, the hospital makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research. Medical services will be offered at the usual charge. However, you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research, including the hospital.[4]

• In the event that you suffer a research-related injury, your medical expenses will be your responsibility or that of your third-party payer, although you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research.[5]

The above examples are permissible under 45 CFR 46.116 and 21 CFR 50.20 because in each example, the waiver or release does not have the general effect of freeing or appearing to free an individual or an entity from malpractice, negligence, blame, fault, or guilt.

Reference: Guidance on Exculpatory Language in Informed Consent, http://www.hhs.gov/ohrp/newsroom/rfc/exculpatorydraft2011.html 

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